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Last update 07 Jul 2026

Dacarbazine

Last update 07 Jul 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

4-(3,3-dimethyl-1-triazeno)imidazole-5-carboxamide, 4-(5)-(3,3-dimethyl-1-triazeno)imidazole-5(4)-carboxamide, 4-(dimethyltriazeno)imidazole-5-carboxamide

+ [18]

Target

DNA

Action

inhibitors

Mechanism

DNA inhibitors(DNA inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [2]

Active Indication

SarcomaPheochromocytomaMalignant melanoma, metastatic+ [7]

Inactive Indication

Acquired Immunodeficiency SyndromeHigh Grade SarcomaLeiomyosarcoma+ [7]

Originator Organization

Southern Research Institute

National Cancer Institute

Active Organization

Accord Healthcare (Pty) Ltd. (South Africa)Sandoz AG

medac Gesellschaft für klinische Spezialpräparate mbH

+ [2]

Inactive Organization

Bayer HealthCare Pharmaceuticals, Inc.

National Cancer Institute

Novartis Pharmaceuticals Corp.

+ [5]

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (27 May 1975),

Hodgkin's LymphomaMelanoma

Regulation-

Structure/Sequence

Molecular FormulaC6H10N6O

InChIKeyFDKXTQMXEQVLRF-UHFFFAOYSA-N

CAS Registry4342-03-4

188

Clinical Trials associated with Dacarbazine

NCT07551583

/ Not yet recruitingPhase 2IIT

A Phase 2 Single Arm Study To Evaluate Safety And Preliminary Efficacy Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With Newly Diagnosed Early-Stage Non-Bulky Classical Hodgkin Lymphoma

The goal of this clinical research study is to learn if nivolumab plus AVD (doxorubicin, vinblastine, and dacarbazine) can help to control newly diagnosed early-stage non-bulky cHL in pediatric, adolescent, and young adult patients.
The safety of this drug combination will also be studied.

Start Date01 Oct 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

CTIS2026-525263-41-00

/ Not yet recruitingPhase 3IIT

Efficacy and Tolerability of N-AVD compared to BrECADD in patients with advanced Hodgkin Lymphoma (N-BRAVE)

Start Date31 Jul 2026

Sponsor / Collaborator-

NCT07275216

/ RecruitingPhase 2IIT

Phase 2 Study of Pembrolizumab With Chemotherapy in Frail Patients With Newly Diagnosed Classical Hodgkin Lymphoma

This phase II trial tests how well pembrolizumab in addition to chemotherapy (gemcitabine, brentuximab vedotin, and dacarbazine) works in treating frail patients with newly diagnosed Hodgkin lymphoma who aren't candidates for standard anthracycline-based treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Dacarbazine is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells and slow down or stop cancer growth. Pembrolizumab in combination chemotherapy may be a safe and effective alternative treatment option for frail patients with Hodgkin lymphoma who can't receive standard anthracycline-based treatment.

Start Date01 Jul 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Dacarbazine

100 Translational Medicine associated with Dacarbazine

100 Patents (Medical) associated with Dacarbazine

4,095

Literatures (Medical) associated with Dacarbazine

01 Dec 2026·CURRENT TREATMENT OPTIONS IN ONCOLOGY

Systemic Therapy for Solitary Fibrous Tumor

Review

Author: Stergiopoulos, Georgios M ; Tinoco, Gabriel ; Robinson, Steven I

OPINION STATEMENT:

Solitary fibrous tumor (SFT) is an exceedingly rare mesenchymal neoplasm classified as a soft tissue sarcoma (STS). While historically considered indolent, up to 50% of cases can recur or metastasize after long-term follow-up. Complete surgical resection constitutes the cornerstone of treatment for localized disease, while the management of locally advanced or metastatic SFT poses a significant clinical challenge underscoring the need for effective systemic therapies. Antiangiogenic agents have shown promising outcomes, particularly in non-dedifferentiated SFT, and are increasingly favored by some as first-line options. Regarding chemotherapy, traditional anthracycline-based STS regimens have demonstrated limited efficacy, shifting the current focus towards combinations with alkylating agents, such as dacarbazine, and other agents such as microtubule inhibitors, like trabectedin. This review summarizes current systemic therapeutic strategies for SFT, highlighting the central role of antiangiogenic therapy as the standard backbone for managing advanced disease. It also discusses current data on chemotherapy, as well as molecularly targeted and immunomodulatory approaches, which are emerging options that require further validation. In addition, we discuss evolving concepts in systemic treatment sequencing, predictive biomarkers, advanced therapeutic combinations under clinical evaluation, and potential future therapeutic agents and targets.

01 Aug 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Simultaneous analysis of various anticancer drugs by supercritical fluid chromatography-mass spectrometry. Part II: Method validation and comparison with liquid chromatography

Article

Author: Fleury-Souverain, Sandrine ; Rudaz, Serge ; Guillarme, Davy ; Bonnabry, Pascal ; Vallet, Virginie ; Nguyen, Nathalie

A complete SFC-MS/MS method validation enabling the simultaneous trace-level analysis of 27 conventional anticancer drugs (CADs) was performed. The selected drugs were the following: 5-fluorouracil, azacitidine, busulfan, carboplatin, cisplatin, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, docetaxel, doxorubicin, epirubicin, etoposide, gemcitabine, idarubicin, ifosfamide, irinotecan, methotrexate, mitomycin, oxaliplatin, paclitaxel, pemetrexed, raltitrexed, topotecan, treosulfan, vinblastine and vincristine. Accuracy profiles were obtained for all CADs. Trueness ranged between 71.0% and 119.8%, while repeatability (1.3-17.5%) and intermediate precision (2.0-24.9%) were determined for all compounds, with limits of quantification comprised between 0.1 and 25 ng.mL^-1. These results were systematically compared with those obtained during the validation of a reference UHPLC-MS/MS method routinely used to analyze 25 of the 27 CADs contained in samples collected from work surfaces in a hospital pharmacy chemotherapy compounding unit. SFC-MS/MS method offered greater accuracy but was hampered by lower precision than the UHPLC-MS/MS method for most of the compounds. Furthermore, although the developed SFC-MS/MS method was characterized by a lower sensitivity, it allowed the quantification of compounds that were difficult to analyze by UHPLC-MS/MS, such as azacitidine and cisplatin, with analytical performance comparable to that obtained for the other CADs analyzed. This feature highlights the complementarity of the two chromatographic approaches in the context of CAD determination in a hospital environment.

01 Jun 2026·NEURAL NETWORKS

The answer lies within: Detecting Trojans from DNNs’ inherent characteristics

Article

Author: Shen, Huawei ; Cao, Qi ; Liu, Xuchao ; Su, Du ; Zhang, Kaike

Deep neural networks (DNNs) are vulnerable to Trojan attacks, where adversaries implant Trojans that cause DNNs to misbehave when encountering specific triggers. Detecting Trojans in DNNs is crucial to mitigate potential safety risks. Traditional methods typically employ trigger reversion techniques, which utilize benign samples to reconstruct potential triggers through iterative optimization. However, their practical applicability is limited by reliance on benign samples and the exceedingly time-intensive optimization. In this paper, we investigate a more general yet challenging setting, the benign sample-free scenario, where detection relies solely on DNN itself. We propose a novel approach for detecting Trojans from DNNs' inherent characteristics (DTIC), which exploits the distinguishable features of Trojaned models. DTIC depicts the characteristics of various DNNs via a unified representation space derived from both views of model structures and parameters, enabling adaptability across diverse DNNs. It requires just one direct inference to assess the presence of Trojans, ensuring high efficiency. We further enhance the performance of Trojan detection, using augmentations based on random perturbations and the lottery hypothesis. Extensive experiments conducted on IARPA TrajAI¹, a widely adopted benchmark, demonstrate the superior effectiveness, efficiency, and generalizability of DTIC.

166

News (Medical) associated with Dacarbazine

24 Jun 2026

·www.globenewswire.com

The Quest to Repair What Multiple Sclerosis Takes Away

AUSTIN, Texas, June 24, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Multiple sclerosis (“MS”) gradually strips people of command over their own bodies, advancing steadily with no available cure. More than 2.9 million people across the globe are currently living with the disease. But even with generations of scientific study and research, every approved treatment still falls short of one essential objective: bringing the disease to a complete stop. Existing therapies can slow its advance, but none can halt it outright. That shortfall translates into a future of mounting disability for millions of MS sufferers. Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (profile) is determined working to change that outcome. The company is developing Lucid-MS, a patented, first-in-class drug candidate that approaches the disease from an entirely different angle by directly targeting the myelin sheath that MS destroys; the potential treatment is now preparing to move into phase 2 clinical trials. Quantum BioPharma stands among a group of companies pursuing therapies for neurological, autoimmune and immune-mediated conditions, a group that also includes Novartis AG (NYSE: NVS), Merck & Co. Inc. (NYSE: MRK), TG Therapeutics Inc. (NASDAQ: TGTX) and Bristol Myers Squibb Company (NYSE: BMY). Multiple sclerosis is especially destructive because of its tendency to worsen progressively.Instead of working through the immune system, Quantum BioPharma’s Lucid-MS acts directly on the myelin sheath.The scientific case behind Lucid-MS rests on years of disciplined research.Quantum BioPharma has finished dosing in both 180-day, repeated-dose oral toxicity and toxicokinetic studies for Lucid-21-302. Click here to view the custom infographic of the Quantum BioPharma editorial. A Disease That Erodes Movement, Independence Multiple sclerosis is a long-term inflammatory condition affecting the central nervous system. In MS, the immune system mistakenly attacks the brain and spinal cord, damaging myelin, the protective coating around nerve fibers that allows electrical impulses to travel efficiently. As myelin breaks down, these signals slow, falter or fail altogether, resulting in a mix of symptoms that can include tingling, vision disturbances, mobility difficulties, cognitive decline and, over time, a progressive erosion of physical control. MS does not spare any age group. The worldwide average age at diagnosis is 32, with an estimated 1.5% of all those with MS diagnosed before turning 18. Women receive an MS diagnosis at twice the rate of men. Within the United States alone, close to one million people are currently living with the disease in the United States, a number that more than doubled over earlier figures once researchers applied more rigorous, contemporary counting methods. Unfortunately, the trend continues upward, with prevalence climbing in every region of the world since 2013. In addition, MS is especially destructive because of its tendency to worsen progressively. Many patients initially experience a relapsing-remitting pattern, in which symptoms flare and then partially subside. Over time, however, a substantial share of patients shift into secondary progressive MS, a phase marked by steadily accumulating disability. According to the National MS Society, many people with MS end up juggling several medications at once, with each med addressing a separate symptom or relapse episode, yet none capable of confronting the underlying nerve damage that continues to erode their quality of life. The disease also imposes a substantial financial toll. The worldwide market for MS therapeutics was valued at roughly $27.4 billion in 2024 and is projected to climb to $38.62 billion by 2030, a trajectory driven not by curative treatments but by the sheer volume of patients requiring care across their lifetimes. That market dynamic highlights just how large the unmet need truly is. Patients require more than ongoing management; they need a therapy capable of interrupting the disease process itself. That is exactly the objective Quantum BioPharma has set out to achieve. The company is advancing Lucid-MS, a patented, first-in-class drug candidate unlike any therapy currently on the market, one engineered to act on the myelin sheath directly with the aim of preventing and protecting its breakdown. Acting Directly on the Myelin Sheath The majority of approved MS treatments function by modulating the immune system. They subdue or redirect the immune response responsible for attacking myelin, an approach that can lower relapse frequency and slow the buildup of disability. These therapies have delivered genuine clinical progress. Yet none of them directly address the myelin tissue itself or work to rebuild what has already been lost. For patients in the progressive stages of MS, immune modulation alone frequently proves inadequate. Lucid-MS charts an entirely separate course. Known technically as Lucid-21-302, the candidate is a patented New Chemical Entity, classified as a first-in-class, nonimmunomodulatory, neuroprotective compound. Instead of working through the immune system, Lucid-MS acts directly on the myelin sheath. In preclinical models, it has demonstrated the ability to protect myelin from degradation, a key pathological process underlying multiple sclerosis. No currently approved treatment offers a comparable mechanism of action. A defining feature of Lucid-MS is that it does not impact immune function. That quality separates it from most existing MS therapies and may translate into a meaningful safety benefit. It also frames Lucid-MS not as a substitute for immune-modulating drugs but as a potential complement to them, or should future trial results support its early promise, as a foundational therapy in its own right. The drug is also being advanced in an oral form, which would offer patients greater convenience than the injectable or infusion-based treatments many currently rely on. Quantum BioPharma controls exclusive global rights to Lucid-MS through its wholly owned subsidiary, Lucid Psycheceuticals Inc. The program is guided by a top-tier scientific team that includes advisor Dr. Lakshmi P. Kotra, recipient of the Julia Levy Award, a senior scientist at the University Health Network and a professor of medicinal chemistry at the University of Toronto. The scientific team also includes Dr. Andrzej Chruscinski, vice president of Scientific and Clinical Affairs, whose career spans Stanford-trained internal medicine alongside cardiology and neurological research. This group is working toward something no approved drug has yet accomplished: an MS therapy that directly safeguards myelin. From Laboratory Findings to Human Studies The scientific case behind Lucid-MS rests on years of disciplined research. The compound has undergone study for upward of a decade, with findings published in some of medicine's most respected journals, including the “Journal of Medicinal Chemistry” and the “Proceedings of the National Academy of Sciences.” These peer-reviewed papers track the compound's indicated capacity to prevent demyelination in preclinical settings. The animal-model results are notable. Across experiments carried out in multiple laboratories over the course of several years, Lucid-MS sped up functional recovery in mouse models of MS, preserved myelin integrity and reduced regional degradation. Documented results report that, following treatment, mice regain the capability to walk. This outcome did not stem from isolated experiments but from an extensive body of studies. The results proved compelling enough to justify advancing the compound into human trials. Quantum BioPharma presented its phase 1 clinical trial application for Lucid-MS to evaluate first-in-human safety and tolerability in 2023. The trial encompassed both Single Ascending Dose (“SAD”) and Multiple Ascending Dose (“MAD”) phases, which were administered among healthy volunteers. Results from the clinical study report identified no safety or tolerability concerns associated with daily dosing. Dosing in phase 1 among healthy human volunteers was successfully completed, with Lucid-MS characterized as exhibiting a favorable safety profile and good tolerability. Should upcoming phase 2 trials in MS patients confirm what the preclinical work suggested — that Lucid-MS can stop and prevent myelin degradation — it would represent an unprecedented milestone. No therapy currently approved for MS has shown the ability to help patients regain physical function previously lost to myelin damage. While human trials remain necessary to determine whether the preclinical results carry over to patients, a decade's worth of accumulated data provides a scientifically credible basis for that optimism. Submitting the IND, Preparing for Phase 2 Late last year, the company finished dosing in both 180-day, repeated-dose oral toxicity and toxicokinetic studies for Lucid-21-302. These studies represent essential elements of the Investigational New Drug (“IND”) application that the U.S. Food and Drug Administration (“FDA”) requires before authorizing a phase 2 trial. Completing these extended safety studies marked a meaningful advance toward formal regulatory submission. The company additionally entered into agreements with a leading contract development and manufacturing organization to develop and produce an oral formulation of Lucid-MS, a critical step in preparing the drug for clinical use. Following that, in April this year, Quantum BioPharma officially filed its IND application with the FDA for Lucid-MS, aiming for a phase 2 trial designed to assess the therapy's efficacy, safety and tolerability among people living with MS. To carry out a phase 2 trial, Quantum BioPharma announced a binding letter of intent with Allucent, a global contract research organization with extensive experience running central nervous system trials. Quantum BioPharma also named a principal investigator for the upcoming trial, marking further progress in the clinical development program. These steps are indicative of an organization that has advanced methodically from encouraging preclinical results to taking the steps towards producing the human clinical data the MS community is waiting for. A Pioneering Partnership Sheds Light on the Path Forward Quantum BioPharma is concurrently working with a tool that could prove vital to assessing Lucid-MS's effectiveness: an advanced imaging technique capable of directly visualizing myelin within the living human brain. Quantum BioPharma recently launched a joint clinical study with researchers at Massachusetts General Hospital (“MGH”) to validate a novel positron emission tomography imaging method for tracking myelin integrity and demyelination in MS. The study centers on a PET tracer known as [18F]3F4AP, developed by Dr. Pedro Brugarolas, who is an investigator in the Department of Radiology at MGH and an assistant professor at Harvard Medical School. Dr. Eric Klawiter, director of the Multiple Sclerosis and Neuromyelitis Optica Unit at MGH and an associate professor of neurology at Harvard Medical School, is co-investigator on the project. In June of last year, the first patient with MS was scanned successfully, which marked the formal start of active patient enrollment. The MGH research team also published encouraging results in the “European Journal of Nuclear Medicine and Molecular Imaging,” in a study funded by the National Institutes of Health. The tracer exhibited strong properties for brain imaging and, notably, was able to distinguish differences among lesions that conventional MRI could not detect. Last month, the study reached the midpoint of patient enrollment, with preliminary imaging results showing encouraging signal strength in acute MS lesions. The importance of this imaging work to Lucid-MS's development is difficult to overstate. One of the central challenges in developing any remyelinating therapy is confirming whether it is genuinely working, and conventional MRI cannot provide a direct, quantitative measure of myelin. Assuming it is validated, the [18F]3F4AP tracer could supply precisely that: a real-time biological window into how effectively a drug is protecting or restoring the myelin sheath. Chruscinski has noted that this tool has the potential to fundamentally reshape how demyelination is assessed, offering a direct view into axonal health and enabling clearer demonstration of how therapies such as Lucid-MS perform. This collaboration among the University Health Network, Massachusetts General Hospital and researchers affiliated with Harvard Medical School brings together world-class scientific expertise around a common purpose. Quantum BioPharma is laser focused on that objective. With the global MS therapeutics market projected to surpass $38 billion by 2030, the commercial stakes involved are substantial. Yet for the nearly three million people living with MS worldwide, what matters most is whether a therapy can finally achieve what none has accomplished before: Halting the disease, repairing the damage it causes and restoring the bodily control that MS has taken away. Should Lucid-MS fulfill its preclinical promise in human trials, it would represent more than a new drug; it would mark a genuine turning point. Advancing Treatment Options Across Sectors Recent developments across the biopharmaceutical industry highlight continued momentum in the development of therapies for autoimmune, immune-mediated and chronic inflammatory diseases. Companies are reporting encouraging clinical results, expanding development programs and achieving important regulatory milestones as they work to address conditions that can significantly impact quality of life and often remain difficult to treat. Novartis AG (NYSE: NVS) presented data from the RemIND trial at the European Academy of Allergy and Clinical Immunology (EAACI) Congress. The data showed that Rhapsido(R) (remibrutinib) met its primary endpoints across the three most common chronic inducible urticaria (CIndU) subtypes, becoming the first-ever treatment to demonstrate efficacy in a global Phase III CIndU clinical trial. In the RemIND trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. These results demonstrate that Rhapsido may provide sustained relief for patients whose disease remains inadequately controlled after treatment with second-generation H1-antihistamines. Merck & Co. Inc. (NYSE: MRK) announced positive topline results from the phase 3 ATLAS-UC induction-only study (study 2). The study evaluated tulisokibart (“MK-7240”), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderately to severely active UC. The study successfully met its primary endpoint of clinical remission according to the Modified Mayo Score at week 12, as well as key secondary endpoints. In addition, consistent with previously reported phase 2 studies, no safety concerns were identified. TG Therapeutics Inc. (NASDAQ: TGTX) reported positive topline phase 1 data for subcutaneous BRIUMVI in patients with myasthenia gravis. The company also announced the initiation of a phase 2 clinical trial evaluating BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG. The company noted that the encouraging results support continued development of BRIUMVI in MG and also mark an important milestone in expanding the potential utility of BRIUMVI beyond multiple sclerosis. Bristol Myers Squibb Company (NYSE: BMY) announced that the European Commission has approved Opdivo(R) (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine for the treatment of adult and adolescent patients 12 years of age and older with previously untreated stage 3 or 4 classical Hodgkin lymphoma. This approval marks a significant milestone, establishing the Opdivo plus AVD combination as the first immunotherapy-based regimen available in the European Union for newly diagnosed advanced cHL. As scientific understanding of immune system dysfunction continues to evolve, researchers are uncovering new therapeutic targets and refining treatment strategies across a broad range of diseases. These efforts reflect a growing focus on delivering therapies that offer greater efficacy, convenience and durability while helping address substantial unmet medical needs. For more information, visit Quantum BioPharma Ltd. About BioMedWire BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness. BMW is where breaking news, insightful content and actionable information converge. To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only) For more information, please visit https://www.BioMedWire.com DISCLAIMER: BioMedWire (BMW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by BMW are solely those of BMW. Readers of this Article and content agree that they cannot and will not seek to hold liable BMW for any investment decisions by their readers or subscribers. BMW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security. 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BMW HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and BMW undertakes no obligation to update such statements. Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/Disclaimer BioMedWireAustin, Texaswww.BioMedWire.com512.354.7000 OfficeEditor@BioMedWire.com BioMedWire is powered by IBN

Clinical ResultPhase 2Phase 1

01 Jun 2026

·www.biospace.com

Bristol Myers Squibb Announces Opdivo® (nivolumab) in Combination with AVD Receives Expanded EU Label with Approval in Frontline Advanced Classical Hodgkin Lymphoma

First-ever immunotherapy combination approved in Europe for adult and adolescent patients, ages 12 and older, with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL) PRINCETON, N.J.--(BUSINESS WIRE)-- $BMY #HodgkinLymphoma -- Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo ® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adult and adolescent patients 12 years of age and older with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL). This approval marks a significant milestone, establishing the Opdivo plus AVD combination as the first immunotherapy-based regimen available in the European Union (EU) for newly diagnosed advanced cHL. 1 This new EC approval reinforces the expanding impact of Opdivo in cHL, building upon the U.S. Food and Drug Administration (FDA) approval of Opdivo in combination with AVD for previously untreated Stage III or IV cHL in adults and pediatric patients 12 years and older, granted in March 2026. 2 Earlier this year, the EC also approved Opdivo in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents, and adults up to 30 years of age with relapsed or refractory cHL after one prior line of therapy. 1 “Today’s approval of Opdivo in combination with AVD for previously untreated advanced classical Hodgkin Lymphoma marks an important advancement for patients in the European Union, 1 ” said Monica Shaw, MD, senior vice president of Oncology Commercialization, Bristol Myers Squibb. “For decades, patients newly diagnosed with this aggressive blood cancer have faced intensive treatment approaches. 3,4 This approval underscores the benefit and critical role of immunotherapy-based approaches in hematologic cancers like cHL and reflects our continued commitment to bringing these innovative options to patients earlier in their treatment journey across cancer types.” The EC approval is based on data from the Phase 3 SWOG 1826 (Study CA2098UT) which demonstrated a 58% reduction in the risk of disease progression or death with Opdivo in combination with AVD versus brentuximab vedotin plus AVD, as determined per investigator (Hazard Ratio [HR] 0.42; 95% Confidence Interval [CI] 0.27-0.67; P =<0.0001).The trial demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS), based on a median follow-up of 13.7 months in the intent to treat population. After a median follow-up of 36.7 months, the median overall survival (OS) had not been reached in either treatment arm with a total of 26 deaths: 9 (1.8%) deaths in the Opdivo in combination with AVD arm and 17 (3.4%) deaths in the standard of care over brentuximab vedotin plus AVD arm. 5 “For patients with newly diagnosed Stage III or IV classical Hodgkin Lymphoma, finding an effective and tolerable first-line treatment remains crucial to achieving long-term remission, especially for adolescents and the elderly,” said Franck Morschhauser, MD, PhD, Professor of Hematology at the University of Lille and Hospital Claude Huriez. “The SWOG 1826 study provided compelling data demonstrating that nivolumab-based combination therapy significantly improved progression-free survival compared with the standard of care. The availability of the first-ever IO combination in this earlier setting and across a broad spectrum of ages offers a potentially practice-changing approach to the treatment of frontline cHL.” This approval by the EC for Opdivo plus AVD for the treatment of adult and adolescent patients 12 years of age and older with previously untreated Stage III or IV cHL is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein and Norway. In addition to this approval in cHL, Opdivo- based options are also approved for treatment of multiple tumor types in the EU. Bristol Myers Squibb thanks the SWOG Cancer Research Network and its investigators for leading the Phase 3 SWOG 1826 (CA2098UT) trial and the patients for their important contributions to this study. About SWOG 1826 (CA2098UT) SWOG 1826, also known as CA2098UT, is a randomized, multicenter, Phase 3 study evaluating Opdivo ® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL). 3 The study is designed to assess progression-free survival as the primary endpoint, with key secondary endpoints that include overall survival and other measures of efficacy and safety. 3 The SWOG 1826 study is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) under a Cooperative Research and Development Agreement with Bristol Myers Squibb and conducted in the NCI National Clinical Trials Network (NCTN) led by the SWOG Cancer Research Network in collaboration with the Children’s Oncology Group (COG). 3 It is the largest cHL study conducted in the NCTN. 3 Bristol Myers Squibb co-sponsored the study and supplied Opdivo to the NCI through a Cooperative Research and Development Agreement. 3 Select Safety Pro SWOG 1826 (CA2098UT) Serious adverse reactions occurred in 39% of patients receiving Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) (n=490). The most frequent serious adverse reactions reported in ≥5% patients who received Opdivo in combination with AVD were neutropenia (7%), pyrexia (7%), febrile neutropenia (6%), and nausea (6%). Fatal adverse reactions occurred in 3 patients (0.6%), all from sepsis. The most common adverse reactions were nausea (70%), neutropenia (61%), fatigue (59%), anemia (51%), constipation (49%), leukopenia (44%), musculoskeletal pain (42%), transaminases increase (41%), peripheral neuropathy (41%), vomiting (33%), and stomatitis (30%). About Classical Hodgkin Lymphoma Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. 6 HL is the most common cancer diagnosed in adolescents (ages 15-19). 7 It is most often diagnosed in early adulthood (ages 20-39) and late adulthood (older than 55 years of age). 8 Classical Hodgkin lymphoma is the most common type of HL, accounting for 95% of cases. 9 Despite progress in frontline therapy, advanced-stage HL still carries a substantial risk of relapse, highlighting the need for innovative approaches that deliver durable remission for patients. 8 About Opdivo Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union. INDICATIONS OPDIVO ® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. OPDIVO ® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. OPDIVO ® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). OPDIVO ® (nivolumab) in combination with platinum-doublet chemotherapy, is indicated for neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO ® as adjuvant treatment after surgery. OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). OPDIVO ® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. OPDIVO ® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. OPDIVO ® (nivolumab), in combination with cisplatin and gemcitabine, is indicated as first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. OPDIVO ® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO ® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). OPDIVO ® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1). IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis. In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12). Immune-Mediated Colitis OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%). Immune-Mediated Hepatitis and Hepatotoxicity OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%). OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. Immune-Mediated Endocrinopathies OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456) of patients, including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%). In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456) of patients, including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%). In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.7% (22/666) of patients, including Grade 3 (4.5%) and Grade 2 (2.2%). In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%) and Grade 2 (4.5%). In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypothyroidism occurred in 20% (91/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypothyroidism occurred in 18% (122/666) of patients, including Grade 3 (0.6%) and Grade 2 (11%). In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, diabetes occurred in 2. Contacts Bristol Myers Squibb M edia Inquiries: media@bms.com Investors: investor.relations@bms.com Read full story here

ImmunotherapyClinical ResultPhase 3Drug ApprovalAccelerated Approval

20 Apr 2026

·allsci.com

Immunocore’s tebentafusp doubles five-year survival in metastatic uveal melanoma Phase III trial

Immunocore Holdings (Nasdaq: IMCR) reported five-year overall survival data from the Phase III CT029 trial at AACR 2026, showing that tebentafusp (Kimmtrak) doubled the likelihood of survival at five years compared to investigator’s choice in previously untreated HLA-A*02:01-positive patients with metastatic uveal melanoma — the longest prospective OS follow-up reported in a randomized trial in this disease and, according to the company, for any T cell engager studied in a solid tumor. The CT029 trial is a randomized Phase III study enrolling previously untreated HLA-A*02:01-positive patients with unresectable or metastatic uveal melanoma, comparing tebentafusp against investigator’s choice of pembrolizumab, ipilimumab, or dacarbazine in the first-line setting. The five-year readout extends a survival trajectory that was already visible at the three-year analysis published in the New England Journal of Medicine in 2023 and represents the longest prospective OS follow-up reported in a randomized trial in this disease. Survival benefit was observed across high-risk subgroups, including patients with high tumor burden and elevated lactate dehydrogenase, and in some patients whose best radiographic response was progressive disease, reinforcing prior observations that imaging responses may not fully capture tebentafusp activity. Exploratory analyses suggest that continued treatment beyond progression and early ctDNA reductions may be associated with improved outcomes, though these findings remain hypothesis-generating. Tebentafusp is a T cell–redirecting therapy targeting gp100 and remains the only systemic therapy to demonstrate an overall survival benefit in metastatic uveal melanoma. Its use is limited to HLA-A*02:01-positive patients, representing roughly half of the population. Further OS maturation and additional analyses from CT029 are ongoing. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

100 Deals associated with Dacarbazine

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KEGG	Wiki	ATC	Drug Bank
D00288	Dacarbazine	L01AX04	DB00851

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Sarcoma	Australia	Accord Healthcare (Pty) Ltd. (South Africa)	18 Jun 2026
Pheochromocytoma	Japan	Sandoz AG	25 Mar 2013
Malignant melanoma, metastatic	Brazil	Libbs Farmacêutica Ltda.	27 Nov 2006
Metastatic melanoma	Austria	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Belgium	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Denmark	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Germany	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Ireland	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Italy	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Netherlands	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Portugal	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	Sweden	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Metastatic melanoma	United Kingdom	medac Gesellschaft für klinische Spezialpräparate mbH	08 Oct 1997
Lymphoma	China	Nanjing Pharmaceutical Factory	01 Jan 1985
Soft Tissue Neoplasms	China	Nanjing Pharmaceutical Factory	01 Jan 1985
Hodgkin's Lymphoma	United States	Bayer HealthCare Pharmaceuticals, Inc.	27 May 1975
Melanoma	United States	Bayer HealthCare Pharmaceuticals, Inc.	27 May 1975

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Melanoma recurrent	Phase 3	-	National Cancer Institute	01 Apr 2002
Melanoma, Cutaneous Malignant	Phase 3	United States	-	01 Aug 2000
Melanoma, Cutaneous Malignant	Phase 3	Australia	-	01 Aug 2000
Non-Hodgkin Lymphoma	Phase 2	United States	-	13 Oct 2017
Relapsing classical Hodgkin lymphoma	Phase 2	United States	-	13 Oct 2017
Uveal Melanoma	Phase 2	United States	National Cancer Institute	31 Jul 2013
Uveal Melanoma	Phase 2	Canada	National Cancer Institute	31 Jul 2013
Acquired Immunodeficiency Syndrome	Phase 2	United States	National Cancer Institute	08 Mar 2013
Acquired Immunodeficiency Syndrome	Phase 2	France	National Cancer Institute	08 Mar 2013
Classical Hodgkin's Lymphoma	Phase 2	United States	National Cancer Institute	08 Mar 2013

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2026	Not Applicable	Uveal Melanoma First line	31	Pembrolizumab	cndsihqttp(qhgsmqikcg) = weppgdqvml ucmgfspxzi (mipqlutybe ) View more	Negative	29 May 2026
				Dacarbazine (Second line)	wlxwjhjqrd(rvdqgdnzee) = smmzkreycn bozocfcgoi (omywyvrzav )
ChiCTR2400084334 (DART-PCS, ASCO2026)	Phase 2	-	20	ToripalimabDacarbazine (DTIC)l doxorubicin (PLD) + ToripalimabDacarbazine (DTIC) + ToripalimabDacarbazine (DTIC)	mffrdrmxpx(lvflrrnknm) = pvxvkalhoa vkznpojzjr (ommojsjypy ) View more	Positive	29 May 2026
EHA2026	Not Applicable	Classical Hodgkin's Lymphoma First line	95	ABVD (Early-stage (I-II))	vipyyivncv(fyztqyylav) = tqynuyfgwk bthtzaxypp (mgvzwtoier ) View more	Positive	12 May 2026
				ABVD (Advanced-stage (III-IV))	vipyyivncv(fyztqyylav) = rteixgcoet bthtzaxypp (mgvzwtoier ) View more
ESMO_SRC2026	Not Applicable	Leiomyosarcoma First line	146	Doxorubicin plus dacarbazine	mbwklbvvyi(pcuxzmrhbi) = gamezsxujn lcyxizpcbe (hndiugxcfe ) View more	Positive	09 Mar 2026
				Doxorubicin plus ifosfamide	mbwklbvvyi(pcuxzmrhbi) = tjtnbxfsbo lcyxizpcbe (hndiugxcfe ) View more
ESMO_SRC2026	Not Applicable	Leiomyosarcoma	336	Gemcitabine combined with docetaxel	gsgnicaijb(hgkgwrbasu) = iieigduutm tqiiezyenn (fqllxslinw ) View more	Positive	09 Mar 2026
ASH2025	Not Applicable	Classical Hodgkin's Lymphoma	144	Brentuximab vedotin+doxorubicin+vinblastine+dacarbazine	awzassiegm(zajuzhszum) = ppzwocixdm rupyttnmuv (xozrusobme ) View more	Positive	06 Dec 2025
				doxorubicin+bleomycin+vinblastine+dacarbazine	awzassiegm(zajuzhszum) = edusirksqy rupyttnmuv (xozrusobme ) View more
NCT05922904 (ASH2025)	Phase 2	Classical Hodgkin's Lymphoma	25	Brentuximab vedotin + pembrolizumab + doxorubicin + dacarbazine	yazqnukrsp(ulhmpwhykb) = 15/25, 60% swcpewkxsc (vjljsjnzfg ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Classical Hodgkin's Lymphoma First line	311	Nivolumab + doxorubicin + vinblastine + dacarbazine (NAVD)	wrkgmpntzg(fqifhklqvi) = pzskqjgltx zbdgvywonq (yazmdlgoyq ) View more	Positive	06 Dec 2025
				Nivolumab+doxorubicin+vinblastine+dacarbazine (Rutherford et al)	wrkgmpntzg(fqifhklqvi) = ctvuvufnon zbdgvywonq (yazmdlgoyq ) View more
NCT02661503 (HD21, Pubmed \| J Clin Oncol)	Phase 2	Classical Hodgkin's Lymphoma First line	83	Brentuximab vedotin + Etoposide + Cyclophosphamide + Doxorubicin + Dacarbazine + Dexamethasone (BrECADD) (PET2-negative)	pkryixgzsu(ehdljebokz) = nlczmpicof qbtevefeiu (caxogtyyma, 84 - 98) View more	Positive	20 Sep 2025
NCT03517137 (COBRA \| EORTC-1537-COBRA, CTgov)	Phase 2	Hodgkin's Lymphoma \| Relapsing classical Hodgkin lymphoma	150	Radiation Therapy+Dacarbazine+Etoposide+Cyclophosphamide+Adriamycin+Vinblastine+Brentuximab Vedotin	pejlwgvuda(wbookzllva) = rruwgpfapy vjbegsrxwi (yysahxntvj, kbigpojlkt - rzqonlzxof) View more	-	11 Aug 2025

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