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Last update 24 Mar 2025

Nivolumab

Last update 24 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Nivolumab (Genetical Recombination), Nivolumab (genetical recombination) (JAN), Nivolumab (USAN/INN)

+ [14]

Target

PD-1

Action

inhibitors

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [13]

Active Indication

Malignant neoplasm of gastro-oesophageal junctionAdvanced Hepatocellular CarcinomaUnresectable Hepatocellular Carcinoma+ [493]

Inactive Indication

Acidemia, IsovalericAcquired Immunodeficiency SyndromeAcute lymphoblastic leukemia recurrent+ [105]

Originator Organization

Ono Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

Active Organization

National Cancer Institute

Bristol Myers Squibb Co.Bristol-Myers Squibb Pharma EEIG

+ [26]

Inactive Organization

Nektar Therapeutics

Transgene SA

Navire Pharma, Inc.Startup

+ [11]

Drug Highest PhaseApproved

First Approval Date

Japan (04 Jul 2014),

Esophageal CarcinomaMelanoma

RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (Australia), Priority Review (United States), Breakthrough Therapy (United States), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 93681H

Source: *****

Sequence Code 93684L

Source: *****

1,849

Clinical Trials associated with Nivolumab

NCT05835804

/ Not yet recruitingPhase 2IIT

Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers

Patients with locally recurrent squamous-cell carcinoma of the head and neck (SCCHN) after Chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic options.
Intratumoral chemotherapy (ITC) with cisplatin and epinephrine in order to increase the local cisplatin retention lead to a 50 % response rate in several studies but was given up due to the poor local tolerance with frequent necrosis of the peritumoral tissues. Gemcitabine, carboplatin and paclitaxel (GCP) are used in advanced SCCHN. These chemotherapies seem to be interesting options for intratumoral infusion: their different effect could lead to avoid chemotherapy resistance with a good tolerance profile, without tissue necrosis profile. The other major option for recurrent SCCHN is immunotherapy by Nivolumab, an anti PD-1 with a 13% mediane response rate. Nevertheless, the failure of this treatment stay unclear, but immunosuppressive action of the tumour is suspected. The presence of tumoral antigen could lead to better response to immunotherapy; association of chemotherapy and immunotherapy seems a promosing association to avoid treatment resistance as cytotoxic release tumoral antigen; it could also be associated to an abscopal effect.
The aim of the study is to evaluate the efficacy of ITC using GCP in LOCAL recurrent SCCHN treated by nivolumab.

Start Date01 Nov 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire Amiens-Picardie

NCT06794229

/ Not yet recruitingPhase 2IIT

A Phase II, Open-label, Single-arm Study of NEoadjuvant Zanzalintinib (XL092) Plus NivoLumab in Patients with LOcally Advanced And/or InopeRable ClEar Cell Renal Cell Carcinoma with or Without Non-measurable Metastasis (EXPLORE-RCC)

All subjects will receive zanzalintinib 100mg orally (PO) once daily plus nivolumab standard of care dosing (i.e., 240mg IV every 2 weeks or 480mg IV every 4 weeks) for a total of 12 weeks, followed by restaging scan/evaluation for surgical operability and an adaptive approach that includes (1) surgical resection if the participant is eligible for surgery (Cohort A), (2) up to 48 weeks total (from Cycle 1 Day 1) of zanzalintinib plus nivolumab if the participant has partial response or stable disease but remains inoperable (Cohort B1), or (3) stopping protocol mandated treatment to receive standard of care systemic therapy and continue follow up per protocol if the participant has disease progression (Cohort B2).

Start Date01 Nov 2025

Sponsor / Collaborator

Hoosier Cancer Research Network

[+2]

NCT06047015

/ Not yet recruitingPhase 1/2IIT

Immune Response to Irreversible Electroporation (NanoKnife ®) and a Checkpoint Inhibitor With or Without CpG Oligodeoxynucleotides for the Treatment of Stage IV Colorectal Cancer

The goal of this pilot clinical trial is to learn about the combination of immune boosting drugs and irreversible electroporation (IRE) in patients with colon cancer that has spread to the liver (metastasis). The main questions it aims to answer are:
1. to document the rate of complications associated with combining IRE with immune boosting drugs.
2. After one liver metastasis is treated with IRE and immune boosting drugs, what is the change in the size of the non-IRE-treated liver metastases?
3. What is the immune response (measured in a blood sample) when IRE is combined with one or two types of immune boosting drugs?

Start Date01 Jul 2025

Sponsor / Collaborator

University of Saskatchewan

100 Clinical Results associated with Nivolumab

100 Translational Medicine associated with Nivolumab

100 Patents (Medical) associated with Nivolumab

14,489

Literatures (Medical) associated with Nivolumab

31 Dec 2025·Human Vaccines & Immunotherapeutics

State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changes

Review

Author: Marchetti, Andrea ; Mollica, Veronica ; Mottaran, Angelo ; Piazza, Pietro ; Rosellini, Matteo ; Danielli, Linda ; Ricci, Costantino ; Schiavina, Riccardo ; Tassinari, Elisa ; Massari, Francesco ; Santoni, Matteo

In recent years, several clinical trials focused on the potential role of immune-checkpoint inhibitors (ICIs) in the adjuvant treatment of muscle-invasive urothelial cancer (UC). Heretofore, only the anti-programmed death protein 1 (anti-PD1) nivolumab received European Medical Agency (EMA) approval for cisplatin-unfit patients. In our work, we deeply analyzed the results of the three pivotal studies in view of the rapidly evolving therapeutic advanced UC's scenario. Furthermore, there are several ongoing research to investigate ICIs and other emerging immune agents in this setting; results are awaited. Additionally, current efforts have been made to assess the role of these agents in earlier disease settings, particularly in high-risk non-muscle-invasive bladder cancer (NMIBC). In our review, we analyzed the potential role of predictive and/or prognostic biomarkers that may improve patient selection and treatment efficacy. To conclude, we highlighted the upcoming changes that could redefine the standard of care for patients with early-stage UC.

31 Dec 2025·Human Vaccines & Immunotherapeutics

PD-1/PD-L1 inhibitors related adverse events: A bibliometric analysis from 2014 to 2024

Article

Author: Chang, Lei ; Lu, Wenping ; Zhang, Dongni ; Mei, Heting ; Zhuo, Zhili ; Cui, Yongjia ; Yu, Zongliang ; Song, Qingya

Programmed cell death-1 (PD-1) inhibitors and programmed cell death ligand 1 (PD-L1) inhibitors are considered effective alternatives for the primary treatment of recurrent metastatic cancers. However, they can induce various adverse events affecting multiple organ systems, potentially diminishing patients' quality of life, and even leading to treatment interruptions. Adverse events related to PD-1/PD-L1 inhibitors differ from those associated with CTLA-4 inhibitors and are more commonly observed in the treatment of solid tumors. This study aimed to address the knowledge gap regarding adverse events related to PD-1/PD-L1 inhibitors. A visual bibliometric network was constructed using VOSviewer, CiteSpace, R software, and the Web of Science Core Collection (WoSCC) to quantitatively analyze this research field. Future research directions were also explored. The USA ranked first in publication count and total citations. Over time, publication types transitioned from case reports to clinical trials. Research on for nivolumab was the most prevalent. The spectrum of cancers treated by PD-1/PD-L1 inhibitors expanded beyond melanoma and lung cancer to include renal cell carcinoma, esophageal cancer, and others. Common adverse events included pneumonitis, myasthenia gravis, and vitiligo. There was a significant increase in multi-phase clinical trials and studies related to biomarkers. This study offers valuable insights for potential collaborators and institutions, highlighting trends in the study of adverse events related to PD-1/PD-L1 inhibitors. The management of these adverse events has become more refined and standardized. Biomarker research and multi-phase clinical trials are likely to be key areas of focus in future studies.

31 Dec 2025·OncoImmunology

Clinical impact of cancer cachexia on the outcome of patients with non-small cell lung cancer with PD-L1 tumor proportion scores of ≥50% receiving pembrolizumab monotherapy versus immune checkpoint inhibitor with chemotherapy

Article

Author: Katayama, Yuki ; Hasegawa, Isao ; Kijima, Takashi ; Iwasaku, Masahiro ; Kawachi, Hayato ; Date, Koji ; Shimose, Takayuki ; Yamada, Tadaaki ; Nakao, Akira ; Harada, Taishi ; Okada, Asuka ; Tokuda, Shinsaku ; Morimoto, Kenji ; Tamiya, Motohiro ; Nishioka, Naoya ; Shiotsu, Shinsuke ; Tanimura, Keiko ; Goto, Yasuhiro ; Takayama, Koichi ; Negi, Yoshiki ; Tamiya, Nobuyo ; Chihara, Yusuke ; Takeda, Takayuki

This retrospective, multicenter cohort study aimed to determine whether cancer cachexia serves as a biomarker for determining the most effective treatment for patients having non-small-cell lung cancer (NSCLC) with high programmed death ligand 1 (PD-L1) expression treated with immune checkpoint inhibitors (ICIs) alone or combined with chemotherapy (ICI/chemotherapy). We included 411 patients with advanced NSCLC with a PD-L1 tumor proportion score of ≥50%. The patients were treated with pembrolizumab monotherapy or ICI/chemotherapy. Cancer cachexia was defined as a weight loss of >5% of the total body weight or a body mass index of <20 kg/m² coupled with an additional weight loss of >2% within 6 months before starting treatment. Eighty-five (21%) patients met the cancer cachexia criteria. Overall survival (OS) was significantly shorter in patients with cachexia than in those without cachexia in both the pembrolizumab monotherapy group (17.2 vs. 35.8 months, p < 0.001) and the ICI/chemotherapy group (27.0 months vs. not reached, p = 0.044). However, after stratifying by cancer cachexia status, no significant difference in OS was observed between the pembrolizumab monotherapy and chemoimmunotherapy groups, regardless of cachexia. In conclusion, ICI/chemotherapy offers limited benefits for NSCLC patients with high PD-L1 expression and concurrent cancer cachexia. Considering the frailty associated with cachexia, ICI monotherapy may be preferred to ICI/chemotherapy for these patients. New interventions that can better address the negative prognostic impact of cachexia in patients treated using ICIs with or without chemotherapy remain warranted.

1,794

News (Medical) associated with Nivolumab

23 Mar 2025

·www.prnewswire.com

Everest Medicines Announces FDA Clearance of IND Application for Tumor-Associated Antigen Vaccine EVM14

EVM14 received U.S. FDA clearance for its IND application, becoming Everest's first internally discovered program, and the first mRNA therapeutic cancer vaccine to be cleared for global clinical development. Preclinical highlights： EVM14 induced a dose-dependent, antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. As a therapeutic vaccine, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence. In combination with immune checkpoint inhibitors (ICIs), EVM14 significantly enhanced anti-tumor activity, supporting exploration of combination therapies in clinical trials. EVM14, EVM16 and in-vivo CAR-T programs are the core pillars of Everest's oncology and autoimmune disease innovation strategy. SHANGHAI, March 23, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a Tumor-Associated Antigen (TAA) vaccine. EVM14 is Everest's first internally developed mRNA therapeutic vaccine to receive FDA IND approval, marking a significant milestone in the Company's efforts to develop innovative mRNA therapeutics in oncology. EVM14 is an off-the-shelf mRNA cancer vaccine targeting multiple TAAs and is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. It utilizes mRNA encoding multiple TAAs encapsulated in a lipid nanoparticle (LNP) delivery system. Following intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs), where the mRNA is translated into target antigens. These antigens are then processed and presented by major histocompatibility complex (MHC) molecules to T cells, triggering an antigen-specific immune response. The activated T cells migrate to tumor tissues, recognize and kill the cancer cells expressing the target antigens. In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. EVM14 promoted T cell infiltration into tumor tissues, increased T cell activation and cytotoxic function, decreased the Treg population and cytotoxic T lymphocyte (CTL) exhaustion - all well correlated with its anti-tumor activity. Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence, offering hope for long-term cancer-free survival. Furthermore, preclinical data demonstrated that the combination of EVM14 with ICIs greatly enhanced the anti-tumor activity, supporting clinical exploration of combination therapies. "With FDA IND approval, EVM14 has become the Everest's first internally developed mRNA therapeutic vaccine to receive clearance for global clinical development. This marks a critical breakthrough, advancing our mRNA technology from early-stage research to global clinical trials and highlighting our growing capabilities in mRNA technology. It also represents a new chapter in our 'dual-engine' strategy, evolving from a license-in model to a balanced integration of both license-in and in-house R&D innovation." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Through our clinically validated and fully-integrated mRNA platform, we have realized synergies with our 'AI-powered' pipeline, underscoring Everest's leadership position in advancing innovation in oncology and immunology. EVM14, along with EVM16, which is a personalized cancer vaccine in clinical development and in-vivo CAR-T programs, will serve as foundational elements of our innovation strategy in oncology and autoimmune diseases. Everest is at the forefront of China's mRNA and AI-powered therapeutic development, having advanced mRNA cancer therapeutic vaccines to the clinical trials. Over the past four years, Everest has utilized its AI- and big data-powered mRNA platform to accelerate target identification, sequence design, and delivery optimization. Our proprietary algorithm for mRNA design, now in its third generation, has significantly improved target protein expression and continues to evolve through big data-driven modeling." Luo added: "This approach has enabled key breakthroughs in mRNA technology, expanded our global pipeline, and unlocked potential new opportunities for international collaboration. We look forward to advancing EVM14 into clinical trials and providing new treatment options for cancer patients. Additionally, we will submit the IND application for EVM14 to the China National Medical Products Administration (NMPA) in the near future." According to Globocan 2022 statistics, nearly 20 million new cancer cases were diagnosed worldwide, with approximately 9.7million cancer-related deaths1. Lung cancer remains the most prevalent cancer globally, responsible for almost 2.5 million new cases. Lung cancer was also the leading cause of cancer death, with an estimated 1.8 million deaths. Non-small cell lung cancer (NSCLC) accounts for 85%–90% of all lung cancers2, with squamous NSCLC (sq-NSCLC) comprising 25%–30%3. However, targetable genetic alterations, such as EGFR mutations, ALK, and ROS1 rearrangements occur in fewer than 10% of sq-NSCLC cases4, underscoring the urgent need for new treatment options. Additionally, Global Cancer Statistics 2022 reports that head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer, accounting for an estimated 890,000 new cases and 450,000 deaths annually5. more than 50% of patients with locally advanced HNSCC who have completed definitive treatment ultimately experience recurrence or metastasis6, leading to poor prognosis, high mortality rates, and diminished quality of life. Neither immunotherapy nor targeted therapy can offer long term benefits to cancer patients. EVM14's unique mechanism offers the potential to complement current treatments by enhancing the efficacy via combination therapies and delaying disease recurrence, aligning with current trends in oncology drug development. Everest has built end-to-end capabilities within its proprietary mRNA platform. The Company is advancing multiple mRNA therapies targeting cancer and autoimmune diseases, including personalized cancer vaccines (PCVs), tumor-associated antigen (TAA) cancer vaccines, immunomodulatory cancer vaccines, and in vivo CAR-T therapies. Additionally, the Company is working on next-generation LNP delivery systems to further boost cell-mediated immune responses. The Company's first internally developed personalized mRNA cancer vaccine, EVM16, has completed its first patient dosing in an investigator-initiated clinical trial (IIT) in March 2025. Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China, is designed to comply with global cGMP standards and to produce at clinical- and commercial-scale. About EVM14 EVM14 Injection is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) cancer vaccine. It is formulated with mRNA solution encoding multiple tumor-associated antigens (TAAs), encapsulated in a lipid nanoparticle system. After intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs) and translated into target antigens. These antigens are processed, presented to T cells by major histocompatibility complex (MHC) molecules and activated antigen-specific T cells. The activated T cells can migrate to tumor tissues, recognize, and kill the tumor cells expressing the target antigens. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at . Forward-Looking Statements This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. Reference: 1. Globocan统计数据：. 2. Duma, N., R. Santana-Davila, and J.R. Molina, Non–Small Cell Lung Cancer: Epidemiology, Screening, Diagnosis, and Treatment. Mayo Clinic Proceedings, 2019. 94(8): p. 1623-1640 3. Socinski, M.A., et al., Current and Emergent Therapy Options for Advanced Squamous Cell Lung Cancer. Journal of Thoracic Oncology, 2018. 13(2): p. 165-183 4. Zhou, C., et al., A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004). Cancer Cell, 2024. 42(2): p. 198-208.e3 5. Bray, F., Laversanne, M., Sung, H., et al. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 1-35. 6. Haddad, R.I., et al., Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651. J Clin Oncol, 2023. 41(12): p. 2166-2180 SOURCE Everest Medicines WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccinePhase 3ImmunotherapymRNAIND

20 Mar 2025

·www.prnewswire.com

Caris Life Sciences Publishes Study Featuring the Largest Real-World Cohort of Tissue-Agnostic Indications Revealing Over 20 Percent of Patients Are Eligible for "Pan-Cancer" Therapies

A 295,000+ patient study revealed variable efficacy among cancers for patients treated with tissue-agnostic drugs and uncovered the potential for expanding approvals to other drugs of the same class IRVING, Texas, March 20, 2025 /PRNewswire/ -- Caris Life Sciences® (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, today announced the publication of "Real-world evidence provides clinical insights into tissue-agnostic therapeutic approvals" in Nature Communications. Utilizing the largest real-world clinical and genomic dataset of tissue-agnostic indications reported to date across more than 295,000 patients, the study provides a comprehensive evaluation of real-world outcomes for patients eligible for these powerful "pan-cancer" therapies, such as pembrolizumab and larotrectinib. These drugs are categorized as tumor-agnostic therapies, targeting specific genetic or molecular features of tumors rather than their anatomical location or histology. The study focused on the use and clinical benefits of tissue-agnostic therapies, which target specific molecular biomarkers across numerous cancer types. Key findings include: More than 20 percent of patients are candidates for a tissue-agnostic drug. Approximately five percent of patients who lacked any tumor-specific indication were found to carry a tissue-agnostic indication and became eligible for tissue-agnostic drug treatment. Tissue-agnostic therapy uptake was poor for rare indications, illustrating the need for enhanced clinical education. Current tissue-agnostic indications could potentially be expanded, as evidenced by clinical benefits in tumor types and drugs of the same class that were not investigated in the original clinical trials. "By harnessing the power of Caris' large clinico-genomic dataset, we have shown that tissue-agnostic drugs produce different outcomes in different tissues," said George W. Sledge, Jr., MD, EVP and Chief Medical Officer of Caris and study author. "We additionally found evidence of clinical benefit beyond approved indications, illustrating the enormous potential of real-world data to inform the clinical use of tissue-agnostic drug approvals, potentially improving patient outcomes." "Caris has generated one of the most extensive clinico-genomic datasets in oncology through years of comprehensive molecular profiling," said Caris President and study author David Spetzler, MS, PhD, MBA. "Our advanced analyses of real-world data now enable us to uncover findings of clinical value for large patient populations. One in five patients in our study were eligible for a tissue-agnostic drug, which demonstrates the widespread impact of our findings." Detailed Scientific Information This study used a real-world database of 295,316 molecularly profiled tumor samples with associated clinical outcomes data across 57 tumor types to investigate the utility and uptake of six tissue-agnostic therapies (pembrolizumab, larotrectinib, entrectinib, dostarlimab, dabrafenib and selpercatinib). At least one current FDA-approved tissue-agnostic indication (TMB-High, MSI-High/dMMR, BRAFV600E mutations, and NTRK and RET fusions) was detected in 21.5% of patients, including 5.4% lacking any tumor-specific indication. In patients with rare NTRK fusions, there was poor clinical uptake of the clinically successful targeted therapies larotrectinib and entrectinib, underlining the need for oncologist education on rare indications. Strikingly, significant differences in pembrolizumab-associated outcomes were observed across tumor types for the most common indications (TMB-High and MSI-High/dMMR), demonstrating that the effects of these therapies are not tissue-agnostic. Clinical benefits were also observed in tumor types and drugs of the same class (such as nivolumab) that were not investigated in pivotal clinical trials. This suggests the possible expansion of therapeutic avenues for a given tissue-agnostic indication. These findings demonstrate the power of Caris' extensive real-world dataset for generating valuable clinical insights to inform the clinical implementations of tissue-agnostic drug approvals and improve outcomes for patients with cancer. Designed to capture and analyze molecular information from tissue and blood in a comprehensive manner, the proprietary Caris Platform is a powerful set of precision medicine solutions, providing Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) as standard practice. Caris sequences at sector-leading depth of coverage, which directly correlates to increased accuracy and detection of low-frequency biomarkers of relevance. Caris also evaluates protein biomarkers through an extensive menu of immunohistochemical (IHC) tests analyzed in a tumor-type specific manner, which in combination with WES and WTS, provides a comprehensive view of a patient's disease across DNA, RNA and proteins. The Caris approach reveals an individualized molecular blueprint of a patient's disease, providing actionable, personalized treatment pathways and driving superior clinical outcomes for patients. About Caris Life Sciences Caris Life Sciences® (Caris) is a leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, multimodal database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides a differentiated platform to deliver the next generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with a vision to realize the potential of precision medicine in order to improve the human condition. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets. To learn more, please visit CarisLifeSciences.com. Caris Life Sciences Media: Corporate Communications [email protected] 214.294.5606 SOURCE Caris Life Sciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

20 Mar 2025

·pipelinereview.com

Alvotech Acquires Xbrane’s R&D Operations in Sweden and Further Affirms its Global Leadership Position in Biosimilars Development and Production

REYKJAVIK, Iceland and STOCKHOLM, Sweden I March 20, 2025 I Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the acquisition of Xbrane Biopharma AB’s (“Xbrane”) R&D operations and a biosimilar candidate (the “Acquisition”), further expanding Alvotech’s development capabilities, and establishing a footprint in the Swedish life science sector. The Acquisition includes Xbrane’s R&D operations based in Campus Solna, at the Karolinska Institute outside Stockholm, Sweden, as well as the biosimilar candidate XB003, referencing Cimzia® (certolizumab pegol). Xbrane retains other pre-clinical assets and will focus on the commercialization of this portfolio. Alvotech also announced that it intends to explore the possibility of a listing of Swedish Depository Receipts (SDR), equity share equivalents, on Nasdaq Stockholm, in the future. The acquisition in brief “Alvotech has a best-in-class biosimilars manufacturing site in Iceland, both for drug substance and drug products. At the same time, our strong in-house R&D capabilities have put Alvotech in a leading position among pure play biosimilar companies in terms of the market value of our product pipeline. This acquisition will further expand Alvotech’s development capacity, allowing our commercial network of 19 leading commercial partners worldwide to continue increasing patient access to quality biologics,” said Robert Wessman, founder, Chairman and CEO of Alvotech. “Furthermore, we will establish a strong presence for Alvotech in the Swedish life science sector, which rivals the U.S. in this field. It will allow Alvotech to attract new talent, create opportunities for scientific collaboration, and support our growth. This is yet another milestone for Alvotech in establishing us as a leader in biosimilars development and production globally.” “With this transaction Xbrane is significantly strengthening its financial position and retains over 75% of the competitively adjusted addressable market of the portfolio including Ximluci (Lucentis biosimilar candidate) currently being approved and sold in Europe as well as Xdivane (Opdivo biosimilar candidate), recently partnered with Intas. Xbrane will, with a more lean and flexible organization after the transaction, be better equipped to fully focus on realizing the full value of Ximluci and Xdivane with the ambition to generate meaningful royalties/profit sharing from these programs in the years to come,” said Martin Åmark, CEO of Xbrane. Headquartered in Reykjavik, Iceland, Alvotech’s shares are listed on Nasdaq Iceland and Nasdaq US. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Since 2013, Alvotech has invested about $1.9 billion in a purpose-built biosimilars R&D and manufacturing platform, established commercial partnerships with 19 leading companies in over 90 of the largest global markets and developed one of the most valuable portfolios in the biosimilars industry. Advisors DNB Carnegie is acting as financial advisor to Alvotech in connection with the Acquisition. Cirio and Westerberg are legal advisors to Alvotech in connection with the Acquisition. About Alvotech Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com . None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal , and our website or follow us on social media on LinkedIn , Facebook , Instagram , and YouTube . SOURCE: Alvotech

AcquisitionDrug ApprovalBiosimilar

100 Deals associated with Nivolumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10316	Nivolumab	L01XC17	DB09035

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Malignant neoplasm of gastro-oesophageal junction	European Union	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Malignant neoplasm of gastro-oesophageal junction	Iceland	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Malignant neoplasm of gastro-oesophageal junction	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Malignant neoplasm of gastro-oesophageal junction	Norway	Bristol-Myers Squibb Pharma EEIG	17 Mar 2025
Advanced Hepatocellular Carcinoma	European Union	Bristol Myers Squibb Co.	08 Mar 2025
Advanced Hepatocellular Carcinoma	Iceland	Bristol Myers Squibb Co.	08 Mar 2025
Advanced Hepatocellular Carcinoma	Liechtenstein	Bristol Myers Squibb Co.	08 Mar 2025
Advanced Hepatocellular Carcinoma	Norway	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	European Union	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	Iceland	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	Liechtenstein	Bristol Myers Squibb Co.	08 Mar 2025
Unresectable Hepatocellular Carcinoma	Norway	Bristol Myers Squibb Co.	08 Mar 2025
Skin Neoplasms	Japan	Ono Pharmaceutical Co., Ltd.	09 Feb 2024
Mesothelioma, Malignant	Japan	Ono Pharmaceutical Co., Ltd.	24 Nov 2023
Resectable Lung Non-Small Cell Carcinoma	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Resectable Lung Non-Small Cell Carcinoma	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Resectable Lung Non-Small Cell Carcinoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Resectable Lung Non-Small Cell Carcinoma	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Urothelial Carcinoma of the Urinary Bladder	Japan	Bristol Myers Squibb Co.	28 Mar 2022
Unknown Primary Neoplasms	Japan	Bristol Myers Squibb Co.	24 Dec 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mismatch repair-deficient Colonic Cancer	NDA/BLA	China	Bristol-Myers Squibb (China) Investment Co. Ltd.	18 Apr 2024
Mismatch repair-deficient Rectal Cancer	NDA/BLA	China	Bristol-Myers Squibb (China) Investment Co. Ltd.	18 Apr 2024
Advanced Gastric Adenocarcinoma	Phase 3	United States	National Cancer Institute	24 Jun 2024
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	United States	National Cancer Institute	24 Jun 2024
Metastatic gastric adenocarcinoma	Phase 3	United States	National Cancer Institute	24 Jun 2024
stomach adenocarcinoma	Phase 3	United States	National Cancer Institute	24 Jun 2024
HER2 negative Gastric Cancer	Phase 3	Japan	Ono Pharmaceutical Co., Ltd.	05 Nov 2021
HER2 negative Gastric Cancer	Phase 3	South Korea	Ono Pharmaceutical Co., Ltd.	05 Nov 2021
HER2 negative Gastric Cancer	Phase 3	Taiwan Province	Ono Pharmaceutical Co., Ltd.	05 Nov 2021
Mediastinal large B-cell lymphoma	Phase 3	United States	National Cancer Institute	05 Oct 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05543629 (CTgov)	Phase 1/2	Advanced Malignant Solid Neoplasm \| Non-Small Cell Lung Cancer	36	BMS-986442 (Part A: Treatment 1)	cnzbuwgxem = wumueetxlq grgtkxyfvv (xflamkzkva, oqkaikewej - llyutbpclt) View more	-	18 Mar 2025
				BMS-986442 (Part A: Treatment 2)	cnzbuwgxem = qxidgxxyci grgtkxyfvv (xflamkzkva, mvhjbptugf - rbdtvmwzaw) View more
NCT03727061 (CTgov)	Phase 1	Recurrent Head and Neck Carcinoma	5	Quality of Life Assessment+Nivolumab+Porfimer Sodium	bbtnhnxiun = dwwdxqggns fkmvtatsej (fwmnpuiayh, ckyaotwzcu - sgwtmjmklm) View more	-	11 Mar 2025
NCT03285321 (BTCRC-LUN16-081 \| BTCRC LUN 16-081, CTgov)	Phase 2	Unresectable Lung Non-Small Cell Carcinoma	105	Nivolumab (Arm 1: Nivolumab)	yjevyvhhmx = wtnbhhyomi uqnuxxjnpu (rrshmnkczm, pxejhwpvyi - lsnruqugmg) View more	-	11 Mar 2025
				Ipilimumab+Nivolumab (Arm 2: Nivolumab Plus Ipilimumab)	yjevyvhhmx = oivbmdbjdn uqnuxxjnpu (rrshmnkczm, ydvbiqypjh - lntyrvzbrx) View more
NCT03158129 (NEOSTAR, CTgov)	Phase 2	Non-small cell lung cancer stage I \| Non-small cell lung cancer stage IIIA \| Non-small cell lung cancer stage II	101	Nivolumab (Arm A - Nivolumab)	owzcdjbetw = ycsiuveyxa rrprovgdsu (dvlvvsxerm, ruwnyhkjgz - gtqjrlvqmy) View more	-	05 Mar 2025
				Ipilimumab+Nivolumab (Arm B - Nivolumab + Ipilimumab)	owzcdjbetw = iymkmftbut rrprovgdsu (dvlvvsxerm, eltuvyheid - dwpshphvgg) View more
NCT04731467 (CM24, ESMO_TAT2025)	Phase 2	Pancreatic Cancer CEACAM1	31	CM24 + Nivolumab + Chemotherapy	lbsiomgaex(lsqqetbaxn) = 4 vs 1 pts rjvaeysgci (etyuzehrgm ) View more	Positive	03 Mar 2025
				Chemotherapy only
NCT05297565 (CheckMate-6GE, CTgov)	Phase 3	Melanoma \| Metastatic melanoma	14	BMS-986298+rHuPH20 (Arm A)	yogubwyqfk = keimrlvwxu dephrdezlr (hwmfawfqfu, yhokldlzxk - fkawzalcfe) View more	-	27 Feb 2025
				Nivo IV (Arm B)	yogubwyqfk = zwgcbrakks dephrdezlr (hwmfawfqfu, aiymllvrvn - gujerleowj) View more
NCT04322643 (CTgov)	Phase 2	Advanced Urothelial Carcinoma	4	nivolumab+Avelumab+Atezolizumab+pembrolizumab+Durvalumab	dmjfggvpnt = rdggvhptbv coscyasjtl (kbrzbbdpoj, bleryvnpyh - rpaxqkpgjk) View more	-	25 Feb 2025
NCT02998528 (CheckMate -816, Company_Website) Manual	Phase 3	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	358	Opdivo + Chemotherapy	wljkhgkkez(dfivchpjdz) = statistically significant and clinically meaningful improvement in OS. bpkbxrrscc (nqcrckvfrk ) View more	Positive	19 Feb 2025
				Chemotherapy
NCT05122546 (ASCO_GU2025) Manual	Phase 1	Metastatic Renal Cell Carcinoma	30	Cabozantinib (cabo) and nivolumab (nivo)nivolumab (nivo) with CBM588 (40mg PO QD and 480mg IV monthly, respectively; 80mg PO BID)	whdthxpdqo(vqbryhrixi) = vbdyqdtzpr disoebdibv (fwficcaujp ) View more	Positive	13 Feb 2025
				Cabozantinib (cabo) and nivolumab (nivo)nivolumab (nivo) without CBM588 (40mg PO QD and 480mg IV monthly, respectively))	whdthxpdqo(vqbryhrixi) = inbnizaxhd disoebdibv (fwficcaujp ) View more

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