Delving into the Latest Updates on Nivolumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

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

+ [17]

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

MSI-H/dMMR Rectal CancerPD-L1 positive Non-Small Cell Lung CancerMetastatic hepatocellular carcinoma+ [466]

Inactive Indication

Acidemia, IsovalericAcquired Immunodeficiency SyndromeAcute bilineal leukemia+ [145]

Originator Organization

Ono Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

Active Organization

National Cancer Institute

Ono Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

+ [25]

Inactive Organization

Vedanta Biosciences, Inc.

The University of Texas Southwestern Medical Center

Nektar Therapeutics

+ [17]

License Organization

Nektar Therapeutics

NeoImmuneTech, Inc.

Vedanta Biosciences, Inc.

+ [19]

Drug Highest PhaseApproved

First Approval Date

Japan (04 Jul 2014),

Esophageal CarcinomaMelanoma

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

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Structure/Sequence

Sequence Code 93681H

Source: *****

Sequence Code 93684L

Source: *****

This study is open to Japanese adults with different types of advanced cancer (solid tumors). People can join the study if their cancer has spread, and previous treatments were not successful or no treatments exist.
The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people can tolerate when taken together with an anti-PD1 antibody. The anti-PD1 antibody is already used to treat different cancers. Participants receive BI 1831169 together with an anti-PD1 antibody, which is given as an infusion into a vein for up to 1 year.
Participants visit the study site regularly. The number of site visits vary based on the study part and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.

Start Date03 Aug 2027

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT07572123

/ Not yet recruitingPhase 2/3IIT

A Two Cohort Randomized Study for Patients With High Risk (Phase II) and Standard Risk (Phase III) Classical Hodgkin Lymphoma in First Relapse

This phase II trial compares the impact of brentuximab vedotin and nivolumab after radiation to standard of care high dose chemotherapy (HDT)-autologous stem cell transplant (ASCT) in standard-risk patients with classic Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). In addition, the phase III trial will compare the effect of pembrolizumab after HDT-ASCT to standard of care HDT-ASCT alone in high-risk patients with relapsed or refractory classic Hodgkin lymphoma. 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. Immunotherapy with monoclonal antibodies, such as nivolumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. An ASCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving HDT before an ASCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Radiation therapy (RT) uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving brentuximab vedotin and nivolumab after radiation may be safe, tolerable and more effective than standard of care HDT-ASCT in treating patients with standard risk relapsed or refractory classic Hodgkin lymphoma. In addition, giving pembrolizumab after standard of care HDT-ASCT may be safe and tolerable and more effective than HDT-ASCT alone in treating high-risk patients with relapsed or refractory classic Hodgkin lymphoma.

Start Date04 Dec 2026

Sponsor / Collaborator

National Cancer Institute

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

100 Clinical Results associated with Nivolumab

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100 Translational Medicine associated with Nivolumab

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100 Patents (Medical) associated with Nivolumab

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10,908

Literatures (Medical) associated with Nivolumab

31 Dec 2026·PLATELETS

Immune thrombocytopenia triggered by dostarlimab in a patient with endometrial carcinoma: first reported case

Article

Author: Pazmiño-Zambrano, M. Belén ; García-Jaén, Pablo ; González-Porras, José Ramón ; Bastida, José María ; Reguera-Puertas, Pablo ; Fernández-Sánchez, Adolfo ; Puerta-Vázquez, Carlos

Immune checkpoint inhibitors (ICIs) have transformed the treatment landscape for various malignancies, but they are associated with a range of immunerelated adverse events, including rare hematological complications. Immune thrombocytopenia (ITP) has been reported with other antiPD1 agents such as nivolumab and pembrolizumab, but to date, no cases have been described with dostarlimab. We report the first case of ITP in a patient receiving dostarlimab for relapsed endometrial carcinoma. A 55yearold woman developed severe thrombocytopenia (3 × 10⁹/L) accompanied by rectal bleeding, resulting in a lifethreatening condition. Secondary causes were excluded, and bone marrow findings supported a diagnosis of ITP. Initial treatment with highdose corticosteroids and intravenous immunoglobulin achieved only a partial response, while sustained platelet recovery was obtained with the addition of romiplostim. The patient remained on dostarlimab following hematological recovery without further episodes of ITP. This case highlights a potentially lifethreatening adverse effect of a widely used immunotherapy and underscores the importance of early recognition and timely escalation of treatment in ICIinduced ITP.

01 Sep 2026·Value in Health Regional Issues

Cost Savings in Oncology Chemotherapy: The Role of Vial Sharing in Centralized Preparation

Article

Author: Jalil, Mariam Abdel ; El-Dahiyat, Faris ; Almomani, Alaa ; Ballout, Mohammad ; Abu-Farha, Rana K ; Allan, Aya ; Hammour, Khawla Abu

OBJECTIVES:

The objective of this study was to find out how much money can be saved by introducing a vial sharing program in a Jordanian tertiary hospital's centralized intravenous admixture service.

METHODS:

From March 2023 to September 2025, 1662 prescriptions for 24 intravenous anticancer medications were part of this quasi-experimental study. Efficiency of a centralized vial share program and a conventional dispersed preparation technique were compared. Time efficiency, drug waste minimization, and total cost saving (JD) were some of the outcomes that were measured.

RESULTS:

A total of 309 patients were enrolled in the study and followed for 28 months and had 1662 prescription orders for 24 chemotherapy drugs. Median age was 58 years, and most patients were females (54.7%). The most common diagnoses were lymphoma (10.0%), breast cancer (9.1%), and acute myeloid leukemia (6.8%). Most patients (99%) had insurance. Doxorubicin (291 prescriptions, 17.5%), vincristine (234 prescriptions, 14.1%), and rituximab (210 prescriptions, 12.6%) were the highest prescribed medications. Implementation of a vial-sharing system resulted in cost savings of 39.6%, amounting to JD 254 743.28 (USD 359 188.02). Nivolumab caused most cost savings per prescription, followed by trastuzumab, whereas vincristine and fluorouracil saved very minimal amounts per prescription. Based on total savings, Rituximab led the list with JD 83 211.31 (USD 117 327.94).

CONCLUSIONS:

Vial sharing as part of a centralized preparation model has significantly decreased the cost and drug wastage in oncology care. It provides a viable method to increase resource efficiency in cancer care, especially within institutions that have limited healthcare budgets.

01 Aug 2026·JOURNAL OF NEUROIMMUNOLOGY

Re-challenge of immune checkpoint inhibitor after ICI-encephalitis: A case report

Article

Author: Shah, Suma ; Baker, Virginia

Immune-checkpoint inhibitor (ICI) related encephalitis (ICI-IE) is a severe adverse event, associated with high morbidity and mortality and requiring prompt ICI discontinuation. The safety of rechallenge with ICI after initial adverse event is largely unknown and must be considered only after cautiously weighing risks and benefits of resuming treatment. A 66-year-old otherwise healthy female was diagnosed with localized renal cell carcinoma, which was treated with immunotherapy, ipilimumab/ nivolumab. After the second cycle of treatment, she developed subacute progressive personality changes, memory loss and encephalopathy, and was diagnosed with CTCAE grade III immune-related limbic encephalitis. Her chemotherapy regimen with ipilimumab and nivolumab were promptly discontinued and she was treated with seven days of intravenous solumedrol with prolonged oral steroid taper. Four years later, she had recurrent metastatic disease, prompting the decision to pursue palliative immunotherapy with cabozantinib and immune checkpoint rechallenge with Nivolumab. Given her history of ICI-IE, neuroimmunology was consulted to discuss risks of rechallenge with ICI. Over 9 months after initiation of therapy, she remained without recurrence of immune-related adverse events (irAE) related to treatment. We present one of the first reports of successful rechallenge of immune checkpoint inhibition after ICI-IE in the setting of recurrent metastatic renal cell carcinoma. This treatment success may bolster the management options for refractory oncologic disease. Given potential risks associated with ICI rechallenge, it is imperative to employ a multidisciplinary approach with consideration of potential risks and benefits of treatment.

2,264

News (Medical) associated with Nivolumab

22 May 2026

·www.prnewswire.com

Parker Institute for Cancer Immunotherapy Brings the Power of Its Integrated Network to ASCO 2026

PICI leaders, investigators, and collaborators are contributing to more than 50 oral sessions, posters, and publications across the meeting SAN FRANCISCO, May 22, 2026 /PRNewswire/ -- The Parker Institute for Cancer Immunotherapy (PICI) today announced that research and expertise from across its network will be on prominent display throughout the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 29 – June 2. PICI leaders, investigators, and collaborators are contributing to more than 50 oral sessions, posters, and publications — a presence that reflects the breadth, urgency, and clinical momentum of the network's contributions to cancer immunotherapy. The work spans from foundational discovery to practice-changing trials, including new data in glioblastoma, melanoma, prostate, breast, lung, and urothelial cancers; updated readouts on CAR T-cell and TIL-based therapies; personalized neoantigen vaccine strategies; and immune profiling platforms that aim to predict who will benefit from checkpoint inhibition. Adding to this strong presence, PICI will unveil the latest results from its RADIOHEAD pan-cancer cohort, with new multimodal immunoprofiling data leveraging foundation models of the immune system to predict immunotherapy response and toxicity — building on the data that PICI featured at AACR earlier this year. PICI will also announce the inaugural recipient of the Conquer Cancer PICI Endowed Young Investigator Award this year, to recognize an outstanding early-career clinical oncology investigator as they transition from fellowship training to faculty appointments. "Cancer continues to demand urgency, and the PICI Network is designed to meet that challenge through coordinated, collaborative science," said Dr. Karen Knudsen, CEO of PICI. "Our participation at ASCO 2026 reflects the strength of this model, bringing together researchers and investigators to translate discoveries into meaningful progress for patients." Presentation Highlights from the Network Gliobastoma Glioblastoma remains one of oncology's most difficult challenges, and the PICI Network is bringing data this year that build directly on the encouraging signals shared at ASCO 2025. University of Pennsylvania ( Carl June, MD, Director of the PICI Center at Penn; Donald O'Rourke, MD): Updated overall survival, safety, and neurologic function outcomes from a Phase 1 trial of a bivalent CAR T-cell therapy in recurrent glioblastoma (Abstract 2013, oral session). Dana-Farber Cancer Institute ( Catherine J. Wu, MD; Patrick Ott, MD, PhD): A personalized neoantigen vaccine designed to reprogram the immune landscape of glioblastoma (Abstract 2006, oral session) — a continuation of PICI's long-standing commitment to neoantigen-based strategies in CNS cancers. Massachusetts General Hospital ( Marcela Maus, MD, PhD): Rituximab pre-conditioning in the Phase 1 INCIPIENT trial of CARv3-TEAM-E for recurrent glioblastoma (Abstract 2059) — extending the CARv3-TEAM-E program that PICI has supported through earlier readouts. Melanoma TrioMBM ( Allison Betof, MD, PhD — Stanford): A multicenter Phase 2 trial of relatlimab, nivolumab, and ipilimumab in patients with asymptomatic and symptomatic melanoma brain metastases (Abstract TPS9604, lead author). OBX-115 TIL Therapy ( Allison Betof, MD, PhD — Stanford): Phase 2 results of engineered tumor-infiltrating lymphocyte cell therapy with regulatable membrane-bound IL-15 in advanced melanoma after ICI progression (Abstract 9507, oral session). STAMP ( Jedd Wolchok, MD, PhD — Weill Cornell Medicine): Updated outcomes from ECOG-ACRIN EA6174 evaluating adjuvant pembrolizumab in surgically treated Merkel cell carcinoma (Abstract LBA9505, late-breaking oral co-author). RELATIVITY-047 ( F. Stephen Hodi, MD — Dana-Farber): A five-year update of nivolumab plus relatlimab in advanced melanoma (Abstract 9532), alongside a long-term indirect treatment comparison versus nivolumab plus ipilimumab (Abstract 9530). Botensilimab ± Balstilimab ( Patrick Ott, MD, PhD — Dana-Farber): Phase 2 results in patients with advanced cutaneous melanoma refractory or resistant to anti–PD-(L)1 ± CTLA-4 (Abstract 9543). Prostate Cancer RiboX ( Karen Knudsen, MBA, PhD — PICI): A randomized Phase Ib/II study of enzalutamide with and without ribociclib in patients with RB-retaining metastatic castration-resistant prostate cancer (Abstract 5057). CHAMP ( Ana Aparicio, MD — MD Anderson): A Phase 2 multicenter trial of chemoimmunotherapy for patients with neuroendocrine or aggressive-variant metastatic prostate cancer (Abstract 5016, oral co-author). ENZAMET Correlatives ( Eli Van Allen, MD — Dana-Farber): Germline genetic correlates in metastatic hormone-sensitive prostate cancer treated with ADT plus a non-steroidal anti-androgen or enzalutamide (Abstract 5099). C3NIRA ( Padmanee Sharma, MD, PhD; Sangeeta Goswami, MD, PhD; Ana Aparicio, MD — MD Anderson): Single-cell data on early chemo-induced tumor microenvironment alterations as a predictor of response to PD-1 blockade in aggressive-variant prostate cancer (Abstract 5065). Breast Cancer P-RAD (TBCRC-053) ( Elizabeth Mittendorf, MD, PhD — Dana-Farber): Primary results from the triple-negative cohort of a randomized trial of no-, low-, or high-dose preoperative radiation with pembrolizumab and chemotherapy in node-positive breast cancer (Abstract 1011, oral co-author). Post-NCIT Outcomes ( Elizabeth Mittendorf, MD, PhD — Dana-Farber): Outcomes after recurrence on neoadjuvant chemo-immunotherapy in patients with high-risk early-stage triple-negative breast cancer (Abstract 601, oral co-author). ASPRIA ( Elizabeth Mittendorf, MD, PhD — Dana-Farber): A single-arm Phase 2 trial of atezolizumab with sacituzumab govitecan to prevent recurrence in triple-negative breast cancer (Abstract TPS644). Lung & Urothelial Cancers RICHIS ( Jonathan Villena-Vargas, MD — Weill Cornell Medicine): A randomized multicenter Phase 2 trial of radioimmunotherapy versus chemoimmunotherapy followed by surgery for c-stage IB–III non–small cell lung cancer (Abstract TPW8132, lead author). Urothelial ctDNA Dynamics ( Sangeeta Goswami, MD, PhD — MD Anderson): Circulating tumor DNA dynamics as an early biomarker of response to enfortumab vedotin plus pembrolizumab in advanced urothelial carcinoma (Abstract 4582). Macrophage Polarization in Urothelial Cancer ( Nina Bhardwaj, MD, PhD — Icahn Mount Sinai): The CXCL9:SPP1 ratio as a predictor of outcomes with pembrolizumab or enfortumab vedotin plus pembrolizumab in metastatic urothelial cancer (Abstract 4573). Translational Platforms & Immune Profiling RADIOHEAD ( John Connolly, PhD — PICI): Multimodal immunoprofiling of peripheral blood using foundation models of the immune system for predicting immunotherapy response and toxicity in the RADIOHEAD pan-cancer cohort (Abstract 2533). CTX-8371 ( Patrick Ott, MD, PhD — Dana-Farber): Phase 1 dose escalation of a novel PD-1 × PD-L1 bispecific antibody in patients with advanced malignancies post checkpoint inhibition (Abstract 2629). Axi-Cel Real-World Outcomes ( David Miklos, MD, PhD — Stanford): Long-term real-world outcomes of axicabtagene ciloleucel in relapsed/refractory large B-cell lymphoma (Abstract 7028). About the Parker Institute for Cancer Immunotherapy (PICI) The Parker Institute for Cancer Immunotherapy (PICI) is a 501c3 nonprofit organization driving the next generation of cancer treatment by accelerating the development of breakthrough immune therapies to turn all cancers into curable diseases. Founded in 2016 through the vision of Sean Parker, PICI unites the nation's top cancer centers into a collaborative consortium that fuels high-risk, high-reward science with shared goals, data, and infrastructure. Unlike traditional research models, PICI goes beyond discovery by actively advancing promising innovations through clinical testing, company formation and incubation, and commercialization. PICI has supported more than 1,000 investigators across its network and has a portfolio that includes 17 biotech ventures with over $4B raised in capital. PICI is uniquely positioned to close the gap between scientific discovery and patient access. By integrating scientific excellence with entrepreneurial execution, PICI is reimagining how cures are made, and accelerating their path to the people who need them most. | Learn more about PICI: Media Contact: Kate Kaminsky Parker Institute for Cancer Immunotherapy (475) 213-3198 [email protected] SOURCE Parker Institute for Cancer Immunotherapy 21% more press release views with Request a Demo

ImmunotherapyClinical ResultPhase 2ASCOPhase 1

22 May 2026

·endpoints.news

Ibrance's would-be successors, the data that helped sell Tubulis to Gilead, and more at ASCO

All of the regular ASCO abstracts dropped Thursday afternoon, with the biggest news coming from the VEGF bispecific race , Merck and Kelun-Biotech’s TROP2 ADC known as sac-TMT, and multiple head and neck cancer updates . But there were plenty of other developments across cancer trials and new mechanisms, and we’ve rounded up the best of the rest here. Find updates below on potential successors for Pfizer’s blockbuster Ibrance, the Tubulis data that got Gilead Sciences excited enough to buy it out, and more. Both Pfizer and BeOne Medicines (formerly BeiGene) are developing CDK4 inhibitors in a bid to take up Ibrance’s mantle in breast cancer, as the first Ibrance biosimilars are expected as soon as next year. For Pfizer, the successor is called atirmociclib. The drugmaker toplined a separate Phase 2 success earlier this year in HR-positive, HER2-negative breast cancer, but an abstract released Thursday supplemented those results. Patients received either a combination of atirmociclib and an aromatase inhibitor called letrozole, or letrozole alone. Efficacy was measured with an endpoint called “complete cell cycle arrest,” or CCCA, which examines how quickly patients’ tumor cells stopped dividing. After 14 days, 45 of 51 patients (88.2%) who took the combination regimen saw their cell division slow by a meaningful amount, compared to 10 of 56 (17.9%) who only received letrozole. The data come from patients with advanced breast cancer who progressed after treatment with a CDK4/6 inhibitor (including Ibrance). Pfizer enrolled patients whose tumor cells were dividing rapidly. BeOne, meanwhile, is researching a program called BGB-43395 and reported data from a safety expansion cohort of a Phase 2 study, also looking at a combination with letrozole. The company has enrolled 58 patients so far across three dosing regimens. After a median follow-up of 6.8 months, the median time-to-response was 3.6 months and progression-free survival was not reached. Unlike these experimental drugs, Ibrance is a CDK4/6 inhibitor. Global Ibrance sales peaked in 2022 with $5.12 billion. In 2025, Ibrance was selected for the second round of price negotiations under the Inflation Reduction Act, with new prices expected to be implemented for patients with Medicare starting next year. Gilead paid $3.15 billion upfront last month to acquire the ADC-focused biotech Tubulis, and an ASCO abstract released Thursday attempts to show why. The biotech’s lead program is called TUB-040, a NaPi2b-directed ADC that is in testing for certain forms of ovarian cancer and non-small cell lung cancer. Tubulis administered the drug to patients with platinum-resistant ovarian cancer across four dose levels in a Phase 1/2a study, 46 of whom could be evaluated for efficacy. Of those 46 patients, 28 saw their tumors shrink by at least 30%, good for a confirmed objective response rate of 60.9%. Responses were spread almost evenly across all dose levels, with seven patients responding in each of the two lowest doses, eight responding in the third level and six responding at the highest dose. Gilead and Tubulis initially signed a partnership in 2024 before this year’s buyout. Gilead could pay another $1.85 billion if all milestones in the deal are met. Earlier this month, the FDA approved Pfizer and Arvinas’ drug vepdegestrant (brand name: Veppanu) for patients with a certain form of breast cancer. But it’s unclear how many patients will take it, and the companies shipped the drug’s rights to Rigel Pharmaceuticals for $70 million upfront — a fraction of the $1 billion Pfizer initially paid for the partnership. Data released Thursday from a Phase 1b/2 study continued to illustrate why the drug has disappointed. In second-line patients with certain ER-positive/HER2-negative breast cancers, Veppanu plus an aromatase inhibitor induced responses in just eight of 33 patients at the highest dose measured (24.2% confirmed ORR). Only five of 31 who received the low dose responded to the therapy. Response rates were lower in patients with ESR1 mutations, with three of 14 patients (21.4%) responding to the high dose. These mutations are where the expected competition of oral SERDs has largely been a success. Pfizer and Arvinas presented Phase 3 data for the drug at last year’s ASCO, showing it was no better than oral SERDs. AstraZeneca’s B7-H4 ADC: The drug is called puxitatug samrotecan, or puxi-sam. At its low dose, 14 of 31 patients with endometrial cancer (34.1% ORR) and four of 33 with ovarian cancer (12.1% ORR) saw their tumors shrink by at least 30%. At the high dose, 24 of 50 endometrial cancer patients (48% ORR) and 11 of 45 individuals with ovarian cancer (24.4% ORR) saw the same level of tumor shrinkage. Median PFS in endometrial cancer was 8.1 months and seven months at the high and low doses, respectively. In ovarian cancer, median PFS was 5.7 months at the high dose and 4.8 months at the low dose. Additionally, the company released very early data from a cohort looking at patients with biliary tract cancer. After a median follow-up of 2.2 months, two of 20 patients saw their tumors shrink by at least 30%, good for an ORR of 10%. The company hopes more patients will respond after longer periods of time. Immuneering posts more pancreatic cancer results: The biotech rolled out another update for its oral MEK inhibitor atebimetinib, after multiple positive updates in the last 12 months measuring it in combination with chemotherapy. After a median follow-up of 10.4 months, median PFS was 8.4 months and median overall survival was not reached among 50 patients. Six- and nine-month OS rates were 88% and 79%, respectively. AstraZeneca’s Neogene data: The first data from AstraZeneca’s 2022 buyout of Neogene were released Thursday, showing results from the NT-175 program in patients with TP53 mutations in solid tumors. Investigators said 10 of 21 patients who received the therapy responded after a median six months of follow-up. This included five of six patients with pancreatic cancer who took part in the study. NT-175 is an autologous engineered T-cell receptor (eTCR) T cell therapy. Replimune’s three-year survival rates: The company’s therapy RP1, which was rejected twice by the FDA , achieved a three-year OS rate of 45.5% in patients with advanced melanoma. Patients got RP1 along with the anti-PD-1 drug Opdivo after previously failing anti-PD-1 therapy.

Clinical ResultPhase 3Drug ApprovalPhase 2Cell Therapy

22 May 2026

·firstwordpharma.com

ASCO26: OSE says its vaccine strategy extends PFS in platinum-sensitive ovarian cancer

French biotech OSE Immunotherapeutics said Friday that its cancer vaccine Tedopi (OSE2101) may help slow disease progression in patients with recurrent ovarian cancer when used alongside Merck & Co.'s Keytruda (pembrolizumab).Topline results from the Phase II TEDOVA study, slated for presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting, offer a promising signal in a setting where treatment options remain limited after PARP inhibitors and bevacizumab, according to Alexandra Leary, the study's lead investigator.Tedopi is an off-the-shelf therapeutic cancer vaccine designed to stimulate T-cell responses against five tumour-associated antigens in HLA-A2-positive patients. The company said it works by expanding tumour-specific T lymphocytes, and could potentially enhance the activity of checkpoint inhibitors like Keytruda.Merck's PD-1 inhibitor recently secured a US approval in platinum-resistant ovarian cancer, but not in the platinum-sensitive maintenance setting studied in TEDOVA. For related analysis, see – KOL Views Q&A: Relacorilant set for early uptake in platinum-resistant ovarian cancer).The Phase II study enrolled 185 patients with platinum-sensitive ovarian cancer whose disease had progressed after, or who were ineligible for, PARP inhibitors and bevacizumab. Patients whose disease had stabilised or responded to platinum chemotherapy were randomised to receive best supportive care, Tedopi alone, or Tedopi plus Keytruda as maintenance treatment. The primary endpoint compares progression-free survival (PFS) in the Keytruda combo arm versus best supportive care.OSE said the trial succeeded on that measure, with Tedopi plus Keytruda showing median PFS of 4.1 months versus 2.8 months for supportive care alone, corresponding to a 47% reduction in the risk of progression or death (p<0.001). The addition of Keytruda to Tedopi also reduced the risk of progression or death by 28% compared to Tedopi monotherapy, though that comparison didn't reach statistical significance (p=0.074).Treatment-emergent adverse events were more frequent in the combo arm than Tedopi alone, including cytokine release syndrome (28% vs 9%) that was mostly mostly grade 1 or 2, arthralgia (21% vs 17%), and grade 2 or higher immune-related events (18% vs 4%)."Ovarian cancer patients treated with platinum sensitive relapse post bevacizumab and PARP-inhibitors represent an unmet medical need with a PFS of less than 3 months post platinum-based chemotherapy," noted Leary. "TEDOVA brings the first proof of concept for a vaccine strategy in ovarian cancer, and actually the first positive trial in platinum-sensitive ovarian cancer in years."Tedopi is also being evaluated in the Phase III ARTEMIA study in second-line non–small-cell lung cancer (NSCLC) for patients who developed resistance to checkpoint inhibitors. Additional Phase II trials are investigating the vaccine in pancreatic cancer and as a combination with Bristol Myers Squibb's Opdivo (nivolumab) in NSCLC.

Clinical ResultPhase 2ASCOVaccineDrug Approval

100 Deals associated with Nivolumab

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KEGG	Wiki	ATC	Drug Bank
D10316	Nivolumab	L01XC17	DB09035

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
MSI-H/dMMR Rectal Cancer	Japan	Ono Pharmaceutical Co., Ltd.	25 Aug 2025
PD-L1 positive Non-Small Cell Lung Cancer	China	Bristol-Myers Squibb Pharma EEIG	22 Jul 2025
Metastatic hepatocellular carcinoma	Australia	Bristol-Myers Squibb Australia Pty Ltd.	26 Jun 2025
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
Carcinoma	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

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
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
Mediastinal large B-cell lymphoma	Phase 3	United States	National Cancer Institute	05 Oct 2021
Mediastinal large B-cell lymphoma	Phase 3	Australia	National Cancer Institute	05 Oct 2021
Mediastinal large B-cell lymphoma	Phase 3	Canada	National Cancer Institute	05 Oct 2021
Refractory Cancer	Phase 3	United States	Bristol Myers Squibb Co.	01 Jun 2021
Refractory Cancer	Phase 3	United States	Bayer AG	01 Jun 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03646461 (CTgov)	Phase 2	Recurrent Squamous Cell Carcinoma of the Head and Neck	5	Ibrutinib 560mg PO daily (Imbruvica)+Cetuximab (Arm A: Ibrutinib + Cetuximab)	ahwvsagavs = njdvcgkyuu awfuzewuin (tsikamipnm, jveoxhjnfz - rrbdpgcwec) View more	-	22 May 2026
				Ibrutinib 560mg PO daily (Imbruvica)+Nivolumab (Arm B: Ibrutinib + Nivolumab)	ahwvsagavs = utnzecmwdr awfuzewuin (tsikamipnm, eloqsruljn - bxjxblitfs) View more
NCT04019964 (CTgov)	Phase 2	Recurrent Prostate Carcinoma \| Microsatellite instability-high cancer	8	Nivolumab	zysnccouas = yanbyxvnuc yctmhcbjjw (remvzleawt, hmsusjfbwy - qgznqiceud) View more	-	15 May 2026
NCT01703949 (3060, CTgov)	Phase 2	Non-Hodgkin's lymphoma refractory \| Refractory Hodgkin Lymphoma \| Recurrent Non-Hodgkin Lymphoma ... View more	28	Laboratory Biomarker Analysis+Brentuximab Vedotin (Arm A (Brentuximab Vedotin))	tvvgfjbjss = pnelghrykg tylhkgjjfz (jaowajccax, uqsoqrocad - kvuylumpvh) View more	-	12 May 2026
				Laboratory Biomarker Analysis+Nivolumab+Brentuximab Vedotin (Arm B (Brentuximab Vedotin, Nivolumab))	tvvgfjbjss = fhblofmlrd tylhkgjjfz (jaowajccax, jzdetwriow - abqpdbprxb) View more
NCT03767582 (CTgov)	Phase 1/2	Advanced Pancreatic Ductal Adenocarcinoma \| Locally Advanced Pancreatic Adenocarcinoma	22	GVAX+Nivolumab+Gemcitabine+BMS-813160 (Phase I - Dose Level 1)	ssshdzvtme = vlawpadvwe xehgrkmlsg (yvisdhcwnc, sracqiigad - ypqtmhfjdm) View more	-	11 May 2026
				GVAX+Nivolumab+Gemcitabine+BMS-813160 (Phase I - Dose Level 2)	ssshdzvtme = dklylmowgk xehgrkmlsg (yvisdhcwnc, srconwfvkw - zwaoeyrkoj) View more
NCT03637543 (CTgov)	Phase 2	Non-metastatic prostate cancer	29	Nivolumab (PD-L1 Negative)	dunemnrmjx = rgodbtncvf solsfiquvh (qvhbnneuks, kthtflbvyk - deewoqhtzd) View more	-	08 May 2026
				Nivolumab (PD-L1 Positive)	dunemnrmjx = uhfkhfqnww solsfiquvh (qvhbnneuks, zjbpqdiqmr - cwetfsmmgw) View more
NCT03355560 (CTgov)	Phase 2	Squamous Cell Carcinoma of Head and Neck	39	Nivolumab	mmfhwimrtz = ibrkcoyqxo pabucfrfgx (evmuhugrms, xsqbsbubem - cvgtjtdlmb) View more	-	06 May 2026
NCT04339738 (Alliance A091902, CTgov)	Phase 2	Hemangiosarcoma \| Soft Tissue Sarcoma	90	FDG-Positron Emission Tomography+Nivolumab+Paclitaxel (Arm I (Nivolumab, Paclitaxel))	ovvlcmgqgg(csqilgipbu) = anczohafzw ewrhyhdbmb (gxtgnxdpov, afaowroelx - mtajskblfz) View more	-	05 May 2026
				FDG-Positron Emission Tomography+Paclitaxel (Arm II (Paclitaxel))	ovvlcmgqgg(csqilgipbu) = yjuuxayeys ewrhyhdbmb (gxtgnxdpov, xafkeawacs - aojdatbpnw) View more
NCT05144529 (TOP2101, CTgov)	Phase 2	metastatic non-small cell lung cancer	19	Ipilimumab+Nivolumab (Ipilimumab/Nivolumab)	ibskxnmrwv = bvtywafddg bhyutkoupi (zxnjuisclg, rgeosluinz - emqwornrvh) View more	-	05 May 2026
				Evolocumab+Ipilimumab+nivolumab (Ipilimumab/Nivolumab/Evolucumab)	ibskxnmrwv = ftzzixwfet bhyutkoupi (zxnjuisclg, ecnqyuvckb - xzartstdcf) View more
NCT03439891 (Pubmed \| JHEP Rep)	Phase 2	Hepatocellular Carcinoma	16	Sorafenib + Nivolumab	diqkjnqgbc(nwoqmrcgnq) = hfjtavoxxb hpzuosajwy (hrakmabbfz ) View more	Negative	01 May 2026
NCT03367741 (CTgov)	Phase 2	Metastatic endometrial cancer \| Advanced Endometrial Carcinoma \| Recurrent Endometrial Cancer	82	Computed Tomography+Nivolumab+Cabozantinib S-malate (Arm A (Cabozantinib S-malate, Nivolumab))	ceewgvjxkt(dxujkinjpa) = fsbwykmjnn zxajduaqmm (qahysxxtkw, trkdxbnxyi - akqullwvpj) View more	-	29 Apr 2026
				Computed Tomography+Nivolumab (Arm B (Nivolumab))	ceewgvjxkt(dxujkinjpa) = jlslatezzt zxajduaqmm (qahysxxtkw, tqldagkqih - fcrlwzvgkm) View more

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