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Last update 24 Jan 2025

Nivolumab

Last update 24 Jan 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

Mechanism

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

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [13]

Active Indication

Skin NeoplasmsMesothelioma, MalignantResectable Lung Non-Small Cell Carcinoma+ [496]

Inactive Indication

Acidemia, IsovalericAcquired Immunodeficiency SyndromeAcute lymphoblastic leukemia recurrent+ [98]

Originator Organization

Ono Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

Active Organization

Bristol Myers Squibb Co.

National Cancer Institute

Ono Pharmaceutical Co., Ltd.

+ [26]

Inactive Organization

Transgene SA

Navire Pharma, Inc.Startup

The University of Texas Southwestern Medical Center

+ [11]

Drug Highest PhaseApproved

First Approval Date

JP (04 Jul 2014),

Esophageal CarcinomaMelanoma

RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Priority Review (AU), Conditional marketing approval (CN), Orphan Drug (JP)

Structure/Sequence

Sequence Code 93681H

Source: *****

Sequence Code 93684L

Source: *****

1,820

Clinical Trials associated with Nivolumab

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

NCT06745076

/ Not yet recruitingPhase 2IIT

PRECISE-HL: Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation in Advanced Hodgkin Lymphoma

This phase II trial tests how well personalized reduction of chemotherapy (nivolumab, doxorubicin, vinblastine and dacarbazine) based on circulating tumor deoxyribonucleic acid (ctDNA) evaluation works for treating patients with Hodgkin lymphoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Chemotherapy drugs, such as nivolumab, doxorubicin, vinblastine and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many types of tumors tend to lose cells or release different types of cellular products including their DNA, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids and, based on the result, assign patients to a reduced number of chemotherapy treatments or the standard number of chemotherapy treatments. Using ctDNA to assign a personalized reduction of chemotherapy may be effective in treating patients with advanced Hodgkin lymphoma.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Washington

NCT06708949

/ Not yet recruitingPhase 2IIT

A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)

This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.

Start Date01 May 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

100 Clinical Results associated with Nivolumab

100 Translational Medicine associated with Nivolumab

100 Patents (Medical) associated with Nivolumab

10,041

Literatures (Medical) associated with Nivolumab

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·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·OncoImmunology

Circulating cytokine associations with clinical outcomes in melanoma patients treated with combination nivolumab plus ipilimumab

Article

Author: Baginska, Joanna ; Rodig, Scott J. ; Severgnini, Mariano ; Hodi, F. Stephen ; Chen, Jiajia ; Manuszak, Claire ; Brennick, Ryan ; Weirather, Jason L. ; Manos, Michael ; Ranasinghe, Srinika ; Liu, David ; Huang, Amy Y. ; Holovatska, Marta ; Hathaway, Emma ; Nazzaro, Matthew ; Giobbie-Hurder, Anita ; Tarantino, Giuseppe ; Pfaff, Kathleen L. ; Russell, Janice D.

Nivolumab plus ipilimumab (aCTLA-4/aPD-1) combination therapy has significantly improved clinical outcomes in patients with metastatic melanoma, with 50%-60% of patients responding to treatment, but predictors of response are poorly characterized. We hypothesized that circulating cytokines and peripheral white blood cells may predict response to therapy and evaluated 15 cytokines and complete blood counts (CBC with differentials) from 89 patients with advanced melanoma treated with combination therapy from three points in time: pre-treatment, one month and approximately three months after starting therapy. Clinical endpoints evaluated included durable clinical benefit (DCB), progression-free survival (PFS), and overall survival (OS). A parsimonious predictive model was developed to identify cytokines predictors of response to combination therapy. In this study, we found that pre-treatment, patients with DCB had higher IL-23, lower CXCL6, and lower IL-10 levels. Lower NLR one month after starting therapy predicted better PFS and OS, primarily driven by an increase in absolute lymphocytes. A multivariate model demonstrated that baseline CXCL6, IL-10, IL-23 were independent predictors of therapy response, and the combined model has reached an area under the curve (AUC) of 0.79 in prediction of response to combination therapy. Our study identified baseline CXCL6, IL-23, and IL-10 as predictors of response to aCTLA4/aPD1 combination therapy among patients with metastatic melanoma. This study also provides a framework for identifying patients who are likely to respond to combination ICB, as well as a subset of patients with high risk of developing resistance and are thus in need of alternative therapeutic options, such as clinical trials.

1,789

News (Medical) associated with Nivolumab

22 Jan 2025

·ir.zailaboratory.com

Zai Lab Receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of Small Cell Lung Cancer (SCLC)

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 22, 2025-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate (ADC), for the treatment of small cell lung cancer (SCLC). “Receiving an Orphan Drug Designation for ZL-1310 recognizes its potential to treat patients with SCLC. These patients have an urgent need for innovative treatment options with improved efficacy, safety and ready access in tertiary care and community settings,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “ZL-1310 has demonstrated promising objective response rates and a favorable safety profile from the ongoing Phase 1 trial in patients with recurrent SCLC recently disclosed. We look forward to continuing to advance the clinical development of this promising asset across lines of therapy in SCLC and other DLL3-expressing tumors.” ZL-1310 will be eligible for certain development incentives, including a waiver of the Prescription Drug User Fee Act registration application fee, tax credits for certain clinical trials and the potential to receive a seven-year U.S. market exclusivity period granted upon product approval. This important regulatory designation follows promising data from the ongoing global Phase 1a/1b study in patients with previously treated extensive-stage SCLC (ES-SCLC) after at least one prior platinum-based chemotherapy regimen, which was presented at the EORTC-NCI-AACR (ENA) Symposium 2024 in October 2024. About ZL-1310 ZL-1310 is a novel ADC in Zai Lab’s growing, global oncology pipeline that targets Delta-like ligand 3 (DLL3), an antigen that is overexpressed in many neuroendocrine tumors, is typically associated with poor clinical outcomes, and is a validated therapeutic target for SCLC. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody linked to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN®, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, including off-target payload toxicity. The ongoing Phase 1a/1b clinical trial is evaluating ZL-1310 as monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for the treatment of ES-SCLC. About Small Cell Lung Cancer (SCLC) SCLC is one of the most aggressive and lethal solid tumors, accounting for ~15% of approximately 2.5 million patients diagnosed with lung cancer worldwide each year1,2. Two-thirds of all SCLC patients are diagnosed at extensive stage3, which is associated with high rates of relapse and poor prognosis. The outcomes of the patients with ES-SCLC are dismal, with median survival of approximately 12 months following initial therapy4 and a 5~10% overall five-year survival rate5. Treatment options are limited when patients progress, with the current standard of care resulting in limited clinical benefit. Despite recent advancements, new readily available treatment options with improved efficacy and manageable safety are needed. References: 1 J Thorac Oncol. 2023 Jan;18(1):31-46; Lung Cancer Foundation of America. 2 WHO Globocan 2022. 3 Sabari JK, et al. Nat Rev Clin Oncol. 2017;14:549-561. 4 Phase 3 IMpower133 (atezolizumab) and CASPIAN study (durvalumab). 5 National Cancer Institute. www.cancer.gov. Accessed October 15, 2024. About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.X.com/ZaiLab_Global, www.twitter.com/ZaiLab_Global. Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing next generation ADCs, including ZL-1310, the potential benefits of ZL-1310, and the potential treatment of SCLC and neuroendocrine tumors. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.sec.gov. View source version on businesswire.com: https://www.businesswire.com/news/home/20250123670143/en/ For more information, please contact: Investor Relations: Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Source: Zai Lab Limited

ImmunotherapyPhase 1Orphan DrugClinical ResultAACR

21 Jan 2025

·www.globenewswire.com

Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma

PDUFA action date of July 22, 2025, with priority reviewWOBURN, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025. The FDA also informed the Company that they are not currently planning to hold an advisory committee meeting in relation to this application, and at this time have not identified any potential review issues. The BLA is supported by the primary analysis data of the IGNYTE trial, evaluating RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma. A confirmatory Phase 3 trial, IGNYTE-3, is currently underway with over 100 sites planned globally. “There are limited treatment options and a significant unmet need for patients with advanced melanoma who previously received an anti-PD-1 containing regimen,” said Sushil Patel, Ph.D., Chief Executive Officer, Replimune. “The BLA acceptance is an important milestone for Replimune, and we look forward to working closely with the FDA on the review of our application.” The FDA grants Priority Review to applications for medicines that, if approved, provide significant improvements in the safety or effectiveness of the treatment of a serious condition. Recently, Replimune received Breakthrough Therapy designation for RP1 in combination with nivolumab for the treatment of advanced melanoma, based on the safety and clinical activity observed in the anti-PD-1 failed melanoma cohort of the IGNYTE clinical trial. The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. For more information, please visit https://replimune.com/clinical-trials/ignyte-3/. About MelanomaMelanoma is the fifth most common cancer, with approximately 100,000 new cases and 8,000 deaths estimated in the U.S. in 2024.i Standard of care therapy includes treatment with immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment. Options are limited after immune checkpoint blockade therapy, with no standard of care available to patients. About RP1RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response. About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. Forward Looking StatementsThis press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the FDA review process, review timing and outcome of our BLA, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues and the Russian-Ukrainian and Israel-Hamas political and military conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor InquiriesChris BrinzeyICR Healthcare339.970.2843chris.brinzey@icrhealthcare.com Media InquiriesArleen GoldenbergReplimune917.548.1582media@replimune.com i American Cancer Society. “Cancer Facts and Figures 2024”. Atlanta: American Cancer Society; 2024.

Phase 3ImmunotherapyPriority ReviewBreakthrough Therapy

16 Jan 2025

·www.prnewswire.com

BioWorld by Clarivate Releases Comprehensive 2024 Year in Review

Series Recaps Biopharma, MedTech, and Science Trends and Breakthroughs That Shaped the Year LONDON, Jan. 16, 2025 /PRNewswire/ -- BioWorld™ published by Clarivate Plc (NYSE:CLVT), a leading global provider of transformative intelligence, has released its highly anticipated 2024 Year in Review series. This multipart special report offers an in-depth analysis of the therapeutic trends, regulatory actions and economic shifts that defined biopharma, med tech and scientific innovation over the past year while forecasting key developments for 2025. As the biopharma and med-tech industries continue to evolve, 2024 proved to be a landmark year. The comprehensive recap by BioWorld highlights therapeutic breakthroughs in psychiatry, oncology, women's health and infectious diseases, alongside economic highs and lows that challenged the global landscape. The series also examines regulatory changes, including U.S. court cases and international policy shifts, that could shape the future of drug pricing, reimbursement, and innovation. Lynn Yoffee, Publisher of BioWorld, said: "The 2024 Year in Review series provides a powerful lens into the transformative events and advancements that shaped our industry this year. With our team of expert journalists and analysts, we strive to distill complex developments into actionable insights, empowering stakeholders to make informed decisions as they navigate 2025 and beyond." Key Highlights of the BioWorld 2024 Year in Review Series: BioWorld Year in Review : This section highlights the top mergers and acquisitions, licensing deals, financings, and first approvals of 2024. It also provides insights into key therapeutic trends such as GLP-1 receptor agonists, antibody-drug conjugates (ADCs), psychedelics, and the evolving role of precision psychiatry, alongside innovations spurred by the pandemic. Featured articles include: The Economy: Top Biopharma Trends of 2024 by Amanda Lanier A comprehensive infographic that highlights how 2024 showcased resilience amidst challenges, with biopharma financing and deal values rebounding significantly despite over 18,000 job losses and a tempered IPO market. Spotlights include record-high deal values, a steady M&A pace with reduced total value, and a slightly increased rate of workforce reductions compared to 2023. Year's top US court cases to present new challenges for 2025 by Mari Serebrov The Loper Bright decision ended the Chevron doctrine, curbing agency authority and reshaping regulatory dynamics for 2025. Meanwhile, Gilead's $40 million settlement over HIV drug delays highlights new liability risks for biopharma. Both developments underscore the evolving legal landscape and its potential to reshape regulatory and innovation dynamics in 2025. European VC improves in 2024, driven by ADCs and CNS, inflammatory drugs by Nuala Moran European biotech funding improved in 2024, with venture capital raised exceeding 2020 levels but still trailing the pandemic peak. Investors favored later-stage programs with clearer paths to exits, while antibody-drug conjugates (ADCs) and central nervous system (CNS) assets drew significant interest. Despite challenges like closed public markets and antimicrobial fragility, optimism for 2025 is growing, fueled by expected macroeconomic improvements and strong M&A activity. GLP-1 receptor agonists continue their global victory tour by Anette Breindl GLP-1 receptor agonists (GLP-1RAs) had a transformative 2024, expanding into new therapeutic indications, including FDA approval for treating obstructive sleep apnea in adults with obesity, while continuing to demonstrate benefits in cardiovascular health, kidney disease, and other conditions. Despite their success, GLP-1RAs remain treatments rather than cures for underlying conditions like diabetes, prompting ongoing research into root-cause solutions. BioWorld MedTech Year in Review : This section recaps key med-tech and diagnostic breakthroughs, covering cutting-edge advancements in brain mapping and pregnancy health, as well as regulatory developments expected to impact the sector in 2025. Coverage includes: AI drives financings, approvals for APAC med-tech in 2024 By Marian (YoonJee) Chu In 2024, AI spurred significant financings and approvals in APAC med-tech, leveraging regional strengths like talent pools, data infrastructure, and government support. Key highlights included AI-powered IPOs, billion-dollar pharma collaborations, and national investments, solidifying APAC's role in AI-driven healthcare innovation. Medicare coverage issues abound in 2024 by Mark McCarty In 2024, Medicare faced challenges in covering emerging technologies, with the new TCET policy offering limited scope. Coverage for digital health and SaaS remained stalled due to outdated benefit categories. Meanwhile, Medicare's reimbursement rates for radiation oncology and skin substitutes sparked controversy. BioWorld Science Year in Review : This section explores key research milestones, featuring global collaborations in infectious diseases, breakthroughs in curable tumors and innovations in women's health and neuroscience. Key highlights include: The map for a journey to the center of the brain by Mar de Miguel The year 2024 marks a milestone with the end of a long journey: a complete cellular map of the fruit fly brain, Drosophila melanogaster, and a cubic millimeter of the human brain. The adventure is just beginning for the thinking species Homo sapiens. Progress in cancer research, even the toughest types by Mar de Miguel and Anette Breindl Among the most profound results presented at the 2024 European Society for Medical Oncology Congress were the 10-year data from the Checkmate-067 and Keynote-006 trials, the phase III trials that tested Opdivo (nivolumab, Bristol Myers Squibb Co.) and Keytruda (pembrolizumab, Merck & Co. Inc.) as first-line agents in advanced or metastatic melanoma. The series also includes the BioWorld editorial picks for the "Best of 2024," dynamic infographics summarizing key data, and a global perspective on funding and policy changes across Europe and Asia. To access the full BioWorld special series, visit . Join the conversation and mention BioWorld on X and LinkedIn as well as Clarivate for Life Sciences & Healthcare on X and LinkedIn. About BioWorld With writers and editors stationed around the globe, BioWorld published by Clarivate, reports the breaking news - and provides key perspective on thousands of therapeutics and devices in development, the companies behind those candidates, the business development transactions that evolve the markets, and the regulatory hurdles that both challenge and guard the processes. BioWorld has a long tradition of excellence in journalism. Collectively, the news services have been honored with 70 awards dating back to 1998. About Clarivate Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit . Media Contact: Catherine Daniel Director, External Communications, Life Sciences & Healthcare [email protected] SOURCE Clarivate Plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical Result

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
Skin Neoplasms	JP	Ono Pharmaceutical Co., Ltd.	09 Feb 2024
Mesothelioma, Malignant	JP	Ono Pharmaceutical Co., Ltd.	24 Nov 2023
Resectable Lung Non-Small Cell Carcinoma	EU	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Resectable Lung Non-Small Cell Carcinoma	IS	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Resectable Lung Non-Small Cell Carcinoma	LI	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Resectable Lung Non-Small Cell Carcinoma	NO	Bristol-Myers Squibb Pharma EEIG	14 Jul 2023
Urothelial Carcinoma of the Urinary Bladder	JP	Bristol Myers Squibb Co.	28 Mar 2022
Unknown Primary Neoplasms	JP	Bristol Myers Squibb Co.	24 Dec 2021
Unknown Primary Neoplasms	JP	Ono Pharmaceutical Co., Ltd.	24 Dec 2021
Gastrooesophageal junction cancer	US	Bristol Myers Squibb Co.	16 Apr 2021
Mesothelioma	JP	Bristol Myers Squibb Co.	21 Aug 2018
Small Cell Lung Cancer	US	Bristol Myers Squibb Co.	16 Aug 2018
Metastatic melanoma	AU	Bristol-Myers Squibb Australia Pty Ltd.	06 Jul 2018
Hepatocellular Carcinoma	US	Bristol Myers Squibb Co.	22 Sep 2017
Stomach Cancer	JP	Ono Pharmaceutical Co., Ltd.	22 Sep 2017
Stomach Cancer	JP	Bristol Myers Squibb Co.	22 Sep 2017
Colorectal Cancer	US	Bristol Myers Squibb Co.	31 Jul 2017
Head and Neck Neoplasms	JP	Ono Pharmaceutical Co., Ltd.	24 Mar 2017
Head and Neck Neoplasms	JP	Bristol Myers Squibb Co.	24 Mar 2017
Hodgkin's Lymphoma	US	Bristol Myers Squibb Co.	17 May 2016

Developing

10 top R&D records.

to view more data

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


NCT03406871 (REGONIVO \| REGONIVO, EPOC1603, CTgov)	Phase 1	Metastatic Solid Tumor \| Advanced Malignant Solid Neoplasm	50	Regorafenib (Dose Escalation Cohort Regorafenib 80mg)	fqaztyggsp(mewjndursd) = wiibzdhsml hzybiskfnx (iheleclgjn, lnaiffilpp - rqwhlpqpql)	-	24 Jan 2025
				Regorafenib (Dose Escalation Cohort Regorafenib 120mg)	fqaztyggsp(mewjndursd) = bdzsgpbvaf hzybiskfnx (iheleclgjn, ofufweaqdf - gfzwbycpnv)
NCT02693535 (TAPUR, ASCO_GI2025) Manual	Phase 2	Pancreatic Cancer BRCA2 Mutation \| BRCA1 Mutation	32	Nivolumab plus ipilimumab	dbfzhougoj(ayjtnefczw) = wdnhfcttbm nwjjaxzzzq (fwpicxzmev, 18 - 100) View more	Positive	23 Jan 2025
NCT04039607 (CheckMate 9DW, ASCO_GI2025) Manual	Phase 3	Unresectable Hepatocellular Carcinoma	668	Nivolumab + Ipilimumab	fixmuxgqft(xvqdrblkut) = qoharxbcvv wlkxhyqnte (pkklhxeytd, 31 - 42) View more	Positive	23 Jan 2025
				Lenvatinib/sorafenib	fixmuxgqft(xvqdrblkut) = dnssxmzrfv wlkxhyqnte (pkklhxeytd, 10 - 17) View more
NCT04350463 (CTgov)	Phase 2	Advanced cancer	92	CC-90011+Nivolumab (Cohort A 40 mg)	mkzgaqxbsh(adzwclqpoj) = xwctgqekss brnfvautvm (syfceymczz, zzttnndang - zfbumfcman) View more	-	22 Jan 2025
				CC-90011+Nivolumab (Cohort A 60mg)	mkzgaqxbsh(adzwclqpoj) = aufoamvpts brnfvautvm (syfceymczz, cbsixvtzur - ggcfmmehil) View more
NCT02960230 (CTgov)	Phase 1/2	Diffuse midline glioma, point mutation K27M in histone H3 \| Diffuse Intrinsic Pontine Glioma	50	K27M peptide (Stratum A: Newly Diagnosed DIPG)	anxiizmffe(xeimkitmwx) = fdiumujhge gukscyfnvi (xltycmyhty, sfaxoqnrpv - nciukuweuo) View more	-	22 Jan 2025
				K27M peptide (Stratum B: Newly Diagnosed Glioma (Non-DIPG))	anxiizmffe(xeimkitmwx) = lbiufvsxox gukscyfnvi (xltycmyhty, ljdyryecou - xyesihlaue) View more
NEWS Manual	Not Applicable	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	-	纳武利尤单抗240 mg (PD-L1≥50%)	ccfrcgwwxo(fkyvfhcbxe) = jtkygnvarr bipqbxqesd (wokhrjvbmf ) View more	Positive	20 Jan 2025
				纳武利尤单抗240 mg + Relatlimab 80 mg (PD-L1≥50%)	ccfrcgwwxo(fkyvfhcbxe) = qgqdxotokd bipqbxqesd (wokhrjvbmf ) View more
NCT04187833 (CTgov)	Phase 2	Metastatic melanoma \| Unresectable Melanoma	8	Nivolumab+Talazoparib	xvezyunvop(zrexmjzwly) = vxywtkorvs tkfflnzllz (spqjgdxjxw, hfgoeittou - wtzqxqbrki) View more	-	14 Jan 2025
NCT03980925 (GETNE T1913, CTgov)	Phase 2	Neuroendocrine neoplasm of gastrointestinal tract \| Gastro-Enteropancreatic Neuroendocrine Tumor	37	Nivolumab+Etoposide+Carboplatin	bmxtmcjtgg(aatikbtnfo) = qiyffdepqe jwccoamfyd (dplorrzsen, pmvmvtlory - yxphaggdmj) View more	-	13 Jan 2025
NCT03452579 (NAVAL \| ATIM-40, CTgov)	Phase 2	Recurrent Glioblastoma	90	Standard Dose Bevacizumab+Nivolumab (Nivolumab + Standard Dose Bevacizumab)	dihazewwhi(dytagqtpws) = upaghbsfha oaqsnoxcgu (fvtvaexsru, akndeifefm - lmxfiydtht) View more	-	13 Jan 2025
				Low Dose Bevacizumab+Nivolumab (Nivolumab + Low Dose Bevacizumab)	dihazewwhi(dytagqtpws) = gxdesvffkk oaqsnoxcgu (fvtvaexsru, ogdvaltpcq - omaawtnaed) View more
NCT03715946 (CTgov)	Phase 2	Squamous Cell Carcinoma of the Oropharynx \| Squamous Cell Carcinoma of Head and Neck	40	Radiotherapy (RT)+Nivolumab Injection	ilninoysab(cuhuuufoqp) = inqztvdvqu fugohwicvn (ebpvkyahos, tnzzwiyeir - aoabknwkrp) View more	-	13 Jan 2025

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