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)

+ [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+ [500]

Inactive Indication

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

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

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)

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Structure/Sequence

Sequence Code 93681H

Source: *****

Sequence Code 93684L

Source: *****

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]

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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13,123

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

Final 3-year results from the EVIDENS study, an observational study of nivolumab in non-small cell lung cancer

Article

Author: Debieuvre, Didier ; Asselain, Bernard ; Brellier, Florence ; Auliac, Jean-Bernard ; Khalife, Yaacoub ; Cotté, François-Emery ; Moro-Sibilot, Denis ; Barlesi, Fabrice ; Pérol, Maurice ; Bombaron, Pierre ; Dixmier, Adrien ; Raspaud, Christophe ; Audigier-Valette, Clarisse ; Benoit, Nicolas

EVIDENS was a prospective, non-interventional, longitudinal study conducted in non-small cell lung cancer (NSCLC) patients receiving nivolumab in France. It recruited adults with pathologically confirmed NSCLC who initiated nivolumab between October 2016 and November 2017; the final results are reported here. Primary outcomes included baseline characteristics and 36-month overall survival (OS). Secondary outcomes included progression free survival (PFS), objective response rate (ORR), safety and health-related quality of life (HRQoL; assessed regardless of nivolumab continuation or interruption). Overall, 1423 patients were included in the analysis population (median age 66 years; non-squamous histology 69.1%; stage IV disease 91.5%; brain metastases 19.9%). Almost all patients (99.7%) had received prior chemotherapy, and most patients received nivolumab as second-line (73.5%) or later (26.1%) therapy. The 36-month OS rate was 19.7% (95% confidence interval [CI] 17.5-22.0); OS was significantly shorter in patients with squamous versus non-squamous tumors (9.8 [95% CI 8.6-11.2] months vs 11.8 [95% CI 10.2-13.2] months; p = 0.005). The 36-month PFS rate was 8.8% (95% CI 7.3-10.4). The 12-month investigator-assessed best ORR in the overall population was 20.4%. Eastern Cooperative Oncology Group performance status, smoking status, tumor histology, disease stage and liver metastasis independently predicted survival. Grade 3 and 4 treatment-related adverse events were reported in 8.0% and 0.8% of patients, respectively; eight treatment-related deaths occurred (0.005%). HRQoL was maintained with slight improvement throughout the study, without statistical significance. These results confirm that the real-world effectiveness and safety of nivolumab in these patients is similar to that observed in clinical trials.

1,823

News (Medical) associated with Nivolumab

15 Apr 2025

·pipelinereview.com

Aulos Bioscience Doses First Patient in Phase 2 Cohort Evaluating AU-007 in Combination With Nivolumab for Second-Line Treatment of Melanoma

LARKSPUR, CA, USA I April 14, 2025 I Aulos™ Bioscience, an immuno-oncology company working to revolutionize cancer care through development of immune-activating antibody therapeutics, today announced dosing of its first patient with a combination of AU-007, the anti-PD-1 antibody nivolumab and low-dose, subcutaneous aldesleukin in a Phase 2 expansion cohort focused on second-line treatment of melanoma. This new cohort is part of Aulos’ Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic cancer. Preliminary Phase 2 data presented in November at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting showed that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in patients with melanoma, with durable objective responses achieved. The additional Phase 2 cohort in melanoma now allows the nivolumab combination portion of this study to progress. “We are excited that the first patient is receiving treatment in this new Phase 2 cohort evaluating AU-007 in combination with nivolumab,” said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer . “Given its unique mechanism of action and the positive data presented to date on AU-007 and low-dose, subcutaneous aldesleukin, we believe that AU-007 holds real promise as a novel immuno-oncology treatment in combination with checkpoint inhibitors in multiple cancer types. These include non-small cell lung cancer, for which we initiated a Phase 2 cohort with the anti-PD-L1 antibody avelumab in November, and now melanoma.” AU-007 is the first human monoclonal antibody designed with the assistance of artificial intelligence to enter a human clinical trial. The antibody harnesses the power of interleukin-2 (IL-2) by binding precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells. Aulos anticipates presenting preliminary data from the Phase 2 cohort evaluating AU-007, nivolumab and low-dose, subcutaneous aldesleukin as a second-line treatment for melanoma in the second half of 2025. The company will present new Phase 2 data for AU-007 and low-dose, subcutaneous aldesleukin without a checkpoint inhibitor as a second-line treatment for melanoma at the American Association for Cancer Research (AACR) Annual Meeting later this month. To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626 ). For patients and providers in the U.S., please visit www.solidtumorstudy.com . For patients and health professionals in Australia, please visit www.solidtumourstudy.com . About AU-007 AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy. About Aulos Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through immune-activating antibody therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a human antibody designed by leveraging artificial intelligence that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners ( ATP ) and is led by pioneers in the fields of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulos.com , X ( @AulosBioscience ) and LinkedIn . SOURCE: Aulos Bioscience

Phase 2ImmunotherapyAACRClinical Result

15 Apr 2025

·www.biopharmadive.com

Bristol Myers stumbles in bid to widen heart drug’s use

Dive Brief:Bristol Myers Squibb on Monday said its drug Camzyos failed a Phase 3 trial in people with a progressive heart condition, closing off an opportunity to expand use of a medicine it sees as a future blockbuster.According to Bristol Myers, Camzyos missed the dual main goals of a study focused on the non-obstructive form of HCM, or hypertrophic cardiomyopathy. It failed to meaningfully improve peak oxygen consumption as well as scores on an assessment of heart health. The company didnt provide study details, but said more information will be shared with the scientific community in the future.Camzyos was acquired through the $13 billion buyout of MyoKardia in 2020 and two years later became the first drug cleared for use in the obstructive and more common form of the disease. Biotechnology companies Cytokinetics and Edgewise Therapeutics are developing similar medicines that are both in the advanced stages of clinical testing. Cytokinetics drug, aficamten, could be approved in the U.S. later this year.Dive Insight:Camzyos setback carries implications for Bristol Myers as well as the companies trying to develop better medicines for HCM, a chronic condition characterized by a potentially deadly stiffening of the heart muscle.Bristol Myers is bracing for the losses of billions of dollars in yearly revenue when the patents expire for its cancer immunotherapy Opdivo and blood thinner Eliquis. The company already announced a cost-cutting plan under CEO Chris Boerner, and is looking to a handful of medicines, Camzyos among them, to grow sales in the years ahead.Camzyos generated $602 million in sales in 2024. But Bristol Myers has said that number could reach $4 billion in 2029, and one way to get there was a clearance in the non-obstructive setting, which is estimated to account for about a third of the people with the condition. The setback is a disappointment, wrote Leerink Partners analyst David Risinger, though Bristol Myers could rebound if a series of coming Phase 3 readouts are successful.The study failure also stirred debate among analysts as to whether drugs like Camzyos, known as cardiac myosin inhibitors, can help all people with HCM. Camzyos has proven beneficial for the obstructive form that impedes blood flow and can lead to heart failure as well as other potentially serious complications. The non-obstructive type doesnt, but can still put people at risk of poor health outcomes. The new study tested whether Camzyos might be similarly helpful for those people as well.The fact that Camzyos wasnt suggests obstructive and non-obstructive HCM are two unique diseases, said Milind Desai, the director of the Cleveland Clinics HCM Center, in a statement provided by Bristol Myers.Analysts were mixed on whether the cardiac myosin inhibitors Cytokinetics and Edgewise are developing might similarly struggle in non-obstructive HCM. Cytokinetics drug, aficamten, is under Food and Drug Administration review in obstructive HCM and in a Phase 3 trial in non-obstructive disease. Edgewises EDG-7500 could join it in late-stage testing next year.Matt Phipps, of the investment bank William Blair, wrote that Camzyos shaky performance in the latest study as well as Phase 2 testing in non-obstructive HCM patients may be more attributed to disease biology, which has negative implications for the whole drug class.That form of the disease is also more heterogeneous, making it tougher for a drug to succeed in testing, added RBC Capital Markets Leonid Timashev.Still, there are key differences between the drugs and their development plans that leave some analysts optimistic about Cytokinetics and Edgewises chances. Aficamten appeared to perform better in earlier testing in non-obstructive patients, and Cytokinetics Phase 3 study is designed differently, wrote Mizuho Securities Salim Syed. RBCs Timashev added that EDG-7500s unique mechanism could overcome the limitations of other medicines in non-obstructive HCM.We now see a 2-handed market split between Cytokinetics and Edgewise, Timashev wrote. '

Drug ApprovalPhase 3AcquisitionPhase 2Immunotherapy

14 Apr 2025

·endpts.com

Bristol Myers says Camzyos fails Phase 3 study in genetic heart condition

The centerpiece of Bristol Myers Squibb’s $13 billion MyoKardia acquisition failed a Phase 3 study meant to expand the product’s usage, BMS said Monday post-market, a development that could considerably cap its sales ceiling. The pharma company’s heart drug Camzyos failed to meet either of its two primary endpoints in a study for non-obstructive hypertrophic cardiomyopathy, or nHCM. Specific data were not disclosed in the announcement , and Bristol Myers said it would present the full results at a medical meeting at some point in the future. Camzyos was first approved in 2022 to treat a heart condition related to nHCM called obstructive hypertrophic cardiomyopathy, or oHCM. Last year, it netted $602 million in worldwide sales, a 141% increase from 2023. It’s one of the drugs Bristol Myers lists in its “growth portfolio,” a relatively new classification set up by CEO Chris Boerner around the same time he enacted sweeping cost-cutting measures to get the company on track. BMS expects the company’s growth portfolio to make up half its sales this year. Monday’s trial failure is likely to lower Camzyos’ sales potential since Bristol Myers is not currently running any other clinical trials for it in other diseases, according to the company’s most recent pipeline update from February. But BMS is still running a pediatric trial for Camzyos in oHCM for adolescents aged 12 to 17. BMS’ stock price $BMY fell about 2% post-market Monday. The February pipeline update said Bristol Myers was preparing for a potential 2026 launch if the Phase 3 study succeeded. Back in 2022, the company projected that peak sales of the drug could reach $4 billion by 2029. Other medicines that Bristol Myers considers growth drivers include the CAR-T therapies Abecma and Breyanzi, the PD-1 inhibitor Opdivo, the immunology drug Sotyktu, and the newly-approved schizophrenia drug Cobenfy. Editor’s note: This story was updated to correct that Bristol Myers is running another trial for Camzyos in the pediatric oHCM setting, and to clarify the timing of when it began classifying drugs under its “growth portfolio.”

Phase 3Drug Approval

100 Deals associated with Nivolumab

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External Link

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
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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03313804 (CTgov)	Phase 2	Squamous Cell Carcinoma of Head and Neck \| Non-Small Cell Lung Cancer \| metastatic non-small cell lung cancer	76	nivolumab	rkeoydnomy = koywjvcifp ctosczxlgk (emxrvyhawo, octximedgm - oozlvcefgy) View more	-	06 Apr 2025
NCT04938232 (CTgov)	Phase 2	Relapsing classical Hodgkin lymphoma \| Refractory Hodgkin Lymphoma	13	ipilimumab+Nivolumab	yhhbrsqjrn = csjacdilqm hppdasowrc (lmucghherh, hhjmsmtowd - avuhhqbwtn) View more	-	03 Apr 2025
NCT04698187 (CTgov)	Phase 2	Refractory Melanoma \| Melanoma \| Metastatic melanoma ... View more	44	CMP-001+Nivolumab	ogjfrrnfnt = wckupacykf pplbrgevpw (tmaatdxjya, fxfmrnxhxa - ommvvkaaqi) View more	-	02 Apr 2025
NCT03035890 (CTgov)	Not Applicable	metastatic non-small cell lung cancer	35	Radiation+Immuno-Therapeutic Agent	xcbkynrnnq(caqtpworpq) = ijvfqbimlk aspcomfiol (wwvayhsqks, swwldfgfrw - mecaxxfval) View more	-	01 Apr 2025
ESMO_ELCC2025	Not Applicable	Non-Small Cell Lung Cancer Second line PD-L1 \| LAG-3 \| CD-155	78	nivolumab (High CD-155 expression)	rbdtcluxhf(ecsmoxysdm) = youtiohgqf jautfgctfo (vmsbxpvzmk, 4.9 - 7.8)	Negative	26 Mar 2025
				nivolumab (Low CD-155 expression)	rbdtcluxhf(ecsmoxysdm) = clwaoudkhl jautfgctfo (vmsbxpvzmk, 6.9 - 15.8)
ESMO_ELCC2025	Not Applicable	Non-Small Cell Lung Cancer Neoadjuvant \| Adjuvant	461	Nivolumab + chemotherapy	ipfyhxdquq(cavkkrtyto) = buaoolyifc yixxtddcnn (wanbxshkry )	Positive	26 Mar 2025
				Placebo + chemotherapy	ipfyhxdquq(cavkkrtyto) = gnxssrjcku yixxtddcnn (wanbxshkry )
NCT03351361 (GFPC 08-2015 ENERGY, ESMO_ELCC2025)	Phase 3	Non-Small Cell Lung Cancer First line	217	Nivolumab plus Ipilimumab	cbjzmsrdlb(ccltseonoj) = aexsktreou tsxvmlrnjh (meuesrfdia, 18.2 - 31.6) View more	Negative	26 Mar 2025
				Carboplatin-based Doublet	mqlyownwby(epmargxurm) = svbdtqsxmd upcnsovlcw (nouzahlbpq, 7.5 - 12.2) View more
RW-9LA (ESMO_ELCC2025)	Not Applicable	Advanced Lung Non-Small Cell Carcinoma programmed death-ligand (PD-L1) negative	40	Ipilimumab/Nivolumab + Chemotherapy	ppztksylfc(ydxkesoalr) = wdmryggkfk rkbdsusyac (dicvfnvtxo ) View more	Positive	26 Mar 2025
NCT03377023 (CTgov)	Phase 1/2	metastatic non-small cell lung cancer	66	Ipilimumab+Nivolumab+Nintedanib (Phase 1-Dose Escalation)	urfydndpng = tbxqoersyz vkyrkcdisr (wuppkdrztt, puongyvwvg - tqrxaixxed)	-	25 Mar 2025
				ipilimumab+Nivolumab+Nintedanib (Phase 2 - Arm A)	uekytiriig = gcgxozzaen mlmtskxtzw (ghvyctsuft, evyrtknlge - rcwhdigkfz) View more
NCT05543629 (CTgov)	Phase 1/2	Advanced Malignant Solid Neoplasm \| Non-Small Cell Lung Cancer	36	BMS-986442 (Part A: Treatment 1)	xyhjaturov = ucrfezfvht zjaihlanlg (shwedqnpmn, veetsbsgki - hqjabolktt) View more	-	18 Mar 2025
				BMS-986442 (Part A: Treatment 2)	xyhjaturov = qefcbcyoax zjaihlanlg (shwedqnpmn, hwhghaizhd - czyqmpybqf) View more

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Nivolumab

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