RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Priority Review (United States)

Structure/Sequence

Sequence Code 12981416H

Source: *****

Sequence Code 13030670L

Source: *****

Clinical Trials associated with Retifanlimab

NCT07219576

/ RecruitingPhase 1/2IIT

PRISM: Phase 1b of Retifanlimab and Ruxolitinib In Solid Malignancies Progressing on Prior Checkpoint Inhibition

The goal of this clinical trial is to learn what dose of ruxolitinib can be given safely together with retifanlimab in patients with metastatic renal cell carcinoma and non-small cell lung carcinoma.
The main question it aims to answer is:
What is the maximum dose of ruxolitinib that can be used safely in patients with metastatic renal cell carcinoma and non-small cell lung carcinoma, and will it work?
Participants will:
Take drug ruxolitinib twice a day and keep a diary of when they take ruxolitinib at home; visit the clinic for infusions of retifanlimab every 4 weeks; visit the clinic for checkups and tests.

Start Date08 Jan 2026

Sponsor / Collaborator

University of California San Diego

[+1]

NCT06896188

/ RecruitingPhase 1IIT

A Phase Ib Study of 9-ING-41 (Elraglusib), a Glycogen Synthase Kinase 3-beta (GSK-3β) Inhibitor, Combined With Retifanlimab, a PD-1 Inhibitor, Plus Modified FOLFIRINOX as Frontline Therapy for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)

This is a study of the combination of 9 ING-41 (elraglusib) and retifanlimab plus mFOLFIRINOX in patients with pancreatic cancer without prior systemic therapy for advanced disease. The safety lead-in cohort will consist of 6 patients, followed by dose de-escalation if necessary, based on safety assessments. After evaluating the safety and tolerability at the initial dose level, the study will proceed to an expansion cohort at the determined safe dose level, with the total maximum enrollment not exceeding 12 patients for the entire study.

Start Date22 Sep 2025

Sponsor / Collaborator

University of Pittsburgh

[+2]

NCT06959537

/ RecruitingPhase 1IIT

A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC)

The goal of this clinical research study is to find the best dose of the drugs cyclophosphamide and axatilimab that can be given in combination with the standard dose of retifanlimab to patients with metastatic TNBC.

Start Date13 Aug 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

100 Clinical Results associated with Retifanlimab

100 Translational Medicine associated with Retifanlimab

100 Patents (Medical) associated with Retifanlimab

Literatures (Medical) associated with Retifanlimab

01 Dec 2025·Lancet Respiratory Medicine

Retifanlimab versus placebo in combination with platinum-based chemotherapy in patients with first-line non-squamous or squamous metastatic non-small-cell lung cancer (POD1UM-304): a phase 3, multiregional, placebo-controlled, double-blind, randomised study

Article

Author: Gogishvili, Miranda ; Munteanu, Mihaela C ; Cornfeld, Mark ; Shi, Jianhua ; Moiseenko, Fedor ; Kuchava, Vladimer ; Cicin, Irfan ; Cil, Timucin ; Nguyen, Hoang Gia ; Arslan, Cagatay ; Lu, Shun ; Vynnychenko, Oleksandr ; Petrovic, Marina ; Nguyen, Duong Thanh ; Kulyaba, Yaroslav ; Artac, Mehmet ; Sette, Claudia V M ; Ibrahim, Aishah ; Bibichadze, Khatuna ; Olmez, Omer Fatih ; Bondarenko, Igor ; Tian, Chuan

BACKGROUND:

Checkpoint inhibitors, including combinations with standard-of-care chemotherapy, have shown survival benefit in patients with metastatic non-small-cell lung cancer (NSCLC); however, access to these drugs varies. We aimed to evaluate the efficacy of the PD-1 inhibitor retifanlimab plus platinum-based chemotherapy as first-line treatment for non-squamous or squamous metastatic NSCLC.

METHODS:

POD1UM-304 was a phase 3, multiregional, placebo-controlled, double-blind, randomised study conducted in approximately 124 hospitals and private clinical centres in 16 countries. Male and female adults aged 18 years or older with squamous or non-squamous stage IV NSCLC (staging by American Joint Committee on Cancer version 8) with Eastern Cooperative Oncology Group performance status 0 or 1 and no previous systemic therapy for metastatic NSCLC were eligible. Patients were randomly assigned (2:1) using interactive response technology to receive intravenous retifanlimab 375 mg or matching placebo on day 1 of each 21-day cycle plus standard platinum-based chemotherapy according to tumour histology for up to 2 years. Patients with non-squamous NSCLC received pemetrexed 500 mg/m² plus cisplatin 75 mg/m² on day 1 for four cycles, or carboplatin area under the curve (AUC) 5 on day 1 for four cycles, followed by pemetrexed 500 mg/m² on day 1 of each subsequent 21-day cycle, all administered intravenously, until disease progression or unacceptable toxicity. Patients with squamous NSCLC received intravenous carboplatin AUC 6 plus intravenous paclitaxel 200 mg/m² on day 1 for four cycles or intravenous nab-paclitaxel 100 mg/m² on days 1, 8, and 15 for four cycles. Treatment with retifanlimab or placebo was given for up to 35 cycles, unless there was disease progression, unacceptable toxicity, or withdrawal of consent. Randomisation was stratified by PD-L1 expression tumour proportion score, geographical region, and predominant tumour histology. The primary endpoint was overall survival, defined as time from randomisation until death due to any cause, analysed in the full analysis set. Safety was evaluated in all randomly assigned patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov (NCT04205812) and is active but no longer enrolling.

FINDINGS:

Between Sept 11, 2020, and March 14, 2023, 1388 patients were assessed for eligibility, 583 of whom were randomly assigned to retifanlimab plus chemotherapy (n=391) or placebo plus chemotherapy (n=192). 381 (65%) patients had non-squamous NSCLC and 202 (35%) had squamous NSCLC; 467 (80%) patients were male and 116 (20%) were female. Median age was 64 years (IQR 58-68). Median overall survival was longer in the retifanlimab plus chemotherapy group than in the placebo plus chemotherapy group (18·1 months [95% CI 16·2-21·0] vs 13·4 months [11·0-16·7]; hazard ratio 0·75 [95% CI 0·60-0·93]; p=0·0042). Overall, higher incidences of treatment-emergent adverse events that were serious (158 [41%] of 389 vs 57 [30%] of 190), grade 3 or worse (238 [61%] vs 103 [54%]), or led to retifanlimab or placebo dose delay (169 [43%] vs 67 [35%]) or discontinuation (33 [8%] vs nine [5%]) were observed in the retifanlimab plus chemotherapy group than in the placebo plus chemotherapy group. The proportions of fatal COVID-19-related treatment-emergent adverse events were similar in the retifanlimab plus chemotherapy group and the placebo plus chemotherapy group (four [1%] vs five [3%]).

INTERPRETATION:

Retifanlimab improved overall survival compared with placebo when added to platinum-based chemotherapy, with a safety profile that is representative of previous PD-1 and PD-L1 inhibitor-chemotherapy combinations. Adding retifanlimab to first-line chemotherapy could be a potential treatment option for patients with squamous or non-squamous metastatic NSCLC.

FUNDING:

Incyte.

13 Aug 2025·Immunotherapy

Successful treatment of localized Merkel cell carcinoma with avelumab in a patient with amyotrophic lateral sclerosis

Article

Author: Leding, Julia ; Tomsitz, Dirk ; French, Lars E. ; Janjic, Nina ; Arnold, Lisa ; Buchillon, Raquel ; Senner, Sonja ; Frey, Surina ; Heinzerling, Lucie

Currently, the first-line treatment of non-metastatic Merkel cell carcinoma (MCC) is complete resection. In case of unresectable or metastatic MCC, immune checkpoint inhibitor (ICI) therapy with avelumab (or in the US also pembrolizumab or retifanlimab) is indicated. We report on a patient with a primary, non-metastatic MCC on the left eyelid and amyotrophic lateral sclerosis (ALS). Due to ALS, the patient's communication was limited to eye movement and blinking. Complete resection or definitive radiotherapy of the tumor while preserving the function of the eye muscles was not possible. No prior data was available for patients with ALS under ICI therapy. In agreement with the patient and his family, a monotherapy with avelumab, a programmed death ligand 1 (PD-L1) inhibitor, was initiated. This led to a complete remission of the tumor with a progression-free survival of over 24 months and importantly no deterioration of the ALS.

01 Aug 2025·Journal for ImmunoTherapy of Cancer

Phase II study of retifanlimab in patients with recurrent locally advanced or metastatic Merkel cell carcinoma (POD1UM-201)

Article

Author: Montaudié, Henri ; Gaudy-Marqueste, Caroline ; Bhatia, Shailender ; Cornfeld, Mark ; Spada, Francesca ; Morano, Federica ; Grignani, Giovanni ; Rutkowski, Piotr ; Guida, Michele ; Burgess, Melissa ; Pulini, Jennifer ; Yeung, Cecilia C S ; Depenni, Roberta ; Spagnolo, Francesco ; Tian, Chuan ; Lebbé, Céleste

Background:

POD1UM-201, an open-label, single-arm, phase II multiregional study, evaluated efficacy and tolerability of retifanlimab, a humanized monoclonal antibody targeting programmed cell death protein-1 (PD-1) in chemotherapy-naive patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Methods:

Patients were enrolled across 34 sites in the USA, Canada, and Europe. Eligible patients were ≥18 years with confirmed recurrent advanced locoregional or metastatic MCC not amenable to surgery or radiation therapy, had not received previous systemic treatment, had measurable disease, and Eastern Cooperative Oncology Group performance status 0–1. Retifanlimab 500 mg was administered intravenously every 4 weeks (Q4W) for up to 2 years. The primary endpoint was objective response rate (ORR). Key secondary endpoints included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

Results:

A total of 101 patients were enrolled between February 12, 2019, and June 16, 2021, with a median duration of follow-up for response of 22.2 (range: 1.1–55.3) months. ORR was 54.5% (95% CI: 44.2% to 64.4%; n=55), including 18 patients (17.8%) with complete responses (CRs) and 37 (36.6%) with partial responses (PRs). DCR was 60.4% (95% CI: 50.2% to 70.0%; n=61). Median DOR was not reached (95% CI: 14.0 months to not estimable (NE)) in patients who achieved CR and was 25.3 months (95% CI: 14.2 months to NE) in those with PR. With a median follow-up of 9.3 (range: 0.0–57.1) months, the estimated median PFS was 16.0 months (95% CI: 9.0 months to 32.2). Median OS was not reached with 63% of patients alive at 3 years. The safety profile was representative of the PD-(ligand)1 inhibitor class, with grade 3 immune-related adverse events occurring in 11 patients (10.9%).

Conclusions:

Retifanlimab 500 mg Q4W led to frequent and durable responses in chemotherapy-naive patients with advanced MCC with an acceptable safety profile. Retifanlimab represents a new immunotherapy option for patients with locally advanced or metastatic MCC.

Trial registration number:

NCT03599713; EudraCT 2018-001627-39

119

News (Medical) associated with Retifanlimab

22 Dec 2025

·www.businesswire.com

Incyte Japan Announces Approval of Zynyz ® (retifanlimab) for the First-Line Treatment of Advanced Anal Cancer

TOKYO--(BUSINESS WIRE)--Incyte Biosciences Japan G.K. today announced the Japan Ministry of Health, Labour and Welfare (MHLW) approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC). "Today's approval marks a significant milestone for patients with advanced anal cancer in Japan – the MHLW’s approval of Zynyz as the first and only first-line treatment for SCAC," said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan G.K. "Today's approval marks a significant milestone for patients with advanced anal cancer in Japan – the MHLW’s approval of Zynyz as the first and only first-line treatment for SCAC," said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan G.K. "By offering combination therapy with chemotherapy, Zynyz provides a vital new path forward for patients facing this challenging disease, addressing a significant unmet need in cancer care for patients with SCAC and their families." The approval was based on data from the Phase 3 POD1UM-303/InterAACT2 trial evaluating Zynyz in combination with platinum-based chemotherapy (carboplatin-paclitaxel) in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy. Results from POD1UM-303/InterAACT2 (NCT04472429) published in The Lancet showed a statistically significant 37% reduction in the risk of progression or death (P=0.0006). 1 Patients in the Zynyz and chemotherapy combination group achieved a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for patients in the placebo combination group.1 No new safety concerns were identified. Serious adverse reactions occurred in 47% of patients receiving Zynyz in combination with chemotherapy.1 The most frequent serious adverse reactions (≥ 2% of patients) were sepsis, pulmonary embolism, diarrhea and vomiting.1 SCAC accounts for approximately 16% to 24% of anal canal cancer cases in Japan, with adenocarcinomas comprising about 70%.2 The overall incidence rate for anal canal in Japan is approximately 0.26 to 0.41 per 100,000 persons.2 This is the first regulatory approval for Zynyz in Japan, and the second regulatory approval for Zynyz in advanced SCAC. In May 2025, the U.S. Food and Drug Administration (FDA) approved Zynyz in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic SCAC. Incyte has also submitted a Type II variation Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for retifanlimab in advanced SCAC. About Squamous Cell Carcinoma of the Anal Canal (SCAC) Worldwide, SCAC is the most common type of anal cancer, making up 85% of cases.3 It is a rare disease for which the incidence increases approximately 3% per year.4,5,6,7 About 90% of cases are associated with human papillomavirus (HPV) infection—the number one risk factor for anal cancer.7 HIV is an important amplifier of anal cancer, as people with HIV are 25 to 35 times more likely to develop it.8,9 Anal cancer shares many of the same symptoms as non-cancerous conditions, such as hemorrhoids—including pain, itching, a lump or mass and changes in bowel movements—and as a result can go undetected leading to the majority of patients presenting with locally advanced disease.10 About POD1UM The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-303, POD1UM-202 and several other Phase 1, 2 and 3 studies for patients with solid tumors, including a registration-directed trial evaluating retifanlimab in combination with platinum-based chemotherapy for patients with non-small cell lung cancer. About Zynyz® (retifanlimab) Zynyz® (retifanlimab) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). Zynyz is also indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Zynyz is marketed by Incyte in the United States. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. Zynyz is a registered trademark of Incyte. Important Safety Please refer to the Zynyz package insert for precautions concerning indications, dosage and administration, and safety information in Japan, Japan Pharmaceuticals and Medical Devices Agency. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Incyte Biosciences Japan G.K. is a wholly owned subsidiary of Incyte. For more information on Incyte in Japan, visit www.incyte.jp. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and when Zynyz might provide a successful treatment option for patients with SCAC, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the MHLW, FDA, EMA and other regulatory authorities; the efficacy or safety of Incyte and its partners’ products; the acceptance of Incyte and its partners’ products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended September 30, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements. 1 Rao S, Samalin-Scalzi E, Evesque L, et al. Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial. Lancet 2025;405(10495):2144-52. 2 Yamada K, Saiki Y, Komori K, et al. Characteristics of anal canal cancer in Japan. Cancer Med 2022;11:2735-2743. 3 Symer MM, Yeo HL. Recent advances in the management of anal cancer. F1000Research 2018;7:F1000 Faculty Rev-1572. 4 Islami F, Ferlay J, Lortet-Tieulent J, et al. International trends in anal cancer incidence rates. Int J Epidemiol 2017;46:924–938. 5 Giuliano AR, Nyitray AG, Kreimer AR, et al. EUROGIN 2014 roadmap: differences in human papillomavirus infection natural history, transmission and human papillomavirus-related cancer incidence by gender and anatomic site of infection. Int J Cancer 2015;136:2752-2760. 6 Morris V, Eng C. Strengthening the immunotherapy paradigm in anal cancer. J Gastrointest Oncol 2016;7:721-726. 7 U.S. Centers for Disease Control and Prevention. Cancers linked with HPV each year. Available at: https://www-cdc-gov.libproxy1.nus.edu.sg/cancer/hpv/cases.html. Accessed November, 2025. 8 Wang CJ, Sparano J, Palefsky JM. Human immunodeficiency virus/AIDS, human papillomavirus, and anal cancer. Surg Oncol Clin N Am 2017;26:17-31. 9 NCCN clinical practice guidelines in oncology: cancer in people with HIV. Version 1.2021. 2021. 10 Anal Cancer Foundation. Anal cancer: signs, symptoms, causes & treatment. Available at: https://www.analcancerfoundation.org/what-is-anal-cancer/. Accessed November 2025.

Phase 3Drug ApprovalClinical ResultLicense out/inImmunotherapy

19 Nov 2025

·www.businesswire.com

Oncolytics Biotech ® Aligns with FDA on Pivotal Study Design for Pelareorep in First-Line Pancreatic Cancer

SAN DIEGO--(BUSINESS WIRE)--Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced alignment with the U.S. Food and Drug Administration (“FDA”) regarding the design of its pivotal study of pelareorep in combination with standard-of-care therapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The Company and the FDA completed a recent Type C meeting and have agreed on the key elements of the Phase 3 trial, which will evaluate pelareorep in combination with chemotherapy with or without a checkpoint inhibitor (“CPI”) compared to chemotherapy alone. As a result, Oncolytics now has a clear path to launch what it believes will be the only such pivotal study of an immunotherapy in mPDAC, an indication for which immunotherapies have provided very little benefit. “We now have regulatory clarity to allow us to start a pivotal study and ultimately the chance to bring the first approved immunotherapy treatment option to the pancreatic cancer treatment landscape,” said Jared Kelly, Chief Executive Officer of Oncolytics Biotech. “The data speaks for itself, but we want to sincerely thank the FDA for its great work in helping us clear this initial regulatory hurdle. Although we still have work to do, we are laser-focused on bringing potential treatments to pancreatic cancer patients who desperately need more options.” The pivotal trial design includes a control arm of gemcitabine plus nab-paclitaxel (GnP), an experimental arm evaluating GnP plus pelareorep and an additional optional experimental arm evaluating GnP plus pelareorep plus a CPI. The primary endpoint of the study is overall survival. Progression-free survival and objective response rate are secondary endpoints. The trial will be statistically powered to demonstrate a clinically meaningful survival benefit and will potentially incorporate an interim analysis to support the option for an accelerated registration timeline. Either experimental arm or potentially both could meet the required success criteria. The study protocol also permits flexibility in CPI selection for the triple-combination arm. Pelareorep has been combined successfully with multiple checkpoint inhibitors—including atezolizumab, pembrolizumab, nivolumab, and retifanlimab—in gastrointestinal and other tumor types. The final CPI choice will reflect ongoing discussions internally and with potential partners. Dr. Thomas Heineman, Chief Medical Officer of Oncolytics, stated, “The FDA’s feedback confirms that our design is appropriate to support registration if successful. We are now completing the administrative activities necessary to initiate the study, including finalizing the protocol, generation of supporting documents, and site selection. We also plan to announce the lead principal investigator once these preparations are complete.” The Company is engaged in study start-up activities, including protocol review and site selection, and will provide periodic updates on the trial initiation process. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics. Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; expectations regarding the initiation, design, protocol, lead principal investigator, and outcomes of a planned study of pelareorep in combination with standard-of-care therapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma; expectations relating to outcomes of ongoing and future studies; Oncolytics’ plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives; and its belief in the clinical promise of pelareorep in metastatic pancreatic and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.

ImmunotherapyPhase 2Phase 3Fast TrackClinical Result

11 Nov 2025

·endpoints.news

Why class competition hasn't brought checkpoint inhibitor prices down

A new study examining 11 FDA-approved checkpoint inhibitors across 55 cancer indications found little movement in price between 2015 and 2024 . The majority still cost about $12,000 per month. The research shows how checkpoint inhibitors have effectively steered around the commonly-held belief in the pharma industry that more competition typically leads to lower drug prices. The prices “did not meaningfully change from 2015 to 2024 with the entrance of new brand-name drugs with the same mechanism of action, although some new drug class entrants were priced at slight discounts compared with the existing drugs,” the authors from Harvard Medical School’s Program on Regulation, Therapeutics, and Law and Memorial Sloan Kettering Cancer Center wrote last week in an ASCO publication. “This may be partially explained by lack of overlapping indications, which hinders direct competition among within-class drugs,” they wrote. At the start of 2024, monthly prices for the checkpoint inhibitors ranged from $7,923 per month for Bristol Myers Squibb’s Yervoy to $14,872 for GSK’s Jemperli, the research found. Average sales prices decreased for all drugs across the timeline studied, with reductions per year ranging from 0.21% for Merck’s Keytruda to 4.85% for Incyte’s Zynyz. The prices were based on NSCLC dosing with the exceptions of Jemperli for endometrial cancer, Zynyz for Merkel cell carcinoma, and Coherus’ Loqtorzi for nasopharyngeal carcinoma. Companies are not required to run comparative effectiveness studies, so the various prices are not necessarily indicative of efficacy or safety advantages. “It’s hard to say whether the prices are reflective of efficacy because there are not many head-to-head studies comparing different checkpoint inhibitors for the same indication,” lead author Jeddeo Paul told Endpoints News . Co-author Ben Rome also told Endpoints that only one or two of the checkpoint inhibitors are approved in most of the different cancer indications, making it more difficult to know if one is better or if they’re interchangeable. “That’s a big problem if you are relying on within-class competition to lower prices,” he said. But these relatively stagnant prices could come down further following the introduction of biosimilars — Keytruda is due to see biosimilar competition as soon as 2028 — and upcoming government price negotiations under the Inflation Reduction Act. Paul said he thinks both will help lower prices via “increased direct competition (as has been seen in the biosimilar insulin market) and the second through direct negotiation with a large payor with significant bargaining power.” He added that Keytruda and Bristol Myers’ Opdivo will become eligible for IRA negotiations in 2028, “so this may have a nearer impact than biosimilar introduction, which technically could happen around the same time but will likely get delayed due to a mix of factors including litigation, multiple patents, and the complexity of biosimilar approvals.”

Biosimilar

100 Deals associated with Retifanlimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11827	-	-	DB15766

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anal canal squamous cell carcinoma	United States	Incyte Corp.	15 May 2025
Metastatic Merkel Cell Carcinoma	United States	Incyte Corp.	22 Mar 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Endometrial Carcinoma	Phase 3	China	Zai Lab (Shanghai) Co., Ltd.	20 Sep 2021
squamous cell carcinoma of the anus	Phase 3	United States	Incyte Corp.	12 Jan 2021
squamous cell carcinoma of the anus	Phase 3	Japan	Incyte Corp.	12 Jan 2021
squamous cell carcinoma of the anus	Phase 3	Australia	Incyte Corp.	12 Jan 2021
squamous cell carcinoma of the anus	Phase 3	Belgium	Incyte Corp.	12 Jan 2021
squamous cell carcinoma of the anus	Phase 3	Denmark	Incyte Corp.	12 Jan 2021
squamous cell carcinoma of the anus	Phase 3	France	Incyte Corp.	12 Jan 2021
squamous cell carcinoma of the anus	Phase 3	Germany	Incyte Corp.	12 Jan 2021
squamous cell carcinoma of the anus	Phase 3	Italy	Incyte Corp.	12 Jan 2021
squamous cell carcinoma of the anus	Phase 3	Norway	Incyte Corp.	12 Jan 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04472429 (POD1UM-303, ESMO_IO2025)	Phase 3	squamous cell carcinoma of the anus First line	308	Retifanlimab + carboplatin-paclitaxel	vtwvavlqze(jxarsmlwjr) = vchahhjbhe sgkkjhtnsr (qorfhuwwab ) View more	Positive	12 Nov 2025
				Placebo + carboplatin-paclitaxel	vtwvavlqze(jxarsmlwjr) = yuxmspjspb sgkkjhtnsr (qorfhuwwab ) View more
EUCTR2021-005775-39-BE (ESMO2025)	Phase 2	PD-L1+	176	Retifanlimab (RETI)	nhphvtxjcd(taiohwdgvf) = kifazaulfj onpmqckqbn (uvfdktdjoi, 3.5 - 9.7) View more	Negative	17 Oct 2025
				Retifanlimab + Tuparstobart (doublet tx)	nhphvtxjcd(taiohwdgvf) = voalhzmnyp onpmqckqbn (uvfdktdjoi, 3.7 - 7.6) View more
NCT04205812 (POD1UM-304, Pubmed) Manual	Phase 3	Non-Small Cell Lung Cancer First line	583	Retifanlimab + chemotherapy	lzntnlrjnk(ffhitwormi) = aihalyuhvm xptchzppiq (kutcllgxko, 16.2 - 21.0) View more	Positive	19 Sep 2025
				Placebo + chemotherapy	lzntnlrjnk(ffhitwormi) = iolcqtgjkb xptchzppiq (kutcllgxko, 11.0 - 16.7) View more
NCT03532295 (CTIM-23, CTgov)	Phase 2	Glioblastoma Multiforme \| Glioblastoma \| Recurrent Glioblastoma	51	Radiation therapy+Bevacizumab+Retifanlimab (Regimen A: Retifanlimab+RT+bevacizumab)	bivembephg = vikwfynydc wzlccynfbt (xriiugdomp, ucyhdehsyd - ombkbraeqx) View more	-	07 Aug 2025
				Radiation therapy+Bevacizumab+Epacadostat+Retifanlimab (Regimen B: Retifanlimab+RT+bevacizumab+epacadostat)	bivembephg = cocoggxveb wzlccynfbt (xriiugdomp, wrbajxmmtp - hhpfzcwrpp) View more
NCT04116073 (CTgov)	Phase 2	Pancreatic carcinoma non-resectable	25	PD-1 antibody+INCMGA00012	avqlcjyaqw = ngzszyaoga wkijzutymt (okcyhtwrrd, qzhcijxtto - ttiqotqqxf) View more	-	29 Jul 2025
NCT05239182 (RiLEY, CTgov)	Phase 2	Pancreatic adenocarcinoma \| Pancreatic Ductal Adenocarcinoma \| Advanced Pancreatic Adenocarcinoma	7	9-ING-41+Abraxane+Gemcitabine+Retifanlimab	ifooyyhlkc = grwkbxdiep rdnzskmcgw (dbnylgkjgi, gnnsmwohuj - qmckxcyqyx) View more	-	17 Jul 2025
NCT04472429 (POD1UM-303/InterAACT 2, BusinessWire) Manual	Phase 3	Anal canal squamous cell carcinoma	308	Retifanlimab + Carboplatin + Paclitaxel	qeyurfppde(pkszywhrpb) = ycotqrwmmb jfghuwuvqw (frkpzeweya, 7.5 - 11.3) View more	Positive	14 Jun 2025
				Placebo + Carboplatin + Paclitaxel	qeyurfppde(pkszywhrpb) = krraoaukcm jfghuwuvqw (frkpzeweya, 7.1 - 7.7) View more
NCT04472429 (POD1UM-303/InterAACT 2, ASCO2025) Manual	Phase 3	Anal canal squamous cell carcinoma	308	Retifanlimab + chemotherapy (PD-L1 ≥ 1%)	qibapizsed(udyblwxbjc) = mlupugbqli mlljlfcwnq (pjaivwjpab ) View more	Positive	30 May 2025
				Retifanlimab + chemotherapy (PD-L1 < 1%)	qibapizsed(udyblwxbjc) = bwyvzvzxvi mlljlfcwnq (pjaivwjpab )
PODIUM303/InterAACT 2 (ASCO2025)	Phase 3	Anal canal squamous cell carcinoma First line	-	Carboplatin + paclitaxel	kwlmfyacea(mfsfigwtxg) = yjitpxysvh aekcfyrltt (tzhbsbapjs ) View more	Positive	30 May 2025
				Immune checkpoint inhibitors (ICIs)	irkydvdpwa(qedmgitjpb) = daqegnbwpq xpizaecumx (onleudglud, 5.5 - 23.0)
NCT03599713 (POD1UM-201, ASCO2025)	Phase 2	Metastatic Merkel Cell Carcinoma	101	Retifanlimab 500 mg	lzbvzryuxo(uedxwgqueq) = ykdgnqlrkq cwgiizpmkr (buxibwnjii ) View more	Positive	30 May 2025

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