RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), 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

NCT06896188

/ Not yet 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 Date31 May 2025

Sponsor / Collaborator

University of Pittsburgh

[+2]

NCT06873789

/ Not yet recruitingPhase 1/2

A Phase 1/2, Open-Label, Multicenter Study of INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors

This study will be conducted to evaluate INCB177054 given as monotherapy or in combination with retifanlimab in participants with select advanced or metastatic solid Tumors.

Start Date24 Apr 2025

Sponsor / Collaborator

Incyte Corp.

NCT06939036

/ RecruitingPhase 1/2

A Multicentre, Open-label, Phase I/II Study Investigating the Safety, Tolerability, and Preliminary Efficacy of 225Ac-SSO110 in Participants With Extensive Stage Small Cell Lung Cancer (ES-SCLC) or Merkel Cell Carcinoma (MCC) Receiving Standard of Care (SoC)

This study aims to determine safety, tolerability, recommended phase 2 dose (RP2D), and preliminary antitumor activity of 225Ac-SSO110 with standard of care (SoC) therapy in patients with somatostatin receptor 2 expressing (SSTR2+) extensive-stage small cell lung cancer (ES-SCLC) and recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Start Date01 Apr 2025

Sponsor / Collaborator

Ariceum Therapeutics GmbHStartup

100 Clinical Results associated with Retifanlimab

100 Translational Medicine associated with Retifanlimab

100 Patents (Medical) associated with Retifanlimab

Literatures (Medical) associated with Retifanlimab

01 Apr 2025·European Urology Oncology

Retifanlimab in Advanced Penile Squamous Cell Carcinoma: The Phase 2 ORPHEUS Study

Article

Author: López-Montero, Laura ; Páez López-Bravo, David ; Climent, Miguel A ; Necchi, Andrea ; Gómez de Liaño, Alfonso ; Sampayo-Cordero, Miguel ; Alcalá-López, Daniel ; Cuéllar-Rivas, Miler Andrés ; Giannatempo, Patrizia ; Maroto, Pablo ; Castellano, Daniel ; García Del Muro, Xavier ; P Valderrama, Begoña ; Mina, Leonardo

BACKGROUND AND OBJECTIVE:

Patients with advanced penile squamous cell carcinoma (PSCC) have poor outcomes and very limited therapeutic options are available. Most PSCC cases have high PD-L1 expression, which is associated with worse prognosis. Immunotherapy targeting PD-L1 could benefit patients with PSCC. Our aim was to evaluate the efficacy and safety of the anti-PD-1 antibody retifanlimab in patients with advanced/metastatic PSCC.

METHODS:

ORPHEUS was a single-arm, multicenter, phase 2 trial in 18 patients with advanced/metastatic PSCC, previously untreated with anti-PD-1/anti-PD-L1 agents. Patients received retifanlimab 500 mg intravenously every 4 wk for up to 2 yr. The primary endpoint was the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included the clinical benefit rate (CBR), disease control rate, duration of response (DoR), time to response, progression-free survival (PFS), overall survival (OS), maximum tumor shrinkage, and safety. The Wilson method was used for the primary endpoint, and the Clopper-Pearson and Kaplan-Meier methods for secondary endpoints.

KEY FINDINGS AND LIMITATIONS:

Median follow-up was 7.2 mo. The ORR was 16.7% (95% confidence interval [CI] 5.8-39.2); three patients had a partial response. Median DoR was 3.3 mo (range 1.8-8.5). The CBR was 22.2% (95% CI 6.4-47.6%). Median PFS was 2.0 mo (95% CI 1.6-3.3) and median OS was 7.2 mo (95% CI 3.0-9.8). One patient (5.6%) experienced grade 3 treatment-related adverse events (AEs). There were no grade >= 4 treatment-related AEs. The small sample size is the main limitation.

CONCLUSIONS AND CLINICAL IMPLICATIONS:

Single-agent retifanlimab exhibited signals of clinical activity in advanced/metastatic PSCC, with no new safety signals. Further investigation of retifanlimab in this setting is warranted.

PATIENT SUMMARY:

Advanced penile cancer of the squamous cell type is a rare tumor with poor prognosis. The aggressiveness of this cancer is usually associated with high levels of a protein called PD-L1. We investigated whether retifanlimab, an immunotherapy drug against PD-1, has activity against this type of penile cancer. Tumor regression or stabilization occurred in one-third of the patients and the side effects were manageable.

01 Jan 2025·BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS

High-resolution crystal structure of PD-1 in complex with retifanlimab, the FDA-approved immune checkpoint blocking antibody for treating Merkel cell carcinoma

Article

Author: Choi, Seung-Beom ; Park, Jeong-Min ; Lee, Eun Ho ; Heo, Yong-Seok ; Cho, Seong-Ha ; Jang, Yu-Jeong ; Song, Ye Han

Retifanlimab is a humanized monoclonal antibody that specifically targets programmed cell death protein 1 (PD-1), an essential immune checkpoint that modulates T-cell immune responses. Several anti-PD-1 antibodies have been market-approved, marking a significant advancement in the treatment of diverse tumor types by restoring the T-cell immune response. Recently, the US FDA approved retifanlimab for treating metastatic or recurrent locally advanced Merkel cell carcinoma. We present the crystal structure of PD-1 in complex with the retifanlimab Fab at a resolution of 1.54 Å to elucidate the structural basis for the mechanism of action of this antibody. This work clarifies the detailed interactions and conformational alterations that occur upon antibody binding. The epitope of retifanlimab partially overlaps with the ligand binding site, and its binding induced unique conformations of the flexible loops within PD-1, including BC, C'D, and FG loops, thereby optimizing interactions with the antibody. A thorough analysis of its interaction with PD-1 and other FDA-approved anti-PD-1 antibodies may provide valuable insights into the rational design of enhanced therapies to regulate immune responses in cancer treatment.

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

News (Medical) associated with Retifanlimab

19 Mar 2025

·www.biospace.com

GLP-1 Drug Boom Recalls the Rise of PD-1 Checkpoint Inhibitors

iStock, Noppharat05081977 The explosion of GLP-1 weight loss drugs is reminiscent of the early days of PD-1 inhibitors, but key market differences suggest history may not repeat itself. If you’ve been around drug development for a while, the rise of GLP-1 therapies might sound familiar to you: a breakthrough emerges after years of hard work in the clinic. A leader captures the market. Billions are made. Copycats follow, hoping for a slice of the pie. It’s the story of PD-1 inhibitors and the immunotherapy boom that redefined how we treat cancer a decade ago. Many industry insiders often call back to this cancer revolution when talking about the meteoric rise of GLP-1s. But within the storied history of PD-1s lies a flashing warning sign for the “fast-follower” approach, experts say. That’s because the harsh reality that was laid bare with PD-1 inhibitors is that many of the companies gambling on being the second or third drug in an indication will not be successful. Despite oncology being the dominant market for R&D over the last decade, “there are a large number of biotech companies, as well as Big Pharma companies, rushing to enter the GLP-1 space at a rate not seen before, even with PD-1s,” Akash Patel, a pharma analyst at GlobalData, told BioSpace . “The race out of the gate to achieve a highly efficacious GLP-1 therapy has been huge.” Winners and Losers in the PD-1 Space Keytruda was the first approved PD-1 therapy, entering the market in September 2014, but the jockeying for supremacy in the space began well before that drug was ever approved. Merck’s immuno-oncology juggernaut was not always the dominant cancer therapeutic. While Bristol Myers Squibb’s PD-1 therapy Opdivo was approved second in December 2014, it quickly established a sales lead. By the end of 2015, Opdivo had generated $942 million in full year sales against Keytruda’s $566 million. “Initially, Bristol Myers Squibb was dominating that race—they had broader approvals and bigger indications,” Matt Phipps, a partner at William Blair, told BioSpace . “And then Merck completely took over based on better trial design and approvals in lung cancer.” Fast forward to 2024, full-year results show the gulf that now exists between the two treatments, with Keytruda generating global sales of $29.4 billion—by far the best-selling drug of the year —while Opdivo brought in just $9.3 billion worldwide. That was, however, still enough to make the number nine slot on the list of the top-10 best selling drugs of 2024 , and is still a healthy earner for BMS. Opdivo’s sales fell away from Keytruda around 2018 and have never made up the gap; sales produced by both treatments show the scale of the market and the opportunity for competitors to carve out a smaller, but substantial, slice. There are other examples of drugs that were developed later but ultimately became more successful, Phipps noted, such as with statins and TNF-alpha inhibitors. This history suggests that subsequent weight loss drug developers could catch up to Eli Lilly and Novo Nordisk, the current market leaders . Beyond the big two PD-1 therapies, there was still space for two other major entrants to carve out a market share, in Roche’s Tecentriq and AstraZeneca’s Imfinzi, both of which inhibit PD-1’s molecular partner, PD-L1, Phipps said. Of the treatments that arrived later to market, the strategy has been to go after smaller indications that were not already targeted by BMS or Merck. Roche’s PD-1 Tecentriq, for example, achieved sales of $4.1 billion worldwide in 2024, becoming the Swiss pharma’s leading oncology seller. AstraZeneca’s PD-1 Imfinzi brought in $4.7 billion the same year, the third-largest drug overall for the U.K. company. Even against such heavyweights, smaller companies are still pushing forward with PD-1s. Incyte Biosciences received approval for its PD-1 inhibitor, Zynyz, in 2023 . The drug brought in sales of $3 million for the full year 2024. When asked about the possibility to differentiate in a competitive space, an Incyte spokesperson told BioSpace the company sees an opportunity to “meet the needs of different patient populations.” Incyte is aiming to make Zynyz the first PD-1–targeting drug to achieve approval against squamous cell anal carcinoma with the POD1UM-303/InterAACT2 trial currently in Phase III. But those are just the successful examples. The clinical record is also littered with failed followers. The PD-1 market witnessed a surge of R&D, but both Big Pharmas and small-scale biotechs struggled to translate this into successful treatments. Pfizer developed Bavencio with Merck KGaA,which was fourth-to-market but struggled to achieve significant sales, leading Pfizer to return the drug’s rights to its partner in 2023. The treatment is still marketed by Merck KGaA but managed only $735 million in full-year 2024 results. The same occurred with Novartis’ PD-1 treatment Tevimbra, developed alongside BeiGene, with the partnership on the drug cancelled in 2023. The treatment is still on the market but had just $621 million in full-year 2024 sales. The relative failure of these treatments shows that even the financial firepower of Big Pharma is not always enough to successfully break into the market as a fast follower. For small-cap companies, Phipps said that many tried to develop combination therapies to improve efficacy over monotherapies and retain ownership of their assets. However, this approach “didn’t really pan out to be as good as they hoped,” due to the failures to show improved efficacy. This resulted in various unsuccessful partnerships, such as Nektar Therapeutics and BMS’ investigational combination therapy . A similar story unfolded with Innate Pharma and AstraZeneca’s Phase III trial of monalizumab. One certainty for those investing in weight loss drugs is that, like PD-1s, there will be failures. Phipps thinks the fallout could be even more severe given the major differences between the two markets. Different Markets, Different Challenges Demand for PD-1 therapies was based on their potential to dramatically improve the survival chances of those with cancer. This was largely driven by physician prescribers. The GLP-1 market, on the other hand, is consumer-led. GLP-1 weight loss treatments have broken out of the traditional medical field and become instilled into the public consciousness, and even pop culture. The lower perceived medical necessity also means there are ongoing discussions between drug developers and payers over discounts to pricing and rebates in weight loss, which will impact revenue for any would-be entrants onto the market. The dynamic in the oncology market is different for PD-1s, with drug developers competing on efficacy and expanding on approved indications rather than on pricing . Another major drawback that Phipps identified is “patient churn,” where within one year most patients will stop taking GLP-1 treatments, with these figures declining even further at the two-year mark. By comparison, PD-1 drugs were initially approved when there were no other treatment options, which meant patients would complete treatment courses because there were no alternative pathways for recovery from cancer. The urgency of treating cancer, for both patients and physicians, therefore does not allow for direct parallels to be drawn between sales growth for PD-1s and GLP-1s. This differing market dynamic led Phipps to caution that some estimates suggesting the weight loss drug market will continue to expand at current rates are likely flawed. Analysts have put potential sales as high as $150 billion by the early 2030s, but Phipps does not think the market will reach that because drug developers have not yet solved the problem of how to keep people on the therapies. Without patient retention, revenues for any potential treatment developed could be limited, with Phipps noting that both Novo Nordisk and Eli Lilly delivered 2025 guidance that was “a little below analysts’ expectations,” though he added that this could also be due to manufacturing issues. One area that could unfold similarly in the journeys of PD-1s and GLP-1s is the gathering of indications. Expanding a drug’s label can help extend its patent exclusivity period and boost revenue. Since Keytruda’s 2014 approval, Merck has gone to work collecting indications to add to its roster. The drug is now approved to treat nearly 50 different types and stages of cancer, from lung to melanoma, breast to non-Hodgkin lymphoma. The drug has also been granted biomarker-based approvals allowing its use with certain genetic mutations regardless of tumor type. Oncology offersa far broader range of potential indications for drug developers than those available to GLP-1 drug developers. But obesity companies could still follow this playbook, Patel said. Indeed, Novo and Lilly are pursuing a similar strategy for their weight loss drugs. Novo’s Wegovy has received a label expansion for reducing cardiovascular risk . Lilly, meanwhile, added an FDA nod for the treatment of obstructive sleep apnea . The companies are also pursuing metabolic dysfunction-associated steatohepatitis (MASH), kidney disease , Alzheimer’s and alcohol use disorder , among other indications. For investors seeking a potential blockbuster weight loss drug that could emerge from a heaping pile of options, Phipps said there are three important considerations: improving efficacy, improving tolerability and being a small molecule formulation. Each could potentially offer advantages over current treatments, with greater weight loss potentially attracting more patient interest, improved tolerability allowing people to take the treatment for longer and small molecules offering significant manufacturing and dosing advantages, such as the ability to be taken orally. This is different from the early stages of the PD-1 market, Phipps noted, where the focus was on quickly developing a “me-too” treatment. As a result, he said, investing in the obesity space is “less enticing” because of the complexity of developing a differentiated product. What is not yet clear is which approach investors will favor, with Phipps describing the market as being in the “early innings” of discovering how to best serve patients.

Drug ApprovalPhase 3Immunotherapy

12 Mar 2025

·www.prnewswire.com

PD-L1 Measured by Blood Test Reveals Important Clinical Information

MONMOUTH JUNCTION, N.J., March 12, 2025 /PRNewswire/ -- Researchers from Creatv Bio, Division of Creatv MicroTech, Inc. (Monmouth Junction, NJ) and The Mayo Clinic (Jacksonville, FL), in collaboration with BriaCell Therapeutics Corporation (Philadelphia, PA), have shown in a study of Metastatic Breast Cancer (mBC) patients treated with SV-BR-1-GM vaccine in combination with an immunotherapy drug, that the vaccine can change the PD-L1 expression of the tumor. The PD-L1 expression is determined by the LifeTracDx® blood test, which captures Circulating Tumor Cells (CTCs) and Cancer Associated Macrophage-Like cells (CAMLs) by staining the cells for PD-L1 marker. The data was presented at the annual San Antonio Breast Cancer Symposium (SABCS) in December 2024, and is titled: PD-L1 Upregulation in Circulating Tumor Associated Cells Predicts for Clinical Outcomes in a Phase 1/2 Clinical Trial Using SV-BR-1-GM Vaccine with the Check Point Inhibitor Retifanlimab in Metastatic Breast Cancer Patients, an Interim Analysis. . The data of 36 patients showed that a decrease in CTCs/CAMLs numbers significantly correlated with better Progression Free Survival and trended for better Overall Survival. In addition, SV-BR-1_GM therapy appeared to upregulate PD-L1 expression in 15 patients which correlated with better responses to combination treatment with the anti-PD-L1 check point inhibitor. LifeTracDx® can predict treatment response, and at the same time provide information about companion diagnostics for a wide variety of tumor markers. The test isolates CAMLs and CTCs from the blood of the cancer patient. CAMLs are macrophages that have engulfed tumor cells from tumor site. Thus, both CAMLs and CTCs contain tumor material, ideal for companion diagnostic. About Creatv Bio Creatv Bio is a cancer screening and cancer diagnostics company providing testing services to patients and to pharma companies to support drug development from its CLIA/CAP laboratory in NJ. Creatv's scientists were the first to publish on CAMLs found in the blood of cancer patients. LifeTracDx® blood tests have many other applications: predicting response to a new therapy within just 30 days, providing PD-L1 companion diagnostics, providing information about aggressiveness of the cancer, detection of minimal residual disease, early detection of cancer recurrence, and cancer screening. For a complete listing of our journal publications and posters, please visit our website at . For more information contact: SOURCE Creatv MicroTech, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccineImmunotherapyClinical StudyClinical ResultASCO

10 Mar 2025

·www.prnewswire.com

BAVENCIO Continues to Strengthen Its Position in the Immuno-Oncology Landscape | DelveInsight

With the rising adoption of checkpoint inhibitors and combination therapies, BAVENCIO's market growth is driven by expanding indications and strategic partnerships. However, competition from KEYTRUDA and TECENTRIQ poses challenges, making differentiation through combination strategies key to its success. LAS VEGAS, March 10, 2025 /PRNewswire/ -- DelveInsight's " BAVENCIO Market Size, Forecast, and Market Insight Report" highlights the details around BAVENCIO, a human IgG1 lambda monoclonal antibody that targets programmed death-ligand 1 (PD-L1). The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of BAVENCIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Pfizer/Merck/EMD Sereno's BAVENCIO (avelumab) Overview BAVENCIO is a human antibody targeting programmed death ligand-1 (PD-L1). Preclinical studies have demonstrated its ability to activate both adaptive and innate immune responses. By inhibiting the interaction between PD-L1 and PD-1 receptors, BAVENCIO helps restore T cell-mediated antitumor immunity in preclinical models. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and commercialize BAVENCIO. In the U.S., BAVENCIO is approved for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-based chemotherapy. It is also indicated for patients with locally advanced or metastatic UC who experience disease progression during or after platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-based treatment. Additionally, BAVENCIO in combination with axitinib is approved in the U.S. for the first-line treatment of patients with advanced renal cell carcinoma. The FDA has also granted accelerated approval for BAVENCIO in the treatment of adults and pediatric patients (12 years and older) with metastatic Merkel cell carcinoma, based on tumor response rate and duration of response. Continued approval may depend on further clinical trials confirming its benefits. Currently, BAVENCIO is approved in 50 countries for at least one indication. Learn more about BAVENCIO projected market size for merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma @ BAVENCIO Market Potential Urothelial carcinoma is the most common cancer of the urinary system, arising from urothelial cells and primarily affecting individuals over the age of 50. It is more prevalent in males, with an incidence rate two to three times higher than in females. According to DelveInsight's analysis, approximately 41 million new cases of urothelial carcinoma were reported across the 7MM in 2023. The standard treatment primarily involves chemotherapy, particularly cisplatin-based regimens. For patients who do not respond to initial systemic therapy, immunotherapy—using agents such as atezolizumab and pembrolizumab—serves as a secondary option. In some cases, surgical interventions like nephroureterectomy are also performed. Approved treatment options for urothelial carcinoma include OPDIVO (nivolumab), PADCEV (enfortumab vedotin-ejfv), KEYTRUDA (pembrolizumab), and BAVENCIO (avelumab), among others. The urothelial carcinoma treatment market is projected to experience substantial growth, rising from USD 900 million in 2023 at a notable CAGR through 2034, driven by the introduction of innovative therapies currently in clinical trials. However, challenges such as treatment complications in elderly patients and dependence on blood transfusions may pose barriers to market expansion. Dive deep into an in-depth assessment of the Urothelial Carcinoma Market Merkel cell carcinoma is a rare and aggressive neuroendocrine skin cancer that originates from Merkel cells—specialized mechanoreceptors located at the dermo-epidermal junction responsible for touch sensation. According to DelveInsight's estimates, approximately 9,000 new cases of MCC were reported in the 7MM in 2023, with the United States accounting for 37% of these cases. Several approved treatments for MCC are currently available, primarily focusing on immune modulation. Notable therapies include BAVENCIO, a monoclonal antibody developed by Merck KGaA; KEYTRUDA (pembrolizumab), a PD-1 inhibitor from Merck; and ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor co-developed by Incyte Corporation and MacroGenics. DelveInsight's analysis estimates that the MCC treatment market in the 7MM was valued at approximately USD 411 million in 2023. Over the forecast period from 2024 to 2034, this market is expected to grow at a CAGR of 8.7%, driven by the introduction of innovative therapies. Discover more about the Merkel cell carcinoma market in detail @ Merkel Cell Carcinoma Market Report Renal cell carcinoma is the most prevalent form of kidney cancer, comprising approximately 90% of all cases. It ranks among the ten most common cancers worldwide. The prognosis for advanced RCC remains poor, with a five-year survival rate of around 11-12%. Research indicates that RCC accounts for the vast majority of kidney cancer cases. Over the past decade, the treatment landscape for advanced RCC has evolved significantly, driven by the introduction of novel therapies and advancements in surgical and ablative techniques. Treatment approaches have become increasingly personalized, with prognostic groups established to tailor interventions based on disease severity. For patients in good health with isolated metastases, surgical excision, radiotherapy, or ablative therapy may be recommended to postpone systemic treatment. Meanwhile, those ineligible for surgical removal may benefit from alternatives such as cryoablation, thermal ablation, or stereotactic ablative body radiation therapy. Additionally, targeted treatments like tyrosine kinase inhibitors (TKIs) and anti-VEGF antibodies have become essential in both first- and second-line therapy, offering effective management options for advanced RCC. The market outlook for advanced RCC appears promising, driven by ongoing innovations and the expansion of therapeutic options. As investigational treatments advance through clinical trials, they have the potential to significantly improve patient outcomes and address existing gaps in care. The competitive landscape is rapidly evolving, with developments in targeted therapies, immunotherapies, and combination treatments aiming to enhance survival rates and quality of life for patients with advanced RCC. For more insights on the evolving landscape of renal cell carcinoma, visit @ Advanced Renal Cell Carcinoma Market Emerging Competitors of BAVENCIO The urothelial carcinoma pipeline is highly dynamic, with promising new therapies in development, including IMFINZI + IMJUDO + SoC (AstraZeneca), Disitamab vedotin (Pfizer), Vactosertib + IMFINZI (MedPacto), TYRA-300 (Tyra Biosciences), LYTGOBI + KEYTRUDA (Taiho Oncology), UGN-104 (UroGen Pharma), and others. In the Merkel cell carcinoma space, the potential emerging competitors of BAVENCIO include IFx-2.0 (TuHURA Biosciences), NIDLEGY (L19-IL2/L19-TNF) (Philogen), ITI 3000 (Immunomic Therapeutics), PH 762 (Phio Pharmaceuticals/AgonOx), KT 253 (Kymera Therapeutics), MCLA 145 (Merus N.V.), and others. Key companies such as Exelixis/Bristol-Myers Squibb (Zanzalintinib (XL092) + Nivolumab), AstraZeneca/ HUTCHMED (Savolitinib + Durvalumab), Corvus Pharmaceuticals (Ciforadenant (CPI-444)), Xynomic Pharmaceuticals (Abexinostat), NiKang Therapeutics (NKT2152), and others are involved in developing drugs for advanced RCC. To know more about the number of competing drugs in development, visit @ BAVENCIO Market Positioning Compared to Other Drugs Key Milestones of BAVENCIO In January 2021, EMD Serono and Pfizer Inc. announced that the European Commission (EC) approved BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In December 2020, EMD Serono and Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In June 2020, EMD Serono and Pfizer Inc. announced that the FDA has approved the supplemental Biologics License Application (sBLA) for BAVENCIO as a maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed following first-line platinum-based chemotherapy. In June 2020, Merck KGaA and Pfizer Inc. announced that the European Medicines Agency (EMA) had accepted for review the Type II variation application for BAVENCIO as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma. In April 2020, EMD Serono and Pfizer Inc. finalized the submission of a supplemental Biologics License Application (sBLA) to the FDA for BAVENCIO as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma. In October 2019, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has granted approval for BAVENCIO in combination with axitinib as a first-line treatment for adults with advanced renal cell carcinoma (RCC). In May 2019, Merck KGaA and Pfizer Inc. announced that the FDA granted approval for BAVENCIO in combination with INLYTA as a first-line treatment for patients with advanced renal cell carcinoma (RCC). In December 2017, Merck KGaA and Pfizer Inc. announced that the FDA had awarded Breakthrough Therapy Designation to avelumab in combination with INLYTA (axitinib) for newly diagnosed patients with advanced renal cell carcinoma (RCC). In September 2017, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has approved BAVENCIO as a standalone treatment for adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive form of skin cancer. In September 2017, Merck KGaA and Pfizer Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO as the first and only treatment for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive cancer, in Japan. In May 2017, EMD Serono and Pfizer Inc. announced that the FDA approved BAVENCIO Injection to treat patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after platinum-based chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-based treatment. In March 2017, EMD Serono and Pfizer Inc. announced that the FDA has approved BAVENCIO Injection 20 mg/mL, an intravenous treatment for adults and pediatric patients aged 12 and older with metastatic Merkel cell carcinoma (mMCC). In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and market BAVENCIO. Discover how BAVENCIO is shaping the merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma treatment landscape @ BAVENCIO Injection BAVENCIO Market Dynamics BAVENCIO, co-developed by Merck KGaA and Pfizer, is an anti-PD-L1 checkpoint inhibitor primarily approved for urothelial carcinoma and Merkel cell carcinoma. Its key differentiation lies in its first-in-class approval for maintenance therapy in locally advanced or metastatic urothelial carcinoma, setting it apart from competitors like KEYTRUDA (pembrolizumab) and TECENTRIQ (atezolizumab). However, in the broader immuno-oncology (IO) landscape, BAVENCIO faces stiff competition from other PD-1/PD-L1 inhibitors that dominate indications in lung, renal, and other cancers. BAVENCIO's market uptake has been driven by its unique approval in the urothelial carcinoma maintenance setting, where it demonstrated a significant survival benefit. The drug has gained traction in major markets like the U.S., Europe, and Japan, benefiting from increased awareness and inclusion in treatment guidelines. However, its adoption has been tempered by physician familiarity with established IO therapies and payer considerations around cost-effectiveness, especially in competitive oncology segments. One of BAVENCIO's primary challenges is its limited label expansion compared to blockbuster PD-1 inhibitors like OPDIVO (nivolumab) and KEYTRUDA. While its urothelial carcinoma approval has a strong foothold, its lack of widespread use in high-incidence cancers like NSCLC constrains its market potential. Nonetheless, ongoing clinical trials exploring novel combination strategies with other immunotherapies and targeted agents could enhance its market positioning. Additionally, emerging markets and label expansions offer opportunities for future growth. The future of BAVENCIO will largely depend on its ability to secure new indications and differentiate itself in the crowded IO space. With increasing competition and biosimilar threats on the horizon, strategic partnerships, real-world evidence generation, and market access strategies will be crucial in sustaining its commercial success. Dive deeper to get more insight into BAVENCIO's strengths & weaknesses relative to competitors @ BAVENCIO Market Drug Report Table of Contents Related Reports Urothelial Carcinoma Market Urothelial Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key urothelial carcinoma companies including Pfizer, Merck, Eisai Inc, AstraZeneca, Seagen Inc, Bayer, Incyte Corporation, Acerta Pharma BV, among others. Urothelial Carcinoma Pipeline Urothelial Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key urothelial carcinoma companies, including MedPacto, AstraZeneca, Helsinn, QED Therapeutics, Inovio Pharmaceuticals, Abbisko Therapeutics, Bayer, 4D pharma plc, RemeGen, Infinity Pharmaceuticals, Kyowa Kirin, Inc., Ikena Oncology, Vyriad, Seagen, RemeGen, Pfizer, Incyte Corporation, Prestige BioPharma, TARIS Biomedical, Janssen Research and Development, among others. Merkel Cell Carcinoma Market Merkel Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key merkel cell carcinoma companies including TuHURA Biosciences, Philogen, Immunomic Therapeutics, Phio Pharmaceuticals, AgonOx, Kymera Therapeutics, Merus N.V., among others. Renal Cell Carcinoma Market Renal Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key renal cell carcinoma companies including AstraZeneca, Ipsen, Novartis, Pfizer, Amgen, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapyBreakthrough Therapy

100 Deals associated with Retifanlimab

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KEGG	Wiki	ATC	Drug Bank
D11827	-	-	DB15766

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Merkel Cell Carcinoma	United States	Incyte Corp.	22 Mar 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anal canal squamous cell carcinoma	NDA/BLA	Australia	Specialised Therapeutics Australia Pty Ltd.	04 Apr 2025
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

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04082364 (MAHOGANY \| NCT04082364 \| ###DELETE, CTgov)	Phase 2/3	Metastatic HER2 positive gastroesophageal junction cancer \| Gastrooesophageal junction cancer \| HER2-positive gastric cancer	82	margetuximab+Retifanlimab (Chemotherapy-free Arm)	hxmfwkwnpu = mzdepmysgc hcyiaiphxn (xrkfimelej, patwsxqmco - crdgvvcfdn) View more	-	22 Apr 2025
				Chemotherapy+Trastuzumab (Trastuzumab and Chemotherapy Arm)	gtakzticii = fqwbgcpbfg dguglkfvms (ovucfbnviu, vntmzunkjv - otmgwugrgl) View more
NCT04586244 (Optimus, CTgov)	Phase 2	Muscle Invasive Bladder Urothelial Carcinoma	30	Epacadostat+Retifanlimab (Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W)	rszqshigyi = vfiaydljnd ldkkmovqlf (wrgchuzgyu, puthdzhzfa - ovtguqkgqw) View more	-	10 Mar 2025
				Retifanlimab (Retifanlimab 500 mg Q4W)	qdnnajwkax(ajjhlwgxww) = ypzpwrgcpu kjujbvudgj (alyrcceuxv, 0.9332) View more
NCT04205812 (POD1UM-304, CTgov)	Phase 3	Non-Small Cell Lung Cancer \| Squamous non-small cell lung cancer \| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma ... View more	583	Placebo (Placebo + Chemotherapy)	hdcapxwaoi(kmumvrfxan) = xnkdjyaequ wlgehjeulx (shzqjcfzyg, fjdukywoxa - xjbahdtdkz) View more	-	06 Feb 2025
				Retifanlimab (Retifanlimab + Chemotherapy)	hdcapxwaoi(kmumvrfxan) = fgoewaqvyc wlgehjeulx (shzqjcfzyg, bpowckedvc - kleqqrxtqm) View more
NCT03328026 (SABCS2024 \| GlobeNewswire) Manual	Phase 1/2	Metastatic breast cancer	54	Bria-IMT regimen with pembrolizumab/retifanlimab	uknhogsrdo(xpvdcnpucf) = hgyfbbizdg rtgpmksoca (vwftcrzamh )	Positive	11 Dec 2024
				Bria-IMT regimen with pembrolizumab/retifanlimab (without IFN incubation; phase 3 formulation)	uknhogsrdo(xpvdcnpucf) = mesbebwzoe rtgpmksoca (vwftcrzamh ) View more
NCT04438824 (ESMO2024) Manual	Phase 2	Dedifferentiated Liposarcoma	28	Palbociclibretifanlimab	acheldwmqz(trrwspmbdq) = acvvywdwkv jsgaxcacxv (wqdnmppevn, 4.7 - 33.6) View more	Positive	13 Sep 2024
NCT03328026 (ASCO2024) Manual	Phase 1/2	Metastatic breast cancer \| Advanced breast cancer CAMLs \| CTCs	54	SV-BR-1-GMegimen with oriretifanlimabce	gpcnjrwrnz(cxbplwplus) = eublycgnwm tsauugjmfw (thpcggjlhg ) View more	Positive	24 May 2024
NCT04634825 (CTgov)	Phase 2	Cutaneous Squamous Cell Carcinoma of the Head and Neck	62	Enoblituzumab+Retifanlimab (Retifanlimab Cohort)	hsvoumvtto = alsmieidno kqittovkpx (gzxgolpoje, yhbamgcoic - hsijvmzvjk) View more	-	20 Dec 2023
				Enoblituzumab+Tebotelimab (Tebotelimab Cohort)	phpnkymifg = zwjwggdjmo igwxczoxlb (swecjusraq, xyjhywkizo - debpkbiyok) View more
NCT03059823 (POD1UM-101, ESMO 12023 \| ESMO 22023) Manual	Phase 1	Mismatch repair-deficient Endometrial Carcinoma \| Microsatellite instability-high Endometrial Carcinoma MSI-High \| Deficient DNA Mismatch Repair (dMMR)	76	Retifanlimab 500 mg	xnrfbbwcmf(tnvqjqyyhh) = zubafoxzsy qqiyzgfmzr (pbdcnfzzaq, 32 - 55)	Positive	22 Oct 2023
NCT04370704 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	21	INCAGN02385 350 mg+INCAGN02390 400 mg	seihmvxigm(miefwoduar) = occurred in 1 pt in part 1 (grade [G] 3 vasculitis) and 1 pt in part 2 (G3 myocarditis and pericardial effusion) epqiihhphk (ftmqwfddwz ) View more	Positive	26 May 2023
				retifanlimab 500 mg+INCAGN02385 350 mg+INCAGN02390 400 mg
NCT04225039 (ASCO2023) Manual	Phase 2	Recurrent Glioblastoma	32	INCAGN01876+Retifanlimab+FSRT (single-arm, primary efficacy cohort)	ipceosldrf(oxmaixandi) = mbhaujjkht dcxvjygiha (yvkrprictm, 2.1 - 6.2) View more	Negative	26 May 2023
				INCAGN01876+Retifanlimab+FSRT (two-arm neoadjuvant window-of-opportunity cohort)	ipceosldrf(oxmaixandi) = lonsyvivdp dcxvjygiha (yvkrprictm ) View more

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