Ipilimumab

HAYWARD, Calif.--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, today announced a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY, “BMS”). Under the agreement, Arcus will supply casdatifan, the company’s investigational small-molecule HIF-2a inhibitor, to be evaluated as part of the BMS-sponsored Phase 1/2 ROSETTA RCC-208 clinical trial. This trial evaluates pumitamig (BNT327/BMS986545), an investigational PD-L1/VEGF-A bispecific antibody, being jointly developed by BioNTech and Bristol Myers Squibb, alone or in combination with other potential treatment options in advanced renal cell carcinoma (RCC). As part of this clinical trial collaboration, casdatifan combinations will be added as two new arms of ROSETTA RCC-208. Each company will retain development and commercial rights to their respective assets, and the agreement is mutually non-exclusive. "We believe casdatifan can transform the treatment paradigm in kidney cancer, and our development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every patient has the opportunity to benefit from casdatifan across each line of therapy," said Terry Rosen, Ph.D., chief executive officer of Arcus. "HIF-2a inhibition, PD-L1 and VEGF-A blockade are validated mechanisms in the treatment of kidney cancer with a strong biologic rationale for combination. This strategic collaboration with BMS is a top priority for Arcus in order to potentially deliver an additional effective TKI-free option in the first-line setting." This collaboration is part of Arcus’s holistic development strategy that is intended to provide physicians and patients with: 1) a casdatifan-based and only HIF-2a inhibitor-inclusive TKI-sparing first-line treatment; 2) a casdatifan-based TKI-inclusive first-line regimen; 3) a second-line HIF-2a inhibitor treatment that builds on the second-line standard-of-care TKI, cabozantinib; and 4) a late-line therapy that has been clinically validated to also provide benefit in patients previously treated with a HIF-2a inhibitor-based therapy. About Casdatifan (AB521) Casdatifan is a small-molecule inhibitor of hypoxia-inducible factor 2-alpha (HIF-2a), a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma; ccRCC), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones. Casdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety profile that allows it to be investigated in combination with other treatments. The casdatifan development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every ccRCC patient has the opportunity to benefit from casdatifan across each line of therapy. In addition to partner-operationalized studies, Arcus is investigating casdatifan across multiple cohorts in the ARC-20 platform study, alone and in combination with other potential new treatment options, including in the: First-line setting with cohorts evaluating casdatifan plus zimberelimab, an anti-PD-1 (ongoing); and casdatifan plus zimberelimab and ipilimumab, an anti-CTLA-4 (ongoing) Second-line setting with a cohort evaluating casdatifan plus cabozantinib in immunotherapy (IO)-experienced patients (ongoing) Late-line setting with a cohort evaluating casdatifan plus a TKI in both HIF-2a inhibitor-experienced and HIF-2a inhibitor-naive patients (planned) Arcus is also enrolling patients for PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in IO-experienced metastatic ccRCC. Arcus expects to complete enrollment in PEAK-1 and to initiate a Phase 3 study in first-line metastatic ccRCC by year-end 2026. Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established. Taiho has development and commercial rights in Japan and other countries in Asia, excluding China. Arcus Biosciences holds full rights to casdatifan everywhere else globally. About Pumitamig (BNT327/BMS986545) Pumitamig is a novel investigational bispecific antibody, jointly developed by BioNTech and BMS, combining two complementary, validated mechanisms in oncology into one single molecule. Pumitamig combines PD-L1 checkpoint inhibition aimed at restoring T cells’ ability to recognize and destroy tumor cells with the neutralization of VEGF-A. BioNTech and BMS are currently advancing pumitamig in a broad clinical trial program with more than 20 clinical trials currently ongoing or planned to evaluate pumitamig either as a monotherapy or in combination with other treatment modalities targeting different oncogenic pathways in more than 10 solid tumor indications. About Kidney Cancer According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,450 Americans will be diagnosed with kidney cancer in 2026. ccRCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for kidney cancer is high; for patients with advanced or late-stage metastatic kidney cancer, however, the five-year survival rate is only 19%. For metastatic kidney cancer, targeted drug therapies are one of the main treatment options. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for the treatment of cancer and inflammatory and autoimmune diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of its late-stage portfolio of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com. Arcus Forward-Looking Statements This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential of casdatifan and pumitamig to achieve more sustained tumor control and deliver a TKI-free option in the first-line setting, statements regarding Arcus’s development strategies and plans, and the timing and achievement of milestones, including the completion of enrollment in PEAK-1 and the initiation of a Phase 3 study in 1L metastatic ccRCC. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks associated with: managing Arcus’s collaborations; risks associated with manufacturing or supplying casdatifan; the unexpected emergence of adverse events or other undesirable side effects with casdatifan or casdatifan-based combinations; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission (SEC) and in other filings that Arcus makes with the SEC from time to time, which are available at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release, except to the extent required by law. The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.

Darovasertib combination resulted in a statistically significant and clinically meaningful improvement in median PFS vs. investigator's choice of therapy (ICT) – 6.9 months vs. 3.1 months, HR: 0.42, 58% reduction in risk of disease progression Significantly improved ORR (37.1% vs 5.8%) and DCR (73.3% vs. 31.1%) by BICR vs. ICT, where ~77% were treated with ipilimumab + nivolumab OS not yet mature but early trend favoring the darovasertib combination; targeting to provide the next update as part of the pre-specified interim analysis Manageable safety profile consistent with prior results, with a low rate of TR-SAE (9.2%) and discontinuations due to TRAEs for darovasertib (2.5%) and crizotinib (10%) NDA submission in process under RTOR program; expect to complete filing in H2 2026 SOUTH SAN FRANCISCO, Calif., June 1, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, and Servier, an independent international pharmaceutical group governed by a foundation, today presented complete data from the primary analysis of their registrational Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib (darovasertib combination) in first line (1L) HLA*A2:01 negative metastatic uveal melanoma (mUM) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, Illinois. The data were provided in a late-breaking oral presentation by Dr. Marlana Orloff, M.D., Professor of Medical Oncology at Thomas Jefferson University Hospital and lead investigator on the trial. A copy of the presentation will be available on IDEAYA's corporate website. "The data from OptimUM-02 represent an exciting step forward in the treatment landscape for metastatic uveal melanoma, particularly for patients with HLA*A2:01 negative disease who have no approved treatment options," said Dr. Orloff. "The darovasertib combination drove consistent, robust and clinically meaningful improvements in response rate and progression free survival relative to checkpoint inhibitors that are commonly used today and supports its potential as a new therapeutic standard for patients with this devastating disease." OptimUM-02 is a global, registrational Phase 2/3 trial evaluating a total of 313 patients with 1L HLA*A2:01 negative mUM, randomized 2:1 to the darovasertib combination or an investigator's choice of therapy (ICT) arm reflective of real-world clinical practice that included ipilimumab plus nivolumab (anti-CTLA-4/PD-1) or pembrolizumab (anti-PD-1). The primary endpoint to support accelerated approval is median progression-free survival (PFS) as assessed by blinded independent central review (BICR). Secondary endpoints include safety and investigator assessed PFS, overall response rate (ORR), disease control rate (DCR) and duration of response. Data presented at ASCO were as of a cutoff date of January 23, 2026 and included additional detail on baseline characteristics as well as safety, secondary endpoints and median PFS across patient subgroups. Key Findings from OptimUM-02 Primary endpoint (Phase 2 portion): progression free survival by BICR The trial met the primary endpoint, with patients treated with the darovasertib combination demonstrating a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm by BICR (HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001). Patients treated with the darovasertib combination also had a statistically significant improvement in median PFS of 6.7 months versus 2.7 months for ICT by investigator assessment (HR: 0.36; 95% CI: 0.26, 0.50, p-value: <0.0001). Notably, the darovasertib combination reduced the risk of disease progression by 58% and 64% as assessed by BICR and investigator assessment, respectively. Treatment with the darovasertib combination demonstrated a consistent and meaningful improvement in median PFS relative to the ICT arm across a broad range of patient subgroups, including age and gender, type of immune therapy used in ICT, LDH stratification, ECOG status and site of metastasis. Secondary endpoints: ORR, DCR, duration of response Patients treated with the darovasertib combination had an ORR of 37.1% (78/210) and 39.5% (83/210) as assessed by BICR and investigator, respectively, compared to 5.8% (6/103) and 1.9% (2/103) in the ICT arm (p-value: <0.0001). The darovasertib combination led to a disease control rate of 73.3% (154/210) and 74.3% (156/210) by BICR and investigator assessment, respectively, compared to 31.1% (32/103) and 27.2% (28/103) in the ICT control arm. The median duration of response was 6.8 months (95% CI: 5.5, 11.3) by BICR and 6.8 months (95% CI: 4.8, 9.7) by investigator assessment based on a median follow-up time of 7.4 months as of the cutoff date. Overall survival (Primary endpoint of the Phase 3 portion) As noted in the topline results, data on overall survival (OS) was still immature as of the cutoff date, however, there was an early trend in OS improvement in the darovasertib combination arm relative to the ICT arm. IDEAYA will provide the next OS update as part of the pre-specified interim analysis. Overall survival data, when available, will be used to support a potential full approval in the United States and globally. Safety The darovasertib combination was generally well-tolerated with a manageable safety profile consistent with previous results and known side-effects of each agent alone. Median relative dose intensities of darovasertib and crizotinib were 91.0% and 77.1%, respectively, compared to 100% for the ICT arm. Grade 3/4 treatment-related adverse events (TRAEs) occurred in 40.6% (97/239) of patients in the darovasertib combination arm compared to 37.0% (37/100) of patients in the ICT control arm. Treatment-related serious adverse events (TR-SAE) were 9.2% (22/239) and 25.0% (25/100) in the darovasertib combination and ICT arms, respectively. Low discontinuation rate due to TRAEs for darovasertib (2.5%) and crizotinib (10.0%) relative to ICT (19.0%). The most common Grade 3/4 TRAEs included diarrhea (10.0%), syncope (7.1%) and hypotension (3.8.%) in the darovasertib combination arm compared to elevated liver enzymes (ALT, 7.0% / AST, 7.0%), diarrhea (6.0%), hepatitis (5.0%) and colitis (4.0%) in the ICT control arm. In April 2026, IDEAYA announced the U.S. Food and Drug Administration (FDA) has agreed to review their new drug application (NDA) for darovasertib in combination with crizotinib under the Oncology Center of Excellence Real-time Oncology Review (RTOR) program. This program allows applicants to pre-submit components of their NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. IDEAYA completed its first pre-submission in May and expects to complete the NDA filing in the second half of 2026. About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. About Servier Servier is an independent international pharmaceutical group governed by a foundation. With its governance model, the Group is committed to therapeutic progress to serve patients and integrates the patient voice at every stage of the medicine life cycle. As a leading global player in cardiology and venous diseases, Servier aims to become a leading innovator in oncology and neurology. The Group intends to offer targeted therapeutic solutions, particularly in rare cancers and neurological diseases, and invests nearly 20% of its brand-name sales in R&D. Headquartered in France, Servier relies on its more than 20,000 employees and a solid geographic presence with medicines distributed in more than 130 countries. In the 2024/25 financial year, the Group achieved revenues of €6.9 billion. More information on the Group website: servier.com  Follow us on social media: LinkedIn, Facebook, X, Instagram  Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements regarding: the potential therapeutic benefit, safety, tolerability and clinical activity of darovasertib in combination with crizotinib; the potential significance and implications of data from the Phase 2/3 registrational OptimUM-02 trial; expectations regarding overall survival analyses and timing of interim data updates; IDEAYA's plans and expectations regarding regulatory submissions, including the timing and completion of the NDA submission under the FDA's Real-Time Oncology Review (RTOR) program; the potential for accelerated approval and/or full approval of darovasertib in combination with crizotinib in the United States and globally; and IDEAYA's strategy, business plans and objectives. Such forward-looking statements are based on IDEAYA's current expectations, estimates, assumptions, and beliefs regarding future events and are subject to substantial risks and uncertainties that could cause actual results, outcomes or events to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others: risks related to the discovery, development and regulatory approval of drug candidates; risks related to the timing, progress and results of clinical trials, including uncertainties regarding enrollment, safety, efficacy and durability of response; risks that clinical trial results may not be replicated in future studies or support regulatory approval; risks related to regulatory interactions, submissions and decisions, including the timing and outcome of NDA review processes; risks related to manufacturing and supply; risks related to competition and changes in the standard of care; the timing and success of commercialization efforts; the outcome of collaborations and licensing arrangements; IDEAYA's dependence on third parties; risks related to intellectual property protection; and risks related to IDEAYA's ability to obtain, maintain and enforce intellectual property rights for its product candidates. Additional risks and uncertainties that could affect IDEAYA's business and results are described under the caption "Risk Factors" in IDEAYA's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC. Forward-looking statements contained in this press release are made only as of the date hereof, and IDEAYA undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Investor and Media Contacts IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] Servier Laura Visserias [email protected] SOURCE IDEAYA Biosciences, Inc. 21% more press release views with Request a Demo