On December 12, 2025 Gilead Sciences and Arcus Biosciences reported the discontinuation of the Phase 3 STAR-221 study evaluating the anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab and chemotherapy versus nivolumab plus chemotherapy as first-line treatment for HER2-negative advanced gastric and esophageal cancers. The decision is based on the recommendation from the Independent Data Monitoring Committee (IDMC) following their review of data from a pre-specified interim analysis of overall survival (OS).

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In the pre-specified interim analysis, the combination of domvanalimab plus zimberelimab and chemotherapy did not improve OS relative to nivolumab plus chemotherapy, the standard of care, and there was low likelihood of achieving a positive survival benefit with further follow-up. The safety profile for the combination of domvanalimab plus zimberelimab and chemotherapy was consistent with the control arm, nivolumab plus chemotherapy, and there were no new safety findings.

The companies are informing regulators and communicating with investigators for the STAR-221 and the Phase 2 EDGE-Gastric studies to determine appropriate next steps for patients. The companies are conducting a detailed analysis to understand these results, which will be published in the future.

"These results offer valuable insights into the complexity of treating advanced gastroesophageal cancers," said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. "We will collaborate closely to understand the full scope of the data and engage key stakeholders in determining the appropriate next steps. We are deeply grateful to the patients, families, and healthcare professionals who participated in the STAR-221 study and contributed to this important work."

Currently, there are no changes to other ongoing domvanalimab studies beyond the upper gastrointestinal (GI) program. Arcus and Gilead will share further guidance as it becomes available.

Domvanalimab and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established.

(Press release, Gilead Sciences, DEC 12, 2025, View Source [SID1234661411])

On December 12, 2025, Arcus Biosciences, Inc. (the "Company") reported the discontinuation of the Phase 3 STAR-221 study due to futility. STAR-221 evaluated the anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab and chemotherapy versus nivolumab plus chemotherapy as a first-line treatment for advanced gastric and esophageal cancers.

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The decision is based on the recommendation from the Independent Data Monitoring Committee following its review of data from an event-driven, pre-specified interim analysis of overall survival ("OS"). At the interim analysis, the domvanalimab-based combination did not improve OS relative to nivolumab plus chemotherapy. The safety profile for the domvanalimab-based combination was similar to that of nivolumab plus chemotherapy, and there were no new safety findings identified.

The STAR-221 and the Phase 2 EDGE-Gastric studies will be discontinued, and the Company and Gilead Sciences, Inc. are communicating with investigators to determine appropriate next steps for patients in the study, in addition to conducting a detailed analysis to better understand these results.

Based on existing cash, cash equivalents and marketable securities, the Company expects to be able to fund its planned operations until at least the second half of 2028. Moving forward, the Company’s R&D investment and resources will focus on casdatifan, a potential best-in-class HIF-2a inhibitor, and its emerging small molecule inflammation and autoimmune programs, including an MRGPRX2 inhibitor that is expected to enter the clinic in 2026.

(Press release, Arcus Biosciences, DEC 12, 2025, View Source [SID1234661400])

On December 12, 2025 Genmab A/S (Nasdaq: GMAB) ("Genmab") reported that the conditions, including the minimum tender condition, to the previously announced tender offer (the "Offer") by Genmab Holding II B.V., a wholly owned subsidiary of Genmab ("Purchaser"), to acquire all the issued and outstanding common shares of Merus N.V. (Nasdaq: MRUS) ("Merus") for $97 per common share in cash have been satisfied. The transaction meaningfully accelerates Genmab’s shift to a wholly owned model, expanding and diversifying the company’s revenue, driving sustained growth into the next decade and contributing to Genmab’s evolution into a biotechnology leader.

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"The Merus acquisition marks a pivotal step in the delivery of Genmab’s long-term strategy and strengthens our path to becoming a global biotechnology leader with sustained growth and profitability. We are energized by the potential of petosemtamab to meaningfully impact the lives of people with head and neck cancer. Backed by our track record of successful development and commercial execution, we look forward to unlocking petosemtamab’s full potential and delivering on its promise to patients," said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab.

The addition of petosemtamab, Merus’ lead asset, to Genmab’s promising late-stage pipeline is a compelling strategic fit with Genmab’s portfolio and aligns with Genmab’s expertise in antibody therapy development and commercialization in oncology. Based on this successful track record in late-stage development and excellence in commercial execution, Genmab expects to launch petosemtamab in 2027, subject to clinical results and receipt of regulatory approvals. Genmab also intends to broaden and accelerate petosemtamab’s development with potential expansion into other lines of therapy. Following the initial approval of petosemtamab, Genmab believes that petosemtamab will be accretive to EBITDA with at least one-billion-dollar annual sales potential by 2029, with multi-billion-dollar annual revenue potential thereafter.

At 5:00 p.m. New York City time on December 11, 2025 (the "Expiration Time"), the Offer and withdrawal rights expired as scheduled. The depositary for the Offer has advised Genmab and Purchaser that, as of the Expiration Time, a total of 71,463,077 of Merus’ issued and outstanding common shares, constituting 94.2% of its issued and outstanding common shares, had been validly tendered pursuant to the Offer and not properly withdrawn. Effective at 12:01 a.m. New York City time on December 12, 2025, Purchaser accepted for payment, and expects to promptly pay for, all Merus common shares validly tendered and not properly withdrawn pursuant to the Offer.

Subsequent Offering Period
Genmab also announced that, as previously disclosed, Purchaser is providing a subsequent offering period of ten business days (the "Subsequent Offering Period"), commencing today, December 12, 2025, that will expire at 5:00 p.m., New York City time on December 29, 2025. During the Subsequent Offering Period, Purchaser will offer to purchase additional common shares at the same consideration of $97.00 per share, less any applicable withholding taxes and without interest. All Common shares validly tendered during the Subsequent Offering Period will be immediately accepted and promptly paid for by Purchaser.

Following completion of the Subsequent Offering Period, Genmab and Purchaser intend to complete the acquisition of 100% of Merus through a series of previously disclosed back-end transactions. Merus shareholders who do not tender their common shares of Merus in the Offer will receive payment for their common shares following the completion of these transactions (subject to applicable withholding taxes and without interest).

(Press release, Genmab, DEC 12, 2025, View Source [SID1234661377])

On December 12, 2025 Century therapeutics presented its corporate presentation (Presentation, Century Therapeutics, DEC 12, 2025, View Source [SID1234661401]).

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On December 12, 2025 BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage biopharmaceutical company developing first-in-class immune-modulating cancer therapies, reported results from the Asian subset (n=488) of its global Phase 3 DUBLIN-3 trial evaluating Plinabulin plus docetaxel compared to docetaxel alone in second- or third-line EGFR wild-type non-small cell lung cancer (NSCLC). Dublin-3’s global intent-to-treat (ITT) patient data was published in Lancet Respiratory Medicine in 2024. These new findings were presented by Dr. Baohui Han of Shanghai Chest Hospital at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress 2025.

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In this large Asian intent-to-treat cohort, Plinabulin + docetaxel (DP, n=243) achieved a statistically significant improvement in overall survival compared to docetaxel (D, n=245): DP 10.8 months vs. D 8.8 months, HR 0.81, p=0.0426.

In the mechanism-based non-squamous subgroup, the hazard ratio was 0.69 with a median OS benefit of 3 months (p=0.0064), highlighting enhanced benefit in patients whose disease biology aligns with Plinabulin’s immune-modulating and tumor vasculature-targeting mechanisms.
The combination also doubled 2-year and 3-year survival rates, reflecting durable benefit consistent with Plinabulin’s first-in-class dendritic-cell maturation mechanism.

Plinabulin demonstrated a marked reduction in docetaxel-induced grade 4 neutropenia (DP: 3.9% vs. D 26.5%, p<0.0001), while maintaining a favorable tolerability profile. This safety improvement supports better treatment exposure, an important driver of chemotherapy benefit.

"These data from nearly 500 Asian patients further strengthen the robust global evidence supporting Plinabulin’s potential to become a new standard of care for EGFR wild-type NSCLC," said Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring.

"The consistent survival benefit, particularly in the mechanism-aligned non-squamous population, together with the marked reduction in severe neutropenia, reflects Plinabulin’s first-in-class immune-modulating mechanism and its ability to improve chemotherapy tolerability. These results reinforce our confidence as we advance Plinabulin into a global Phase 3 confirmatory study."

About Plinabulin

Plinabulin is a first-in-class, brain-penetrating, dendritic-cell maturation small molecule. It has been used in over 700 cancer patients, with good tolerability and showed durable anti-cancer benefit across multiple clinical studies. As a reversible binder at a distinct tubulin pocket, plinabulin does not change tubulin dynamics or antagonize tubulin stabilizing agents, such as docetaxel, which contributes to its differentiated activity and tolerability compared to other tubulin binders. In addition, plinabulin significantly reduces chemotherapy-induced neutropenia and could thereby increase docetaxel tolerability.

About DUBLIN-3 Study (103 Study)
DUBLIN-3 (n=559, NCT02504489) was a multicenter, single-blinded (patient) and randomized, phase 3 trial in 58 medical centers (US, China, and Australia). Only patients with EGFR wild-type NSCLC who had progressed after first-line platinum-based therapy were enrolled. Patients were randomized (1:1) to receive docetaxel (75 mg/m2) on Day 1 and either plinabulin (30 mg/m2) or placebo on Days 1 and 8 in 21-day cycles until progression, unacceptable toxicity, withdrawal, or death. Treated patients were included in the safety analysis and ITT population in the primary efficacy analyses. The primary endpoint for the study was OS, and secondary endpoints were PFS, ORR, Duration of Response (DoR), Grade 4 neutropenia and Quality of Life. The study was published in Lancet Resp Med 12:775, 2024.

(Press release, BeyondSpring Pharmaceuticals, DEC 12, 2025, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-esmo-asia-presentation-on-plinabulin-docetaxel-improving-survival-in-large-phase-3-dublin-3-asian-subset-for-egfr-wt-nsclc-compared-to-docetaxel-strengthening-the-case-for-a [SID1234661418])