TIGIT

CHICAGO — Top cancer scientists, former NIH leaders, and patient advocates warned that the Trump administration’s cuts to science funding will have an unprecedented impact on the future of cancer research, and they called on attendees at the American Association for Cancer Research’s annual meeting to take action. “We are navigating political interference, institutional instability and growing uncertainty across the research enterprise. These are not routine challenges,” Yale oncologist Patricia LoRusso said Sunday during a panel. “This is not a time to wait and see. It is a time to be clear-eyed about what is happening and to decide what role each of us is willing to play.” She described a survey conducted by AACR that found only half of researchers had contacted their representatives in Congress. “This is not a criticism,” she said. “It is a reflection of how far we still have to go in claiming our role, not just as scientists, but as stewards of a system that depends on our voices.” The Trump administration has cut NIH grants and fired staff at federal health agencies, among other actions that have shaken up US research institutions. LoRusso received a standing ovation following her speech during a session about the potential impact of the government’s action. “I stand here as a healthy, grateful, thriving cancer survivor,” said former NIH Director Monica Bertagnolli, who stepped down in January. “Every bit of the wonderful treatment I received came from NCI and NIH research — every bit of it — and there are many millions of people like me.” This year’s meeting in Chicago had more than 22,000 attendees, which is around 1,000 fewer registrants compared to last year. Many plan to return to McCormick Place in just a few weeks for the American Society of Clinical Oncology’s annual meeting. Other highlights from the meeting: And if you missed our #AACR25 coverage:

iStock, LevKPhoto Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment landscape for head and neck and lung cancer, and implications for specific drug modalities like TIGIT and VEGF. On Friday, the streets of Chicago, Illinois—or at least, the halls of its McCormick Place Convention Center—will flood with hundreds of cancer experts from across the country. The annual meeting of the American Association for Cancer Research is in town and will host some of the most cutting-edge research in oncology. Expectations are great for this year’s event, which will host a few highly impactful readouts, some of which could have far-reaching implications for the market and for clinical practice. One of the most anticipated presentations is a detailed readout for Merck’s Phase III KEYNOTE-689 study , which evaluated its blockbuster PD-1 blocker Keytruda in head and neck squamous cell carcinoma (HNSCC). In October 2024, the pharma provided a topline peek at the study’s results, noting that Keytruda elicited a “statistically significant and clinically meaningful improvement” in event-free survival and a “trend toward improvement” in overall survival. Merck did not provide specific data at the time, and Keytruda’s magnitude of efficacy in this indication remains unknown. However, in an April 16 note to investors, William Blair analysts said they expect KEYNOTE-689 to have “read-through to the broader” HNSCC treatment space. “Merck’s Keynote-689 will have some impact on the head and neck cancer landscape/market opportunity,” William Blair analyst Matt Phipps added in an email to BioSpace . Detailed findings from the trial will likely affect other players in this space, including Merus and its bispecific antibody petosemtamab, and Exelixis, which is advancing its oral tyrosine kinase inhibitor zanzalintinib, according to Phipps. Aside from HNSCC, AACR 2025 could also witness big readouts in lung cancer. In an email to BioSpace , AACR president-elect Lillian Siu, a senior medical oncologist at the Princess Margaret Cancer Centre in Toronto, pointed to Boehringer Ingelheim’s Beamion LUNG-1 trial, which she said could be “practice-changing.” The trial is studying the HER2 tyrosine kinase blocker zongertinib in non-small cell lung cancer (NSCLC). A Phase Ib readout in September 2024 demonstrated a 66.7% objective response rate for zongertinib, which also shrank tumors in 94% of treated patients. Boehringer Ingelheim is scheduled to release additional findings from Beamion LUNG-1 on Monday . Modality Movement Beyond specific indications, many experts also expect this year’s AACR cycle to be critical for certain treatment modalities. “VEGF-PD(L)1 bispecifics took the oncology world by storm” in September last year, when Summit Therapeutics and Akeso announced that their investigational bispecific antibody ivonescimab bested Keytruda as a frontline NSCLC treatment, Christiana Bardon, co-managing partner at biotech investment firm MPM BioImpact, told BioSpace in an email. The oncology partners doubled down on those results on Wednesday, reporting that the candidate yielded better progression-free survival than BeiGene’s PD-1 inhibitor Tevimbra in patients with NSCLC. “Since [September 2024], a wave of VEGF bispecifics and some trispecifics have emerged,” according to Bardon, who noted that at least 13 of these, including ivonescimab and a candidate developed by Hangzhou DAC Biotechnology and dubbed DXA023-G017 , will have data at AACR. “There’s even a VEGF bispecific with an [antibody-drug conjugate] payload,” she said. Bardon is quick to caution, however, that assets playing in this space “are still mostly at the preclinical stage.” Nevertheless, “they have the potential to disrupt the oncology landscape if successful.” William Blair’s Phipps, for his part, is focused on the TIGIT space, which in recent months has been battered by setbacks. Last month, for instance, BeiGene was forced to scrap its TIGIT asset ociperlimab after disappointing late-stage data, which showed that the candidate was “unlikely to meet the primary endpoint of overall survival” in the Phase III AdvanTIG-302 trial in NSCLC. However, arguably the most high-pro belongs to Roche, which in November 2024 reported that its anti-TIGIT antibody tiragolumab failed the SKYSCRAPER-01 study in locally advanced unresectable or metastatic NSCLC, unable to significantly improve overall survival versus placebo. The pharma did not provide specific data at the time, but will do so at AACR. A more comprehensive readout “will have important implications for the TIGIT inhibitor space,” Phipps said. “We know the trial failed, but are there reasons that can be gleaned that might allow others to still succeed with this target?” Among these other players are partners Gilead and Arcus, which in November 2024 reported Phase III data showing that their anti-TIGIT antibody domvanalimab, when combined with the PD-1 therapy zimberelimab, significantly boosted progression-free and overall survival in patients with a specific type of NSCLC, as compared with zimberelimab or chemotherapy. The partners are also trialing the domvanalimab-zimberelimab combo in HSNCC, for which they are scheduled to present mid-stage data at AACR.

SAN CARLOS, CA, USA I April 03, 2025 I BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced the discontinuation of its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer. The Independent Data Monitoring Committee recommended terminating the ongoing Phase 3 AdvanTIG-302 trial ( NCT04746924 ) based on its findings as part of a pre-planned futility analysis. The overall efficacy and safety data assessment suggested that the study was unlikely to meet the primary endpoint of overall survival. No new safety signals were observed. After thorough deliberation, the Company has made the decision to terminate the trial. “We evaluate our clinical programs to focus our resources on the most promising clinically differentiated candidates while thoughtfully de-prioritizing others. Our commitment remains steadfast: to discover and develop innovative treatments that are more affordable and accessible to cancer patients worldwide,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “We thank the investigators, their patients, and support staff whose participation and dedication made this research possible.” Results from this study will be shared at a later date to help advance science and the understanding of anti-TIGIT activity. About BeiGene BeiGene, which plans to change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeiGene, please visit www.beigene.com . SOURCE: BeiGene