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What was once a promising area of cancer immunotherapy has had another late-stage failure. BeiGene said Thursday that a Phase 3 study for its anti-TIGIT drug, called ociperlimab, was halted for futility after a recommendation from the trial’s independent data monitoring committee. The study’s primary endpoint was overall survival in patients with certain forms of metastatic non-small cell lung cancer. BeiGene has now elected to terminate development of ociperlimab. Researchers were testing a combination of BeiGene’s PD-1 inhibitor Tevimbra with ociperlimab against Merck’s Keytruda. A third study arm also administered Tevimbra as an active comparator. There were no new safety signals, BeiGene said in a release. The failure is the latest in a long-running list of recent TIGIT flops. Last year, Roche and Merck reported late-stage misses for their TIGIT programs, and Merck announced in December that it was discontinuing its drug. Bristol Myers Squibb returned the rights of a partnered TIGIT program to Agenus last year, and Gilead reworked a deal with Arcus to leave TIGIT out of their collaboration. Additionally, ociperlimab’s miss wasn’t the first time it ran into headwinds. Back in 2023, Novartis backed out of a partnership with BeiGene for the program. There is still some hope for the field. GSK and iTeos said in September that an anti-TIGIT drug combined with the PD-1 inhibitor Jemperli improved overall response rates in an advanced form of lung cancer. But the buzz is considerably smaller than a few years ago, when money was flowing toward research into these drugs.

Five months after the FDA blocked its plans for accelerated approval, Agenus is moving ahead with discussions with potential pharma partners to chart a more conventional registrational path for its anti-CTLA-4 drug combo that has new Phase 2 data in advanced colorectal cancer. There are a variety of different partnership proposals on the table, with some focused on co-developing and others on financing, Agenus chief medical officer Steven O’Day told Endpoints News in an interview. “These negotiations are active — they’re moving forward,” he said. During its second-quarter earnings call last year, the company already indicated that it was looking for partnerships for botensilimab, which is combined with its PD-1 candidate balstilimab (BOT/BAL). According to data presented Saturday at the ASCO Gastrointestinal Cancers Symposium in San Francisco, the biotech’s 75 mg dose of botensilimab combined with balstilimab achieved a 19% objective response rate in patients with refractory microsatellite stable metastatic colorectal cancer that had spread to certain body parts but not the liver. This compares well with an ORR of zero for the control arm, which featured standard-of-care: Bayer’s Stivarga or Taiho Pharmaceutical’s Lonsurf. The 75 mg treatment cohort also achieved a 55% disease control rate. This means that more than half the patients treated with the combo were no longer progressing, O’Day said. Hello, Traci Lang You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? Hello, Traci Lang You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? The company has regulatory “alignment” to move forward with the 75 mg regimen in a Phase 3 trial with survival as a primary endpoint, he added. In July 2024, the FDA advised Agenus against pursuing accelerated approval for BOT/BAL based on data from previous Phase 1 and 2 studies in relapsed or refractory non-microsatellite instability-high colorectal cancer. The agency said that response rates in this population have not always translated to survival outcomes, adding it wanted to see a definitive survival study. Now that a Phase 3 is in the cards, Agenus has several options as to the specific subset of colorectal cancer patients it advances in, O’Day said. Other than the late-line setting, “we can also move into earlier-line metastatic colon and neoadjuvant” disease, he said. The company shared results from various BOT/BAL-based regimens in these other settings at ASCO GI. “But clearly the Phase 3 refractory [setting] is the most set up in terms of the work that’s been done with dose and contribution and a large database,” O’Day said. Agenus is no stranger to regulatory struggles. In 2021, the drugmaker withdrew its accelerated BLA for balstilimab in second-line cervical cancer shortly after the FDA cleared Merck’s Keytruda for full approval in the same setting. In August 2024, Bristol Myers Squibb turned its back on a pact with Agenus for a bispecific anti-TIGIT drug that featured more than $1 billion in potential milestones. Last month, the biotech launched a biologics manufacturing business to help it make money. In November, it had just $44.8 million in consolidated cash.