Ociperlimab

A BeiGene study’s independent data monitoring committee recommended terminating a phase 3 trial of ociperlimab.\n BeiGene is scrapping ociperlimab over a disappointing phase 3 outlook two years after Novartis handed back the anti-TIGIT antibody.The global biopharma had been evaluating ociperlimab, alongside BeiGene’s own PD-1 inhibitor Tevimbra, when compared to Merck & Co.\'s megablockbuster cancer med Keytruda in patients with PD-L1-high, locally advanced/recurrent or untreated metastatic non-small cell lung cancer. BeiGene, which is in the process of rebranding to BeOne Medicines, enrolled the first patient in the late-stage study back in 2021, with the aim of assessing the dual targeting of anti-TIGIT and anti-PD-1 antibodies.However, the study’s independent data monitoring committee recommended terminating the phase 3 trial after an early analysis suggested it would miss its primary endpoint of overall survival.After “thorough deliberation,” the study has been terminated, said BeiGene, which pointed out that no new safety signals had been observed.“We evaluate our clinical programs to focus our resources on the most promising clinically differentiated candidates while thoughtfully de-prioritizing others,” Mark Lanasa, M.D., Ph.D., chief medical officer for solid tumors at BeiGene, said in the April 3 release.Pharmas have previously pumped vast sums of money into licensing and developing anti-TIGIT antibodies in the belief they can counter a way tumors suppress immune responses. However, the results have so far failed to justify the outlay. Novartis paid $300 million to enter the TIGIT space by acquiring ociperlimab in 2021 but handed the asset back to BeiGene two years later. A Novartis spokesperson told Fierce Biotech at the time that the decision had been made after assessing \"the totality of the current information, including phase 2 data, benefit/risk, competitive space, timing, development programs, and future investments.\"Meanwhile, Roche’s TIGIT drug tiragolumab has failed a trio of phase 3 trials in various types of lung cancer. Arcus Biosciences and Gilead Sciences also stopped a study in the setting at the start of last year, while Merck ended 2024 by jettisoning its TIGIT prospect vibostolimab.But it’s not over for TIGITs quite yet. Roche hasn’t fully given up on tiragolumab, while GSK began a phase 3 trial of its iTeos Therapeutics-partnered prospect belrestotug last year

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.