California-based biotech BeiGene has terminated the clinical development programme for its lung cancer therapy ociperlimab, after an independent committee ruled that it was unlikely to meet its primary endpoint of impacting overall survival (OS) in a Phase III trial.
The primary endpoint of the AdvanTIG-302 trial (NCT04746924) would have sought to establish an increase in OS, by splitting patients into three arms, with one receiving ociperlimab alongside the company’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr), whilst the others received Tevimbra alone or a dose of Merck’s Keytruda (pembrolizumab) alone.
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BeiGene said it would put an end to the development of the drug after a pre-planned futility analysis discovered that ociperlimab was unlikely to beat out its comparators when it comes to extending OS in the Phase III trial.
BeiGene chief medical officer Mark Lanasa said: “We evaluate our clinical programmes to focus our resources on the most promising clinically differentiated candidates while thoughtfully de-prioritising others. Our commitment remains steadfast: to discover and develop innovative treatments that are more affordable and accessible to cancer patients worldwide.”
Ociperlimab is described as a humanised immunoglobulin G1 (IgG1) monoclonal antibody with the potential to enhance T cell-mediated immune responses against cancer.
The announcement comes after BeiGene, which is rebranding to BeOne Medicines, received a positive opinion from the European Medicines Agency (EMA) for its non-small cell lung cancer (NSCLC) drug Tevimbra (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment.
In 2021, BeiGene entered a collaboration and licence agreement with pharmaceutical giant Novartis to commercialise Tevimbra, with BeiGene seeing an initial payout of $650m, but that deal was terminated in September 2023.
