BMS targets doubling of registrational assets over next 18 months
14 Sep 2023
Phase 3Cell TherapyPhase 1Priority ReviewImmunotherapy
At its R&D day on Thursday, Bristol Myers Squibb revealed that it intends to double its registrational pipeline from six to 12 new assets over the next 18 months. The company also indicated that cell therapy and targeted protein degradation platforms will take centre stage, offering the potential to expand treatment options across several therapeutic areas.
"We are seeing the impact of our focused efforts to strengthen our R&D engine and pipeline as we've executed against our priorities over the past four years," said Giovanni Caforio, who is set to retire from the role in November. "We are well-positioned to deliver more medicines to patients even faster in the future," he added.
The pipeline update comes as Bristol Myers Squibb faces pressure from declining demand for Revlimid (lenalidomide) and Eliquis (apixaban), which face generic competition. The latter, which is partnered with Pfizer, also recently landed on the list of 10 drugs that will be subject to the first-ever price negotiations by the US Medicare programme.
Three cell therapies that target immune disorders, cancer
Candidates seen advancing include the CD19-directed NEX-T cell therapy BMS-986353, which Bristol Myers Squibb said it intends to move into clinical trials for immunologic diseases such as severe refractory systemic lupus erythematosus (SLE). BMS-986353 expresses the same CD19-specific CAR construct as Breyanzi (lisocabtagene maraleucel), but with a "differentiated safety profile" and enhanced manufacturing process, the company noted. Data from a Phase I trial in SLE is anticipated in 2024.
Two other assets – the CAR-T BMS-986393, which is a potential first cell therapy targeting GPRC5D, and the BCMAxCD3 T-cell engager alnuctumab – are advancing into registrational testing for relapsed/refractory multiple myeloma, the latter in Phase III. The protein degrader golcadomide is also moving into Phase III next year for first-line large B-cell lymphoma.
Meanwhile, a first asset from Bristol Myers Squibb's ligand-directed protein degradation platform, an androgen receptor degrader, is moving into pivotal studies in metastatic castration-resistant prostate cancer, while the BET inhibitor BMS-986158BET inhibitor BMS-986158 for myelofibrosis is awaiting proof-of-concept data early next year.
These would add to a batch of six candidates already in registrational trials, including the ROS1 inhibitor repotrectinib, which is currently under priority review at the FDA for non-small-cell lung cancer (NSCLC), with a decision date set for November 27. Protein degraders iberdomide and mezigdomide are both in registrational trials for second-line-plus multiple myeloma, with first data expected in 2026.
The company is also developing the anti-IL-13 asset cendakimab for eosinophilic esophagitis, and milvexian in secondary stroke prevention, acute coronary syndrome and atrial fibrillation in collaboration with Johnson & Johnson. Meanwhile, Bristol Myers Squibb on Thursday also outlined Phase III trials for its LPA1 antagonist BMS-986278 in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis that will evaluate both the 60mg and 120mg doses of the drug.
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