Bristol Myers Squibb and bluebird bio filed their BCMA-targeting CAR-T therapy for FDA approval, teeing it up for a potential green light in 2020—and laying the groundwork for a potential payout to Celgene investors.
The treatment, known as bb2121 or idecabtagene vicleucel (ide-cel), is one of three programs upon which BMS’ acquisition of Celgene hinged. The Big Pharma made a last-minute change to its offer to buy Celgene: Instead of $57 per share in cash and a one-to-one share trade, BMS offered $50, plus one BMS share and a $9 payout per Celgene share.
The catch? That payout, in the form of a contingent value right (CVR) per Celgene share, would only come if three of Celgene’s top prospects made it to market by March 2021. If any of them fail, the return will be zero. Those programs are ide-cel, a treatment for multiple myeloma, lisocabtagene maraleucel (liso-cel), for a type of lymphoma, and ozanimod, a multiple sclerosis med that earned the FDA nod in March after weathering a rejection from the agency in 2018.
With the latest filing, BMS looks on track to deliver what it promised. It plans to market ozanimod under the name Zeposia for relapsed multiple sclerosis. Although the company is delaying the launch due to the COVID-19 pandemic, analysts predict Zeposia will hit $1.6 billion in sales in 2024. As for liso-cel, BMS submitted it for approval for the treatment of patients with large B-cell lymphoma who had tried at least two other therapies. The FDA expects to make a decision by Aug. 17. If ide-cel gets the same timeline, it could be approved by the end of the year.
BMS is seeking approval for ide-cel for patients with multiple myeloma who have tried at least three types of therapies, including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody. The application is based on data from a pivotal phase 2 study, which tested three doses of ide-cel in 128 patients. Top-line data reported in December showed that the treatment shrank tumors in nearly three-quarters of patients and eliminated them in nearly one-third. The highest dose did the best, shrinking tumors in 82% and banishing tumors in 35% of patients.
That said, ide-cel may still face an uphill battle in the multiple myeloma space. The FDA approved Sarclisa, Sanofi’s challenger to Johnson & Johnson’s blockbuster Darzalex in March. Both are anti-CD38 antibodies, but competition is coming from other BCMA-targeting meds, too.
J&J is working on its own anti-BCMA CAR-T, JNJ-4528, which shrank multiple myeloma tumors in all 29 of the patients in a small trial presented at the annual meeting of the American Society of Hematology in December. That same month, GlaxoSmithKline filed its antibody-drug conjugate (ADC), belantamab mafodotin, for FDA approval. The treatment shrank tumors in about one-third of 100 patients with advanced multiple myeloma. The numbers are in line with response rates typically seen in studies involving very sick patients, but GSK thinks the ADC could do even better in earlier lines of treatment.