Bristol Myers hits CAR-T manufacturing bottleneck as Abecma demand outstrips supply

abecma
Strong demand amid a shortage of viral vectors is outstripping Bristol Myers Squibb's supply of BCMA-targeted CAR-T cell therapy Abecma. (BMS)

After watching manufacturing problems play out for the first wave of CAR-T therapies, one might expect a smoother experience for third-to-market Bristol Myers Squibb. But the New York pharma now says it’s also hitting a production snag.

Demand for Bristol Myers’ newly launched multiple myeloma CAR-T drug Abecma is outstripping capacity, company executives said during a conference call Wednesday. Approved by the FDA in late March, Abecma generated $24 million in second-quarter sales.

Abecma is the first BCMA-targeted cell therapy, and “the sole focus that we have there is on steadily increasing manufacturing capacity,” Bristol Myers’ chief commercial officer, Chris Boerner, said on the call.

So far, the company has managed to increase the number of manufacturing slots available to patients to catch up with Abecma demand through August, Boerner said. Like other CAR-T drugs, Abecma is a personalized treatment that engineers each patient’s own T cells to fight cancer, so drugmakers need to reserve manufacturing slots to make each patient’s version.

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Another problem causing the supply gap is a shortage of viral vectors, which are used to deliver the cell therapy, Boerner said. Limited viral vector supply has haunted other cell therapies globally, and the situation remains “fairly dynamic,” he noted, adding that he wouldn’t put a specific date to when supply would improve significantly. Ensuring a more stable supply of vectors would be a key strategy for BMS next year and beyond, the exec said.

Gilead Sciences’ Kite Pharma, probably sick of the industry’s constraint in viral vector supply, in 2019 unveiled a plan to bring viral vector manufacturing in-house with a 67,000-square-foot facility at its Oceanside, California, biologics site. The plan was to have the upgraded factory begin commercial manufacturing in the second half of this year.

Gilead makes the CD19-targeted CAR-T drugs Yescarta and Tecartus. Novartis, for its part, has suffered from manufacturing out-of-spec issues that have hampered the rollout of its CD19 CAR-T therapy, Kymriah.

RELATED: Bristol Myers, flush with pair of CAR-T approvals, blueprints first cell therapy factory in Europe

BMS itself recently launched its own CD19 CAR-T, Breyanzi. The drug hauled in $17 million in second-quarter sales. The company said it has so far activated more than 65 sites to administer the drug.

Beyond the newly-found, bittersweet CAR-T problem, BMS in the second quarter successfully overcame another headache: PD-1 inhibitor Opdivo has returned to growth.

After a 3% sales decline in 2020 and another drop in the first quarter, Opdivo ginned up 16% year-over-year growth in Q2 with sales of $1.91 billion.

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New patient claims, while still lagging behind pre-COVID levels, are recovering quarter over quarter, Boerner said. Opdivo, used in tandem with chemotherapy, in April became the first immuno-oncology therapy approved for newly diagnosed metastatic stomach cancer. The new use is driving up Opdivo new patient share among checkpoint inhibitors, he said.

But the company on Wednesday said the same CheckMate-649 trial that supported the FDA nod for Opdivo and chemo in first-line stomach cancer found the dual immunotherapy combination of Opdivo and Yervoy failed to outdo chemo at extending the lives of patients whose tumors express PD-L1 at a combined positive score of at least 5.

All told, BMS recorded second-quarter revenues of $11.7 billion, representing year-over-year growth of 16%.