BMS sees CAR-T sales rocket in line with increased capacity

Bristol Myers Squibb will continue to expand vector and drug product capacity for Abecma and Breyanzi but says manufacturing success is just as essential in ensuring supply.

For the full year 2022, Bristol Myers Squibb (BMS) reported its chimeric antigen receptor (CAR) T-cell therapies Abecma (ide-cel) and Breyanzi pulled in $388 million and $182 million, respectively – up from $164 million and $87 million the year prior. While full year comparisons are slightly unfair as both drugs received approval in Q1 2021, fourth quarter sales rose 81% and 38% respectively, year-on-year.

These increases reflect “significant patient demand and the work the company has done to increase manufacturing capacity,” CFO David Elkins said on a financial call.

“We remain focused on continuing to ramp up capacity and believe this will enable us to get Abecma to more patients with highly refractory myeloma,” he continued, adding: “We continue to expect growth driven by demand for Breyanzi in second-line plus large B-cell lymphoma, and we remain focused on continuing to build manufacturing capacity to further support the uptake and prepare for additional indications.”

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Elkins’ comments alluded to supply constraints for both CAR-T therapies seen by the company, with shortages of both viral vectors and drug product capacity.

In February 2022, BMS described how it overcame supply constraints for Abecma by accelerating partnerships with contract development and manufacturing organizations (CDMOs) while simultaneously increasing inhouse operational efficiency, capacity, and qualified staff.

And while in September the firm said a planned lentiviral vector capacity expansion was delayed, management told stakeholders it was able to accelerate this project.

“For Breyanzi, we had anticipated the expansion of capacity would wait until we got into this year. We were very happy to see that expansion be accelerated into Q4,” said Christopher Boerner, chief commercial officer.

He added manufacturing for both Abecma and Breyanzi will continue to be an area of focus going forward and outlined a threefold strategy:

“First, we continue to stay focused on manufacturing success rates. That’s one of the more important elements that frankly affect all cell therapy products. These are complex drugs, they’re living products and you have to stay focused on your manufacturing success rate.

“Second, we’ve talked at length about vector supply, and we obviously have a number of strategies in play from dual sourcing to increasing the number of suites and ultimately switching to a next-generation suspension vector on that front.

“And then finally, drug product, and there it’s mainly about bringing additional manufacturing sites online, and we’ve discussed previously our efforts in Devens, Massachusetts, and Leiden [The Netherlands] to do just that.”