BMS confident Breyanzi capacity issues will be resolved in 2023

Bristol Myers Squibb will apply the same strategy used to increase Abecma supply to increase capacity for Breyanzi as it pushes back projected timelines into next year.

Bristol Myers Squibb (BMS) has with its chimeric antigen receptor (CAR) T-cell therapy Breyanzi (liso-cel) “a best-in-class profile,” Christopher Boerner, EVP & chief commercialization officer told stakeholders at the Morgan Stanley Global Healthcare Conference last week.

Having been approved in February 2021 for Large B-cell Lymphoma, the therapy won second-line approval for relapsed or refractory large B-cell lymphoma (LBCL) in June, which “gives us the broadest label of any CAR-T product in non-Hodgkin’s lymphoma.”

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But the therapy remains a long way off being the key growth driver BMS has touted it to be, pulling in just $39 million in the second quarter this year. In July, the company said high demand was stifled by lower-than-expected manufacturing success rates but claimed the manufacturing issues had now been addressed.

However, Boerner told Morgan Stanley Conference delegates Breyanzi’s success was now dependent on scaling-up production, specifically ensuring increased lentiviral vector (LVV) supply but a planned increase in vector capacity expansions has now been delayed.

“With the second-line approval, we had hoped to be able to improve capacity coming into the second half of the year. It looks like now, that’s going to be pushed into 2023,” he said.

“As you know from the history of CAR-T manufacturing, this technology is very complicated. Almost every company that’s been in this space has encountered some challenges. We have confidence we’ll work through it.”

Boerner’s confidence is well-founded, with BMS’s other commercialized CAR-T therapy Abecma (ide-cel) – approved in March 2021 as a multiple myeloma treatment – has also felt the strain of manufacturing issues and a shortage of LVV.

In February, the company spoke about overcoming the supply constraints by accelerating partnerships with contract development and manufacturing organizations (CDMOs) and simultaneously increasing inhouse operational efficiency, capacity, and qualified staff.

“The good news though is the same manufacturing team at a sort of general level that was working on Abecma is focused on Breyanzi,” he said.

“We had anticipated being able to increase the (Abecma) supply going into the second half of the year. We actually increased supply in Q2, and we’re continuing to see an improvement in our supply ability, both on the vector and the product supply coming into the second half of this year and going into next year.”

Second quarter Abecma sales stood at $89 million, up 370% from the previous quarter.