Some good news for liso-cel at last


With US approval at long last for Bristol Myers Squibb’s liso-cel, lymphoma doctors can make a direct comparison of FDA-curated data for the three anti-CD19 Car-T therapies now available. The good news for Bristol is that the agency broadly agrees with the safety and efficacy cited in the most recent cut of liso-cel’s pivotal Transcend study. Thus liso-cel, now branded Breyanzi, has efficacy on a par with Gilead’s Yescarta, with more durable responses and distinctly less cytokine release and neurotoxicity. This at least backs claims made by the product’s originator, Juno, that Breyanzi’s defined 50/50 CD4+/CD8+ T-cell ratio gives a more controllable and safer therapy. This is where the good news ends, however: hospital staff are becoming increasingly expert at handling such toxicities, and a defined-cell product is more expensive to manufacture than one generated from bulk cells. Margins on Car-T therapy are already vanishingly small, and whether Bristol can ever make Breyanzi profitable is a key unknown. And Friday’s approval is cold comfort for funds that had held contingent value rights related to Bristol’s Celgene acquisition: Breyanzi approval not having come by December 31, 2020, the security had already expired.

Comparison of CD19-directed Car-T therapy for DLBCL
Product Yescarta Kymriah Breyanzi
Company Gilead Novartis BMS
Black box CRS & neurotox CRS & neurotox CRS & neurotox
Patients evaluable 101 (108 for safety) 68 (106 for safety) 192 (268 for safety)
ORR 72% (51% CR) 50% (32% CR) 73% (54% CR)
mDOR 9.2 mth Not evaluable 16.7 mth
CRS 94% (13% ≥gr3) 74% (23% ≥gr3) 46% (4% ≥gr3)
Neurotoxicity 87% (≥gr3 not given) 58% (18% ≥gr3) 35% (12% ≥gr3)
Source: US product labels.

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