Glaxo edges towards first approval for anti-BCMA mechanism

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In a clear indication of the limited options available for patients with relapsed or refractory multiple myeloma an FDA advisory committee yesterday voted 12-0 in favour of approving Glaxosmithkline’s belantamab mafodotin. The nod came despite underwhelming efficacy and the severe ocular toxicity associated with the product. While the committee's thumbs-up could make belantamab the first anti-BCMA approved for rrMM, other contenders, particularly Car-T therapies, have shown much better efficacy, albeit with toxicities of their own. Johnson & Johnson’s JNJ-4528 produced an impressive 100% ORR in similar patient population, admittedly in only a handful of subjects, versus the 31% belantamab showed in the Dreamm-2 trial. And despite a four-month filing delay Bristol Myers Squibb’s ide-cel could also pose serious competition if and when it is approved: the registrational Karmma trial generated a 76% ORR. Unsurprisingly, belantamab’s nod comes with strings: patients must have received at least four prior therapies, while a black box warning will be on the label and a REMS programme implemented. With the adcom hurdle behind it, the next test for belantamab will be whether patients are willing to accept the significant risk to their eyesight. The project's weighty $1.25bn 2026 sales forecast depends on a yes to this question.

Targeting BCMA - a selection of the most advanced candidates
      Annual sales ($m)
  BCMA targeting mechanism  Company 2020e 2023e 2026e
Filed          
Belantamab mafodotin ADC Glaxosmithkline 61 621 1,251
ide-cel (bb2121) Car-T  Bristol-Myers Squibb/Bluebird Bio 11 658 1,425
Phase III          
JNJ-4528 Car-T 

Johnson & Johnson

- - -
Earlier stages          
ALLO-715 Car-T  Allogene/Cellectis - 25 446
CTX120 Car-T  Crispr Therapeutics - - 209
HPN217 Tri-specific T cell activating construct (TriTAC) Abbvie/Harpoon Therapeutics - - 82
AMG 420 Bispecific (BiTE) Amgen - 8 19
bb21217 Car-T  Bristol Myers Squibb/Bluebird Bio - 6 15
AMG 701 Bispecific (BiTE) Amgen/Beigene - - -
JNJ-7957 (teclistamab) Bispecific (duobody)  Johnson & Johnson/Genmab - - -
Orva-cel (JCARH125) Car-T  Bristol Myers Squibb - - -
PBCAR269A Car-T  Precision Biosciences - - -
REGN5458 Bispecific  Regeneron/Sanofi - - -
Note: this list is far from exhaustive. The presence of sales forecasts does not necessarily indicate that a product is more advanced; the vast majority of projects are not attracting sellside projections. Source: EvaluatePharma. 

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