Roche’s rejection of cell therapy lives on through Polivy

Roche has famously refused to buy into cell therapy, and last year it went as far as trumpeting the fact that its anti-CD79b antibody-drug conjugate polatuzumab vedotin generated efficacy in relapsed lymphoma similar to that of CAR-T therapy. Yesterday the US FDA endorsed the enthusiasm, approving the drug as Polivy for third-line diffuse large B-cell lymphoma in combination with bendamustine. The GO29365 study on which approval is based had shown a remarkable 65% reduction in risk of death (p=0.0008) at the 2017 Ash meeting, but this included some second-line subjects, and the label cites only the overall remission surrogate – 45% versus 18% for bendamustine alone. Polivy is a largely overlooked asset, but Roche will rely on it as part of its haem-onc armamentarium, along with Gazyva, Venclexta and mosunetuzumab. CD79b is part of the B-cell receptor complex, so targeting it offers the possibility of knocking out B cells. A separate Roche asset, DCDS0780A, has yielded impressive monotherapy activity, but is even more obscure than Polivy. The only other industry asset targeting CD79b appears to be Provention Bio/Macrogenics’ PRV-3279; this is in development for lupus on the premise that it can stimulate a negative feedback loop on B cells.

Selected industry assets targeting CD79b
Project Companies Mechanism Trial ID Detail
Polivy Roche/Seattle Genetics Anti-CD79b ADC NCT02257567 mOS 11.8mth vs 4.7mth in ≥2L lymphoma
DCDS0780A Roche Anti-CD79b Thiomab ADC NCT02453087 ORR 60% (CR 43%) in DLBCL subgroup
PRV-3279 Provention/Macrogenics Anti-CD32B x CD79b bispecific NCT02376036 Earlier development by Takeda abandoned; current focus is lupus

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