Asco 2022 – Roche bids for the CD20 bispecific prize
Abbvie/Genmab’s epcoritamab is the anti-CD20 bispecific that has impressed the most so far, but Roche is not far behind. Asco today heard of the pivotal lymphoma dataset for glofitamab that Roche will soon take to the FDA: at Roche's favoured step-up 2.5/10/30mg dose in DLBCL the overall remission rate is 52%, with 18.4-month median duration of response. Complete remissions, the primary endpoint of study NP30179, are at 39%, and a look at the survival curves reveals a benefit that Peter MacCallum Cancer Centre’s Dr Michael Dickinson called “clinically significant”. The data are all the more impressive since 34% of patients were after Car-T therapy, and the CR rate in these was 35%. The study includes less aggressive lymphomas, but Roche is zeroing in on these DLBCL subjects, including those with transformed follicular lymphoma, for a US filing expected in the third quarter; an EU submission has already been made. Mosunetuzumab, a separate Roche anti-CD20 T-cell engager, is filed in the US and approved in the EU for less aggressive follicular lymphoma. The glofitamab data are an advance on the 41% ORR Roche reported with lower doses a year ago, but for many epcoritamab’s 63% figure is the one to beat.