Roche (OTCQX:RHHBY) unit Genentech announces encouraging data from early-stage studies of two investigational T-cell engaging bispecific antibodies, mosunetuzumab and CD20-TCB, in treatment-resistant non-Hodgkin lymphoma (NHL) patients, including some who failed to respond to CAR T therapy. The results were presented at ASH in Orlando.
An open-label dose-escalation Phase 1 trial, GO29781, is evaluating mosunetuzumab alone and in combination with Tecentriq (atezolizumab) in NHL and CLL patients. In NHL patients, the overall response rate (ORR) was 63% (n=42/67) in those with slow-growing cancer and 37% (n=46/124) in those with aggressive cancer. The complete response rates were 43% and 19%, respectively. In patients refractive to CAR T therapy, the ORR was 39% (n=7/18) including four (22%) complete responders.
On the safety front, the rate of cytokine release syndrome was 29%, most (28%) mild or moderate. The rate of serious adverse neurological events was 4%.
Another open-label dose-escalation Phase 1, NP30179, is evaluating CD20-TCB alone and in combination with Gazyva (obinutuzumab) in relapsed/refractory B-cell NHL patients. The ORR in subjects receiving the combo was 54% (n=15/28), including 13 (46%) complete responders. The complete response rate was 67% (n=4/6) in a subset of follicular lymphoma patients and 41% (n=9/22) in a subset of patients with aggressive NHL.
On the safety front, the most common (68%) treatment-related adverse event was cytokine release syndrome (n=19/28), most being low grade.
Development is going.
BiTE-related ticker: Amgen (NASDAQ:AMGN)