Roche's Potential 'First-in-class' Bispecific Therapy Wins EU CHMP Support

Roche announced today that the European Commission for Medicinal Products for Human Use (CHMP) has recommended conditional approval of mosunetuzumab, a bispecific antibody targeting CD20 and CD3, for the treatment of relapsed or refractory follicular lymphoma. These patients had previously received two prior therapies. If approved, mosunetuzumab would be the first CD20/CD3 T cell engaging bispecific antibody to treat this patient population, the press release states. Provide patients with a ready-to-use new treatment option.

Follicular lymphoma is the second most common lymphoma worldwide, accounting for 20% of all non-Hodgkin lymphomas. It is considered incurable, and disease recurrence is common. Mosunetuzumab is a T-cell-engaging bispecific antibody targeting CD20 and CD3, which activates a patient's existing T cells and directs them to attack B cells. It has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the treatment of patients with follicular lymphoma who have received at least two prior systemic therapies.

The CHMP recommendation is based on positive results from the Phase 1/2 clinical trial GO29781. The trial results showed that at a median follow-up of 18.3 months, the complete response rate was 60% (n=54/90), the objective response rate was 80% (n=72/90), and the median progression-free survival was The duration of response was 17.9 months, and the median duration of response was 22.8 months. The results were presented last December at the American Society of Hematology (ASH) annual meeting.

"Most patients with follicular lymphoma experience multiple relapses, with each relapse leading to shorter remissions and survival with subsequent treatments," said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. The decision is a recognition of mosunetuzumab as a ready-to-use, effective treatment option that may offer new hope for patients."