CHMP recommends EU conditional approval of Roche’s antibody Mosunetuzumab for people with relapsed Follicular Lymphoma

Roche recently announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval under conditional marketing authorisation for Mosunetuzumab for the treatment of adult patients with relapsed or refractory (R/R) Follicular Lymphoma (FL), who have received at least two prior systemic therapies. Based on this positive CHMP opinion, a final decision regarding the conditional approval of Mosunetuzumab is expected from the European Commission in the near future, Roche notified in a statement.

The CHMP recommendation is based on positive results from the phase-I/II GO29781 study where Mosunetuzumab showed high Complete Response (CR) rates, with the majority of complete responders maintaining responses for at least 18 months, and favourable tolerability in people with heavily pretreated FL. After a median follow-up of 18.3 months, the CR rate was 60 per cent (n=54/90), the objective response rate was 80 per cent (n=72/90), and median progression-free survival was 17.9 months (95% CI: 10.1-not estimable). The median duration of response among those who responded was 22.8 months (95% CI: 9.7-not estimable). The most common adverse event was cytokine release syndrome (44.4 per cent) which was generally low grade (grade 1: 25.6%; grade 2: 16.7%), and resolved by end of treatment. The treatment was administered without mandatory hospitalisation. Results were presented for the first time in December 2021 at the 63rd American Society of Hematology Annual Meeting & Exposition, the statement further said.

It also noted that in June 2020, Mosunetuzumab was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the treatment of adult patients with FL who have received at least two prior systemic therapies. A robust development programme for Mosunetuzumab is ongoing including two phase-III studies: Celestimo investigating Mosunetuzumab plus lenalidomide in second line plus (2L+) FL, and SUNMO, investigating Mosunetuzumab plus Polivy (polatuzumab vedotin) in 2L+ diffuse large B-cell lymphoma (DLBCL).

This recommendation is Roche’s second CHMP positive opinion in NHL in 2022, following the positive opinion for Polivy in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin and prednisone in previously untreated DLBCL, the statement concluded.