ASH19: Roche presents early upbeat data on CD20-CD3 bispecific cancer immunotherapies in NHL

Roche announced promising data at the American Society of Hematology (ASH) annual meeting for two experimental CD20-CD3 T-cell engaging bispecific antibodies in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). Levi Garraway, head of global product development, said "we're encouraged by these early results."

The Phase I/Ib GO29781 study is evaluating mosunetuzumab in people with relapsed or refractory B-cell NHL, including those who have relapsed following, or are resistant to, CAR T-cell therapy, with outcomes including best objective response rate (ORR) and maximum tolerated dose. Results showed that the therapy was associated with an ORR of 62.7% in 67 patients with slow-growing NHL and 37.1% in 124 subjects with aggressive NHL.

Further data demonstrated a complete response (CR) rate of 43.3% in slow-growing NHL and 19.4% in aggressive NHL. Roche noted that 82.8% of patients with slow-growing NHL remain in remission up to 26 months off initial treatment and 70.8% of those with aggressive NHL remain in remission up to 16 months off initial treatment. Meanwhile, of the participants who received prior CAR T-cell therapy, the ORR was 38.9%, with 22.2% achieving a CR.

The Phase I/Ib NP30179 study is evaluating CD20-TCB as a single agent and in combination with Roche's Gazyva/Gazyvaro (obinutuzumab), following pre-treatment with a one-time, fixed dose of Gazyva/Gazyvaro, in people with relapsed or refractory B-cell NHL. Outcomes of the trial include overall response rate, CR and maximum tolerated dose.

Results detailed at the ASH meeting showed an overall response rate of 54% in 28 treated patients, with a CR rate of 46%. The company said that the findings included an overall response rate and CR of 66.7% in four subjects with follicular lymphoma and an overall response rate of 50% and a CR of 40.9% in 22 participants with aggressive NHL.

According to Roche, cytokine release syndrome (CRS) occurred in 28.9% of patients in the GO29781 study and 67.9% of subjects in the NP30179 trial.

Mosunetuzumab and CD20-TCB are being investigated as monotherapies and in combination with other therapies for the treatment of people with CD20-positive B-cell NHL, including diffuse large B-cell lymphoma and follicular lymphoma. The drugmaker noted that while both antibodies have the same two targets, they differ in their structures, with mosunetuzumab consisting of one 'Fab' region targeting CD20 and another targeting CD3. Meanwhile, CD20-TCB is engineered to have two 'Fab regions that bind to CD20, and one 'Fab' region targeting CD3.


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