Roche's CD20xCD3 dual anti-mosunetuzumab obtained FDA breakthrough therapy designation
Recently (July 14), Roche announced that its CD20xCD3 T cell combined with dual-characteristic cancer immunotherapy mosunetuzumab has received FDA Breakthrough Therapy Designation (BTD).
Dr. Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said: "We are very pleased that the FDA has granted mosunetuzumab breakthrough therapy qualification and recognized the early efficacy data of this molecule.
The early efficacy data mentioned here comes from a multi-center phase I/IIb clinical study code-named GO29781 (NCT02500407). At the 2019 ASH Conference, Roche announced the clinical data of the study. The results showed that for patients with refractory/relapsed non-Hodgkin’s lymphoma who had received at least five lines (median) systemic therapy in advance (most of them did not respond to CD20 therapy, some relapsed after receiving CAR-T therapy) In terms of mosunetuzumab, the effect is remarkable.
In terms of objective response rate (ORR), inert NHL was 62.7% (n=42/67), aggressive NHL was 37.1% (n=46/124), and complete response rate (CR) was 43.3% (n =29/67), invasive NHL was 19.4% (n=24/124). In terms of CR persistence, 82.8% (n=24/29) of indolent NHL patients were still in remission within 26 months after initial treatment, and 70.8% (n=17/24) of aggressive NHL patients were in remission after initial treatment16 It was still in remission within months.
In the subgroup who received CAR-T therapy in advance, ORR and CR were 38.9% (n=7/18) and 22.2% (n=4/18), respectively.
In terms of safety, 28.9% of patients had cytokine release syndrome (CRS), of which 20.0% were grade 1 and 1.1% were grade 3. The incidence of grade 3 neurological adverse events was 3.7%.
Mosunetuzumab is a bispecific antibody under development that can target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting feature can activate and redirect patient T cells, contact and release cytotoxic proteins to B cells.
The structure of Mosunetuzumab is similar to human natural antibody, with two Fab segments. But unlike natural antibodies, one of the Fab targets CD20, while the other targets CD3. Currently, mosunetuzumab clinical research and development program is underway, its purpose is to explore the molecule as a single or combination therapy for patients with CD20-positive B-cell non-Hodgkin’s lymphoma (including follicular lymphoma, diffuse large B-cell lymphoma and other Blood cancer).
In addition to Roche, Regeneron, IGM Biosciences, Genmab, Xencor and other companies all have CD20xCD3 double antibodies. In China, Cinda and Roche have reached a US$2 billion cooperation that includes TCB double antibodies, while Zai Lab introduced the regenerant CD20xCD3 bispecific antibody REGN1979 for US$190 million.
Research CD20xCD3 double antibody