On July 14, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that its investigational CD20xCD3 T-cell engaging bispecific mosunetuzumab has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma who have received at least two prior systemic therapies (Press release, Hoffmann-La Roche, JUL 14, 2020, View Source [SID1234561840]).
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"We are pleased that the FDA has granted Breakthrough Therapy Designation to mosunetuzumab, recognising the promising early efficacy data for this molecule and the remaining unmet need in follicular lymphoma," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Indeed, we are excited by the potential of both our CD20xCD3 bispecific antibodies – mosunetuzumab and glofitamab – in development for difficult-to-treat lymphomas, and remain committed to developing innovative therapies to improve outcomes for patients."
This designation was granted based on encouraging efficacy results observed in the phase I/Ib GO29781 study [NCT02500407] investigating mosunetuzumab in R/R non-Hodgkin lymphoma (NHL). The safety profile of this T-cell engaging bispecific was consistent with its mechanism of action. Results from this study were previously presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting.
BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies. This is the 34th BTD for Roche’s portfolio of medicines, and the 10th designation for its haematology portfolio.
A robust clinical development programme for mosunetuzumab is ongoing across a number of lymphoma indications and earlier lines of treatment, investigating the molecule alone and in combination to identify where mosunetuzumab may be able to provide benefit over current treatment options. This includes further investigation of mosunetuzumab in combination with Roche’s Polivy (polatuzumab vedotin) and Tecentriq (atezolizumab) as well as with chemotherapy regimens and non-Roche molecules.
About mosunetuzumab
Mosunetuzumab is an investigational CD20xCD3 T-cell engaging bispecific designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. Mosunetuzumab has a structure similar to that of a natural human antibody in that it has two ‘Fab’ regions, but is different from naturally-occurring antibodies in that one ‘Fab’ region targets CD20 and the other ‘Fab’ region targets CD3. A robust clinical development programme for mosunetuzumab is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with CD20-positive B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.
About the GO29781 study
The GO29781 study [NCT02500407] is a phase I/Ib, multicentre, open-label, dose-escalation study evaluating the safety and pharmacokinetics of mosunetuzumab in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include best objective response rate by revised International Working Group criteria, maximum tolerated dose, and tolerability.
About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3; Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.