Biogen has reached an agreement with Genentech – a member of the Roche group – on the potential commercialisation of the investigational bispecific antibody, glofitamab, as part of the companies’ long-standing collaboration on antibodies targeting CD20.
Under the terms of the agreement, Genentech will have sole decision-making rights on the commercialisation of glofitamab within the US and, if the drug gets approved, Biogen will be eligible to receive tiered royalties in the mid-single digits range on potential net sales of glofitamab within the US.
Glofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody currently under development for the treatment of B-cell non-Hodgkin’s lymphomas, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma and other blood cancers.
Updated results from the phase 2 NP30179 study in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), presented by Genentech at the American Society of Hematology Annual Meeting and Exposition (ASH), showed glofitamab induced early and durable responses that were maintained beyond the end of treatment.
Most patients who had achieved a complete response (CR) at the end of treatment experienced durable responses, with a median CR follow-up from end of treatment of 11.5 months. Twelve months after the end of treatment with glofitamab, 61% of patients maintained a CR, 92.6% remained progression-free, and only one patient experienced disease progression.
Data from the study has been submitted for review to the European Medicines Agency (EMA), the companies said, and submissions to additional health authorities worldwide, including the US Food and Drug Administration (FDA), are ongoing.
At the beginning of this year, Biogen also exercised its option to have joint decision-making rights related to the development and potential commercialisation of mosunetuzumab, the other half of the partners’ antibody portfolio, by paying a $30m one-time option fee to Genentech as well as covering a portion of the 2021 development expenses.
Updated results for mosunetuzumab were also presented at ASH 2022, which showed the antibody continued to demonstrate clinically meaningful outcomes in patients with heavily pretreated follicular lymphoma (FL).
The European Commission granted conditional marketing authorisation for mosunetuzumab for the treatment of people with R/R FL who have received at least two prior systemic therapies in June 2022, making it the first and only fixed-duration bispecific antibody to be approved in Europe for lymphoma. Mosunetuzumab is also currently under Priority Review with the FDA.