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December 20, 2021updated 07 Jan 2022 7:17am

Positive pivotal data for bispecific cancer immunotherapy agent mosunetuzumab

Follicular lymphoma patients have been shown to have a 46.3% progression-free survival (PFS) at 13 years. However, there is still an unmet need to improve the prognostic outcomes of a substantial number of patients.

By GlobalData Healthcare

Follicular lymphoma (FL) patients generally have an excellent prognosis with frontline lenalidomide therapy, rituximab, obinutuzumab-based chemoimmunotherapy, and more recently with CD20-targeted therapy. Patients have been shown to have a 46.3% progression-free survival (PFS) at 13 years. However, there is still an unmet need to improve the prognostic outcomes of a substantial number of patients who are double refractory, or those with progression of disease within two years (POD24).

At the virtual 2021 annual American Society of Haematology (ASH 2021) meeting on 11–14 December, Roche-Genentech reported promising results from its single-arm study of the bispecific monoclonal antibody mosunetuzumab in patients with relapsed/refractory (R/R) FL (following two or more prior therapies). Mosunetuzumab induced a median PFS of 17.9 months and a complete response rate (CRR) of 60%, significantly improving this subset’s 14% CRR historical control. Mosunetuzumab-related adverse and cytokine release syndrome (CRS) events were transient and reversible low grades 1–2, indicating a manageable safety and tolerability profile.

Roche-Genentech also presented key data at ASH 2021 for glofitamab, another T-cell-engaging bispecific antibody in the company’s portfolio. The company noted high objective response rates (ORRs) in its phase I/Ib NP30179 dose-escalation study evaluating glofitamab as a monotherapy (81% ORR) in combination with Gazyva (Obinutuzumab) (100% ORR), following pretreatment with Gazyva in patients with R/R FL.

Roche-Genentech is at the forefront of bispecific antibody development and is expected to increase its sizeable share in the lucrative and competitive market of B-cell non-Hodgkin lymphoma, following the introduction of bispecific antibodies. Roche-Genentech should expect competition from recently approved agents such as Epizyme’s Tazverik (tazemetostat), an EZH2 inhibitor; Gilead’s Yescarta (Axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy; TG Therapeutics’ Ukoniq (umbralisib), a phosphoinositide 3-kinase (PI3K) inhibitor; and Secura Bio’s Copiktra (duvelisib), a PI3K inhibitor). Still, GlobalData anticipates that CAR-T therapy and bispecific antibodies will eventually become the standard of care for R/R FL patients due to their enhanced clinical outcomes and improved risk-benefit ratios. Therefore, ample opportunities exist for breakthrough designated mosunetuzumab to penetrate the R/R therapy segment along with glofitamab.

While CAR-T therapy has shown great promise, cell generation and administration processes are expensive (costing approximately $373,000–475,000), cumbersome, and not readily available in hospitals, which may reduce its market traction. In turn, GlobalData anticipates less CAR-T competition with bispecific agents for R/R patients in the future. Additionally, bispecific antibodies have the potential to be given in an outpatient setting.

Roche’s current haematologic oncology lead marketed drug MabThera (rituximab), a monoclonal anti-CD20 antibody, witnessed a 30% decline from $5.3 billion in 2019, to $3.5 billion in 2020 in oncology sales due to biosimilar erosion and the effects of the Covid-19 pandemic. However, the recent market authorisation application for mosunetuzumab to the European Medicines Agency will increase its clinical positioning and provide an opportunity for it to compensate for its losses in sales of MabThera by acquiring shares from competing agents.

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