Lunsumio (Mosunetuzumab): First-in-Class CD20/CD3 Bispecific Antibody Approved for Relapsed/Refractory Follicular Lymphoma
Roche
Oncology Drug Research, Development, and Manufacturing
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
ByLeaves
On June 8, Roche announced that the European Commission had granted conditional marketing authorization for Lunsumio (mosunetuzumab), a CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. By dual targeting, it activates and redirects patients' existing endogenous T cells, eliminating malignant B cells by releasing cytotoxic proteins into them. Lunsumio is currently still in development as a monotherapy or in combination with other drugs for the treatment of patients with B-cell non-Hodgkin lymphoma, including follicular lymphoma, diffuse large B-cell lymphoma, and other blood cancers.
Lunsumio has previously been granted Breakthrough Therapy Designation (BTD) by the FDA, and in April this year, the EMA's Committee for Medicinal Products for Human Use (CHMP) also issued a positive opinion, recommending the approval of mosunetuzumab.
This approval is mainly based on the GO29781 study, a Phase I/II multicenter, open-label, dose-escalation and expansion study, which aims to evaluate the safety, efficacy, and pharmacokinetic profile of Lunsumio (mosunetuzumab) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The primary endpoints include the complete response rate (best response) determined by an independent review committee, while secondary endpoints encompass objective response rate, duration of response, progression-free survival, as well as safety and tolerability.
Results presented for the first time at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition showed that Lunsumio induced a high complete response rate in FL patients who had received multiple prior treatments, with most complete responses lasting at least 18 months and being well-tolerated. After a median follow-up of 18.3 months, the median duration of response for responders was 22.8 months (95% CI: 9.7-not estimable), with a complete response rate of 60% (n=54/90) and an objective response rate of 80% (n=72/90).
The most common adverse event was cytokine release syndrome (39%), typically low-grade (Grade 2: 14%), and resolved by the end of treatment. Other common (≥20%) adverse events (AEs) mainly included neutropenia, fever, hypophosphatemia, and headache.
Follicular Lymphoma (FL) is the most common indolent (slow-growing) form of non-Hodgkin's Lymphoma (NHL), accounting for approximately one-fifth of NHL cases. It is estimated that more than 100,000 people worldwide are diagnosed with FL each year, including over 28,000 in Europe.
Lunsumio is currently undergoing a Phase III study (CELESTIMO) comparing its combination with lenalidomide to rituximab combined with lenalidomide for patients with relapsed or refractory follicular lymphoma who have received ≥1 line of systemic therapy, as well as efficacy studies in combination with Polivy (CD79b antibody-drug conjugate) for the treatment of diffuse large B-cell lymphoma (DLBCL).
In addition to Lunsumio, Roche is also concurrently developing another CD20xCD3 bispecific antibody, glofitamab, which is also in Phase III clinical trials. Recently, data presented at the ASCO 2022 meeting once again demonstrated that glofitamab can induce a high and durable complete response rate in patients with heavily pretreated diffuse large B-cell lymphoma.
(Original text has been abridged)
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