Roche: Lansumio (Mosunetuzumab)

The main articles are:

• Lymphoma
• Drugs to treat cancer

2023: Approval by the Ministry of Health

Roche announced that on November 14, 2023, the Ministry of Health of the Russian Federation approved mosunetuzumab (trade name Lansumio) as monotherapy in adult patients with relapsed or refractory follicular lymphoma (FL) who have previously received at least two lines of systemic therapy. Commercial availability of the drug in the Russian Federation is expected in mid-2024.

Roche remains true to its mission to provide patients with innovative solutions, - said Ekaterina Fadeeva, head of the department for scientific and medical interaction at Rosh-Moscow JSC. - We are sincerely glad that now the drug for the treatment of recurrent or refractory follicular lymphoma will be available to Russian patients, because the options for the treatment of this disease are extremely limited.

The approval is based on the positive results of the pivotal phase II study of the GO29781 drug mosunetuzumab in patients with FL who have previously received at least 2 lines of systemic therapy, including patients with a high risk of disease progression or refractory to previous courses of therapy. The study results demonstrated a high frequency (ORR) and duration of response (DoR) and an acceptable safety profile. Overall response was observed in 80% (72/90 [95% CI 70-88]) of patients treated with mosunetuzumab, with a median duration of response of 35.9 months (20.7-NR) 2,3. A complete response was achieved in 60% of patients (54/90 [95% CI: 49-70], with a median follow-up of 37.4 months, the median duration of complete response was not achieved by RD (33-ND).2,3 The most common adverse event (AE) reported in the study was cytokine release syndrome (CRS) (44%), which was mostly Grade 1-2. Among others, fatigue, headache, neutropenia, fever, and itching were common (≥20%) AEs.

This approval is an important milestone for patients with recurrent or refractory follicular lymphoma, - said Irina Poddubnaya, Academician of the Russian Academy of Sciences, Chairman of the Russian Society of Oncohematologists. - As a first-in-class anti-CD20xCD3 bispecific antibody, mosunetuzumab has high efficacy rates and a fixed duration of treatment that can be administered on an outpatient basis. This gives reason to believe that it is able to radically change the approach to the therapy of the most complex cohort of patients with follicular lymphoma.

Mosunetuzumab is administered as an intravenous infusion, the duration of therapy is fixed, which allows the patient to have time free from treatment.

Mosunetuzumab for December 2023 is being investigated in a subcutaneous form, as well as in phase III studies that will expand the understanding of its efficacy in patients with non-Hodgkin's lymphoma in early lines of therapy.