Roche Initiates Phase 1 Clinical Trial of CD20/CD3 Bispecific Antibody Mosunetuzumab in China for Relapsed or Refractory Follicular Lymphoma

By | Pharma Insights

According to the China Drug Clinical Trial Registration and Information Disclosure Platform, Roche has initiated a Phase I clinical trial in China evaluating RO7030816 (mosunetuzumab) in patients with relapsed or refractory follicular lymphoma. Public information indicates that mosunetuzumab is an investigational bispecific antibody targeting CD20 and CD3. According to a recent press release from Roche, the company is expected to submit a regulatory application for mosunetuzumab in overseas markets by the end of this year.

Screenshot Source: Clinical Trial Registration and Information Disclosure Platform

Bispecific antibody therapy is a therapeutic approach that utilizes T cells from the patient's immune system to kill tumor cells. Unlike the single-target specificity of monoclonal antibody drugs, bispecific antibodies contain two distinct antigen-binding sites. By binding to different epitopes, they exert specialized biological functions, such as inducing targeted immune responses.

As a bispecific antibody, mosunetuzumab binds to the CD20 antigen on the surface of B cells with one arm and to the CD3 receptor on the surface of T cells with the other, thereby recruiting T cells to the vicinity of tumor cells and activating them to kill the tumor cells. In September 2021, the drug was granted implied approval for clinical trials in China and is being developed for the treatment of relapsed/refractory follicular lymphoma.

Roche has initiated an open-label, multicenter, Phase I clinical trial to evaluate the pharmacokinetics, safety, and efficacy of mosunetuzumab monotherapy in patients with relapsed or refractory follicular lymphoma. The trial will be conducted at six clinical research sites, enrolling 15 patients, with Dr. Junning Cao from Fudan University Shanghai Cancer Center serving as the Principal Investigator.

According to information from the Chinese Drug Clinical Trial Registration and Information Publicity Platform, the primary objectives of this Phase I clinical trial mainly include: ① characterizing the pharmacokinetic (PK) profile of mosunetuzumab; ② evaluating the safety, tolerability, efficacy, and immune response of mosunetuzumab monotherapy.

Follicular lymphoma (FL) is a common indolent B-cell lymphoma and a subtype of indolent non-Hodgkin lymphoma (NHL). It arises from the malignant proliferation of germinal center B cells. The malignancy typically grows slowly but may become more aggressive over time. Although current treatment modalities have improved the overall survival of FL patients, FL remains an incurable malignancy. We hope that subsequent studies on mosunetuzumab will proceed successfully, bringing new treatment options to patients in the near future.

References:

[1] China Drug Trials Registry. Retrieved Nov 4, 2021, from http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml

[2] Roche Q3 2021 Presentation. Retrieved October 22, 2021, from https://www.roche.com/dam/jcr:17321367-06a5-4a0e-8f39-1be5299e7db4/en/irp211020.pdf

[3] Roche reports strong growth in the first nine months – outlook for 2021 raised. Retrieved October 22, 2021, from https://www.roche.com/investors/updates/inv-update-2021-10-20.htm

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