Chugai Gains Approval for "LUNSUMIO" for Follicular Lymphoma in Japan

Chugai Pharmaceutical Co., Ltd. has recently secured approval from Japan's Ministry of Health, Labour and Welfare for the use of LUNSUMIO®, an innovative treatment for individuals with relapsed or refractory follicular lymphoma (FL). This new therapeutic option, available as an intravenous infusion, targets patients who have not responded to at least two previous standard treatments.

LUNSUMIO, with its active ingredient mosunetuzumab, is a bispecific antibody that engages T-cells by simultaneously targeting CD20 on B-cells and CD3 on T-cells, thereby activating the immune system to attack cancer cells. This mechanism promises high response rates and potential long-lasting remission, offering hope to those battling this challenging form of cancer.

The treatment regimen of LUNSUMIO is tailored according to the patient's response, potentially easing the treatment burden. Therapy duration is typically set at six months to a year, determined by the individual’s response to the drug. This flexibility aims to offer a more patient-friendly experience compared to indefinite treatment courses.

Dr. Osamu Okuda, President and CEO of Chugai, emphasized the significance of this approval, noting the persistent challenge in treating FL which frequently relapses, necessitating innovative solutions. LUNSUMIO, as a monotherapy, could provide much-needed durable remission for these patients. The company is actively preparing to make this treatment readily available.

The approval of LUNSUMIO is supported by thorough clinical trials, including a Japanese Phase I study and an international Phase I/II trial conducted by Roche. These studies focused on patients with relapsed or refractory FL who previously underwent two or more standard treatment cycles. The trials assessed LUNSUMIO's efficacy and safety as a standalone therapy.

In the Japanese study, involving 19 patients, the complete response rate (CRR) was found to be 68.4%, as evaluated by an independent review facility. The primary side effects observed included a decrease in lymphocyte count, cytokine release syndrome, and elevated liver enzymes. Meanwhile, the overseas study, involving 90 participants, reported a CRR of 57.8%, with common adverse reactions such as cytokine release syndrome, fever, and neutropenia.

The treatment is specifically indicated for patients who have shown resistance or relapse after conventional therapies, including anti-CD20 monoclonal antibodies. Dosage is administered in cycles, starting with a smaller dose and gradually increasing, depending on the cycle and the patient's response.

Follicular lymphoma is a type of cancer originating from B lymphocytes, part of the body's immune system. It typically exhibits a slow progression, and although initial treatments may be effective, recurrences are common, often complicating subsequent treatment efforts. In Japan, approximately 9,000 new cases are diagnosed annually, emphasizing the demand for advanced treatment options.

LUNSUMIO, already approved in 61 countries, is being developed in both intravenous and subcutaneous forms for treating not only FL but also other aggressive B-cell non-Hodgkin lymphomas. This development aligns with a global effort to improve therapeutic strategies for lymphomas, offering patients renewed hope for effective management of their condition.