Chugai Gains Approval for Tecentriq to Treat Alveolar Soft Part Sarcoma

In a significant advancement in cancer treatment, Chugai Pharmaceutical Co., Ltd. announced receiving regulatory approval from Japan's Ministry of Health, Labour and Welfare for Tecentriq® (atezolizumab) to treat unresectable alveolar soft part sarcoma (ASPS). This approval marks a milestone as Tecentriq becomes the first immune checkpoint inhibitor available in Japan for this rare and challenging condition.

Unresectable alveolar soft part sarcoma is a rare and aggressive form of cancer predominantly found in adolescents and young adults, often leading to a dire prognosis with limited treatment options. The new approval covers the use of Tecentriq for adults and children over two years old, providing a new avenue for patients who have historically had no established standard treatment for this disease.

This decision was grounded in the promising results from both a Japanese phase II clinical trial, known as the ALBERT study, and an international study conducted by the U.S. National Cancer Institute (NCI). The ALBERT study, a phase II trial led by Japan's National Cancer Center Hospital, evaluated Tecentriq's efficacy and safety in patients aged 16 and older. The study enrolled 20 participants to explore the drug's effects, forming part of the broader MASTER KEY project focused on rare cancer treatment development through collaboration between industry and academia.

Dr. Osamu Okuda, President and CEO of Chugai Pharmaceutical, expressed satisfaction with the approval, emphasizing the significance of providing Tecentriq as a new treatment option for patients battling this rare type of sarcoma. Given the rarity and severity of ASPS, the availability of Tecentriq represents a crucial development for affected individuals and their families.

Alveolar soft part sarcoma accounts for less than 1% of soft tissue sarcomas, with an estimated 15-40 cases diagnosed annually in Japan. The cancer predominantly affects the limbs, especially the thighs, and poses a higher risk for the Adolescent and Young Adult (AYA) population, typically those between 15 and 35 years old. Its aggressive nature and lack of standard treatment options have historically led to poor outcomes for patients.

Tecentriq, a monoclonal antibody targeting the protein PD-L1, functions by inhibiting the interaction between PD-L1 and T cell receptors PD-1 and B7.1, thereby potentially reactivating T cells and enhancing the immune response against cancer cells. Since its introduction to the Japanese market in 2018, Tecentriq has received approval for various indications, including extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, and hepatocellular carcinoma.

The approval of Tecentriq for unresectable alveolar soft part sarcoma underscores Chugai Pharmaceutical's commitment to addressing unmet medical needs in oncology and advancing innovative treatments to improve patient outcomes. By expanding the potential applications of Tecentriq, Chugai continues to contribute to the evolving landscape of cancer therapy, offering renewed hope to patients with this ultra-rare sarcoma.

The introduction of Tecentriq for this particular indication represents a critical step forward in providing new therapies for rare cancers, aligning with global efforts to enhance treatment options and improve survival rates for challenging oncological conditions.