On January 27, a new indication for two Class 1 innovative drugs independently developed by Chia Tai Tianqing—Bemosudab Injection combined with Anlotinib Hydrochloride Capsules—was approved for marketing by the National Medical Products Administration (NMPA). The indication is for the treatment of recurrent or metastatic endometrial carcinoma that is non-microsatellite instability-high (non-MSI-H) or non-mismatch repair-deficient (non-dMMR) in patients who have failed prior systemic anti-tumor therapy and are ineligible for curative surgery or radiotherapy.
Endometrial carcinoma ranks second among malignant tumors of the female reproductive system in China and first in developed countries. In recent years, due to the impact of high-fat, high-calorie diets and sedentary lifestyles, the incidence of endometrial carcinoma in China has shown an upward trend. At present, the first-line treatment regimen for endometrial carcinoma in China is platinum-based chemotherapy. However, when endometrial carcinoma recurs or metastasizes, and patients have failed prior systemic anti-tumor therapy or are not suitable for curative surgery or radiotherapy, treatment options become extremely limited and the prognosis is usually poor, highlighting an urgent need to explore more effective therapeutic approaches.
At the 2024 Annual Meeting of the International Gynecologic Cancer Society (IGCS), Chia Tai Tianqing announced the phase II study (ETER200) of bemosudab combined with anlotinib in the treatment of recurrent or metastatic endometrial carcinoma. The study data showed that among 85 non-MSI-H/non-dMMR patients, the Objective Response Rate (ORR) was 34.1%, the Disease Control Rate (DCR) was 77.7%, the median Progression-Free Survival (PFS) was 8.8 months, and the median Overall Survival (OS) was 21.8 months, demonstrating the therapeutic potential of bemosudab combined with anlotinib for endometrial carcinoma.
This approval for the treatment of endometrial carcinoma marks the second indication for bemosudab and the seventh indication for anlotinib. Last May, the first indication of the combination therapy—bemosudab plus anlotinib, carboplatin and etoposide for the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC)—was approved for marketing. Last August, the marketing application for this combination therapy for the first-line treatment of advanced unresectable or metastatic renal cell carcinoma (RCC) was accepted by the Center for Drug Evaluation (CDE). These achievements fully validate the broad application prospects of immunotherapy combined with anti-angiogenic therapy.
Last November, the combination of bemosudab and anlotinib for the treatment of patients with alveolar soft part sarcoma was designated as a Breakthrough Therapy by the CDE, which is expected to address the unmet clinical needs of Chinese patients at an earlier date. In addition, multiple phase III clinical trials of this combination therapy are underway, covering several key areas such as first-line non-small-cell lung cancer and maintenance therapy after chemoradiotherapy for non-small-cell lung cancer. Chia Tai Tianqing will actively explore the therapeutic potential of the "immunotherapy + anti-angiogenic therapy" combination regimen, providing more treatment options and bringing greater hope to patients in the new era of precision cancer therapy.
