The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting was held in Chicago from May 31 to June 4, local time. Chiatai Tianqing's recently launched Class 1 innovative biologic Benmelstobart announced a number of research results at the meeting, covering the fields of digestive and gynecological oncology. Benmelstobart monoclonal antibody is an innovative humanized anti-PD-L1 monoclonal antibody with a new sequence, which was just approved for marketing in May 2024. The first approved indication is for the first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SLC) in combination with amilotinib hydrochloride capsule, carboplatin and etoposide.

Endometrial cancer is one of the most common gynecologic malignancies and its incidence is on the rise worldwide. Most patients with endometrial cancer are diagnosed at an early stage and have a good overall prognosis, with a 5-year survival rate of 95%. Once localized spread or distant metastasis occurs, the 5-year survival rate decreases significantly, and the 5-year survival rate of endometrial cancer patients with distant metastasis is only 17%.

Currently, the first-line systemic treatment option for advanced, metastatic or recurrent endometrial cancer is mainly paclitaxel combined with platinum-based chemotherapy, and there is no clear standard treatment option for advanced endometrial cancer after failure of platinum-based chemotherapy, and there is a serious unmet need for second-line and beyond treatment for advanced endometrial cancer.

TQB2450-II-08: Benmelstobart monotherapy in combination with anitrotinib for advanced recurrent or metastatic endometrial cancer: a multicenter, open-label phase II clinical study

The results of the study showed an objective remission rate (ORR) of 31.76%, a median progression-free survival (mPFS) of 8.38 months, and a median overall survival (mOS) of 21.72 months (Table 1 and Figure 1). The treatment of recurrent or metastatic endometrial cancer with Benmelstobart monotherapy in combination with amlotinib or Benmelstobart monotherapy showed promising antitumor activity.

In April 2022, Benmelstobart monoclonal antibody in combination with amlotinib hydrochloride capsules for the treatment of recurrent or metastatic endometrial cancer has been included in the breakthrough therapeutic varieties by the Center for Drug Evaluation of the State Drug Administration of China (CDE), and in January 2024 it was included in the CDE Priority Review and Approval Program.

Currently, Benmelstobart monoclonal antibody in combination with Amlotinib hydrochloride capsules is undergoing several clinical phase III trials, including first-line renal cell carcinoma, first-line non-small cell lung cancer, and maintenance after radiotherapy for non-small cell lung cancer. Among them, the Phase III study of Benmelstobart monoclonal antibody combined with Anrotinib for the first-line treatment of advanced renal cell carcinoma has achieved positive results and will submit the marketing application to CDE in the near future. This is the first pivotal Phase III study of dual domestically produced innovative drug combination for immunotherapy of advanced renal cancer, which is expected to bring new therapeutic hope to the majority of advanced renal cancer patients and address the unmet clinical needs.

In the future, Chiatai Tianqing will continue to promote the development of Benmelstobart monoclonal antibody and Anrotinib hydrochloride capsules to bring new treatment options to more patients. With the company's continuous investment in innovative drug R&D, innovative products have achieved continuous breakthroughs, and the innovation pipeline has entered the harvest period.

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