CStone Pharmaceuticals announced that the registrational clinical study of Zhijimei (R) (sugemalimab injection) for the first-line treatment of esophageal squamous cell carcinoma has reached the primary endpoint and intends to submit a marketing application for a new indication

CStone Pharmaceuticals (HKEx: 2616), a leading biopharmaceutical company focused on the development, development and commercialization of innovative immunotherapies and precision therapies for oncology, announced on January 3 that its first-line clinical study (GEMSTONE-304) in combination with chemotherapy for the treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (® GEMSTONE-304) met its primary endpoint
。 The results showed that compared with placebo plus chemotherapy, the combination of chemotherapy ® significantly improved progression-free survival (PFS) and overall survival (OS) as assessed by the blinded Independent Center Review Committee (BICR), and the difference was statistically significant and clinically significant
.
The safety profile is consistent with the results of previously reported clinical studies related to Zejiemei, ® and no new safety signals
have been found.

The GEMSTONE-304 study is a randomized, double-blind, multicenter, placebo-controlled, phase III registrational clinical trial designed to evaluate the efficacy and safety
of Thermia plus FP chemotherapy regimen (fluorouracil + cisplatin) as a first-line treatment for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma ® that cannot be resected 。 The primary endpoints of the trial were progression-free survival (PFS) and overall survival (OS) as assessed by the blinded Independent Central Review Committee (BICR), and secondary endpoints included investigator-assessed PFS, BICR, and investigator-assessed objective response rate (ORR) and duration of response (DoR).

The phase Ib study [1] showed that the objective response rate of Zegema plus FP chemotherapy as the first-line treatment for advanced esophageal squamous cell carcinoma ® reached 67.
6% (25/37), the disease control rate reached 89.
2%, and the response was sustainable
.

®Professor Li Jin, principal investigator of the GEMSTONE-304 study and director of the Department of Oncology, Dongfang Hospital Affiliated to Tongji University, said: "Esophageal cancer is a malignant tumor
with Chinese characteristics.
Clinically, about 70% of patients with esophageal cancer have developed locally advanced or distant metastases at initial diagnosis, and even in operable esophageal cancer, 50% to 60% of patients will recur or develop distant metastases
after surgery.
The success of the GEMSTONE-304 study shows that the combination of chemotherapy ® has shown good antitumor activity and good safety in the first-line treatment of esophageal squamous cell carcinoma
.
We expect this immunotherapy to provide new treatment options
for the majority of esophageal cancer patients.
" ”

Dr.
Jianxin Yang, CEO of CStone Pharmaceuticals, said, "We are pleased to see the success
of Zegemin's ® research in esophageal cancer, a global cancer with high incidence.
This is also the fifth successful registration study after ® stage III and IV non-small cell lung cancer, extranodal NK/T-cell lymphoma, and gastric cancer, completing a grand slam achievement
in the treatment of high-incidence tumors.
Currently, no PD-L1 antibody has been approved for the treatment of esophageal cancer, and we look forward to promoting this new treatment to more patients
.
" As a biopharmaceutical company with the core of innovative R&D of tumor immunotherapy and precision therapy drugs, CStone will continue to focus on the research and development of best-in-class targets and strive to bring more innovative therapies to patients
.
”

CStone plans to submit ® a marketing application for this new indication to the National Medical Products Administration (NMPA) of China in the near future, and the detailed research data will be presented
at international academic conferences.