AstraZeneca Initiates Phase III Clinical Trial of CMG901 (AZD0901) with First Patient Dosed in CLARITY-Gastric 02 Study

Zhitong Finance APP reported that Keymed-B (02162) announced the latest developments regarding the collaboration between its group and AstraZeneca AB (AstraZeneca, a global biopharmaceutical company) on the core product CMG901 (sonesitatug vedotin, also known as AZD0901). As of the date of this announcement, AstraZeneca announced that it has initiated a multicenter, randomized controlled, Phase III clinical study (CLARITY-Gastric 02) investigating sonesitatug vedotin (AZD0901) in combination with capecitabine, with or without rilvegostomig, as a first-line treatment for Claudin 18.2-positive, HER2-negative advanced/metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma, and has completed the first patient dosing.

Subject to the terms and conditions of the license agreement, the completion of the first subject dosing in the aforementioned clinical trial has triggered the relevant milestone payment, with a total amount of 45 million US dollars. The Group has received the payment from AstraZeneca (the actual amount received is subject to deduction of bank charges).

CMG901 is an antibody-drug conjugate (ADC) targeting Claudin 18.2, containing a Claudin 18.2-specific antibody, a cleavable linker, and a cytotoxic payload—monomethyl auristatin E (MMAE). It is the first Claudin 18.2 antibody-drug conjugate to receive clinical trial application approval in both China and the United States. The expression of Claudin 18.2 is highly selective and widespread in gastric cancer, pancreatic cancer, and other solid tumors, making it an ideal target for cancer therapy.

In September 2022, CMG901 was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of Claudin 18.2-positive advanced gastric cancer patients who have failed or are intolerant to first-line or above treatments. Previously, CMG901 had received Orphan Drug Designation and Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of recurrent/refractory gastric cancer and gastroesophageal junction adenocarcinoma.

As of the date of this announcement, in addition to the aforementioned clinical trials, AstraZeneca has also initiated multiple clinical studies on sonesitatug vedotin (AZD0901) for the treatment of advanced solid tumors, with indications including gastric cancer, pancreatic cancer, and biliary tract cancer (only the highest clinical stage trial is listed for identical indications).

(1) A multicenter, open-label, sponsor-blinded, randomized Phase III clinical study (CLARITY Gastric 01) comparing AZD0901 monotherapy with investigator's choice of treatment in adult subjects with previously treated second-line or above, Claudin 18.2-expressing advanced/metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

(2) An open-label, multi-drug, multi-center Phase II study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of novel agents or combination regimens as perioperative treatments in subjects with locally advanced resectable gastroesophageal adenocarcinoma (GEMINI-PeriOp GC).

(3) A Phase II, open-label, multi-center clinical study assessing the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of AZD0901 as monotherapy and in combination with anti-tumor drugs in subjects with advanced solid tumors (including gastric cancer/gastroesophageal junction adenocarcinoma, pancreatic cancer, and biliary tract cancer) expressing Claudin 18.2 (CLARITY-PanTumour01).