Merck Launches Phase III Clinical Trial of TROP2 ADC MK-2870 as Second-Line Therapy for Recurrent or Metastatic Cervical Cancer in China
MSD
Pharmaceutical R&D and Manufacturer
On September 26, the Drug Clinical Trial Registry and Information Disclosure Platform showed that MSD initiated a Phase III clinical trial of injectable MK-2870 in China.In subjects with recurrent or metastatic cervical cancerComparison of MK-2870 with Treatment Selected by Physician (TPC)As a second-line treatmentEfficacy and safety.
Screenshot from:Drug Clinical Trial Registration and Information Disclosure Platform
MK-2870 (SKB264) is co-developed by MSD and Kelun Biotech.TROP2 ADC Sacituzumab GovitecanIn China, Lumoxiti has submitted two NDAs:
In December 2023, the first NDA for this drug was accepted by the CDE (CXSS2300093), for patients who have previously received at least 2 systemic treatments (at least one of which was for advanced or metastatic stage).Locally Advanced or Metastatic Triple-Negative Breast Cancer, the application has been included in the priority review, and the Insight database predicts that it is expected to be approved in Q4 this year;
In August 2024, the CDE accepted the second NDA for Kansatuzumab (CXSS2400087), used to treat patients who have failed treatment with EGFR-TKI and platinum-based chemotherapy.Locally Advanced or Metastatic EGFR-Mutant NSCLC, the application has also been included in the priority review, and the Insight database predicts that it is expected to be approved in Q3 2025.
This newly registered study is a randomized, positive-controlled, parallel-group, open-label, international multicenter Phase III clinical trial, aimed at comparing MK-2870 withDoctor's Choice of TreatmentEfficacy and Safety for Second-Line Treatment of Recurrent or Metastatic Cervical Cancer. The China segment of this study plans to be conducted across 32 medical institutions in China, with an enrollment target of 70 participants.
Insight database shows that, in addition to the Phase III clinical trial launched this time, ravulizumab is also undergoing several Phase III clinical trials in China, with indications involvingNon-Small Cell Lung Cancer, Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer, Triple-Negative Breast Cancer, HR-Positive/HER2-Negative Breast Cancer, Endometrial Cancer, Gastric Cancer, Esophageal CancerIn multiple disease areas.
