MSD begins cervical cancer trials for its drug candidate

in KOR

MFDS approves phase 3 trials for 'MK-2870' as the second-line treatment

11 clinical trials have been approved since February…ahead of Keytruda's patent expiry

The phase 3 clinical trials for MSD’s new drug candidate 'MK-2870 (sacituzumab tirumotecan)' for the second-line treatment of patients with cervical cancer are being conducted in South Korea.

 

This drug is an antibody-drug conjugate (ADC) currently being studied in multi-national clinical trials for various cancer types, including cervical cancer.

 

On July 16th, the Ministry of Food and Drug Safety (MFDS) approved 'The Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy versus Treatment of Physician's Choice as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20).' MK-2870 is an ADC for which MSD acquired global rights, excluding China, from Kelun-Biotech.

 

The deal size for this acquisition was US$1.41 billion.

 

It targets TROP-2 (tumor-associated calcium signal transducer 2), which is overexpressed in over 80% of triple-negative breast cancer patients.

 

TROP-2 is associated with growth, transformation, regeneration, and proliferation processes.

 

Notably, in South Korea, 11 clinical trials have been approved, including those recently approved for the treatment of cervical cancer.

 

Phase 3 clinical trials for MK-2870 have been approved since February.

 

The clinical trials are recruiting ▲Patients with endometrial cancer who have previously received platinum-based chemotherapy and immunotherapy ▲Patients with advanced or metastatic non-squamous NSCLC who have previously been treated and have EGFR mutations or other genomic alterations, and ▲Patients with advanced or metastatic esophageal cancer (esophageal adenocarcinoma and esophagogastric junction adenocarcinoma) in third-line or later treatment settings.

 

Since the patent of MSD's leading product, 'Keytruda,' used in cancer immunotherapy, will expire in 2028, MSD is focusing on developing ADC treatments that can substitute for Keytruda.

 

In South Korea, clinical trials for drugs in combination with Keytruda were approved.

 

For instance, the following clinical trials for monotherapies or treatments in combination with Keytruda have been approved: ▲Participants with resectable stage II-IIIB (N2) NSCLC who underwent surgery after platinum-based doublet chemotherapy plus Keytruda adjuvant therapy but did not achieve pathologic complete response (pCR) ▲Participants with EGFR mutation-positive advanced non-squamous NSCLC progressing on prior EGFR tyrosine kinase inhibitor therapy ▲First-line treatment in metastatic NSCLC patients with PD-L1 TPS ≥ 50% using Keytruda combination therapy, and ▲Monotherapy or Keytruda combination therapy in participants with HR+/HER2- inoperable locally advanced or metastatic breast cancer.

 

Meanwhile, global pharmaceutical companies have developed ADCs that have demonstrated effects in various breast cancer types, including triple-negative breast cancer and hormone-positive·HER2-negative breast cancer.

 

ADC is a new anticancer drug that combines an antibody targeting a specific antigen on cancer cell surfaces with a cell death-inducing drug (payload) linked via a linker molecule.

 

ADC has the advantage of increasing treatment effects while minimizing adverse reactions.

 

The drug selectively targets cancer cells using targeted antibody selectivity and cell death-activation.