South Korean biotech company GI Innovation has entered a clinical trial collaboration and supply agreement with Merck & Co (MSD) to assess GI-102 in combination with Keytruda (pembrolizumab) for various types of cancer.
The Phase II trial will evaluate the combination regimen for metastatic liver cancer, melanoma, and renal cell carcinoma.
Patients who have developed resistance or non-responsiveness to immuno-oncology treatments, leaving them with no viable treatment options, will be part of the study.
The trial will involve 14 hospitals in South Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Severance Hospital of Yonsei University and St Vincent’s Hospital.
It will also be carried out at various US sites, including the Mayo Clinic campuses in Rochester, Florida and Arizona, as well as Cleveland Clinic and Memorial Sloan Kettering Cancer Center.
The partnership is GI Innovation’s second trial collaboration with MSD, following an earlier agreement involving GI-101A.
GI-102 has previously demonstrated significant anti-cancer efficacy, achieving a 42.9% overall response rate (ORR) in melanoma patients who did not respond to standard treatments with three partial responses out of seven patients.
In preclinical studies, GI-102 monotherapy led to complete tumour regression in 60% of mice with liver cancer.
GI Innovation chief scientific officer Dr Myung-Ho Jang said: “We are pleased to enter into another clinical trial collaboration and supply agreement with MSD, a world leader in immuno-oncology.
“We aim to maximise the therapeutic value of GI-102 by combining it with KEYTRUDA, MSD’s anti-PD-1 therapy.”
Earlier this month, MSD discontinued the Phase III KeyVibe-008 trial of a fixed-dose combination of vibostolimab and pembrolizumab with chemotherapy for extensive-stage small cell lung cancer (ES-SCLC).
The trial was cancelled after a recommendation from an independent Data Monitoring Committee (DMC), as a pre-planned analysis indicated that the trial’s primary endpoint of overall survival met pre-specified futility criteria.
