GI Innovation and MSD jointly test the GI-102 therapy regimen against cancer

The study investigates combination therapy for metastatic liver cancer, renal cell carcinoma and melanoma. Image credit: Evgeniy Kalinovskiy / Shutterstock.

South Korean biotechnology company GI Innovation has entered into a clinical trial collaboration and supply agreement with Merck & Co (MSD) to test GI-102 in combination with Keytruda (pembrolizumab) for various types of cancer.

The phase II study will investigate the combination regimen for metastatic liver cancer, melanoma and renal cell carcinoma.

The study will include patients who have developed resistance or non-response to immuno-oncology treatments and for whom no viable treatment options exist.

The study will involve 14 hospitals in South Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Yonsei University Severance Hospital and St. Vincent's Hospital.

The study is also being conducted at various sites in the United States, including the Mayo Clinic campuses in Rochester, Florida and Arizona, as well as the Cleveland Clinic and Memorial Sloan Kettering Cancer Center.

The partnership is GI Innovation's second experimental collaboration with MSD following an earlier agreement on GI-101A.

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GI-102 has previously demonstrated significant anti-cancer efficacy, achieving an overall response rate (ORR) of 42.9% in melanoma patients who did not respond to standard treatments, with three of seven patients experiencing partial remissions.

In preclinical studies, GI-102 monotherapy resulted in complete tumor regression in 60% of mice with liver cancer.

Dr. Myung-Ho Jang, Chief Scientific Officer of GI Innovation, said: “We are delighted to enter into further clinical trial collaboration and supply agreement with MSD, a global leader in immuno-oncology.

“We want to maximize 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 vibrostolimab and pembrolizumab with chemotherapy for advanced-stage small cell lung cancer (ES-SCLC).

The study was stopped on the recommendation of an independent Data Monitoring Committee (DMC) because a pre-planned analysis showed that the study's primary outcome measure, overall survival, did not meet pre-specified criteria for futility.