GI Innovation said on the 24th that it received approval from the Ministery of Food and Drug Safety for a phase 2 clinical trial to evaluate the combination therapy of the immuno-oncology candidate "GI-102" and "Keytruda" in patients with metastatic melanoma (skin cancer).
The trial will target treatment-naive patients with metastatic melanoma and compare, in a randomized design, the standard-of-care monotherapy of Merck (MSD)'s immunotherapy Keytruda with the combination therapy of GI-102. Following U.S. Food and Drug Administration (FDA) approval, approval of the phase 2 plan in Korea is expected to accelerate the global phase 2 development.
GI-102 was selected for the Ministery of Food and Drug Safety's innovation product commercialization support program "Guide." The program provides consultation and support across the entire cycle from early development to approval, with a dedicated project manager (PM) assigned. When necessary, it is also linked to the expedited review program (GIFT).
If the trial proves the superiority of the GI-102 combination therapy over Keytruda monotherapy, it could become a new option for first-line treatment of metastatic melanoma. At the same time, it could indicate whether to broaden combination strategies for immuno-oncology therapies.
The trial will be conducted at major global medical institutions, including Mayo Clinic, Cleveland Clinic, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Samsung Medical Center, and Asan Medical Center.
Jang Myeong-ho, CEO of GI Innovation, said, "In Korea, the treatment environment for metastatic melanoma makes it difficult for patients to receive sufficient benefits due to various constraints, including reimbursement," adding, "We will make companywide efforts for early commercialization so that we can provide new treatment options more quickly to patients with rare and intractable cancers."