The U.S. Food and Drug Administration (FDA) granted conditional approval for a combination therapy for melanoma from U.S. biotech Replimune, which had twice been rejected. A confirmatory clinical trial to prove actual clinical significance remains.
As combination therapies that pair existing anticancer drugs with new agents like Replimune's approach emerge as a new strategy for treating melanoma, Korea's pharmaceutical and biotech corporations are also jumping into the race, pushing their own drug candidates as combination partners for big pharma cancer drugs.
On the 11th, according to the industry, the FDA recently granted accelerated approval for Replimune's "Tudurivib" in combination with "Opdivo," an immune-oncology drug from Bristol Myers Squibb (BMS). It is indicated for adult melanoma patients whose disease has progressed after prior immunotherapy and for whom surgery is difficult.
Melanoma is a skin cancer that arises from melanocytes and, compared with other skin cancers, often metastasizes quickly and shows resistance to anticancer drugs. In particular, patients who do not respond to existing immunotherapies or whose disease progresses after treatment have limited options. As a result, recent melanoma drug development has actively pursued combination therapies that pair existing immunotherapies with treatments using new mechanisms.
Replimune's Tudurivib is an oncolytic virus therapy injected directly into tumors that both attacks cancer cells and induces an immune response to enhance Opdivo's effect. The company said a trial combining Tudurivib and Opdivo in patients with advanced melanoma who had failed prior anti-PD-1 therapy showed a meaningful response rate.
However, this approval does not mean Tudurivib's therapeutic effect has been definitively proven. Accelerated approval grants authorization first based on surrogate endpoints, with actual clinical benefit to be confirmed later through confirmatory trials. Replimune is conducting a phase 3 confirmatory study comparing the Tudurivib-Opdivo combination with existing treatments.
Global pharmaceutical companies are also entering the melanoma treatment market. Moderna in the United States is developing a therapy combining an mRNA-based cancer vaccine with "Keytruda," an immunotherapy from Merck (MSD), for high-risk melanoma patients. Germany's BioNTech is also developing an mRNA-based cancer vaccine.
In Korea, companies are targeting specific patient groups or pursuing combinations with global drugmakers' existing anticancer drugs to fill treatment gaps.
A leading corporation is Hanmi Pharmaceutical(128940). Hanmi Pharmaceutical is focusing on NRAS-mutant melanoma, which lacks adequate treatment options. It is developing the oral targeted therapy "belvarafenib" and pursuing a strategy of combining it with "cobimetinib," a targeted therapy from Genentech, a subsidiary of Switzerland's Roche. Cobimetinib is a MEK inhibitor that blocks signaling pathways that drive cancer.
NRAS-mutant melanoma, which is related to cancer cell growth, is known to be more invasive and metastatic than typical melanoma and to have a shorter overall survival. However, there is currently no approved standard therapy in Korea or abroad that directly targets NRAS-mutant melanoma.
In a prior global phase 1 study, belvarafenib showed antitumor activity in patients with solid tumors harboring NRAS or BRAF gene mutations that regulate cancer growth signaling. In Korea, a follow-up phase 2 trial is underway in patients with NRAS-mutant locally advanced or metastatic melanoma. Hanmi Pharmaceutical plans to complete the phase 2 trial by 2027 and apply for conditional approval in 2028.
GI Innovation(358570) is also targeting the melanoma market with combination therapy to overcome the limits of existing immunotherapies. It is conducting a phase 2 study evaluating a combination of MSD's Keytruda and its own immunotherapy candidate "GI-102" in patients with metastatic melanoma.
After winning clinical trial approval from the U.S. FDA, it also secured approval for a phase 2 study plan in Korea in April, accelerating global development. GI Innovation said an earlier combination phase 2 study showed tumors shrank by more than 30% in four patients with kidney cancer or melanoma who were nonresponsive or resistant to existing immunotherapies. The company is aiming for FDA accelerated approval in 2028 based on these results.
In next-generation oncology, efforts are increasing to boost treatment efficacy by adding K-bio drugs to existing big pharma cancer therapies. The key question is whether this strategy will translate into real clinical significance, such as extending patient survival.
Industry watchers expect competition in the melanoma therapeutics market to become more segmented. An industry official said, "As immunotherapies like Keytruda and Opdivo have become standard treatments, later entrants must target clearly defined groups, such as patients who do not respond to existing therapies or those with specific gene mutations," adding, "Going forward, combination therapies that pair existing anticancer drugs with new medicines to overcome treatment limits will expand further."