Moderna Cancer Therapy Shows High Response Rate in Melanoma Trial
Early data for mRNA-4359 combined with Keytruda shows a 67% response rate in a key subgroup of skin cancer patients, boosting the firm's oncology pipeline.
Moderna (NASDAQ: MRNA) unveiled promising early-stage results for its investigational cancer therapy, mRNA-4359, in treating an advanced form of skin cancer. The data, presented at the European Society for Medical Oncology (ESMO) Congress, showed significant efficacy in patients with melanoma who had stopped responding to standard checkpoint inhibitor treatments, a major challenge in oncology.
In the Phase 1/2 study, the therapy was tested in combination with Merck’s blockbuster drug, Keytruda. The combination achieved a across patients with checkpoint-resistant melanoma. The results were even more striking in a specific subgroup of patients with PD-L1 positive tumors, where the ORR surged to 67%, indicating a potent anti-tumor effect in this population.
These findings are a critical step forward for Moderna as it aims to expand its mRNA platform beyond infectious diseases and into the highly competitive, and lucrative, field of cancer treatment. The therapy, mRNA-4359, is designed to stimulate the immune system by encoding for both PD-L1 and IDO1, two key proteins that cancers use to hide from immune cells. The goal is to create a more robust and durable anti-cancer response.
Dr. Kyle Holen, Moderna's Head of Development, Therapeutics and Oncology, described the findings as "early" but "." The company highlighted that mRNA-4359 demonstrated a manageable safety profile, a crucial factor for combination therapies.
This positive data helps bolster Moderna's oncology pipeline, which is being closely watched by investors as the company seeks new growth drivers beyond its COVID-19 vaccine. The company is continuing to evaluate mRNA-4359 in its ongoing study for both melanoma and non-small cell lung cancer.
Moderna announced it will on October 17, 2025, to provide a deeper analysis of the data. The results position the company as a serious contender in the next generation of cancer therapies, leveraging the same mRNA technology that made its COVID-19 vaccine a household name.