Merck and Moderna Find Success with Cancer Vaccine Clinical Trial

Pharmaceutical companies Merck & Co and Moderna Inc announced positive clinical trial results for their investigational melanoma vaccine candidate last week. The personalized cancer treatment that utilizes Merck’s Keytruda therapy and Moderna’s mRNA-4157/V940 reduced patients' risk of cancer recurrence or death by 44% compared to Keytruda alone.

The preliminary results published by Moderna shared that the Phase 2b KEYNOTE trial produced statistically significant and clinically meaningful improvement in patients with stage III/IV melanoma following complete surgical resection. The study is the first of its kind to demonstrate efficacy for an investigational mRNA cancer treatment in a randomized clinical trial.

"We will begin additional studies in melanoma and other forms of cancer with the goal of bringing truly individualized cancer treatments to patients. We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as with health authorities," commented Stéphane Bancel, Moderna's Chief Executive Officer, in the company’s announcement.

The trial enrolled 157 stage III or IV melanoma patients who were randomized after complete surgical resection of the cancerous mass. Serious treatment-related adverse events observed during the trial affected 14.4% of those receiving the combination treatment versus 10% of the group who only received Keytruda. Between stages 1 and 2 of the clinical trial, no significant changes in adverse event occurrence were observed.

"The results of this randomized Phase 2b trial are exciting for the field,” said Jeffrey S. Weber, MD, PhD, Deputy Director of the Perlmutter Cancer Center at NYU Langone, and lead investigator of the study. “These data provide the first evidence that we can improve on the rates of recurrence-free survival achieved by PD-1 blockade in resected high-risk melanoma. These findings also provide the first randomized evidence that a personalized neoantigen approach may be beneficial in melanoma."

Moving forward, Moderna and Merck plan to conduct a larger stage 3 clinical trial for their new treatment and eventually explore additional cancer targets for their personalized treatment modality. Leaders at both organizations are optimistic that the treatment presents a new paradigm for treating cancer.

Melanoma is the most dangerous type of skin cancer — diagnosed in nearly 100,000 Americans annually — and is responsible for approximately 7,650 deaths. Treatments usually involve surgical removal of cancerous tissue and targeted therapy to reduce the chance of recurrence.

Recently, the FDA has approved immunotherapy to treat unresectable melanoma, and most new therapies and drugs tend to focus on early-stage immunotherapy interventions that can reduce the risk of recurrence and the burden of disease on patients. Future treatments will likely also involve other types of cancer vaccines, like the Moderna and Merck intervention.