Cancer Vaccine Plus Keytruda Reduces Risk of Recurrence or Death in Melanoma

Patients with advanced-stage melanoma continue to experience reduced risk of recurrence or death following treatment with a combination of mRNA vaccine mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), and Keytruda, an anti-PD-1 therapy, according to recent study findings.

The mRNA-4157 (V940) and Keytruda combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 52% when compared with treatment with Keytruda alone in patients with stage 3 or 4 melanoma with high risk of recurrence following complete resection, as determined by the phase 2b KEYNOTE-942/mRNA-4157-P201 study, according to a news release from drug manufacturers Moderna and Merck.

The latest findings, from a median planned follow-up of approximately three years, build on previously announced primarily analysis data from a median planned follow-up of approximately two years which showed that the combination reduced the risk of recurrence or death by 44% and the risk of distance metastasis or death by 65% when compared with Keytruda alone.

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“As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with KEYTRUDA in people with resected high-risk melanoma,” said Dr. Kyle Holen, Moderna’s senior vice president and head of development, therapeutics and oncology. “These data add another positive analysis to the multiple endpoints and subgroups previously assessed in this study. Importantly for this technology, the KEYNOTE-942/mRNA-4157-P201 study was the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and the first combination therapy to show a significant benefit over Keytruda alone in adjuvant melanoma. We look forward to sharing these data with people impacted by this disease and the broader scientific community.”

KEYNOTE-942 enrolled 157 patients who, after complete resection, received either mRNA-4157 (V940) at one milligram every three weeks for nine doses plus 200 milligrams of Keytruda every three weeks for up to 18 cycles (approximately one year) or Keytruda alone for a year until recurrence or unacceptable toxicity, according to the news release.

Based on the trial’s findings, the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the combination for the post-surgical treatment of patients with high-risk melanoma earlier this year.

Moderna and Merck have also announced the phase 3 INTerpath-001 (V940-001) clinical trial to evaluate the combination as an adjuvant treatment for patients with resected, high-risk stage 3B to 4 melanoma, which is currently enrolling participants, as well as a phase 3 trial for the treatment of patients with non-small cell lung cancer treated with the combination regimen.

“I think that there’s concerted efforts, both on the academic side and also on the industry side, to work on (cancer vaccines),” Dr. Catherine J. Wu, professor at Harvard Medical School, chief of the division of stem cell transplantation and cellular therapies and Lavine Family Chair of Preventive Cancer Therapies at Dana-Farber Cancer Center in Boston, told CURE® earlier this year.

“Academics can do signal finding, they can do small studies,” Wu said. “We really rely on our industry partners to really support the large studies that are going to be able to — to have the resources to be able to follow out the patients and look at the impact. But the signals are all in the positive.”

Side effects observed with treatment via mRNA-4157 (V940) in KEYNOTE-942 at a median follow-up of three years were consistent with previously reported side effects, according to the news release. Grade 3 or higher side effects were reported by 25% of patients in the combination regimen arm and 20% of patients treated with Keytruda alone, with the most common side effects of any grade attributed to mRNA-4157 (V940) being fatigue (60.6%), injection site pain (56.7%) and chills (49%).

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