United States: In a collaborative effort by drugmakers, a promising mRNA vaccine, when combined with immunotherapy, has displayed remarkable effectiveness in treating high-risk melanoma.
Melanoma, though constituting a mere 1% of skin cancer cases, is responsible for the majority of skin cancer-related fatalities, as stated by the American Cancer Society. This year alone, an estimated 100,000 new melanoma diagnoses are projected in the US, with nearly 8,000 fatalities anticipated.
During the extensive three-year trial, participants diagnosed with stage III or IV melanoma, susceptible to cancer recurrence, were closely monitored. Findings revealed that those receiving the Moderna and Merck vaccine alongside Merck’s Keytruda experienced a 49% lower risk of cancer recurrence or mortality and an impressive 62% reduction in distant tumor cell spread or mortality compared to those solely treated with Keytruda, according to CNN Health.
Continuing the study for an additional two years, researchers observed a 44% decreased risk of cancer recurrence or mortality and an astounding 65% decrease in distant metastasis or mortality among individuals administered Keytruda in conjunction with the mRNA-4157/V940 vaccine, in contrast to those exclusively on Keytruda.
Keytruda, initially FDA-approved in 2014, functions as an immunotherapeutic agent empowering the immune system to identify and combat cancerous cells effectively.
The recent FDA designation as a breakthrough therapy for the mRNA-4157/V940 vaccine in combination with Keytruda expedites drug development and evaluation. It signifies a remarkable advancement in treating severe conditions, supported by compelling preliminary clinical data.
Moderna’s CEO, Stephane Bancel, anticipates potential accelerated approval for this personalized therapy as early as 2025. Plans are already underway for a new commercial manufacturing facility in Massachusetts to accommodate the surge in demand.
While the combined treatment exhibited promising results, about a quarter of trial participants reported serious adverse effects, slightly higher than the 20% incidence rate among those solely on Keytruda. Fatigue, injection site discomfort, and chills were among the common side effects linked to the vaccine.
Although the Phase 2b trial data awaits peer review and publication in a professional journal, Moderna and Merck have commenced Phase 3 trials encompassing stage IIB-IV melanoma and non-small-cell lung cancer. Their ambitious agenda includes expanding research to encompass various tumor types, signaling a broader scope for this groundbreaking therapy’s potential impact.