Moderna (MRNA) and Merck (MRK) said Wednesday a late-stage trial of an experimental skin cancer treatment yielded positive topline results, sending the companies' shares higher, with Moderna jumping more than 100%.
The phase 3 trial evaluated the safety and efficacy of intismeran in combination with Merck's Keytruda, compared with Keytruda alone, in patients with high-risk resected cutaneous melanoma. The study enrolled 1,137 patients.
The combination showed "statistically significant and clinically meaningful improvements" in recurrence-free survival and distant metastasis-free survival in certain melanoma patients who had not undergone prior treatment with systemic therapy, the companies said Wednesday.
The trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival. The results also marked the first positive phase 3 readout for an individualized neoantigen therapy and for an mRNA-based cancer therapy, as well as the first late-stage study to show a "clinically meaningful improvement" over Keytruda alone in the adjuvant setting for patients with resected melanoma, Moderna and Merck said. The companies are jointly developing the treatment.
Moderna shares were up 148% in afternoon trade, while Merck jumped 11%.
"For many years, the idea of creating an mRNA treatment designed specifically for an individual patient's cancer was aspirational. We are now helping turn that vision into a reality," Moderna Chief Executive Stephane Bancel said. "Together with Merck, we have started to demonstrate the transformative potential of this technology to address critical unmet needs in the adjuvant melanoma setting."
The trial showed that the safety profiles of intismeran and Keytruda were consistent with previously reported results from the combination, with "no new safety signals" seen, the companies said.
In June, data from a phase 2b trial showed that the combination reduced the risk of recurrence or death by 49%, compared with Keytruda alone. That study also demonstrated a 59% reduction in the risk of the disease spreading to other parts of the body or death.
The latest trial will continue to evaluate other secondary endpoints, such as overall survival, the companies said Wednesday.
"These first phase 3 findings for intismeran in combination with Keytruda as adjuvant therapy reinforce the promise of a more personalized approach to cancer treatment," said Merck Research Laboratories President Dean Li. "We believe individualized neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated."
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