Moderna and Merck's experimental personalized cancer vaccine produced positive results in its inaugural late-stage trial, the companies disclosed Wednesday, bringing regulatory approval within sight for a treatment that could redefine care for the deadliest form of skin cancer, CNBC reported.
In a phase three study of more than 1,100 patients with high-risk or surgically cleared advanced melanoma, the mRNA-based vaccine administered alongside Merck's immunotherapy Keytruda met its primary endpoint – significantly prolonging disease-free survival compared with Keytruda alone while also curbing the likelihood of distant metastasis.
Moderna stock rocketed approximately 90% in premarket trading; Merck shares gained over 8% – a divergence that reflects the two companies' vastly different scales, with Merck entering the day at a roughly $333 billion market cap against Moderna's approximately $25 billion.
"It's a big moment for medicine, a big moment for patients," Moderna CEO Stephane Bancel said on CNBC's "Squawk Box."
The trial will continue to track additional endpoints including overall survival, and both companies plan to present the dataset at an international medical conference; regulatory talks on safety and the path to approval are expected to begin "in the next few months," Dr. Dean Li, president of Merck Research Laboratories, told CNBC.
Melanoma – responsible for roughly 1% of skin cancer cases yet the vast majority of skin cancer fatalities – poses a uniquely difficult prognosis, with most recurrences materializing in the first two to three years after treatment and surgery.
Melanoma patients are "stuck having to deal with the new gravity of that diagnosis and then undergo uncomfortable treatments like surgery, and after that, they're worried about their cancer coming back," Dr. Jane Healy, Merck's head of oncology early development, said in an interview, describing the combination's results as "very exciting" for delivering a "clinically meaningful improvement" over Keytruda with a tolerability profile akin to standard vaccines.
The personalized framework at the heart of the vaccine – built on the principle that every tumor carries a distinctive mutational signature requiring a tailored immune response, amplified by Keytruda's anti-cancer mechanism – has been in development at both companies for decades, Healy said.
"We think [the results are] very meaningful for patients with this disease and really the potential of what it can mean for other patients for cancer in future trials with this particular new class of therapy," she said, as Merck and Moderna extend the program to non-small cell lung cancer, bladder cancer and renal cell carcinoma, CNBC reported.
