Experimental personalized cancer vaccine Merck and moderna has shown positive initial results in its first-ever late-stage clinical trial, moving the treatment option a step closer to filing for approval, the companies announced Wednesday.
The mRNA-based shot in combination with Merck’s immunotherapy Keytruda met key goals in a Phase 3 trial of more than 1,100 patients with high-risk or advanced melanoma whose detectable cancer was completely removed by surgery.
Merck stock rose more than 10% in morning trading, while Moderna stock soared nearly 150%. The size of these moves reflects the relative size of the companies joining Wednesday, with Merck’s market capitalization of about $333 billion, while Moderna’s market cap remains at nearly $25 billion.
This combination therapy met the primary research goal of significantly extending the length of time patients can survive without recurrence of their melanoma compared to Keytruda alone. This treatment also reduced the risk of the cancer spreading to distant parts of the body. These results build on positive phase 2 trial data for the same regimen conducted earlier this year.
“This is a huge moment for healthcare and for patients,” Moderna CEO Stephane Bancel said in an interview on CNBC’s “Squawk Box.”
Researchers work in a lab at Moderna’s headquarters in Cambridge, Massachusetts, on March 26, 2024.
Adam Glanzman Bloomberg | Getty Images
Phase 3 trials will continue to evaluate other outcomes of the regimen, including overall survival benefits. The drug company plans to present the data at an upcoming international medical conference, but it’s unclear when it plans to submit an application for U.S. approval.
Dr. Dean Lee, director of Merck Research Laboratories, told Squawk Box that the drug company will likely begin discussions with regulators about the treatment and its safety “in the coming months.”
Early data suggest this combination could be a new treatment option for melanoma, which accounts for only about 1% of skin cancers but accounts for the majority of skin cancer deaths. Most melanoma recurrences occur within the first 2 to 3 years after initial treatment and excision.
Dr. Jane Healy, director of early oncology development at Merck & Co., said in an interview that melanoma patients “have to deal with the new severity of their diagnosis, then have to undergo unpleasant treatments such as surgery, and then worry that their cancer will come back.”
He said it was “very interesting” that the treatment led to “clinically meaningful improvements” over Keytruda, the standard treatment for melanoma, and was well tolerated by patients. Side effects were similar to other vaccines typically given for other illnesses, Healy noted.
The results also validate the personalized treatment approach that Merck and Moderna have been developing for decades, she added.
Healy said every tumor has a unique set of mutations, even in patients with the same type of cancer. Merck and Moderna’s personalized vaccines are designed to target specific mutations in each patient’s tumor, rather than using a one-size-fits-all approach. The idea is to train the immune system to recognize and kill these unique cancer markers, and combine that response with Keytruda to help the body attack cancer more effectively.
“We think (the results) are very meaningful for patients with this disease, and that future clinical trials with this particular new type of therapy may actually consider what it means for other cancer patients,” she said.
Mani Foruhar, an analyst at Leerink Partners, said in a note in June ahead of the earnings release that the Phase 3 results are a make-or-break event for Moderna stock.
Analysts said before Wednesday’s share price move that the company’s valuation already reflected expectations that personalized cancer vaccines would eventually be effective against multiple types of cancer, not just melanoma.
Merck and Moderna are studying their vaccines in several trials in other tumors, including non-small cell lung cancer, bladder cancer and renal cell cancer.
