Moderna and Merck Cancer Vaccine Shows Promise in Late-Stage Trial, Stocks Surge

An experimental personalized cancer vaccine from Moderna and Merck showed positive initial results in its first late-stage trial for melanoma, sending Moderna shares up 177% and Merck shares up 12%.

An experimental personalized cancer vaccine from Moderna and Merck has shown positive initial results in its first-ever late-stage trial, bringing the companies one step closer to filing for approval of the treatment option. The mRNA-based shot, when combined with Merck's immunotherapy Keytruda, met the main study goal of significantly extending the time patients lived without their melanoma returning.

"It's a big moment for medicine, a big moment for patients," Moderna CEO Stephane Bancel said on CNBC's "Squawk Box."

"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."

The Trial Results

The Phase 3 trial involved more than 1,100 patients with higher-risk or advanced melanoma whose detectable cancer had been completely removed through surgery. The combination regimen of the personalized vaccine and Keytruda significantly extended the time patients lived without their melanoma returning compared to Keytruda alone, and also reduced the risk of the cancer spreading to distant parts of the body.

"Every tumor has a unique set of mutations, even among patients with the same type of cancer," said Dr. Jane Healy, Merck's head of oncology early development. "The personalized vaccine is designed to target the specific mutations in each patient's tumor rather than using a one-size-fits-all approach."

Market Reaction

The news sent Moderna's stock soaring about 177%, while Merck shares climbed more than 12%. The size of those moves reflect the companies' relative size entering Wednesday: Merck's market cap was around $333 billion, while Moderna's sat near $25 billion. Analysts said the company's valuation already reflected expectations that the personalized cancer vaccine could eventually work across multiple types of cancers not just melanoma before Wednesday's stock move.

What's Next

The Phase 3 study will continue to assess other outcomes, including the overall survival benefit of the regimen. The drugmakers plan to present the data at an upcoming international medical meeting, and they will likely start talking to regulatory agencies about the treatment and its safety "in the next few months," according to Dr. Dean Li, president of Merck Research Laboratories. The results also validate a personalized treatment approach that Merck and Moderna have been developing for decades.

"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," Healy said.

Here is the question this breakthrough raises. A personalized cancer vaccine from Moderna and Merck has shown promise in a late-stage trial for melanoma. When a treatment can be tailored to the unique mutations of each patient's tumor, what does it mean for the future of cancer care and the economics of drug development?

As the companies prepare to engage with regulators, The Silicon Review asks a final question. When a cancer vaccine shows promise in one type of cancer and is being studied in others, how soon could this personalized approach become a standard of care?

FAQ:

Q: What is the Moderna and Merck cancer vaccine?
A: The vaccine is a personalized mRNA-based shot designed to target the unique mutations in each patient's tumor. It is combined with Merck's immunotherapy Keytruda.

Q: What type of cancer was tested in the late-stage trial?
A: The trial focused on patients with higher-risk or advanced melanoma, the deadliest form of skin cancer.

Q: How did the cancer vaccine perform in the trial?
A: The combination regimen significantly extended the time patients lived without their melanoma returning compared to Keytruda alone, and reduced the risk of the cancer spreading.

Q: How did the stock market react to the news?
A: Moderna's stock soared about 177%, while Merck shares climbed more than 12% on the positive trial results.

Q: What are the next steps for the cancer vaccine?
A: The companies plan to present the data at an international medical meeting and will likely begin talking to regulatory agencies in the next few months.