Merck and Moderna have reported positive results from the first late-stage trial of their personalised cancer vaccine, moving the treatment closer to possible regulatory approval.
The mRNA-based vaccine, given with Merck’s cancer drug Keytruda, met the main goals of a Phase 3 trial involving more than 1,100 patients with higher-risk or advanced melanoma.
The patients had undergone surgery to remove all detectable cancer before taking part in the trial.
The combination of the vaccine and Keytruda significantly extended the time patients lived without their melanoma returning compared with Keytruda alone. It also reduced the risk of the cancer spreading to distant parts of the body.
The results follow positive findings from a Phase 2 trial of the same treatment earlier this year.
“It’s a big moment for medicine, a big moment for patients,” Moderna CEO Stephane Bancel said in an interview on CNBC’s “Squawk Box.”
The Phase 3 trial will continue to examine other outcomes, including whether the treatment improves overall survival.
Merck and Moderna said they would present the full data at an upcoming international medical meeting. It is not yet clear when the companies will apply for approval in the United States.
Dr Dean Li, president of Merck Research Laboratories, said the companies would likely begin discussions with regulatory agencies about the treatment and its safety “in the next few months.”
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The early results suggest that the treatment could become another option for people with melanoma.
Melanoma accounts for about one per cent of skin cancers but causes most skin cancer deaths. Most melanoma recurrences occur within the first two to three years after the cancer has been treated and removed.
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.
She said it was “very exciting” that the treatment produced a “clinically meaningful improvement” compared with Keytruda, which is a standard treatment for melanoma.
Healy also said the treatment was well tolerated by patients, with side effects similar to those seen with other vaccines commonly given for different diseases.
According to Healy, the results also support the personalised treatment approach that Merck and Moderna have been developing.
She explained that every tumour has its own set of mutations, even among people with the same type of cancer. The vaccine is designed to identify mutations specific to each patient’s tumour rather than using the same vaccine for everyone.
The aim is to train the immune system to identify and attack those cancer markers. The vaccine is then combined with Keytruda, which helps the immune system fight the cancer.
“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.
The trial results also had a major impact on the companies’ shares. Merck’s stock rose more than 12 per cent on Wednesday, while Moderna’s shares jumped about 177 per cent.
The difference reflected the size of the two companies. Merck had a market value of about $333 billion, compared with around $25 billion for Moderna before the market opened on Wednesday.
In a June note ahead of the trial results, Leerink Partners analyst Mani Foroohar described the Phase 3 outcome as a make-or-break event for Moderna’s stock.
Analysts had said Moderna’s valuation already reflected expectations that the personalised cancer vaccine could eventually be used against other cancers, not just melanoma.
Merck and Moderna are currently studying the vaccine in trials involving other cancers, including non-small cell lung cancer, bladder cancer and renal cell carcinoma.
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