USA —A personalized Moderna Inc. cancer vaccine combined with collaborator Merck & Co.’s best-selling drug reduced melanoma deaths in a mid-stage trial, easing concerns about the biotechnology company’s second act following the success of its Covid-19 vaccine.
The combination of the vaccine and Merck’s Keytruda reduced the risk of death or recurrence of melanoma by 44%, the companies said in a statement released.
The result was considered a “statistically significant and clinically meaningful improvement,” the companies said.
After a year of treatment, the combination was generally safe and demonstrated a benefit over Keytruda alone.
Serious drug-related side effects occurred in 14.4% of patients receiving the combination, compared to 10% of patients receiving Keytruda alone.
The combined treatment will enter final-stage studies next year, according to the drugmakers.
The Merck/Moderna collaboration is one of several that combine powerful drugs that activate the immune system with mRNA vaccine technology to target cancers. They are designed to target highly mutated tumors.
The personalized vaccine works in tandem with Merck’s Keytruda, a checkpoint inhibitor designed to block a protein known as programmed death 1 (PD-1), which aids tumors in evading the immune system.
To create the vaccine, researchers collected tumor and healthy tissue samples from patients. The information was used to design a cancer vaccine after decoding the samples’ genetic sequences and isolating mutant proteins associated only with cancer.
When a patient’s cells are injected, they act as a manufacturing plant, producing perfect copies of the mutations for the immune system to recognize and destroy.
The combination trial was conducted in an “adjuvant” setting, in which patients first have tumors surgically removed and then receive treatment to prevent cancer from returning.
Both Keytruda and Bristol Myers Squibb’s Opdivo are already approved in the adjuvant setting.
Moderna’s personalized vaccine can be created in about eight weeks, which Paul Burton, Moderna’s chief medical officer hopes to cut in half in the future.
The findings raised hopes that Moderna’s personalized cancer vaccine approach could build on the success of Merck, Bristol-Myers Squibb, and other pharmaceutical companies in developing checkpoint inhibitors, which impede cancers’ ability to evade immune attack.
Keytruda has been approved for use in 17 different types of cancer since its initial approval in melanoma, including some in which the tumor has a specific mutational signature regardless of organ location.
Other companies working with similar vaccines are Moderna’s COVID-19 rival BioNTech, partnered with Roche, Gritstone Bio, and Nykode Therapeutics.
Merck paid US$250 million in October to license the Moderna vaccine, for which it had signed an option in 2016.
Merck could use combination therapies to help keep biosimilar competition away from Keytruda when its main patent expires in 2028.
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