HQ Team
December 13, 2022: Moderna Inc’s experimental personalized melanoma vaccine combined with Merck & Co’s immunotherapy Keytruda has almost halved the risk of skin cancer’s recurrence or death in a midstage trial.
The randomized trial combined mRNA vaccine technology, behind the development of successful COVID-19 vaccines, with a drug that activates the immune response. They found this combination offered better results for patients with the most deadly type of skin cancer.
The ongoing study involved 157 patients with stage III/IV melanoma whose tumors were surgically removed before being treated with the drug/vaccine combo or Keytruda alone with the aim of delaying disease recurrence.
The combination showed a statistically significant benefit compared with Keytruda alone after a year of treatment. Drug-related severe side effects occurred in 14.4% of patients who received the drug-vaccine combination compared with 10% with Keytruda alone.
The Food and Drug Administration has approved Merck’s Keytruda to treat several different types of cancer.
“It’s a tremendous step forward in immunotherapy,” Eliav Barr, Merck’s head of global clinical development and chief medical officer, said in an interview.
Paul Burton, Moderna’s chief medical officer, said the combination “has the capacity to be a new paradigm in the treatment of cancer.”
Merck’s Keytruda is an inhibitor that disables a protein called programmed death 1, or PD-1, that helps tumors to evade the immune system.
Researchers took samples of patients’ tumors and healthy tissue. After decoding the tumors’ genes, they then isolated mutant proteins associated only with the cancer. This was used to customize the cancer vaccine.
When injected into a patient, the patient’s cells act as a manufacturing plant, producing perfect copies of the mutations for the immune system to recognize and destroy.
Burton said that Moderna’s personalized vaccine can be made in about eight weeks, a timeframe the company eventually hopes to cut in half. Once the vaccine is approved, Moderna will need to “massively scale-up” its manufacturing capabilities. Merck and Moderna plan to discuss the results with regulatory authorities and start a phase 3 study in melanoma patients in 2023.
mrNA-based cancer vaccines
Merck signed a $250 million deal with Moderna in October to develop the therapeutic cancer vaccine personalized for individual patients. The agreement was initially entered in 2016, but Merck is now exercising its option to develop and sell the product The companies will share all costs and profits equally.
mRNA-based cancer treatment vaccines have been tested in small trials for nearly a decade, with some promising early results. Scientists at both Pfizer-BioNTech and Moderna used their long knowledge of working on this vaccine for cancer to develop the one for Covid-19.
Many clinical trials are testing mRNA treatment vaccines in people with various types of cancer, including pancreatic cancer, and colorectal cancer.
