In their first detailed report of a major study, co-developers Moderna Inc.and Merck & Co. revealed that adding a personalized cancer vaccination to the blockbuster Keytruda drug kept more melanoma patient in remission than just the immune therapy.
In a mid-stage study, 79% of patients who received both treatments were cancer-free after 18 months, compared with 62% who only received Merck’s Keytruda. The companies announced this at the annual meeting of the American Association for Cancer Research in Orlando, Florida, on Sunday. The vaccine’s side effects were mild and included fatigue.
Moderna’s post pandemic strategy includes the cancer vaccine as demand for Covid vaccines is waning. Merck Chief medical officer Eliav Barr stated in an interview that the results indicate the combination is effective, but the companies would need to demonstrate the effect of the combination in a larger trial at the final stage before applying for US approval. Moderna executives suggested earlier that the companies may pursue an accelerated approval on the basis of mid-stage results. Barr, however, said they were preparing to complete the phase 3-study which should begin later in the year.
Barr explained that with novel therapies such as this, patients, physicians, guideline writers and payers would all want to see more data in order to better understand the new medicine, and its role.
Analysts and doctors have been debating the extent of the effect since the companies first released the results in December. The data presented at the conference indicates that more patients should be included in the study, according to Sapna patel, MD Anderson Cancer Center’s melanoma oncologist.
Patel stated that “it looks more effective than the standard of care, but it will take a Phase 3 study before we can say for sure if this is truly effective.”
Patients in the trial received two drugs following surgical removal of the melanoma. Moderna used the genetic sequences of each tumor to develop a vaccine to teach the immune system how to recognize abnormal growth. The nine doses were given every three weeks. Keytruda was also given every three weeks, for up to eighteen treatments.
Merck and Moderna intend to test the combination on other cancers that Keytruda has already been used for. Barr stated that they plan to begin a lung cancer study shortly after the next melanoma clinical trial.