Biotech firm Moderna has released comprehensive data from mid-stage research on an experimental vaccination that shows promise in preventing tumor recurrence in individuals with a prevalent form of skin cancer.
During this year’s AACR meeting in Orlando, Florida, researchers are reporting results from a Phase 2 experiment comparing Moderna’s vaccine to Merck & Co.’s immunotherapy Keytruda. Results have been anxiously awaited ever since Moderna and Merck reported the study’s success in December; they imply that a shot generated from messenger RNA might augment the benefits of immune-boosting medications often used to treat cancer.
Keytruda and other medications in the same class, called checkpoint inhibitors, have improved the outlook for individuals with melanoma since they were first introduced more than 10 years ago.
Although checkpoint inhibitors were previously only authorized for people whose cancer had progressed, manufacturers have lately begun testing the drugs in earlier stages of the disease. To prevent cancer from returning after surgery, for example, doctors are increasingly prescribing Keytruda in the “adjuvant” scenario. Treatment was found to lower the risk of mortality or recurrence by 43% compared to a placebo, which led to its approval.
Merck hopes that by including Moderna’s vaccine, that advantage may be maximized. The tailored injection, known as mRNA-4157, is meant to stimulate immune responses targeting protein targets detected in tumor samples taken from a patient. Last year, Merck paid $250 million to Moderna for the right to license the company’s technology after purchasing an option to do so in 2016.
The findings presented at AACR provide some context for understanding why Merck made the purchase. In the study, 157 participants were split into two groups, one receiving Keytruda and the vaccination, and the other receiving Merck’s medicine alone. Patients’ cancers had to have spread to a lymph node through the skin before surgery was performed, in order to qualify. In addition, they had to be deemed to be at high risk of recurrence due to the size or other features of their tumor.
Keytruda and mRNA-4157 patients got nine doses of the vaccination (administered once every three weeks) and up to eighteen doses of Keytruda (given every 21 days).
Researchers monitored patients to see if the combination lowered the chance of death or cancer recurrence after tumor excision surgery. Recurrence-free survival was calculated after all patients had been studied for 12 months and at least 40 had either progressed or succumbed.
In December, Moderna and Merck announced that the Keytruda-mRNA-4157 combination decreased the likelihood of recurrence or mortality by 44% compared to Keytruda alone.
Information presented recently adds valuable insights. 22.4% of individuals given the combination had a disease recurrence or died within a year, compared to 40% for people who received just Keytruda. In addition, after 18 months, 79% of patients who took the combo were still alive and cancer-free, compared to 62% of patients who took Keytruda alone. These results are quite promising.
However, when the firms reported Moderna’s results in December, they were met with considerable skepticism. Although the statistical significance of the 44% disparity in recurrence-free survival was high, the study did not take into consideration the potential that Keytruda may have performed better.