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Wednesday, Modern (NASDAQ: ARNM) announced encouraging results from a clinical trial with an investigational cancer vaccine. Treatment with the messenger RNA candidate, mRNA-4157, reduced tumors in five out of ten patients with squamous cell carcinoma of the head and neck (HNSCC) when given in combination with Keytruda. Two of these patients achieved complete remission.
Keytruda is a successful cancer immunotherapy of Merck (NYSE: MRK) which is approved to treat patients with HNSCC as a single agent. Moderna did not include a control group for comparison, but we do know that the FDA has approved Keytruda to treat patients with advanced stage HNSCC as monotherapy after shrinking tumors for only 16% of patients, including 5 % achieved complete remission.
Unfortunately, treatment with mRNA-4157 plus Keytruda did not reduce any tumors in a group of 17 patients with advanced colon cancer not motivated by microsatellite instability mutations. Keytruda is approved to treat patients with these mutations, but it did not succeed among the larger population of colon cancer patients who do not fit into this category.
Some encouraging responses from the larger group of colon cancer patients would have helped support the idea that mRNA-4157 is an effective therapy. Before assuming that Moderna’s cancer vaccine candidate is responsible for the early responses seen, it’s probably best to wait and see if the impressive response rate holds up as more HNSCC patients are added to the study. .
Since Keytruda’s approval in 2014, barely a month has passed without at least one clinical-stage biotech company reporting impressive early response rates produced by their experimental therapies in combination with Keytruda or drugs. similar. Such combinations remove the brakes on the immune systems so that they can fight cancer. So far, none have led to FDA approval.
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