Celldex and the limits of ‘overall survival benefit’ in cancer trials
Last year, Celldex announced the results of a trial for recurrent GBM where they compared thier new vaccine (Rintega) combined with Avastin against Avastin alone. At 18 months after the start of the trial (which starts at recurrence), twice as many patients were alive in the vaccine + avastin group compared to the Avastin arm. In one subgroup, called Per Protocol, it was more dramatic - the vaccine tripled survival. And best yet - there was NO additional toxicity compared to the avastin group.
This article talks about the disappointing FDA decision that these results are not good enough to qualify for approval yet. They want the company to finish a larger trial before applying for approval. The FDA says the trial is too small, which it is if you look at it objectively. Of course we would like to have more data. However, when you are talking about a disease where just 10-15 % of patients are alive 18 months after recurrence, and a simple vaccine which is injected into the arm with minimal to no side effects can double or triple those alive, it doesn't make sense not to allow patients access to this treatment.
There needs to be another pathway to approval. Perhaps a system where such treatments can be approved provisionally: patients can get them, but every patient has to be registered and followed for survival and side effects. After a predetermined number of patients use the treatment, the FDA can re-evaluate the data and if it is not favorable, remove the approval. Perhaps have a safety monitor watch ongoing data for side effects or increased death rate and pull the approval early if needed.
Posted on: 08/24/2015
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