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Promising Immunotherapy Fails in Much Awaited Lung Cancer Tr

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Promising Immunotherapy Fails in Much Awaited Lung Cancer Trial

August 10th, 2012 - by Dr. Jack West

http://blog.lungevity.org/2012/08/10/pr ... cer-trial/

I was sad to learn this week that the a randomized study of 720 patients with previously treated advanced NSCLC randomized to receive talactoferrin-alpha (TLF) or placebo called FORTIS-M trial was reported in a press release to have failed to demonstrate a benefit. The study’s primary endpoint was overall survival and not only was there no improvement in survival (median 7.5 months with talactoferrin vs. 7.7 months on placebo arm), which can be a lofty goal, the study also failed to demonstrate an improvement in progression-free survival with the active drug.

We still await the full results of the study, which I expect to be presented at an upcoming cancer meeting in September, but officials from the company (Agennix) offered quotes that indicate that they’re in the process of shutting down research on it and cutting their losses. Not surprisingly, the company’s stock was punished severely when they disclosed that TLF had failed on such a large stage: it dropped nearly 80%, and people from the company even indicated that this may lead the company to shut down operations.

I’m certainly disappointed on several levels. Not only was I truly very hopeful about this agent, partly because of its efficacy in phase II trials, and partly because of its extremely favorable tolerability (side effects actually appeared to be lower with TLF added to chemo, compared with chemo alone). There was another trial of trial of chemo + TLF vs. chemo + placebo, but I don’t think we’ll see that trial completed now, sad to say.

What went wrong? I don’t think anyone really knows (at least I don’t). It may be that TLF just joins a long line of therapies that have appeared to confer provocative benefits in early studies, only to disappoint us when held up to the light better in the form of a large randomized phase III trial. Though I was rooting for TLF, I think we can at least be comforted got a fair test in the form of a 720 patient randomized trial that appears to not show any hint of benefit. The only thing worse would be for a promising agent to never get the opportunity to be tested properly.

I’m quite saddened that an agent I was pretty hopeful about fail to emerge as a new effective treatment for lung cancer, but there are others out there. There has still been plenty of momentum in favor of immunotherapies for solid tumors, and I think there’s still reason to be hopeful.



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