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Merck Provides Update on KEYNOTE-407 Trial

(Merck) May 3, 2018 - Merck, known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-407 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as first line treatment for metastatic squamous non-small cell lung cancer (sNSCLC) met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of participants at an interim analysis.

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H. Jack West, MD (Posted: May 03, 2018)

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An important result, one more piece of evidence that is at least somewhat supportive of the idea of giving concurrent immune checkpoint inhibitor therapy with first line chemo. This trial is very similar to the IMpower131 trial of carbo/nab-paclitaxel or paclitaxel with atezolizumab or placebo, which has been reported in a press release to be positive for a significant PFS benefit.

We will see more info at ASCO 2018 on these studies. Importantly, however, in a setting in which we're giving up a line of treatment by moving a previously second line approach into first line, seeing more transient, less important endpoints like PFS or especially response rate improve is not nearly as impressive as seeing these potential changes in practice translate to a significant improvement in overall survival. I personally won't favor adding intensity of treatment, cost, and toxicity to the burden of a line of therapy unless it produces an improvement in OS or a dramatic improvement in PFS, such as 6 months or more, ideally without much of an added toxicity burden.

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