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Merck's Keytruda Succeeds In Late-Stage Lung Cancer Study

(Reuters) May 23, 2018 - Merck & Co on Wednesday said its cancer drug Keytruda helped extend survival and prevented disease progression when tested in a late-stage study in combination with chemotherapy for a type of lung cancer.

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H. Jack West, MD (Posted: May 24, 2018)

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KEYNOTE-407 was already #2 on my top 5 abstracts in lung cancer for ASCO 2018, behind only the KEYNOTE-042 Plenary Session presentation, but this latest press release now makes it rival KN-042 in significance.

With the new results of a significant PFS and OS benefit on top of the already reported 23% higher objective response rate noted in the abstract, we should expect that this will lead to a timely approval of this combination of carbo/nab-paclitaxel/pembrolizumab for first line treatment of advanced squamous NSCLC, regardless of tumor PD-L1 expression level. The landscape is likely to mirror that for non-squamous NSCLC, where a chemo/immunotherapy combination (carbo/pemetrexed/pembro) is approved regardless of PD-L1 expression, while the leading alternative is pembro monotherapy for patients with high PD-L1 based on KEYNOTE-024, or soon even for those with PD-L1 1% or higher, based on KEYNOTE-042.

So in both squamous and non-squamous NSCLC, it's very likely the leading alternatives will be pembro monotherapy vs. chemo/pembro for those with tumors positive for PD-L1, and chemo/pembro for those whose tumors are PD-L1 negative. IMpower131 will also feature some positive results with carbo/nab-paclitaxel/ataezolizumab, but thus far we know only about a significant PFS benefit. Not only will it need to show a significant OS benefit to compete at all with KEYNOTE-407 results, it will be up against a pembro juggernaut, with multiple positive trials and an increasingly powerful narrative of benefit in many NSCLC trials.

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