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KEYTRUDA® (pembrolizumab) Monotherapy Met Primary Endpoint in Phase 3 KEYNOTE-042 Study, Significantly Improving OS as First-Line Therapy in Locally Advanced or Metastatic NSCLC Patients Expressing PD-L1 in at Least 1 Percent of Tumor Cells

(Merck) Apr 9, 2018 - Merck, known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-042 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary endpoint of overall survival (OS).

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H. Jack West, MD (Posted: April 09, 2018)

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**Practice-changing result**!

We obviously need to see the data, but this large phase 3 trial now demonstrates a significant benefit in overall survival for pembrolizumab monotherapy relative to conventional platinum-based doublet chemo as first line therapy for patients with advanced PD-L1 positive (1% or greater PD-L1 expression) squamous or non-squamous NSCLC. Pembro monotherapy has been a preferred standard of care, if not THE irrefutable standard of care, for patients with advanced squamous or non-squamous NSCLC that has 50% or greater PD-L1 expression, which is about 28-30% of patients. These results extend that approach to somewhere in the range of 2/3 of patients with advanced NSCLC.

The leading competition, at least for patients with non-squamous histology, will almost certainly be the concept of chemo/immunotherapy with carbo/pemetrexed/pembrolizumab, as has been shown to be positive for a significant PFS and OS benefit in the phase III KEYNOTE-189 trial being presented at AACR 2018 on 4/16. This was regardless of PD-L1 status so is likely going to be a very compelling option for patients with PD-L1 less than 1%. For those who are PD-L1-positive, pembrolizumab monotherapy would generally be favored based on the tolerability/therapeutic index, but we'll need to see the actual data for both of these trials before drawing firmer conclusions.

Exciting times!

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