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Merck Provides Update on KEYTRUDA® (pembrolizumab) Supplemental Biologics License Application (sBLA) for KEYNOTE-042 Trial

(Merck) Dec 20, 2018 - Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental Biologics License Application (sBLA) for 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) in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor aberrations. The sBLA is based on results of the Phase 3 KEYNOTE-042 trial where KEYTRUDA monotherapy demonstrated a significant improvement in overall survival compared with chemotherapy in this patient population. The company recently submitted additional data and analyses to the FDA, which constitutes a major amendment and extends the Prescription Drug User Fee Act (PDUFA), or target action date, by three months to April 11, 2019. Merck continues to work closely with the FDA during the review of this sBLA.

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H. Jack West, MD (Posted: December 21, 2018)

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This is an indication that, if approved, most lung cancer specialists won't be eager to support. Though patients with PD-L1 1-49% were included in the KEYNOTE-042 trial that came out positive, the subsets clearly illustrate that the study was positive DESPITE their inclusion, which just diluted the real benefit with pembro in the PD-L1>50% population already known to benefit from pembro over chemo based on the KEYNOTE-024 trial.

And while you could argue that pembro coming out with the same survival as first line chemo in the PD-L1 1-49% group represents a favorable option since patients can do just as well without the side effects of chemo, this isn't really true. The control arm getting first line chemo wasn't permitted to cross over, and only 20% of these patients ever got access to immunotherapy upon progression, which is a clear standard of care that has a consistently proven survival benefit. In other words, first line pembro merely looks comparable to first line chemo in survival for patients with PD-L1 1-49% who received substandard care on the control arm.

First line pembro is a poor option for patients with PD-L1 1-49% who are candidates for chemo/immunotherapy, or arguably even chemo followed by immunotherapy. KEYNOTE-042 should not be interpreted as making first line pembro a compelling option for these patients.

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