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Update on Merck's MK-3475 - Analyst Blog

Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

A couple of days back, Merck & Co. Inc. ( MRK ) presented early findings from studies assessing the efficacy of its oncology candidate, MK-3475, an anti-PD-1 immunotherapy, in patients suffering from advanced melanoma and advanced non-small cell lung cancer (NSCLC). The data was presented at the American Association for Cancer Research's (AACR) annual meeting.

Melanoma Study

Early findings on MK-3475 efficacy in 125 evaluable advanced melanoma patients (based on at least 6-month follow-up from the ongoing phase Ib KEYNOTE-001 study) were presented.

Based on response evaluation criteria in solid tumors (RECIST 1.1), the overall response rate in the overall evaluable advanced melanoma population was found to be 40%. Response rates were higher in patients with positive PD-L1 tumors (49%) as compared to patients with PD-L1 negative tumors (13%). The analysis also showed that 71% of advanced melanoma patients had positive PD-L1 tumors.

We remind investors that the FDA has granted MK-3475 Breakthrough Therapy designation for the advanced melanoma indication. The company expects to finish submitting a rolling regulatory application for MK-3475 in patients with advanced melanoma in the first half of 2014.

NSCLC Study

Early findings on MK-3475 efficacy in 129 evaluable treatment experienced NSCLC patients (based on at least 19-month follow-up from the ongoing phase Ib KEYNOTE-001 study) were also presented.

Based on RECIST criteria, the overall response rate in the overall evaluable advanced NSCLC population was found to be 19%. Response rates were higher in patients with positive PD-L1 tumors (37%) as compared to patients with PD-L1 negative or low tumors (11%). The analysis also showed that 45% of advanced NSCLC patients had positive PD-L1 tumors.

Apart from melanoma and NSCLC, MK-3475 is also being evaluated for multiple oncology indications including bladder, colorectal, gastric, head and neck, renal, pancreatic, prostate, triple negative and estrogen-receptor positive HER 2-negative breast, gynecologic, and hematological malignancies. Merck is collaborating with several companies including Amgen Inc. ( AMGN ), Incyte Corp. ( INCY ) and Pfizer Inc. ( PFE ) separately for the evaluation of different combination regimens with MK-3475.

Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Amgen, carrying Zacks Rank #1 (Strong Buy).

AMGEN INC (AMGN): Free Stock Analysis Report

INCYTE CORP (INCY): Free Stock Analysis Report

MERCK & CO INC (MRK): Free Stock Analysis Report

PFIZER INC (PFE): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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