Update on Merck’s MK-3475

Source: Zacks, April 2014

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 – Analyst Report) 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 – Analyst Report), Incyte Corp. (INCY – Analyst Report) and Pfizer Inc. (PFE – Analyst Report) separately for the evaluation of different combination regimens with MK-3475.