Merck’s MRK supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy, Keytruda has been accepted for priority review by the FDA. The company is looking to expand the label into the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present.
With the FDA granting priority review, a response should be out by Oct 2, 2015. The FDA will review the sBLA under its Accelerated Approval program. Keytruda has Breakthrough Therapy designation for advanced NSCLC.
Keytruda is currently approved in the U.S. for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.
In addition to announcing the FDA action date for the advanced NSCLC indication, Merck said that it has entered into a couple of clinical trial collaboration agreements with Dynavax Technologies Corporation DVAX under which Merck’s Keytruda and MK-1966 will be investigated in combination with Dynavax’s pipeline candidate – SD-101.
A phase Ib/II multicenter, open-label study will commence in the second half of 2015 to evaluate the safety and efficacy of combining SD-101 with Keytruda in patients with advanced melanoma. A phase I study evaluating the safety and efficacy of combining SD-101 with MK-1966 in patients with solid or hematological malignancies will also be initiated in the second half of 2015. While the SD-101-Keytruda study will be sponsored and funded by Dynavax, the SD-101 – MK-1966 study will be funded and sponsored by Merck. Either collaboration could be extended later to include a phase III study.
This agreement signifies yet again the growing interest in immuno-oncology. Merck is working on evaluating Keytruda alone and in combination with several other therapies and the product is in more than 100 studies covering more than 30 types of tumor.
Both Merck and Dynavax are Zacks Rank #3 (Hold) stocks. Some better-ranked stocks in the health care sector include Gilead Sciences, Inc. GILD and Amgen, Inc. AMGN. While Gilead is a Zacks Rank #1 (Strong Buy) stock, Amgen is a Zacks Rank #2 (Buy) stock.
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