Print“Early evaluation of immunotherapeutic combinations is important in accelerating the development of new options for patients with cancer, says Eric Rubin, Merck’s vice president of clinical development for oncology.”
Merck is capitalizing on positive momentum behind its leading experimental cancer immunotherapy MK-3475, forming new collaborations with Amgen, Incyte, and Pfizer to explore potential new combination therapies.
Early-stage studies pursued by the partners aim to expand the drug's application to many new cancer types at a time when the number of avoidable cancer deaths is rising fast worldwide.
“Merck clinical scientists intend to explore the potential of our PD-1 inhibitor across a wide range of cancers, both as monotherapy and in combination,” says Roger Perlmutter, president of Merck Research Laboratories.
Merck's shares have risen to highs not seen since 2001 as investors clamor to profit from the potential U.S. Food and Drug Administration approval for MK-3475. The company initiated a rolling submission of its application for the drug, which it expects to complete in the first half of 2014. In April 2013, the FDA accelerated the pace of a review for Merck's application to sell the drug for the treatment of advanced melanoma by granting it a Breakthrough Therapy designation.
With Pfizer, Merck plans to run studies of safety, dosing, and response to MK-3475 in combination with Pfizer’s small molecule kinase inhibitor Inlyta in patients with renal cell carcinoma, and separately MK-3475 plus PF-05082566, an investigational immunotherapy for cancer that targets the human 4-1BB receptor, in multiple cancer types.
Incyte and Merck will collaborate on a randomized, double-blind placebo controlled study to evaluate the safety and efficacy of a regimen combining MK-3475 with Incyte’s investigational immunotherapy agent, INCB24360, an indoleamine 2, 3-dioxygenase (IDO) inhibitor, in patients with previously treated metastatic and recurrent non-small cell lung cancer and other advanced or metastatic cancers.
With Amgen, Merck will evaluate MK-3475 in combination with Amgen’s investigational oncolytic immunotherapy talimogene laherparepvec in a safety, dosage, and response study in patients with previously untreated advanced melanoma.
“Early evaluation of immunotherapeutic combinations is important in accelerating the development of new options for patients with cancer,” says Eric Rubin, Merck’s vice president of clinical development for oncology.
The three new partnerships extend a program Merck unveiled in December 2013 to evaluate MK-3475 in combination with a GlaxoSmithKline kinase inhibitor, pazopanib, in advanced renal cell carcinoma.
Separately, Merck announced it would start a new early-stage “signal finding” study to evaluate the safety and efficacy of MK-3475 monotherapy in 20 different PD-L1-positive solid tumor types not studied previously.
The company says that MK-3475 is being studied in 13 clinical trials that it estimates will enroll more than 4,000 patients across more than 30 types of cancer, including some of the most common types, such as lung, breast, and colorectal cancers.
February 06, 2014
http://www.burrillreport.com/article-merck_inks_collaborations_with_amgen_incyte_and_pfizer.html
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