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news.Merck through its subsidiaries has signed three separate clinical collaboration agreements with Amgen, Incyte and Pfizer to assess new combination regimens with its investigational anti-PD-1 immunotherapy, MK-3475.
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A Phase I/II clinical trial will be carried out by Pfizer and Merck that will assess the safety and anti-cancer efficacy of MK-3475 combined with Pfizer’s small molecule kinase inhibitor axitinib (INLYTA) in renal cell carcinoma (RCC).
Separately a Phase I trial will be conducted to evaluate the safety and tolerability of the combination of MK-3475 and PF-05082566 (PF-2566), Pfizer’s investigational immuno-oncology agent that targets the human 4-1BB receptor, in multiple cancer types.
Meanwhile, Merck and Incyte will collaborate on a randomized, double-blind placebo controlled Phase I/II trial to assess 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 NSCLC, among other advanced or metastatic cancers.
In addition, Amgen and Merck will assess MK-3475 in combination with Amgen’s investigational oncolytic immunotherapy talimogene laherparepvec in a Phase I/II trial in patients with previously untreated advanced melanoma.
Merck is also planning to commence a new Phase I ‘signal finding’ trial to assess the safety and efficacy of MK-3475 monotherapy in 20 different PD-L1-positive solid tumor types that have not been studied previously.
Merck Research Laboratories president Roger Perlmutter said the company’s clinical scientists intend to explore the potential of our PD-1 inhibitor across a wide range of cancers, both as monotherapy and in combination.
"These new collaborations with Amgen, Incyte and Pfizer underscore our shared determination to evaluate treatment regimens with the potential to provide meaningful benefits to patients suffering from cancer," Perlmutter said.
The company said that MK-3475 is currently being studied in 13 clinical trials which is expected to enroll over 4,000 patients across more than 30 types of cancer.
The cancers include bladder, colorectal, gastric, head and neck, melanoma, non-small and small cell lung, renal, pancreatic, prostate, triple negative and estrogen-receptor positive HER 2-negative breast, gynecologic, and hematological malignancies, among others.
In April 2013, MK-3475 was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for advanced melanoma.
In January 2014, Merck announced the start of a rolling submission of a Biologics License Application for MK-3475 in advanced melanoma in the US and it intends to complete the submission in the first half of 2014.
Image: Aerial photo of the Merck site in Darmstadt – the headquarters of the Merck Group. Photo: courtesy of Merck KGaA.