Merck & Co. enters deals with Amgen, Incyte, Pfizer on MK-3475 combination regimens

Merck & Co. said Wednesday that it entered three separate agreements with Amgen, Incyte and Pfizer to investigate combination regimens with its experimental anti-PD-1 immunotherapy MK-3475. Roger M. Perlmutter, president of Merck Research Laboratories, noted that the company "intend[s] to explore the potential of our PD-1 inhibitor across a wide range of cancers, both as monotherapy and in combination." Financial terms of the deals were not disclosed.

Specifically, Merck indicated that Phase I/II trials will evaluate MK-3475 in combination with Pfizer’s kinase inhibitor Inlyta (axitinib) in patients with renal cell carcinoma. In addition, Mk-3475 will be investigated in combination with Pfizer's PF-05082566, an investigational immuno-oncology agent that targets the human 4-1BB receptor, in multiple cancer types.

Meanwhile, Merck and Incyte will collaborate on a Phase I/II study to evaluate a regimen combining MK-3475 with the latter's experimental immunotherapy agent INCB24360, an indoleamine 2, 3-dioxygenase inhibitor, in patients with previously treated metastatic and recurrent non-small-cell lung cancer, as well as other advanced or metastatic cancers. In addition Merck said that it will evaluate MK-3475 in combination with Amgen’s investigational oncolytic immunotherapy talimogene laherparepvec in a Phase I/II study in patients with previously untreated advanced melanoma.

ISI Group analyst Mark Schoenebaum suggested that the combination with Incyte's INCB24360 is the most significant of the three because IDO inhibitors have "generated significant buzz among investors and doctors as a promising immuno-oncology approach that could be complimentary to PD-1." He added that "Merck now seems to get that the PD-1 cancer race is hyper-hyper-hyper competitive, and as such, now seems to be picking up the pace of its announcements." Other companies developing similar drugs include Bristol-Myers Squibb with nivolumab and Roche with MPDL3280A.

MK-3475, which was awarded FDA breakthrough therapy status for advanced melanoma last year, is being studied in 13 clinical trials across more than 30 types of cancer. Merck noted Wednesday that it plans to start a Phase I study of the agent in 20 different PD-L1-positive solid tumour types that have not been studied previously. Earlier this year, the company initiated a rolling submission of a filing with the FDA in advanced melanoma, which is expected to be completed in the first half of 2014.

In December last year, Merck entered a collaboration to study MK-3475 in combination with GlaxoSmithKline's oral kinase inhibitor Votrient (pazopanib) in advanced renal cell carcinoma. Merck also recently signed a deal with Ablynx focused on cancer immunotherapies based on the latter's Nanobody technology (for related analysis, see ViewPoints: Nanobody know-how – Perlmutter returns to Ablynx as Merck & Co. steps up its collaborative efforts in immuno-oncology).

Separately, Merck posted Wednesday its fourth-quarter financial results, reporting net income of $781 million, down 14 percent from the year-ago period while sales in the quarter slipped 4 percent to $11.3 billion.

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