Pfizer and Merck to collaborate on innovative anti-cancer combination studies

PfizerPfizer Inc. (NYSE:PFE) has agreed with Merck & Co., Inc., known as MSD outside the United States and Canada ("Merck"), through two Merck subsidiaries, to explore the therapeutic potential of Merck's investigational anti-PD-1 therapy, MK-3475, in combination with two Pfizer oncology assets. A Phase I/II clinical study will evaluate the safety and anti-cancer efficacy of MK-3475 combined with Pfizer's axitinib (INLYTA®) in renal cell carcinoma (RCC). A separate Phase I study will evaluate the safety and tolerability of the combination of MK-3475 and PF-05082566 (PF-2566), Pfizer's investigational, fully humanized monoclonal antibody (mAb) that stimulates signaling through 4-1BB (CD-137), a protein involved in regulation of immune cell proliferation and survival.

"There has been notable progress in the cancer immunotherapy field over the last year, with new clinical data showing promising efficacy and tolerability for emerging therapies - particularly those that target the PD-1 pathway," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. "These investigational therapies, which harness the body's immune system to treat disease, may hold the greatest potential for patients with cancer when used in combination with other immuno-oncology agents, like PF-2566, to amplify anti-tumor immune responses, or with targeted agents, like axitinib, to optimize their effectiveness. We are pleased to collaborate with Merck to study a diverse group of our anti-cancer agents in combination with MK-3475, with the goal of identifying more efficacious treatment options for patients."

"We are pleased to be collaborating with Pfizer to study MK-3475 as part of these novel combination regimens," said Dr. Eric Rubin, vice president, clinical development for oncology, Merck Research Laboratories. "Early evaluation of immunotherapeutic combinations is important toward potentially accelerating the development of new options for patients with cancer."

Pfizer will conduct the clinical studies of MK-3475 plus axitinib and MK-3475 plus PF-2566. This agreement does not provide for any collaboration between Pfizer and Merck following the completion of the specified studies.

Financial terms were not disclosed.

Under a separate agreement Pfizer and Merck are currently exploring the pre-clinical combination of MK-3475 with Pfizer's investigational therapy palbociclib (PD-0332991). Merck is conducting these pre-clinical studies. Further studies would depend on the outcome of the ongoing pre-clinical studies as well as subsequent agreement by Merck and Pfizer.

About MK-3475
Many tumors are able to evade the immune system through a mechanism that exploits the PD-1 inhibitory checkpoint protein. MK-3475 is an investigational, highly selective anti-PD-1 immunotherapy designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system's T-cells that target cancer by essentially releasing a brake on the immune system.

About INLYTA® (axitinib) tablets
INLYTA, a kinase inhibitor, is an oral therapy that is designed to inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3; these receptors can influence tumor growth, vascular angiogenesis and progression of cancer (the spread of tumors). In the United States (U.S.), INLYTA is approved for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. INLYTA is also approved by the European Medicines Agency (EMA) for use in the European Union (EU) in adult patients with advanced RCC after failure of prior treatment with sunitinib or a cytokine.

About PF-2566
PF-2566 is an investigational, fully human monoclonal antibody (mAb) that targets CD-137, a protein expressed in many immune cells. In pre-clinical models, it has shown anti-tumor activity by enhancing T-cell mediated immune responses. Pfizer is currently evaluating PF-2566 in a Phase I study as a single agent in multiple tumor types, as well as in combination with rituxumab in non-Hodgkin lymphoma patients. PF-2566 is not approved for any indications in any markets.

About Palbociclib
Palbociclib is an investigational, oral and selective inhibitor of cyclin dependent kinases 4 and 6. In April 2013, palbociclib received Breakthrough Therapy designation by the FDA for the potential treatment of patients with advanced breast cancer. Palbociclib is not approved for any indications in any markets.

About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline of biologics and small molecules, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time.

Most Popular Now

In wine, there's health: Low levels of alcohol goo…

While a couple of glasses of wine can help clear the mind after a busy day, new research shows that it may actually help clean the mind as well. The new study, which appe...

Sanofi to acquire Ablynx for €3.9 Billion

Sanofi and Ablynx, a biopharmaceutical company engaged in the discovery and development of Nanobodies®, entered into a definitive agreement under which Sanofi will offer ...

Interim publications of randomized trials make new…

Early results from randomized trials are sometimes published before the trial is completed. The results of such interim publications may generate a great deal of interest...

Drug trial protocol redactions by industry sponsor…

New research published by the Journal of the Royal Society of Medicine exposes the extent of redactions in protocols for industry-sponsored randomised drug trials. Trial ...

Advanced Accelerator Applications receives FDA ap…

Novartis AG (NYSE: NVS) announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approva...

Blood vessel-on-a-chips show anti-cancer drug effe…

Researchers at the Institute of Industrial Science (IIS), the University of Tokyo, CNRS and INSERM, report a new organ-on-a-chip technology for the study of blood vessel ...

Brilinta significantly reduces CV events and coron…

AstraZeneca today announced results from a new sub-analysis of the Phase III PEGASUS-TIMI 54 trial, demonstrating a risk reduction of 19% in MACE (the composite of CV dea...

Guidelines extended to improve the use of feedback…

Researchers have recommended changes to international guidelines used in the development of clinical trials in an effort to gain information about the impact of the treat...

Roche reports good results in 2017

In 2017, Group sales rose 5% to CHF 53.3 billion. Core operating profit grew 3% and Core EPS increased 5%, reflecting the good underlying business performance. On an IFRS...

How old antibiotic compounds could become tomorrow…

As the fight against drug-resistant infections continues, University of Leeds scientists are looking back at previously discarded chemical compounds, to see if any could ...

FDA approves new treatment for certain digestive t…

The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointesti...

Roche purchases shares in tender offer for Ignyta…

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Ignyta, Inc. today announced that Roche's wholly owned subsidiary Abingdon Acquisition Corp., has accepted for payment all shares v...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]