Pfizer and GSK to initiate study of novel combination therapy in patients with melanoma

PfizerPfizer Inc. has entered into an agreement with GSK to explore the anti-cancer efficacy and the safety of GSK's trametinib (GSK1120212) combined with Pfizer's palbociclib (PD-0332991) in a Phase I/II study (Study 200344) in patients with advanced/metastatic melanoma.

Study 200344 is a dose-escalation, open-label study designed to determine the recommended combination regimen (RCR) for trametinib plus palbociclib in patients with melanoma. The study will also evaluate the effect of the combination on tumor biomarkers, safety and anti-cancer activity in patients with BRAFV600 wild type melanoma, including those with NRAS mutations.

"Pfizer Oncology is committed to maximizing the value of our portfolio for patients through the study of novel combinations. This includes combining our own cancer medicines with each other, as well as with those of other companies where there is strong scientific rationale," said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit. "Emerging data suggest the potential for trametinib and palbociclib to work together to treat melanoma. We look forward to collaborating with GSK to explore this potential and evaluate the clinical activity of this combination in melanoma."

The two companies will collaborate on the study, which GSK will conduct. Financial terms of the agreement were not disclosed.

Trametinib, a reversible inhibitor of MEK1 and MEK2, is approved by the U.S. Food and Drug Administration (FDA) under the name Mekinist® for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation as detected by an FDA-approved test. Mekinist is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy.

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

Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.

Most Popular Now

Most popular vitamin and mineral supplements provi…

The most commonly consumed vitamin and mineral supplements provide no consistent health benefit or harm, suggests a new study led by researchers at St. Michael's Hospital...

AstraZeneca heads to 2018 ASCO Annual Meeting with…

AstraZeneca and MedImmune, its global biologics research and development arm, head to the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US...

Tiny particles could help fight brain cancer

Glioblastoma multiforme, a type of brain tumor, is one of the most difficult-to-treat cancers. Only a handful of drugs are approved to treat glioblastoma, and the median ...

New approach to immunotherapy leads to complete re…

A novel approach to immunotherapy developed by researchers at the National Cancer Institute (NCI) has led to the complete regression of breast cancer in a patient who was...

Amgen Foundation and Harvard team up to offer free…

The Amgen Foundation and Harvard University today announced plans to launch a free online science education platform uniquely designed to level the playing field for aspi...

The Pfizer Foundation announces $5 million in gran…

The Pfizer Foundation announced a new $5 million grant commitment to initiatives in low- and middle-income countries that provide family planning access and education for...

Study finds antioxidant-enriched vitamin reduces r…

Researchers at Children's Hospital Colorado (Children's Colorado) and the University of Colorado School of Medicine have found that taking a specially formulated antioxid...

New drugs could also be deployed against lung and …

A new anti-cancer drug may be effective against a wider range of cancers than previously thought. Using a mouse model and samples taken from cancer patients, a team from ...

What would help or hinder patient participation in…

As clinical trials gear up with the aim of attaining the first FDA-approved treatments for mitochondrial disease, a new study reports for the first time what patients and...

Pfizer to expand venture investing with $600 milli…

Pfizer Inc. (NYSE:PFE) today announced it plans to invest $600 million in biotechnology and other emerging growth companies through Pfizer Ventures, the company’s venture...

Update on Phase III clinical trials of lanabecesta…

AstraZeneca and Eli Lilly and Company (Lilly) are discontinuing the global Phase III clinical trials of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibi...

Soy lecithin NSAID combo drug protects against can…

When scientists at The University of Texas Health Science Center at Houston (UTHealth) applied a chemical found in soybeans to a non-steroidal anti-inflammatory drug (NSA...