Pfizer, GSK in melanoma partnership
Pfizer and GSK have entered into an agreement to explore the anti-cancer efficacy and the safety of GSK’s trametinib (GSK1120212) combined with Pfizer’s palbociclib (PD-0332991) in a phase one / two study (Study 200344) in patients with advanced / metastatic 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. 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.”
Garry Nicholson, president and general manager, Pfizer Oncology Business Unit.
In May 2013, the US FDA approved trametinib, which is a reversible inhibitor of MEK1 and MEK2, 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.
In April 2013, the FDA awarded palbociclib with Breakthrough Therapy designation for the potential treatment of patients with breast cancer. Palbociclib is an investigational oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6. Pfizer’s drug is not approved for any indication in any markets.
GSK and Pfizer will collaborate on this new combination study, which GSK will conduct. Financial terms of the agreement were not disclosed.
Pfizer, GSK to Start Phase I/II Study of Combo Melanoma Therapy (Genetic Engineering & Biotechnology News)
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