Today, Pfizer Inc. announced that it has entered into an agreement with GlaxoSmithKline (GSK) to explore the anti-cancer efficacy of combining GSK’s Mekinist (trametinib) with Pfizer’s palbociclib.
GSK agreed to allow Pfizer to combine Mekinist with Pfizer’s blockbuster candidate palbociclib in an early stage study in patients with advanced/metastatic melanoma. The Phase I/II study, which will be conducted by GSK, is a dose-escalation study designed to determine the recommended combination regimen (RCR) for trametinib plus palbociclib, as well as 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.
Earlier this year, GSK’s Mekinist was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation as detected by an approved test. The drug is not approved for the treatment of patients who have received a prior BRAF inhibitor therapy. The drug is also being studied in combination with GSK’s dabrafenib.
Pfizer’s palbociclib is an investigational oral and selective inhibitor of cyclin dependent kinase (CDK) 4 and 6. The drug received Breakthrough Therapy Designation by the FDA for the potential treatment of patients with breast cancer. It has yet to receive approval for any indication in any markets.
“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 those of other companies where there is strong scientific rationale,” Garry Nicholson, president and general manager, Pfizer Oncology Business Unit, stated. “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 companies did not disclose financial terms of the agreement.
Source: Pfizer, Inc.
Last updated: 11/21/13; 2:10PM EST