GlaxoSmithKline (GSK) and Pfizer have agreed to collaborate on a Phase I/II study to explore the anticancer efficacy and safety of GSK’s trametinib (GSK1120212) combined with Pfizer’s palbociclib (PD-0332991) in patients with advanced/metastatic melanoma.
GSK will be responsible for conducting the dose-escalation, open-label study named ‘Study 200344’, which is designed to determine the recommended combination regimen (RCR) for the combination therapy in patients with melanoma.
The trial will also assess the effect of the combination on tumour biomarkers, safety, and anticancer activity in patients with BRAFV600 wild-type melanoma, including those with NRAS mutations.
Pfizer Oncology Business Unit president and general manager Garry Nicholson said that the company’s oncology unit is committed to maximising the value of its 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," Nicholson added.
"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."
In the US, trametinib is approved 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, a reversible inhibitor of MEK1 and MEK2, is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy.
In April 2013, palbociclib received FDA breakthrough therapy designation for the potential treatment of patients with breast cancer.
Palbociclib, which is an investigational oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, is not approved for any indication in any markets.
Image: Histopathologic image of malignant melanoma. Photo courtesy of KGH.