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Pfizer, GSK to conduct study of novel drug combination for treating metastatic melanoma
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Pfizer has announced it will collaborate with GlaxoSmithKline to initiate a phase 1/2 study to explore anticancer efficacy of trametinib combined with palbociclib for treating patients with advanced or metastatic melanoma.
The dose-escalation, open-label study is designed to determine the recommended combination regimen for trametinib (Mekinist, GlaxoSmithKline), a reversible MEK1 and MEK2 inhibitor, and palbociclib (Pfizer), an investigational oral and selective inhibitor of cyclin-dependent kinases 4 and 6, according to a press release. The drug combination’s effect on tumor biomarkers, safety and anticancer activities in patients with BRAF V600 wild-type melanoma, including patients with NRAS mutations, also will be evaluated.
“Emerging data suggest the potential for trametinib and palbociclib to work together to treat melanoma,” Garry Nicholson, president and general manager, Pfizer Oncology business unit, said in the release. “We look forward to collaborating with GSK to explore this potential and evaluate the clinical activity of this combination in melanoma.”
The FDA has approved trametinib for treating adults with unresectable or metastatic melanoma with BRAF V600E or V600K mutation. Palbociclib was given breakthrough therapy designation by the FDA in April as potential therapy for patients with breast cancer.
GSK will conduct the study, according to the release. Financial terms were not disclosed.