Pfizer and GSK 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. The study, named Study 200344, will be conducted by GSK. It is a dose-escalation, open-label study designed to determine the recommended combination regimen for the combination therapy.
The study will also evaluate the effect of the combination on tumor biomarkers, safety, and anticancer 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 of Pfizer’s oncology business unit. “Emerging data suggest the potential for trametinib and palbociclib to work together to treat melanoma.”
Trametinib, one of several melanoma drug candidates from GSK recently approved by the FDA, was cited in a study of potential combination therapies conducted by scientists at the Wistar Institute. A reversible inhibitor of MEK1 and MEK2, trametinib has been approved by the 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.
A study of a combination therapy that includes palbocicilib is being sponsored by the German Breast Group. It is called a Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery (PENELOPE-B).