Clovis Links With GSK For Cancer Drug Combo Trial

Biopharmaceutical firm Clovis Oncology announced that it has signed up with GlaxoSmithKline to conduct a clinical trial that will investigate the combination of rociletinib and trametinib as treatment for patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC).

Clovis’ Rociletinib is an oral, mutant-selective EGFR inhibitor that works to target the activating mutation to EGFR as treatment for EGFR mutated NSCLC. The drug also inhibits the primary resistance mutation factor that develops treatment resistance in 60 percent of patients who have undergone treatment with first- and second-generation EGFR inhibitors. The company recently reported positive results from a separate Phase1/2 study investigating rociletinib as monotherapy wherein the drug demonstrated significant clinical activity and progression-free survival (PFS) in EGFR-mutant NSCLC patients.

GSK’s Trametinib is an oral, active inhibitor of mitogen-activated protein kinase (MEK), which is implicated in downstream mitogen-activated protein kinase (MAPK) pathway signaling. Through its mechanism of action, the drug inhibits growth factor-mediated signaling and cellular proliferation. Trametinib has been approved both in the U.S. and the EU as monotherapy for adults with unresectable or metastatic melanoma with BRAF V600 mutation.

The Phase 1/2 study will investigate the safety and activity of the combo treatment in patients with EGFR mutant NSCLC who had previously undergone treatment with an EGFR tyrosine kinase inhibitor (TKI). The companies said the trial of the cancer drug combo is slated to start in the first half of 2015.

“We have seen significant activity in EGFR mutant NSCLC patients treated with rociletinib monotherapy, and so an important next step in our research is to examine rociletinib in combination with other targeted therapies that may also impact acquired resistance to EGFR inhibitors,” said Lecia V. Sequist, Associate Professor of Medicine at Harvard Medical School and lead investigator for this combination study.

Patrick J. Mahaffy, President and CEO of Clovis Oncology, said, “As we continue to see compelling activity for rociletinib single-agent therapy at our selected dose, we look forward to exploring combination trials in both T790M-positive and T790M-negative patients. We believe that given the tolerability profile of rociletinib, particularly its lack of cutaneous toxicity, it may be a good candidate for combination therapy with trametinib, and other relevant targeted therapies.” He added that the company expects to announce more combination studies for rociletinib in the coming months.