Clovis Oncology, Inc. has entered into a clinical trial collaboration with GlaxoSmithKline to evaluate a novel combination therapy targeting mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC). The Phase 1/2 trial of rociletinib in combination with trametinib is planned for 1H15. The trial will assess the safety and activity of the combination in patients with EGFR mutant NSCLC who were previously treated with an EGFR tyrosine kinase inhibitor (TKI).

Rociletinib targets the activating mutations of EGFR (L858R and Del19) and the T790M mutation, and has demonstrated promising clinical activity and tolerability in Phase 1/2 studies of patients with EGFR mutant NSCLC.

“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,” said Patrick J. Mahaffy, president and chief executive officer of Clovis Oncology. “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. We intend to announce additional combination studies over the next few months.”