Clovis Oncology, Inc. announced that it initiated a clinical trial to evaluate a novel combination therapy of Genentech's investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PD-L1) and rociletinib for the treatment of advanced EGFR-mutant non-small cell lung cancer (NSCLC). Rociletinib is the Company's novel, oral targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. The Phase 1b/2 trial of rociletinib in combination with atezolizumab, which is sponsored by Clovis, is designed to assess the safety and activity of the combination in patients with activating EGFR mutation-positive (EGFRm) advanced or metastatic NSCLC.

The Phase 1b portion of the trial will evaluate the safety, tolerability and pharmacokinetics of the combination in this population. The Phase 2 portion of the trial will evaluate the activity of the combination in two subgroups of patients with EGFR-mutant advanced or metastatic NSCLC: those who have not previously received an EGFR tyrosine kinase inhibitor (TKI) or chemotherapy, and those who have progressed on a prior EGFR TKI. T790M-negative and T790M-positive patients will be enrolled in the Phase 1b portion of the trial and in the Phase 2 portion of the trial in the subgroup of patients who have progressed on a prior EGFR TKI.

While patients' tumors are not required to express PD-L1 to enroll in the study, PD-L1 expression will be assessed in archival and/or fresh tissue as part of the study.