- Clovis Oncology (NASDAQ:CLVS -1.8%) commences a Phase 1b/2 clinical trial assessing the combination of Roche's (OTCQX:RHHBY +0.3%) atezolizumab (MPDL3280A) and rociletinib for the treatment of advanced EGFR-positive non-small cell lung cancer (NSCLC).
- The Phase 1b portion of the Clovis-sponsored study will evaluate the safety, tolerability and pharmacokinetics of the combination and the Phase 2 portion will assess the efficacy in two subgroups of EGFR+ NSCLC patients: those who have not previously received an EGFR tyrosine kinase inhibitor (TKI) or chemotherapy and those who have progressed on treatment with an EGFR TKI. T790M-negative and T790M-positive patients will be included in the Phase 1b and in the Phase 2 subgroup who have progressed on a prior EGFR TKI. Patients will not be required to be PD-L1-positive, although it will be assessed as part of the study.
- Rociletinib (CO-1686) is a mutant-selective inhibitor of epidermal growth factor receptor (EGFR). It is currently under regulatory review in the U.S. and Europe.
- Atezolizumab is a PD-L1 antagonist that is designed to block inhibitory T-cell checkpoints thereby allowing cytotoxic T cells to reach the tumor. It is under development for lung cancer, soft tissue sarcoma, breast cancer and colorectal cancer. Its rolling NDA submission in the U.S. for bladder cancer and lung cancer should be completed this quarter.
- Previously: FDA sets new PDUFA date for Clovis Oncology's rociletinib (Dec. 15, 2015)