Clovis pairs with Genentech for clinical trial collaboration

BOULDER, Colo.—Clovis Oncology Inc. and Genentech, a member of the Roche Group, have entered into a clinical trial collaboration for the evaluation of a novel combination therapy consisting of Genentech’s investigational cancer immunotherapy atezolizumab and Clovis' rociletinib for the treatment of advanced EGFR-mutant non-small cell lung cancer (NSCLC). Atezolizumab is an anti-PDL1 monoclonal antibody, while rociletinib is a novel, oral targeted covalent mutant-selective inhibitor of EGFR being developed as a treatment for NSCLC in individuals with initial activating EGFR mutations, as well as the dominant resistance mutation T790M.

“We are delighted to evaluate atezolizumab with rociletinib to explore whether the combination can add to the clinical benefit in patients with mutant EGFR non-small cell lung cancer,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology, in a press release. “In particular, we are very enthusiastic to explore the potential of this combination in both newly diagnosed patients as well as those previously treated with TKI therapy.”

The two product candidates will be evaluated together in a Phase 1b/2 trial sponsored by Clovis, with the expectation that enrollment will begin before the end of this year. The trial will determine the safety and activity of the combination in patients with activating EGFR mutation-positive advanced or metastatic NSCLC. The safety, tolerability and pharmacokinetics of the combination will be evaluated in the Phase 1b portion of the trial, while the Phase 2 portion will focus on the combination's activity in the following subgroups of patients with EGFR-mutant advanced or metastatic NSCLC: those who have not previously received an EGFR TKI or chemotherapy, and those who have progressed on a prior EGFR TKI. Patients who are T790M-negative and T790M-positive will be enrolled in the Phase 1b trial and in the subgroup of patients who have progressed on a prior EGFR TKI in the Phase 2 trial.

Clovis received Breakthrough Therapy Designation for rociletinib in May of last year, and earlier this month, the company submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application to the European Medicines Agency for the drug candidate for the treatment of patients with mutant epidermal growth factor receptor non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy.

Roughly a month ago, Genentech announced that in its IMvigor 210 study, atezolizumab shrank tumors in patients with locally advanced or metastatic urothelial bladder cancer (UBC) who had progressed on initial treatment (second-line or later). Patients whose cancer had high expression levels of PD-L1 saw an increased response to atezolizumab, and adverse events were in line with those previously seen for the drug candidate. Atezolizumab received Breakthrough Therapy Designation from the FDA in 2014 for metastatic bladder cancer expressing PD-L1.