Clovis Oncology Inc (NASDAQ:CLVS) announced that they have entered into a clinical trial collaboration with Genentech, a member of the Roche Group to evaluate a novel combination therapy of Genentech’s investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) 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 is planned to begin enrolling patients before the end of 2015. The trial, 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 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.
“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 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.”
Rociletinib was granted Breakthrough Therapy designation by the FDA in May 2014. Clovis announced on August 3 that it submitted its New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) and submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) through the centralized procedure for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy. (Original Source)
Shares of Clovis Oncology Inc closed yesterday at $79.81. CLVS has a 1-year high of $102.28 and a 1-year low of $39.45. The stock’s 50-day moving average is $85.03 and its 200-day moving average is $81.20.
On the ratings front, Clovis Oncology has been the subject of a number of recent research reports. In a report issued on August 7, Mizuho analyst Peter Lawson maintained a Buy rating on CLVS, with a price target of $103, which represents a potential upside of 29.1% from where the stock is currently trading. Separately, on the same day, J.P. Morgan’s Cory Kasimov maintained a Buy rating on the stock and has a price target of $103.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Peter Lawson and Cory Kasimov have a total average return of 11.2% and 7.1% respectively. Lawson has a success rate of 53.5% and is ranked #561 out of 3729 analysts, while Kasimov has a success rate of 50.0% and is ranked #675.
The street is mostly Bullish on CLVS stock. Out of 5 analysts who cover the stock, 4 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $106.67, which implies an upside of 33.7% from current levels.
Clovis Oncology Inc is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and additional international markets.