Clovis’ shares closed at $53.78 yesterday. Its results were released after the market closed. When trading opened today, Clovis shares opened at $50 and rose to $52.30 in early trading before dropping to $48.35. It was trading around $49 in the early afternoon.
Boulder-based Clovis (NASDAQ: CLVS) currently is conducting a Phase II clinical trial for rociletinib. The drug is a potential treatment for people with a type of non-small cell lung cancer who are resistant to existing drugs.
Clovis yesterday reported results from 56 patients who had the T790M mutation. It found they had a 67 percent objective response rate when taking 500mg or 625mg of the drug twice daily.
Those patients had median progression-free survival of 10.4 months.
The company also said rociletinib was showing better signs of tolerability. Prior trials suggested serious hyperglycemia was a worrisome side effect, with 22 percent of subjects reporting the condition. This time the figure was 14 percent.
Clovis president and CEO Patrick Mahaffy called the data “very encouraging,” but investors and industry analysts aren’t convinced. One reason is that rociletinib hasn’t shown clear superiority to AstraZeneca’s AZD9291 in early trials. Both drugs are viewed as crucial parts of their companies’ pipelines, and both companies plan to submit results to regulators in 2015.
Analysts with Leerink Swann noted that the median length of progression-free survival for T790M-positive patients taking rociletinib is not much longer than that of those taking AZD9291, which is 9.6 months. The report also noted that Clovis had estimated progression-free survival of more than 12 months at this summer’s American Society of Clinical Oncology conference.
Clovis did say it saw favorable results in the 11 subjects in the trial without the T790M mutation. The objective response rate was 36 percent and median progression-free survival was 7.5 months.
According to Leerink Swann, that was superior than AstraZeneca’s figures, which were 21 percent and 2.8 months. The analysts have set a price target for Clovis’s shares at $100.
Mahaffy said in a release that Clovis will expand its upcoming Phase 3 trial to include patients with and without the mutation.
Clovis released the data late yesterday in advance of its presentation this week at the Symposium on Molecular Targets and Cancer Therapeutics in Barcelona.