FDA Requests Additional Trial Data from Clovis for Lung Cancer Treatment

The FDA has delayed Clovis Oncology’s bid for approval of its new lung cancer treatment, asking for additional trial data that could see the March 30 PDUFA date extended.

The agency asked the company for additional clinical data for its efficacy analysis for rociletinib, a medicine designed to treat non-small cell lung cancer in patients with the EGFR T790M genetic mutation. The data is needed for both 500- and 625-mg arms.

The candidate was granted breakthrough therapy status in 2014. Both that application and Clovis’s NDA for rociletinib offered details on some response rates that were unconfirmed. Alongside its complete data, the company relied on “immature data sets” based on both unconfirmed and confirmed response rates.  

“As the efficacy data have matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected,” Colorado-based Clovis said. The lapse was mostly due to disease advancement and metastasis – primarily in the brain – and scans showing that the medicine did not shrink tumors by more than 30 percent.

Current findings — submitted last week — show a response of 28 percent of 79 cancer patients in the smaller dose and 34 percent of 170 patients in the larger, “with an encouraging duration of response in both doses.”

“We remain confident in rociletinib and its potential to treat patients with mutant EGFR T790M-positive lung cancer, says Clovis CEO Patrick Mahaffy.

Clovis says it will continue to work with the FDA toward approval for the candidate. Clovis was down 68.59 percent on the news last week.

Another EGFR inhibitor — AstraZeneca’s Tagrisso — reaped a first-of-its-kind approval last week for NSCLC.