Clovis Oncology ($CLVS) today buried its controversial lung cancer drug rociletinib, ending all ongoing studies--including the key pivotal trial--and outlining plans to lay off 35% of its staff after the FDA issued a direct message that it is prepping a formal rejection of the drug.
Once a closely watched rival to a similar drug from AstraZeneca ($AZN), Clovis’s roci team was pummeled during a recent panel review of its accelerated approval application for the EGFR inhibitor. The outside experts voted 12 to 1 to force Clovis to finish a late-stage study before it could look at another application. But today the biotech says that study--TIGER-3--will be shuttered along with all other clinical programs for the drug. And the company is withdrawing its European application for roci.
“In a recent meeting with the FDA, Clovis was notified that it could anticipate receiving a Complete Response Letter (CRL) for the rociletinib NDA on or before the PDUFA date of June 28, 2016,” the company said in its Q1 statement. That will cost the jobs of 35% of the staffers and consultants who work for Clovis. In February, Clovis reported that it had 305 staffers on the payroll.
The company immediately switched focus for the next drug in its pipeline, touting plans to complete a rolling submission of its NDA for rucaparib as a treatment for ovarian cancer in Q2.
The move to shutter the roci program leaves AstraZeneca completely in control of that particular market with the recent approval of Tagrisso.
Right from the beginning of the roci panel review, FDA officials raised questions about the serious dangers facing patients taking the drug, the company’s attempted use of unconfirmed tumor responses in its data and whether the drug was superior to existing therapies, a requirement for accelerated approval. Its execs also had to start with an explanation of why they suddenly switched from a recommended 500-mg dose--which was in their original NDA last fall--to a 625-mg dose.
The questionable data inspired a sharply critical report from drug development expert Kapil Dhingra, who told FierceBiotech that it seemed apparent that the company had continued to insist on the drug’s strong efficacy long after it should have become apparent that the actual number of confirmed tumor responses fell far short of what had been reported in the New England Journal of Medicine last year.
Clovis CEO Patrick Mahaffy has kept a low profile since the controversy erupted, declining repeated requests for an interview. There’s also been considerable speculation that he could be booted from Clovis in view of the rociletinib data brouhaha. There wasn't any mention of that, though, in his call with analysts Thursday evening.
"While we are discontinuing our investment in rociletinib," he told the analysts, "we are continuing analyses to determine whether certain population of patients may represent an opportunity for a partner committed to investing in further and specific clinical development."
That could be a very hard sale to make now.
- here's the release