Just three days after celebrating a new FDA approval for use of its drug Rubraca in ovarian cancer, Clovis Oncology quietly disclosed bad news about a saga that dates back two years.
The SEC’s enforcement division has issued “Wells Notices” to Clovis—a preliminary recommendation for civil enforcement action against the company related to rociletinib, a lung cancer drug that it ditched in 2016.
The trouble started in 2015, when Clovis stunned investors by revising the response rate for rociletinib downward by 20 points. And the problem wasn’t just a lack of efficacy. The FDA had other worries, too: An advisory panel for the agency raised serious questions about rociletinib's safety and expressed doubts that the drug was better than existing therapies.
Suddenly, the prospect of Clovis fielding a worthy rival to AstraZeneca’s Tagrisso dissipated, and in May 2016—after strong hints from the FDA that the drug wouldn't be approved—the company pulled the plug on rociletinib trials.
The SEC is concerned about the way Clovis handled news, announced in November 2015, that the FDA was requesting more data on rociletinib. Clovis said the interim trial data it had previously disclosed was based on both unconfirmed and confirmed rates of response to the drug, but the FDA would base its efficacy analysis only on confirmed responses.
“As the efficacy data have matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected,” the company said in its press release. And then it dropped the bombshell that the actual confirmed response rates were 20 points lower than its previous numbers showed—and any potential approval would likely be delayed.
The Wells Notice doesn’t confirm that the SEC has found wrongdoing, and the company has been given a chance to respond. “The receipt of the Wells Notices does not change the Company’s belief that it has complied with all laws and regulations, and therefore, the Company intends to contest any charges that may be brought,” Clovis said in the SEC filing.
Still, Clovis’s behavior throughout rociletinib's development raised some eyebrows in the oncology community. One month before the company ditched the drug, oncologist and biotech consultant Kapil Dhingra published a scathing review in the Annals of Oncology raising the question “did the efficacy actually drop over time or was it a case of lack of full disclosure of the data, consistently and repeatedly?”
Dhingra went on to outline presentations by Clovis at the closely watched annual meeting of the American Society of Clinical Oncology (ASCO) dating back to 2013, referring to data the company highlighted in press releases. “None of the three press releases disclosed what proportion of responses, if any, were confirmed responses according to the usual and customary definition of response,” Dhingra wrote.
He raised other questions, too. When did Clovis become aware of the significant difference between the unconfirmed and confirmed response rates? Had the company disclosed that difference to the clinical trial investigators who were asked to provide glowing quotes for the press releases?
The SEC’s rociletinib investigation will certainly be a distraction at a time when Clovis needs to focus on Rubraca, its PARP inhibitor that was approved Friday for use in ovarian cancer patients who have relapsed after chemotherapy. Now Clovis is in a three-way race with AstraZeneca and Tesaro, both of which have PARP inhibitors approved for recurrent ovarian cancer.
Evercore ISI analyst Steve Breazzano said in a note to investors that the new approval could push sales of Rubraca in the U.S. to $133 million this year, but that Clovis would be unlikely to improve its third-place standing.