- Clovis Oncology, which just shut down clinical trials of its lung cancer drug rociletinib, is facing government investigations into an update the company gave on the drug's efficacy last November, a regulatory filing shows.
- The company did not specify which government agencies are involved, only indicating it had received requests for information regarding its November press release. In the update, Clovis said the rate of confirmed tumor responses to rociletinib treatment was between 28% to 34%, much lower than the originally reported 59%.
- Last week, Clovis said it expected to receive a complete response letter from the FDA rejecting the drug, prompting the company to terminate the drug's trial program and lay off 35% of its staff.
Clovis has been hit with numerous lawsuits alleging the company defrauded investors by purportedly making false statements on rociletinib's progress towards FDA approval.
Now it also has to deal with government investigations. "The Company has received requests for information from governmental agencies relating to the Company’s regulatory update announcement in November 2015 that the FDA requested additional clinical data on the efficacy and safety of rociletinib," the company said in its Form 10-Q.
Earlier this week, researchers who had conducted a trial of rociletinib updated the original, promising results which had led to excitement over the drug's prospects. The actual tumor response rate among patients with a specific mutated form of lung cancer was 45%, the researchers said in a letter published in the New England Journal of Medicine -- a figure still substantially lower than the original 59% but higher than what Clovis reported in November.
At issue was whether patient's partial tumor responses were appropriately confirmed by a second scan. Original data had included patients who had only received one scan of their tumor and were subsequently found to not have been positively affected by the drug.
But the researchers only examined data from a subset of the total trial population in the two trials conducted by Clovis, meaning more data is needed to fully determine rociletinib's full effect.
"This case offers a clear lesson regarding the importance of continued follow-up and supports a strong recommendation to publish rates of confirmed responses," the researchers said.
For Clovis, however, this case offers a more painful lesson. The company has not generated any revenue, registering a loss of $83 million last quarter. While this is typical of companies working to develop their first drug, Clovis had hoped rociletinib could bring in some revenue while it funded more clinical trials.