Clovis Oncology is facing a lawsuit over statements about the safety and efficacy of its now-scrapped lung cancer candidate rociletinib. The lawsuit stems from questions about the timing and truthfulness of statements Clovis made about rociletinib results as it raced against AstraZeneca to bring an EGFR inhibitor to market.
Robbins Arroyo is behind the lawsuit. The law firm is alleging Clovis made “false, incomplete, and misleading statements” about the safety and efficacy of rociletinib. Lawsuits against publicly traded biotechs are a common occurrence. But few are based on events quite as damaging to a biotech and its reputation as the series of revelation that led to Robbins Arroyo filing its case.
The law firm's allegations relate to differences between data Clovis reported in May and November of last year. In May, Clovis said a Phase II trial of rociletinib achieved an overall response rate of 60% in non-small cell lung cancer (NSCLC) patients. When FDA asked for more clinical data in November, Clovis revealed the 60% figure was based on unconfirmed and confirmed responses. The mature data put the ORR at approximately 30%, depending on the dose given.
The shock sank Clovis’ stock, tarnished its reputation and left it with an uphill battle to show how rociletinib could compete with AstraZeneca’s Tagrisso. AstraZeneca won approval for Tagrisso at around the same time as the reevaluation of rociletinib’s ORR. And it did so on the back of chalking up a 59% ORR.
Clovis subsequently stopped all studies of rociletinib and switched its attention to other programs, primarily its PARP drug rucaparib. But the events have dogged Clovis even as it has moved on from the drug.
Six months ago, Clovis said government agencies had asked for information about the statement it released in November 2015. And now Robbins Arroyo is looking to round up investors affected by the crash in Clovis’ stock and pursue the company in the courts.