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Clovis slides as rucaparib response data disappoints

October 7, 2016 7:00 AM UTC

Clovis Oncology Inc. (NASDAQ:CLVS) fell $6.36 (18%) to $29.41 on Friday after reporting response data for PARP inhibitor rucaparib ( CO-338) that disappointed investors. The compound is under FDA Priority Review to treat germline or somatic BRCA-mutated advanced ovarian cancer, with a PDUFA date of Feb. 23, 2017.

In pooled data from 106 patients in two studies, rucaparib led to an overall response rate (ORR) of 54%, including nine complete responses and 48 partial responses. The duration of response was 9.2 months. The population included patients from the Phase II ARIEL2 trial, and the Phase II portion of a Phase I/II study called Study 10, who met inclusion criteria that align with rucaparib's proposed indication. Clovis is seeking accelerated approval of rucaparib as monotherapy following multiple prior chemotherapies. ...