Clovis Oncology ($CLVS) shares were up by about 30% in trading after market close--driven by expectations for its rucaparib to treat advanced ovarian cancer, which was just accepted for filing by the FDA. The candidate has a long roster of tags from the agency for accelerated approval, priority review and breakthrough status.
But the biotech is still working to convince investors after losing most of its market valuation late last year--when it had to revise data on its then lead candidate rociletinib to treat non-small cell lung cancer. An FDA panel subsequently voted against rociletinib, and Clovis discontinued its development this spring.
The stock market uptick drove Clovis’ valuation to almost $900 million with a share price of about $23. That’s still nowhere near its pre-rociletinib scandal high share price of nearly $117.
Clovis is now putting all its eggs in the rucaparib basket. The candidate is aiming for an indication of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations, and who have been treated with two or more chemotherapies.
Foundation Medicine ($FMI) already submitted a rucaparib companion diagnostic PMA application for its FoundationFocus CDxBRCA in June. The test works to identify tumor BRCA mutations, including germline and somatic BRCA mutations; the partners are aiming for drug and diagnostic approvals on a similar timeline.
This would be the earliest line of therapy for an FDA-approved PARP (Poly ADP ribose polymerase) inhibitor. Rucaparib has a PDUFA date of Feb. 23, but no word on a panel meeting yet.
Clovis expects to submit for a European approval during the fourth quarter. The company plans to present rucaparib data at the upcoming European Society for Medical Oncology (ESMO) conference in Copenhagen in October.
Clovis recently did a deal with Roche’s Genentech to combine their cancer immunotherapy atezolizumab and rucaparib, with a focus on ovarian cancer. A Phase Ib trial is slated to start in the first quarter of next year. In addition, there are investigator-backed trials of rucaparib in breast cancer and gastroesophageal cancer that are slated to start this year. The company itself also plans to explore indications beyond these.
“Prostate cancer is a high priority indication for us as it includes a substantial number of patients with BRCA and other mutations that may be responsive to rucaparib,” said Clovis President and CEO Patrick Mahaffy on the company's most recent earnings call. “We plan to initiate two Clovis -sponsored prostate cancer studies in the next few quarters.”
The prostate cancer studies include a Phase II that’s slated to start this year and a Phase III trial in chemotherapy naïve, castration-resistant patients that’s planned for the first quarter of next year and will offer a comparison of rucaparib to targeted therapy or chemotherapy.
- here is the release
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