Clovis Oncology’s Ovarian Cancer Candidate Wins Breakthrough Status from the FDA

Colorado-based Clovis Oncology, Inc. announced that US health regulators granted Breakthrough Therapy designation to its ovarian cancer candidate, sending shares up nearly nine percent in after-hours Monday.

The company said that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational PARP inhibitor, rucaparib, as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations. The news sent Clovis shares up nearly nine percent in yesterday’s extended trading session.

The designation will help to expedite the development and review of Clovis’ ovarian cancer drug. The designation includes all the features of the Fast Track designation, as well as more intensive guidance from the FDA on the drug’s clinical development program.

This is the second Breakthrough Therapy status for Clovis. Last year, the agency granted the designation to Clovis’ lung cancer drug rociletinib. With no currently approved drugs in its portfolio, the breakthrough therapy designations carry significant importance for Clovis’ future. This year, the company’s stock is up 24 percent.

“It is a distinct achievement for a company our size to have been granted Breakthrough Therapy designation for two separate products under development, and especially in less than one year,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “In the case of rucaparib, we believe it is in recognition of the encouraging response rate observed in women with BRCA-mutated advanced ovarian cancer treated with rucaparib, and this designation reinforces the unique profile of rucaparib among PARP inhibitors, as well as our leadership in the differentiated clinical development of a PARP inhibitor. This includes prospectively demonstrating meaningful activity in an additional group of advanced ovarian cancer patients whose tumors are not mutant BRCA, but whose tumors possess similar DNA repair deficiencies that behave like BRCA mutations. Rucaparib is the only PARP inhibitor to have shown activity in this broader, but still selected, patient population.”

The agency granted Breakthrough status to rucaparib based on interim efficacy and safety results from two ongoing Phase II studies in ovarian cancer, including a Phase II study in women with gBRCA mutations and the ARIEL2 treatment study. The company presented a clinical data update from the ARIEL2 study, which demonstrated that 70 percent of evaluable BRCA-mutant patients achieved a RECIST and/or CA-125 response, and 65 percent achieved a RECIST response.

Additionally, the company recently presented data that further demonstrate that Clovis’ proprietary BRCA-like DNA signature, run by its partner Foundation Medicine, successfully predicts which ovarian cancer patients respond to treatment with rucaparib.

“Women with ovarian cancer are in need of better therapeutic options, and there is great focus on the potential of PARP inhibitors; data presented to date in mutant BRCA patients treated with rucaparib are very encouraging, as is Breakthrough Therapy designation conferred by the FDA,” said Robert L. Coleman, MD, Professor & Deputy Chairman, Vice Chair, Clinical Research, Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine at University of Texas MD Anderson Cancer Center in Houston and one of the two principal investigators of the ARIEL3 study. “I am very enthusiastic about the substantive progress made by Clovis with both rucaparib and its patient selection tool that appears to be moving beyond BRCA to efficiently identify responder versus non-responder populations. Continuing successful development of this drug and its companion diagnostic will be a huge advance for women with this disease. Importantly, these data suggest that the majority of women tested might benefit from rucaparib treatment. We hope that the ARIEL2 extension study in around 300 women, and the randomized ARIEL3 trial in 540 women, will offer definitive support both for rucaparib and the companion diagnostic.”

Source: Clovis Oncology, Inc.

Last updated: 4/7/15; 11:25am EST

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