Drug Development

Clovis soars as its PARP drug rucaparib lines up for FDA review with positive data

Clovis Oncology stock $CLVS shot up 30% Tuesday afternoon after the biotech laid out competitive pivotal data for its PARP inhibitor rucaparib, which has now been accepted by the FDA for a priority review. The biotech says it is now starting the clock for a review that should wrap with a formal decision by February 23 as several late-stage rivals look to steal its thunder. The move comes just a day after Pfizer completed a deal to buy Medivation and its Phase III PARP inhibitor talazoparib for $14 billion.

Investigators for Clovis posted an overall objective response rate of 54% from two small studies with 106 patients suffering from advanced ovarian cancer with BRCA mutations. The median duration of response was 9.2 months with a 9% complete response rate. Clovis added that the “ORR was similar for patients with germline BRCA-mutant ovarian cancer or somatic BRCA-mutant ovarian cancer and for patients with a BRCA1 gene mutation or BRCA2 gene mutation.”

That compares favorably with AstraZeneca’s pioneering PARP Lynparza (olaparib), which was approved with a 34% ORR for an average of 7.9 months. The FDA overruled an FDA panel vote against Lynparza in 2014, despite frets over the drug’s efficacy.

There’s a long way to go, though, before Clovis can lay any claims to having a best-in-class drug. First, there’s a lot more data to consider before any final decision arrives. Second, Tesaro $TSRO has already laid out some impressive positive ovarian cancer data of its own for its PARP niraparib. Their data highlighted a clear impact for the targeted drug in a population of germline BRCA mutation carriers, with a median PFS of 21 months in the drug group compared to 5.5 months in the control arm — a 15.5-month advantage.

And, third, Pfizer has to follow up with a much closer look at talazoparib while AbbVie hustles along veliparib in the clinic.

Tesaro shares were down 6% after Clovis’s news hit, but the stock had slipped ahead of the news.

Clovis also has some lingering credibility issues to deal with. Its other big cancer drug, rociletinib, was scuttled earlier this year after the FDA forced it to recalculate the data used in its submission. Questionable methods were used to claim an impact that the final data couldn’t support. The approval attempt imploded as an FDA advisory panel turned thumbs down on the troubled drug and the biotech was forced to restructure in the wake of the debacle. And Clovis has reported in SEC filings that it is under investigation by federal agencies examining the timing of the biotech’s data submissions and corrections.

Clovis, though, retained the commercial infrastructure it had built up, grimly determined to follow through on rucaparib. The biotech has ignored repeated requests for interviews in recent months.

“Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry, or whose tumors have a mutation in the BRCA genes. Despite the available treatment options, few effective therapies are at our disposal. Thus, the opportunity to treat women with germline or somatic BRCA mutations with rucaparib after two prior lines of platinum-based therapy, represents a meaningful step forward for our patients,” said Robert L. Coleman, a professor at University of Texas MD Anderson Cancer Center in Houston and one of the principal investigators in the ARIEL clinical trial program.

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