Clovis Oncology, Inc. CLVS announced that the FDA has accepted and granted priority review to the supplemental new drug application (sNDA) for its PARP inhibitor, Rubraca (rucaparib). The company submitted the sNDA in November last year, seeking approval for the label expansion of Rubraca as monotherapy for BRCA-mutant recurrent, metastatic castrate-resistant prostate cancer (mCRPC). A decision from the FDA is expected by May 15, 2020.
Rubraca is currently approved as second-line maintenance treatment for ovarian cancer and as monotherapy for BRCA-mutant ovarian cancer in third or later-line setting.
Shares of Clovis were up nearly 6% on Jan 15, following the announcement. However, the company’s shares have declined 58.5% in the past year compared with the
industry’s decrease of 1.3%.
The sNDA for Rubraca was based on data from the TRITON program, evaluating the drug in patients with advanced prostate cancer. Data presented last year from the phase II TRITON2 study demonstrated that mCRPC patients with BRCA mutation treated with Rubraca achieved 43.9% confirmed objective response rate. Moreover, 52% of the eligible patients achieved confirmed prostate-specific antigen response. Confirmed radiographic responses lasted for 24 weeks or more in 60% patients.
The company believes that TRITON2 study data readout demonstrates the drug’s potential to provide clinical benefit to eligible patients.
Clovis is also enrolling patients in a phase III study — TRITON3 — which is evaluating Rubraca in mCRPC patients with BRCA mutation and ATM mutation. The primary endpoint of the study is radiographic progression-free survival (rPFS).
A successful approval to Rubraca for mCRPC indication will put the drug ahead of other PARP inhibitors in this patient population. AstraZeneca
AZN and Merck ( MRK Quick Quote MRK - Free Report) are developing their PARP inhibitor, Lynparza, in a phase III study for treating mCRPC. Data from the study presented in October 2019 showed that Lynparza, achieved a median rPFS of 7.4 months. The companies are yet to file a regulatory submission seeking label expansion for Lynparza to include mCRPC patients.
However, investors remain skeptical about future prospects of Rubraca due to increasing competition from large pharma companies in the PARP inhibitor segment. Other PARP inhibitors available in the market include Glaxo’s
GSK Zejula and Pfizer’s Talzenna.
Earlier this month, Clovis announced fourth-quarter preliminary results. The company estimates its fourth-quarter Rubraca sales in the range of $38.3M - $39.3 million and full-year sales between $142.0 million and $143.0 million. Full-year sales projection indicates growth of approximately 50%. The Zacks Consensus Estimate for fourth-quarter and full-year 2019 revenues were within the company’s guided ranges. However, the growth trend for Rubraca sales in 2019 seems to have been slower than Lynparza and Zejula. Successful development of Rubraca in additional indications is necessary for Clovis to remain competitive.
Clovis currently carries a Zacks Rank #2 (Buy).
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