Clovis Oncology, Inc. CLVS announced that it has reached the patient enrollment target in the phase III study — ATHENA — evaluating its sole marketed drug, Rubraca, as a treatment for advanced ovarian cancer.
The study is evaluating Rubraca monotherapy, a PARP inhibitor only regimen, as well as a combination regimen of Rubraca and Bristol Myers’ BMY PD-1 inhibitor, Opdivo, as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer. The study’s primary endpoint is investigator assessed progression-free survival while secondary endpoints include overall survival, objective response rate, duration of response, and safety.
Top-line data from the monotherapy cohort is expected in the second half of 2021. Data from this cohort will support a supplemental new drug application filing seeking label expansion of Rubraca as first-line maintenance treatment for ovarian cancer.
Top-line data from the combination cohort is expected in 2022 or later.
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.
Last month, the drug received accelerated approval from the FDA as monotherapy for BRCA-mutant recurrent, metastatic castrate-resistant prostate cancer (mCRPC). The company is conducting a confirmatory study — TRITON 3 — to support the continued approval for Rubraca for mCRPC patients.
Shares of Clovis have declined 31.5% so far this year against the industry’s increase of 8.5%.
Sales of Rubraca have been growing for the past several quarters. Sales in the first quarter grew 28.5% year over year to $42.6 million. Label expansion in mCRPC is likely to boost sales in the upcoming quarters. Successful development as front-line maintenance treatment for ovarian cancer patient will be a good opportunity for the company. However, a similar label expansion is a couple of years away.
The company is also developing the drug as monotherapy or in combination with other therapies for lung, bladder, breast, pancreatic, gastric cancer and recurrent solid tumors with deleterious homologous recombination repair gene mutations. Apart from Bristol-Myers, Clovis has also collaborated with Merck MRK to evaluate Rubraca in combination with Keytruda as a treatment for several cancer indications.
Meanwhile, competition for Clovis from large pharma companies in the PARP inhibitor segment is rising with availability of other PARP inhibitors including AstraZeneca’s Lynparza, Glaxo’s GSK Zejula and Pfizer’s Talzenna.
Clovis Oncology, Inc. Price
Clovis Oncology, Inc. price | Clovis Oncology, Inc. Quote
Clovis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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