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Clovis' (CLVS) Rubraca Confirmatory Study Meets Endpoint
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Clovis Oncology, Inc. announced that the phase III confirmatory study — ARIEL 4 — evaluating its PARP inhibitor drug, Rubraca (rucaparib) met its primary endpoint of improved investigator-assessed progression-free survival (PFS).
The study compared the drug to chemotherapy in relapsed BRCA-mutated ovarian cancer patients who have received two or more prior lines of chemotherapy. Data showed that treatment with Rubraca achieved statistically significant improvement in PFS compared to chemotherapy. Median PFS for Rubraca was 7.4 months compared to 5.7 months for chemotherapy. Safety data were highly consistent with both the U.S. and EU labels of the drug.
Please note that the drug had received accelerated approval for this indication in the United States in 2016 and Europe in 2018. ARIEL-4 serves as a post-marketing commitment to support the conditional approval in Europe. Detailed data from the study will be presented at an upcoming medical meeting.
Notably, the drug is approved as second-line maintenance treatment for ovarian cancer irrespective of BRCA-mutation in the United States. The drug is also approved as metastatic castration-resistant prostate cancer with BRCA-mutation.
Shares of Clovis were up 8.4% on Dec 21 following the news. However, the company’s shares have declined 49.2% so far this year against the industry’s increase of 9.8%.
Meanwhile, the company is evaluating Rubraca monotherapy as well as a combination regimen of Rubraca and Bristol Myers’ (BMY - Free Report) Opdivo in the phase III ATHENA study. The study is evaluating the regimens as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer.
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.
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 collaborated with Merck (MRK - Free Report) 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 - Free Report) Zejula and Pfizer’s Talzenna.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Clovis' (CLVS) Rubraca Confirmatory Study Meets Endpoint
Clovis Oncology, Inc. announced that the phase III confirmatory study — ARIEL 4 — evaluating its PARP inhibitor drug, Rubraca (rucaparib) met its primary endpoint of improved investigator-assessed progression-free survival (PFS).
The study compared the drug to chemotherapy in relapsed BRCA-mutated ovarian cancer patients who have received two or more prior lines of chemotherapy. Data showed that treatment with Rubraca achieved statistically significant improvement in PFS compared to chemotherapy. Median PFS for Rubraca was 7.4 months compared to 5.7 months for chemotherapy. Safety data were highly consistent with both the U.S. and EU labels of the drug.
Please note that the drug had received accelerated approval for this indication in the United States in 2016 and Europe in 2018. ARIEL-4 serves as a post-marketing commitment to support the conditional approval in Europe. Detailed data from the study will be presented at an upcoming medical meeting.
Notably, the drug is approved as second-line maintenance treatment for ovarian cancer irrespective of BRCA-mutation in the United States. The drug is also approved as metastatic castration-resistant prostate cancer with BRCA-mutation.
Shares of Clovis were up 8.4% on Dec 21 following the news. However, the company’s shares have declined 49.2% so far this year against the industry’s increase of 9.8%.
Meanwhile, the company is evaluating Rubraca monotherapy as well as a combination regimen of Rubraca and Bristol Myers’ (BMY - Free Report) Opdivo in the phase III ATHENA study. The study is evaluating the regimens as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer.
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.
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 collaborated with Merck (MRK - Free Report) 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 - Free Report) Zejula and Pfizer’s Talzenna.
Clovis Oncology, Inc. Price
Clovis Oncology, Inc. price | Clovis Oncology, Inc. Quote
Zacks Rank
Clovis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>