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Clovis Up Nearly 50% on Solid Data from Ovarian Cancer Study
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Clovis Oncology, Inc. shares soared nearly 50% on Monday after it announced positive top-line results from a pivotal late-stage maintenance study on its newly launched ovarian cancer drug, Rubraca.
Promising progression-free survival (PFS) and safety results from the pivotal maintenance confirmatory study, ARIEL3 demonstrated that its PARP inhibitor, Rubraca has a meaningful impact in delaying disease recurrence in advanced ovarian cancer patients. The positive results may expand Rubraca’s label, which could improve the commercial uptake of the drug.
Separately, Clovis announced a proposed offering of common stock to raise aggregate proceeds of approximately $250 million. The offering will be used to fund general corporate purposes, which include promotional and marketing expense associated with Rubraca.
Clovis’ share price movement shows that the stock has outperformed the Zacks classified Medical-Biomedical and Genetics industry, having surged 94.6% this year so far, while the industry rose 2%.
We remind investors that Clovis received accelerated FDA approval in December last year for Rubraca for the treatment of advanced ovarian cancer associated with a specific BRCA mutation in patients who have been treated with two or more chemotherapies. In order to convert the accelerated approval to a continued approval, Clovis is running confirmatory studies including ARIEL3 and ARIEL4.
ARIEL3 (n=564) met the primary endpoint as Rubraca significantly improved progression-free survival (PFS) in all the three ovarian cancer patient populations studied - tumor BRCA-mutant, HRD-positive and overall intent-to-treat populations. The study also met the key secondary endpoint of improved PFS by blinded, independent central review (BICR) in each of the patient populations. Data from the study also revealed that patients with residual disease at study entry, when treated with Rubraca achieved further reduction in tumor burden, including complete responses. Also, the safety profile observed in the study was consistent with historic data for Rubraca. Overall, the study results suggest that advanced ovarian cancer patients can stay on Rubraca treatment for a longer time while gaining benefit, irrespective of their tumor genetics.
Clovis plans to file a supplemental new drug application (sNDA) for a second line or later maintenance treatment for ovarian cancer in patients who have undergone at least one prior therapy within the next four months. Detailed data from the study are expected to be presented at a medical later this year.
Following Clovis’ announcement, shares of Tesaro, Inc. , whose PARP inhibitor Zejula (niraparib) was launched in April this year, fell 1%. Shares of British drug maker, AstraZeneca plc (AZN - Free Report) , which markets another PARP inhibitor Lynparza, were flat.
The first quarter of 2017 was the first full quarter of product revenues for Rubraca, which generated sales of approximately $7.05 million in the quarter. At the first-quarter conference call, the company had said that over 300 different healthcare practitioners had prescribed Rubraca in the quarter with over 350 new patients starting therapy.
Meanwhile, Rubraca is also under review in the EU for a comparable ovarian cancer indication. Clovis expects EU approval in the first quarter of 2018 and is establishing the commercial infrastructure for the same
Meanwhile, the second phase III confirmatory study - ARIEL4 is evaluating Rubraca versus chemotherapy in patients who have failed two prior lines of therapy. Clovis is also looking to expand Rubraca’s label into additional indications like prostrate, breast and pancreatic cancers, among others, either as monotherapy or in combination with other agents.
Several clinical studies were initiated in early 2017, including TRITON2 and TRITON3 in prostate cancer and a Tecentriq- Rubraca combination study in gynecologic cancers, which is sponsored by Roche Holding AG (RHHBY - Free Report) .
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Clovis Up Nearly 50% on Solid Data from Ovarian Cancer Study
Clovis Oncology, Inc. shares soared nearly 50% on Monday after it announced positive top-line results from a pivotal late-stage maintenance study on its newly launched ovarian cancer drug, Rubraca.
Promising progression-free survival (PFS) and safety results from the pivotal maintenance confirmatory study, ARIEL3 demonstrated that its PARP inhibitor, Rubraca has a meaningful impact in delaying disease recurrence in advanced ovarian cancer patients. The positive results may expand Rubraca’s label, which could improve the commercial uptake of the drug.
Separately, Clovis announced a proposed offering of common stock to raise aggregate proceeds of approximately $250 million. The offering will be used to fund general corporate purposes, which include promotional and marketing expense associated with Rubraca.
Clovis’ share price movement shows that the stock has outperformed the Zacks classified Medical-Biomedical and Genetics industry, having surged 94.6% this year so far, while the industry rose 2%.
We remind investors that Clovis received accelerated FDA approval in December last year for Rubraca for the treatment of advanced ovarian cancer associated with a specific BRCA mutation in patients who have been treated with two or more chemotherapies. In order to convert the accelerated approval to a continued approval, Clovis is running confirmatory studies including ARIEL3 and ARIEL4.
ARIEL3 (n=564) met the primary endpoint as Rubraca significantly improved progression-free survival (PFS) in all the three ovarian cancer patient populations studied - tumor BRCA-mutant, HRD-positive and overall intent-to-treat populations. The study also met the key secondary endpoint of improved PFS by blinded, independent central review (BICR) in each of the patient populations. Data from the study also revealed that patients with residual disease at study entry, when treated with Rubraca achieved further reduction in tumor burden, including complete responses. Also, the safety profile observed in the study was consistent with historic data for Rubraca. Overall, the study results suggest that advanced ovarian cancer patients can stay on Rubraca treatment for a longer time while gaining benefit, irrespective of their tumor genetics.
Clovis plans to file a supplemental new drug application (sNDA) for a second line or later maintenance treatment for ovarian cancer in patients who have undergone at least one prior therapy within the next four months. Detailed data from the study are expected to be presented at a medical later this year.
Following Clovis’ announcement, shares of Tesaro, Inc. , whose PARP inhibitor Zejula (niraparib) was launched in April this year, fell 1%. Shares of British drug maker, AstraZeneca plc (AZN - Free Report) , which markets another PARP inhibitor Lynparza, were flat.
The first quarter of 2017 was the first full quarter of product revenues for Rubraca, which generated sales of approximately $7.05 million in the quarter. At the first-quarter conference call, the company had said that over 300 different healthcare practitioners had prescribed Rubraca in the quarter with over 350 new patients starting therapy.
Meanwhile, Rubraca is also under review in the EU for a comparable ovarian cancer indication. Clovis expects EU approval in the first quarter of 2018 and is establishing the commercial infrastructure for the same
Meanwhile, the second phase III confirmatory study - ARIEL4 is evaluating Rubraca versus chemotherapy in patients who have failed two prior lines of therapy. Clovis is also looking to expand Rubraca’s label into additional indications like prostrate, breast and pancreatic cancers, among others, either as monotherapy or in combination with other agents.
Several clinical studies were initiated in early 2017, including TRITON2 and TRITON3 in prostate cancer and a Tecentriq- Rubraca combination study in gynecologic cancers, which is sponsored by Roche Holding AG (RHHBY - Free Report) .
Clovis carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Zacks has just released a Special Report on the booming investment opportunities of legal
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look. See the pot trades we're targeting>>