Clovis Oncology reports positive ovarian cancer results, Shares Soars

Clovis Oncology  announced topline data from the confirmatory phase 3 #ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint for Ovarian Cancer.

Shares of competitor Tesaro (TSRO) tumble on the news

CLVS to submit NDA to FDAShares of Clovis Oncology (CLVS) are surging after the company this morning announced topline data from the confirmatory phase 3 ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression-free survival, or PFS, by investigator review in each of the three populations studied.

Clovis Oncology (CLVS) announced topline data from the confirmatory phase 3 #ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression-free survival, or #PFS, by investigator review in each of the three populations studied. PFS was also improved in the rucaparib group compared with placebo by blinded independent central review, or #BICR, a key secondary endpoint.

Based on these findings, the company plans to submit a supplemental New Drug Application, or sNDA, within the next four months for a second-line and later maintenance treatment indication for all women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy. #NDA

“We are very pleased with these positive #ARIEL3 topline results that strongly demonstrate the potential of rucaparib to help women with platinum-sensitive, advanced ovarian cancer,” said Patrick Mahaffy, President and CEO of Clovis Oncology.

“These results reinforce the potentially foundational role of #rucaparib in the management of advanced ovarian cancer, as demonstrated by both investigator review and the blinded independent central review. Most importantly, we are grateful to the patients, caregivers and investigators who participated in this study. We look forward to sharing these data in greater detail at a medical meeting later this year and submitting our sNDA as rapidly as possible, with the ultimate goal of making rucaparib available to more women battling ovarian cancer.”

Possible $40 Gain

Janney Capital’s analyst Debjit #Chattopadhyay previewed some potential outcomes for the release of topline data from Clovis’ (CLVS) ARIEL3 trial, which is expected over the next two weeks. If Hazard Ratios in g+sBRCA patients are in below 0.3, he sees Clovis shares potentially trading up to $85-$100 per share, which, at the high end, would be about $40 above Clovis’ Friday closing price of $60.

In such a scenario, he thinks competitor Tesaro (TSRO) sliding to $80-$90. With HRs in the range of 0.3-0.35, which he gives a 70% probability of occurring, he sees Clovis trading at $75-$85 and Tesaro falling to $90-$100. Tesaro has a competing drug for ovarian cancer.

PRICE ACTION

In pre-market trading on Monday, CLVS is up $26 to $86.00 in heavy trading. TSRO is down $16 to $128.

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The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

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