Clovis Oncology Inc (NASDAQ:CLVS) announced that comprehensive data from the Phase 3 ARIEL3 study of rucaparib for maintenance treatment of advanced ovarian cancer were published online today in The Lancet. The ARIEL3 study successfully achieved its primary and key secondary endpoints – improved progression-free survival (PFS) by both investigator review and blinded independent central review (BICR), respectively – in each of the three populations studied, as well as its exploratory endpoints.
ARIEL3 is a double-blind, placebo-controlled, phase 3 trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) tumor BRCA mutant (tBRCAmut) patients, inclusive of germline and somatic mutations of BRCA (n=196); 2) HRD patients, including BRCA-mutant patients and BRCA wild-type with high loss of heterozygosity, or LOH-high patients (n=354), and, finally, 3) the intent-to-treat population, or all patients treated in ARIEL3 (n=564). The study achieved its primary endpoint of improved PFS by investigator review in each of three populations. PFS was also improved in the rucaparib group compared with placebo by BICR, a key secondary endpoint, in all three populations. In addition, rucaparib improved objective response rate vs placebo among evaluable trial participants in all three study populations.
“The publication of the ARIEL3 data in this prestigious, peer-review journal reinforces the importance of identifying new therapies that provide meaningful clinical benefit to women with advanced ovarian cancer, and speaks to the high quality of the study design and the data we were able to deliver,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We extend our sincere thanks to the study investigators and authors, as well as the many patients, who supported and participated in ARIEL3.”
“The extension in PFS in the ARIEL3 intent-to-treat population demonstrates that patients with platinum-sensitive ovarian carcinoma can derive robust clinical benefit from rucaparib maintenance treatment, regardless of their mutational status,” said Robert L. Coleman, M.D., professor and vice chair, clinical research, in the Department of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center and the U.S. principal investigator for the ARIEL3 study. “Additionally, the ARIEL3 study was intentionally designed to deliver multiple, key insights that will help inform treatment decisions and management of advanced ovarian cancer patients going forward.”
According to the paper published today, treatment emergent adverse events (TEAEs) in the ARIEL3 rucaparib group were generally managed with dose modifications and not associated with increased mortality or morbidity compared with the placebo group. Safety data from ARIEL3 demonstrate consistency with prior rucaparib studies.
In December 2016, Rubraca® became the first PARP inhibitor approved by the U.S. Food and Drug Administration (FDA) as monotherapy for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more prior chemotherapies. During the fourth quarter of 2016, a Marketing Authorization Application (MAA) was submitted and accepted in Europe for Rubraca in the same ovarian cancer-treatment indication.
Based on the ARIEL3 findings, Clovis Oncology plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA for a second line or later maintenance treatment indication in ovarian cancer by the end of October 2017. In early 2018, the Company plans to file an MAA in Europe for the maintenance treatment indication upon receipt of a potential approval for the treatment indication.
Shares of Clovis Oncology are currently trading at $71.80, up $1.19 or 1.69%. CLVS has a 1-year high of $99.45 and a 1-year low of $25.50. The stock’s 50-day moving average is $75.95 and its 200-day moving average is $68.68.
On the ratings front, CLVS has been the subject of a number of recent research reports. In a report issued on September 11, Oppenheimer analyst Leah R. Cann assigned a Hold rating on CLVS. Separately, on the same day, J.P. Morgan’s Cory Kasimov maintained a Buy rating on the stock and has a price target of $111.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Leah R. Cann and Cory Kasimov have a yearly average return of 25.6% and 4% respectively. Cann has a success rate of 82% and is ranked #141 out of 4642 analysts, while Kasimov has a success rate of 42% and is ranked #1207.
Overall, 2 research analysts have assigned a Hold rating and 7 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $111 which is 57.2% above where the stock closed yesterday.
Clovis Oncology is a biopharmaceutical company which focuses on acquiring, developing and commercializing cancer treatments in the United States, Europe and other international markets. The company has three product candidates in its clinical development pipeline: Rociletinib, Rucaparib and Lucitani.