Clovis Oncology Inc (NASDAQ:CLVS) investors are heading for the hills after the cancer drug maker announced the oral presentation of the primary efficacy and safety data from its NDA dataset for rucaparib, a third-line treatment of ovarian cancer patients with BRCA-mutated tumors, at the 2016 ESMO Congress in Copenhagen. On the negative side, the company disclosed that nine patients had adverse events that led to death, of which 8 were due to disease progression.
Clovis shares reacted to the news, falling nearly 27% to $25.70 in pre-market trading.
“These results demonstrate that rucaparib may represent an important option for women with multiply relapsed BRCA-mutated ovarian cancer based on its encouraging efficacy and tolerability,” said Rebecca S. Kristeleit, MD, PhD, The University College London, Cancer Institute, London, UK. “In my opinion, rucaparib has the hallmarks of an important new therapeutic option for ovarian cancer patients.”
“We are pleased to present the primary efficacy and safety dataset that has been submitted to the FDA as the basis of our NDA for rucaparib in the treatment of advanced ovarian cancer. If approved, rucaparib would be the first PARP inhibitor in the U.S. indicated to treat ovarian cancer patients with germline or somatic BRCA mutations who have received two prior chemotherapies. Women with BRCA mutations represent about 25% of patients in the US living with ovarian cancer,” said Patrick J. Mahaffy, CEO and President of Clovis Oncology. “Our NDA review is ongoing with FDA, and in addition we are actively preparing for a European submission during the fourth quarter of 2016.”
Data from subgroups of two multicenter, single-arm open-label phase 2 studies, Study 10 (NCT01482715) and ARIEL2 (NCT01891344) were combined for an integrated efficacy and safety analysis which further characterized the clinical benefit of rucaparib at the recommended starting dose of 600 mg BID in women with advanced ovarian cancer. In the two studies, 377 patients met the criteria for inclusion in the safety population (diagnosis of ovarian cancer and having received one or more doses of the recommended dose of 600 mg of rucaparib), and 106 patients met the criteria for inclusion in the efficacy population (received 2 or more prior chemotherapies, including 2 or more platinum-based regimens, had a mutation of BRCA (germline or somatic), and received one or more doses of the recommended dose of 600 mg of rucaparib.
The major efficacy outcome measure for this analysis was objective response rate (ORR) and duration of response (DOR) as assessed by the investigator according to RECIST. All responses were confirmed.
For the efficacy population (n=106), the median number of prior chemotherapies was three, with 39% having received two prior therapies and 61% of patients having received three or more prior therapies. The median number of prior platinum-based therapies was two, with 57% having received two prior platinum-based therapies, and 43% having received three or more prior platinum-based therapies. Seventy-five percent of patients in the efficacy population were platinum-sensitive (as defined by recurrence after progression free interval (PFI) of ≥6 months), 19% were platinum resistant (recurrence after PFI <6 months) and 7% were platinum refractory (progression on platinum, PFI <2 months). (Original Source)
On the ratings front, Clovis has been the subject of a number of recent research reports. In a report issued on October 4, Piper Jaffray analyst Steven Breazzano maintained a Hold rating on CLVS, with a price target of $42, which implies an upside of 17% from current levels. Separately, on the same day, Stifel Nicolaus’ Thomas Shrader reiterated a Buy rating on the stock and has a price target of $45.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Steven Breazzano and Thomas Shrader have a total average return of 12.8% and 1.3% respectively. Breazzano has a success rate of 89% and is ranked #1177 out of 4190 analysts, while Shrader has a success rate of 42% and is ranked #1943.
Overall, 4 research analysts have assigned a Hold rating and 3 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 $38.40 which is 7% above where the stock closed yesterday.
Clovis Oncology, Inc. 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.