Clovis Oncology Inc (NASDAQ:CLVS) reported positive data from a late-stage trial for its ovarian cancer drug, Rubraca. While Rubraca already has FDA approval, CLVS stock responded with glee at the possibility that the drug now could gain second-line and later maintenance treatment status as a result of the trial.
Rubraca is a poly ADP-ribose polymerase (PARP) inhibitor that treats patients with deleterious BRCA mutation-associated advanced ovarian cancer who have been treated with two or more prior chemotherapies. The company originally earned accelerated approval for Rubraca back in December.
In its Phase 3 ARIEL3 maintenance treatment trial, Rubraca achieved its primary endpoint across all three primary efficacy analyses, and also met its key secondary and exploratory endpoints as well.
“Rucaparib also showed statistical significance in all 564 patients enrolled in the study. By investigator review, the rucaparib arm successfully achieved statistical significance over the placebo arm for the primary endpoint of PFS with a hazard ratio of 0.36 (p<0.0001). The median PFS for all patients treated with rucaparib was 10.8 months vs. 5.4 months for those who received placebo.”
Rubraca “not only sustained the most recent response to platinum, but in some patients also enhanced that response, including the elimination of residual tumor.”
The larger takeaway from the 564-patient trial is that Rubraca could be useful to four times as many patients as previously thought. That sent CLVS stock to a massive gain early Monday — one that has Clovis at a doubler for 2017.
That puts CLVS at its highest point since 2015, though still well off that year’s highs of around $115.
The ovarian cancer opportunity, while not large — the American Cancer Society predicts more than 22,400 women in the U.S. will be diagnosed with ovarian cancer this year — it’s one of the deadliest cancers (fifth in fatalities), and “causes more deaths than any other cancer of the female reproductive system.”
As of this writing, Robert Martin did not hold a position in any of the aforementioned securities.