Invasive Disease-Free Survival as an End Point for the OlympiA Trial

Charles E. Geyer, MD, co-director of University of Pittsburgh Medical Center’s Hillman Cancer Center’s National Cancer Institute National Clinical Trials Network efforts, and chief scientific officer of the National Surgical Adjuvant Breast and Bowel Project, discusses the end point that was met within the OlympiA study (NCT02032823).

The randomized, double-blind, placebo-controlled, multicenter, phase 3 trial, aimed to evaluate the efficacy and safety of olaparib (Lynparza) in patients with germline BRCA1/2 mutations and high-risk HER2 negative primary breast cancer who had completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.

The study met its primary end point of meaningful and statistically improved invasive disease-free survival at the time of its initial interim efficacy analysis. Findings of the phase 3 OlympiA study were further presented during the March 2022 ESMO Virtual Plenary.

Transcription:

0:08 | The primary end point for OlympiA was presented at the our annual ASCO meeting in 2021 almost a year ago. That was when we conducted the initial interim efficacy analysis. What we saw at that point was that olaparib relative to placebo was already showing a meaningful and statistically improvement in our end point, called invasive disease-free survival. Invasive disease-free survival is actually a composite endpoint that is describing a group of women who are alive and free of any breast cancer or any other type of cancer. It's kind of a composite end point, but it's an important one, because it helps us get a sense of both efficacy and safety.

0:59 | What we saw at that point, with about 2 and a half years of median follow up, [is that] the group of women who had had standard therapy, but then received placebo, 23% of them had already had a recurrence or had died. That's kind of what we were targeting in our patient population. We thought, let's look at patients who is standard therapy, still have invasive disease-free survival rates at 3 years of less than 80%. We saw that in our control group, so we were successful there.

1:40 | Happily in the patients who had received the olaparib, that 77% increased up to 86%, an absolute 9% improvement, a very gratifying step up for staying alive and cancer free. We also did the study to specifically then look at and focus on the most feared part of breast cancer, and that is cancer that comes back out in the body: distant metastasis, because that's what will take a patient's life, and we saw virtually the same sort of improvement. The percentage of patients who were alive and free of distant metastases was 81%, it went up to 88%. Again, very meaningful improvement.