Isabelle Ray-Coquard, MD, discusses the final overall survival results from the phase 3 PAOLA-1/ENGOT-ov25 trial.
Isabelle Ray-Coquard, MD, university lecturer – hospital practitioner, coordinator of the INCa-certified network of expert centers for Rare Ovarian Tumor at Centra Leon Berard, discusses the final overall survival (OS) results from the phase 3 PAOLA-1/ENGOT-ov25 trial (NCT02477644).
In the study, the addition of olaparib (Lynparza) to bevacizumab (Avastin) achieved clinical meaningful improvement in OS in patients with advanced ovarian cancer and homologous recombination deficiency (HRD) vs bevacizumab alone.
The median OS observed in the intent-to-treat population was 56.5 months with olaparib plus bevacizumab compared with 51.6 months with bevacizumab alone (HR, 0.92; 95% CI, 0.76-1.12; P =.4118).
0:07 | This final analysis was planned to be done with a 60 percent data maturity for overall survival, or 3 years after the primary PFS analysis, whichever occurred first. And with our data cut off after 3 years, so we [presented] the final overall survival in the ITT population but also the pre-defined analysis in the molecular subgroups including BRCA-mutated patients and the HRD-positive or -negative population.
0:41 | We have reported an overall survival improvement in the HRD positive population where olaparib with bevacizumab provided a 38% reduction of the risk of death compared to the monotherapy in this population.
1:00 | It is a great improvement for the patients with advanced ovarian cancer. We have to say that it is the first time we see an overall survival benefit in final overall survival analysis in ovarian cancer first-line setting since the taxane 25 years ago, so it's really changing practice for our patients. We can anticipate and we are able to cure some patients with advanced ovarian cancer in the first-line setting. And the good news is also when we looked at the safety profile, we have a longer follow up [and] we don't see more adverse events [such] as myelodysplasia, leukemias, or new primary malignancies [compared to the control arm]. That is very good news for the patients.