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Mansoor Raza Mirza, MD, discusses the final survival analysis of the phase 3 NSGO-AVANOVA2/ENGOT-OV24 trial in recurrent, platinum-sensitive ovarian cancer.
Mansoor Raza Mirza, MD, medical director of the Nordic Society of Gynaecologic Oncology-Clinical Trial Unit and chief oncologist within the Department of Oncology in Rigshospitalet, Copenhagen University Hospital, discusses the final survival analysis of the phase 3 NSGO-AVANOVA2/ENGOT-OV24 trial in recurrent, platinum-sensitive ovarian cancer.
The trial enrolled patients with relapsed and/or platinum-sensitive disease who had a treatment-free interval of more than 6 months, says Mirza. These patients were randomized to receive either niraparib (Zejula) alone or in combination with bevacizumab (Avastin). Normally, the standard of care for these patients would be to receive platinum-based combination chemotherapy. The primary end point of the study was progression-free survival (PFS) and the hazard ratio (HR) reported was 0.34, which is highly significant, says Mirza.
Looking at the secondary end points, such as time to first subsequent therapy, the HR was 0.45, again, statistically significant, adds Mirza. The median time to subsequent therapy was 14.3 months in the combination arm versus 7.2 months in the monotherapy arm. For second objective disease progression, which is a surrogate for overall survival (OS), a statistically significant HR of 0.56 was seen along with a median of 20.5 months versus 15.7 months in the combination and monotherapy arms, respectively.
The same benefit was seen in the time to second subsequent therapy with an HR of 0.56 and a clear benefit with the doublet at 21.8 months versus 17.3 months with the monotherapy. When it comes to overall survival (OS), the HR was 0.75, which translates to a notable risk reduction. However, the numbers are small and the drug was not powered for OS, so the confidence interval passed the boundary of 1; that is why OS improvement cannot be considered to be statistically significant, concludes Mirza.