Olaparib and bevacizumab has been approved in China as a frontline maintenance treatment for patients with advanced homologous recombination deficiency–positive ovarian cancer based on results from the phase 3 PAOLA-1 trial.
Olaparib (Lynparza) in combination with bevacizumab (Avastin) has been approved in China for the first-line treatment of patients with homologous recombination deficiency (HRD)–positive ovarian, fallopian tube, or primary peritoneal cancer who show complete or partial responses to first-line platinum-based chemotherapy, according to a press release from AstraZeneca.1
The approval was based on 5-year follow-up from the phase 3 PAOLA-1 trial (NCT02477644), which highlighted a median overall survival (OS) of 75.2 months with olaparib plus bevacizumab maintenance vs 57.3 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer including those with a BRCA mutation (HR 0.62; 95% CI, 0.45-0.85).2 Moreover, when BRCA mutations were excluded in the HRD population, the median OS was not reached and 52.0 months, respectively.
The efficacy of this treatment was also supported by updated results from the phase 3 SOLO-1 trial (NCT01844986), which identified clinically meaningful improvement in OS with olaparib monotherapy vs placebo in patients with BRCA-mutated newly-diagnosed advanced ovarian cancer. The 7-year OS analysis indicated that 67% of patients in the experimental arm were alive compared with 47% of those in the control group.
“Historically the 5-year survival rate of newly diagnosed patients with advanced ovarian cancer is 30%-50%. In that context, it is phenomenal to share the long-term [OS] data from both PAOLA-1 and SOLO-1, with 2 of 3 patients still alive in these trials. We continue to believe in Lynparza [Olaparib]’s ability to help biomarker-selected patients with advanced ovarian cancer to achieve better outcomes,” Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, said in the press release.
In May 2020, the FDA approved olaparib plus bevacizumab for the treatment of patients with HRD-positive, BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.3