First-Line Olaparib/Bevacizumab Maintenance Combo Approved in China for HRD+ Advanced Ovarian Cancer

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 and SOLO-1 trials.

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 approval 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 bevacizumabfor the treatment of patients with HRD-positive, BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.3

References

  1. Lynparza approved in China as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer. News Release. AstraZeneca. September 22, 2022. Accessed September 22, 2022. https://bit.ly/3qVM6SB
  2. Lynparza in combination with bevacizumab, and as a monotherapy, demonstrates clinically meaningful survival benefit in 1st-line advanced ovarian cancer across two Phase III trials. News Release. AstraZeneca. September 9, 2022. Accessed September 22, 2022. https://bit.ly/3SooaTj
  3. FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers. News release. FDA. May 11, 2020. Accessed September 22, 2022. https://bit.ly/3dBIrpY