|The following article features coverage from the American Society of Clinical Oncology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Treatment with cediranib plus olaparib had similar activity when compared with standard of care platinum-based chemotherapy in patients with recurrent platinum-sensitive ovarian cancer, but the combination failed to meet the primary endpoint of improved progression-free survival in a phase 3 trial (ClinicalTrials.gov Identifier: NCT02446600).
“Overall, although NRG-GY004 did not meet its primary endpoint, non-platinum therapies may still offer alternatives in women with recurrent platinum-sensitive ovarian cancer,” explained Joyce F. Liu, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, who presented the results during the ASCO20 Virtual Scientific Program. “GY004 demonstrated that these can be feasibly explored in future studies in this setting.”
The study enrolled 565 patients with recurrent platinum-sensitive high-grade serous, endometrioid or BRCA-related ovarian cancer. Patients were randomly assigned to investigator’s choice of standard of care platinum-based chemotherapy, olaparib 300 mg twice daily, or cediranib plus olaparib.
The median follow-up was 29.1 months. During that time 53 patients assigned to standard of care arm initiated non-protocol therapy, mostly PARP inhibitor maintenance, prior to progression.
The median progression-free survival for standard of care, olaparib, and olaparib plus cediranib was 10.3, 8.2, and 10.4 months, respectively. The combination did not improve progression-free survival compared with standard of care (hazard ratio [HR], 0.856; 95% CI, 0.663-1.105; P =.077).
“Because the null hypothesis was not rejected for the comparison of cediranib and olaparib chemotherapy, additional treatment comparison cannot be statistically interpreted,” Dr Liu said.
Overall survival data are not currently mature. However, at the time of this analysis no difference in overall survival was observed between the 3 treatment arms.
Patients assigned to standard of care had a response rate of 71.3% compared with 52.4% for olaparib monotherapy and 69.4% for olaparib plus cediranib. There was no statistically significant improvement in response between these arms.
In patients with a germline BRCA mutation, the median progression-free survival was 10.5 months in patients who received standard of care, 18 months with combination cediranib and olaparib, and 12.7 months with olaparib alone. In patients with BRCA wild-type disease, the median progression-free survival was 9.7 months with chemotherapy, 8.9 months with cediranib plus olaparib, and 6.6 months with olaparib alone.
Higher rates of hematologic adverse events were observed in patients assigned to chemotherapy, but higher rates of non-hematologic adverse events occurred with combination olaparib plus cediranib.
Read more of Cancer Therapy Advisor‘s coverage of the ASCO 2021 meeting by visiting the conference page.
Liu JF, Brady MF, Matulonis UA, et al. A phase III study comparing single-agent olaparib or the combination of cediranib and Olaparib to standard platinum-based chemotherapy in recurrent platinum-sensitive ovarian cancer. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 8001.