Adding vistusertib to treatment with paclitaxel does not improve outcomes in patients with platinum-resistant or -refractory ovarian cancer, according to a phase 2 trial published in JAMA Oncology.
The trial showed similar responses, progression-free survival (PFS), and overall survival among patients who received the combination and those who received paclitaxel monotherapy.
This phase 2 trial (OCTOPUS) included 140 patients with platinum-resistant or -refractory high-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. The patients’ median age at baseline was 63 (range, 36-86) years.
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Most patients (82.1%) had platinum-resistant disease, and 17.9% had platinum-refractory disease. They had received 1 prior line of therapy (9.3%), 2 prior lines (37.1%), 3 lines (30.7%), or more (22.9%). Most patients (87.1%) had a taxane-free interval of 6 months or longer.
The patients were randomly assigned to receive vistusertib plus paclitaxel (n=70) or placebo plus paclitaxel (n=70). Patients received weekly paclitaxel (80 mg/m2) and either placebo or vistusertib at 50 mg twice daily on days 1-3, 8-10, and 15-17 of a 28-day cycle.
The primary endpoint was PFS. The median PFS was 4.5 months in the vistusertib-paclitaxel arm and 4.1 months in the placebo-paclitaxel arm (adjusted hazard ratio [aHR], 0.84; 80% CI, 0.67-1.07; P =.18).
The median overall survival was 9.7 months in the vistusertib arm and 11.1 months in the placebo arm (aHR, 1.21; 80% CI, 0.91-1.60). The response rate was 29% and 30%, respectively.
The rate of grade 3-4 adverse events (AEs) was 41.2% in the vistusertib-paclitaxel arm and 36.7% in the placebo-paclitaxel arm. Gastroesophageal reflux, rash, and lymphopenia were significantly more common with the combination than with paclitaxel monotherapy. Quality-of-life outcomes were similar between the groups.
The researchers concluded that vistusertib did not improve clinical outcomes in this patient population, and “potential predictive biomarkers will need to be evaluated in separate study cohorts.”
Disclosures: This research was partly supported by AstraZeneca. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Banerjee S, Giannone G, Clamp AR, et al. Efficacy and safety of weekly paclitaxel plus vistusertib vs paclitaxel alone in patients with platinum-resistant ovarian high-grade serous carcinoma: The OCTOPUS multicenter, phase 2, randomized clinical trial. JAMA Oncol. Published online March 16, 2023. doi:10.1001/jamaoncol.2022.7966
