Trabectedin does not improve outcomes, when compared with physician’s choice of chemotherapy, in patients with BRCA-mutated or BRCAness phenotype recurrent ovarian cancer, according to phase 3 data.
Researchers found no significant difference in progression-free survival (PFS) or overall survival (OS) with trabectedin or physician’s choice of treatment.
These findings, from the MITO23 trial, were presented at the 2022 ASCO Annual Meeting.
The trial (ClinicalTrials.gov Identifier: NCT02903004) included 244 patients with recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. Patients had BRCA1/2 mutations or BRCAness phenotype, which was defined as having responded to at least 2 previous lines of platinum-based chemotherapy.
The patients were randomly assigned to receive trabectedin (n=122) or physician’s choice of chemotherapy (n=122). Chemotherapy choices included carboplatin (35.3%), paclitaxel (20.5%), pegylated liposomal doxorubicin (16.4%), gemcitabine (14.7%), and topotecan (13.1%).
Baseline characteristics were similar between the treatment arms. In the overall population, the median age was 60 years (range, 53-68), 82.8% of patients had high grade serous and endometrioid cancer, and 75.0% of patients had stage III disease. About half of patients (50.8%) had BRCAness phenotype, 34.8% had BRCA1 mutations, and 14.3% had BRCA2 mutations.
The primary endpoint was OS. At a median follow-up of 18.8 months, the median OS was 15.8 months with trabectedin and 17.9 months with physician’s choice (hazard ratio [HR], 1.15; 95% CI, 0.88-1.51; P =.304).
The median PFS was 4.9 months with trabectedin and 4.4 months with physician’s choice (HR, 1.02; 95% CI, 0.79-1.31; P =.897).
The overall response rate was 17.1% with trabectedin and 21.4% with physician’s choice. The median duration of response was 5.62 months and 5.66 months, respectively.
No superior outcomes were observed for trabectedin in any prespecified subgroups.
The researchers conducted an exploratory analysis to compare trabectedin with platinum chemotherapy and non-platinum chemotherapy. There was no significant difference in OS regardless of the chemotherapy type.
More than 90% of patients in each treatment arm experienced an adverse event (AE). The rate of grade 3-4 AEs was 50.0% in the physician’s choice arm and 71.1% in the trabectedin arm. There were no fatal AEs in either arm.
Disclosures: This research was supported by PharmaMar and Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Scambia G, Raspagliesi F, Valabrega G, et al. Randomized phase III trial on trabectedin (ET-743) single agent versus clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal, or fallopian tube cancers of BRCA-mutated or BRCAness phenotype patients (MITO23). Presented at ASCO 2022; June 3-7, 2022. Abstract LBA5504.