The combination of toripalimab, bevacizumab, and platinum-based chemotherapy appears safe and effective for patients with advanced cervical cancer, results of a phase 2 trial suggest.
These results were presented at the 2023 SGO Annual Meeting on Women’s Cancer by Alexander Melamed, MD, of Massachusetts General Hospital in Boston.
The trial (ClinicalTrials.gov Identifier: NCT04973904) included 24 patients with refractory, recurrent, or metastatic cervical cancer. Nineteen patients had squamous cell carcinoma, and 5 had adenocarcinoma. The patients’ median age was 54.5 (range, 33-75) years.
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For prior treatment, 10 patients had undergone surgery and received chemoradiotherapy, 8 patients had received chemoradiotherapy or radiotherapy alone, 3 patients underwent surgery alone, and 3 patients had no prior systemic treatment.
On study, patients received toripalimab at 240 mg on day 1, bevacizumab at 7.5 mg/kg on day 1, and platinum-based chemotherapy (paclitaxel plus cisplatin or carboplatin) on day 1. They were treated every 3 weeks for 6 cycles.
Maintenance therapy consisted of toripalimab and bevacizumab at the aforementioned doses, given every 3 weeks for 12 months or until disease progression or intolerable toxicity.
All 24 patients were treated, and 13 were still on treatment at the data cutoff. The median treatment duration was 5.3 months. Five patients discontinued treatment due to disease progression, 2 due to adverse events (AEs), 2 due to protocol deviations, and 1 due to death that may have been related to treatment.
Twenty-two patients were evaluable for efficacy. The objective response rate was 77.3%, and the disease control rate was 95.5%. Seventeen patients had a partial response, and 4 had stable disease. The median time to response was 1.5 months, and the median duration of response was not reached.
Treatment-related AEs (TRAEs) of any grade occurred in 21 patients (87.5%), grade 3 or higher TRAEs occurred in 13 patients (54.2%), and serious TRAEs occurred in 5 patients (20.8%). One death, due to acute heart failure, was deemed possibly related to treatment.
The most common grade 3 or higher TRAEs were neutropenia (41.7%), leukopenia (16.7%), and rectovaginal fistula (8.3%). There were no grade 3 or higher immune-related AEs.
Based on these results, Dr Melamed concluded that toripalimab plus bevacizumab and chemotherapy “shows a promising response rate and disease control rate” and “appears to be tolerable” for patients with refractory, recurrent, or metastatic cervical cancer.
Disclosures: Dr Melamed disclosed a relationship with AstraZeneca.
Reference
Peng P, Yao H, Liu D, et al. Toripalimab combined with bevacizumab and chemotherapy for refractory, recurrent or metastatic cervical cancer: Preliminary results of a single-arm, open-label, phase II trial. SGO 2023. March 25-28, 2023.
