AI Article Synopsis
- The STRONG study evaluated the safety and effectiveness of durvalumab, an anti-PD-L1 drug, administered at a fixed dose of 1500 mg every four weeks in patients with previously treated platinum-refractory metastatic urothelial carcinoma.
- Among 867 patients, 51% experienced adverse events, with 11% being immune-mediated; the median overall survival was found to be 7.0 months.
- The study concluded that this dosing schedule shows a manageable safety profile and effective clinical activity, aligning with findings from other studies on durvalumab and similar treatments.
Article Abstract
Background: Prior durvalumab (anti-PD-L1 agent) studies in platinum-refractory metastatic urothelial carcinoma evaluated a dose of 10 mg/kg administered every two weeks. The nonrandomised phase 3b STRONG study (NCT03084471) evaluated the safety and efficacy of fixed-dose durvalumab at a more convenient dosing schedule in a previously treated patient population, more similar to a real-world clinical setting.
Patients And Methods: 867 patients with urothelial or nonurothelial urinary tract carcinoma (UTC) who progressed on or after platinum or nonplatinum chemotherapy were treated with durvalumab 1500 mg every four weeks; 87% had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1, and 13% had an ECOG PS of 2. The primary end-point was the incidence of adverse events of special interest (AESIs), including immune-mediated AEs (imAEs). Secondary and exploratory end-points included overall survival (OS), objective response rate (ORR) and disease control rate (at six and 12 months) (DCR).
Results: AESIs of any grade were reported in 51% of patients (8% grade ≥ 3). The incidence of imAEs was 11% (2% grade ≥ 3). The median OS was 7.0 months (95% confidence interval [CI]: 6.4-8.2) and ORR was 18% (95% CI: 14.8-20.6), with complete responses in 5% of patients and a DCR at six months of 19% (95% CI: 16.1-22.1).
Conclusion: Fixed-dose durvalumab monotherapy every four weeks has an acceptable safety profile and yields durable clinical activity in previously chemotherapy-treated patients with UTC. Safety and efficacy are consistent with previous durvalumab studies and other anti-PD-1/PD-L1 agents in this setting. CLINICALTRIALS.
Gov Identifier: NCT03084471https://clinicaltrials.gov/ct2/show/NCT03084471.
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| http://dx.doi.org/10.1016/j.ejca.2021.12.012 | DOI Listing |
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