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Durvalumab Plus Concurrent Radiotherapy for Unresectable, Advanced, PD-L1-Positive NSCLC
Results From the Phase 2 DOLPHIN Study
Results From the Phase 2 DOLPHIN Study
According to results from the phase 2 DOLPHIN study, durvalumab plus concurrent radiotherapy and maintenance durvalumab is an effective and safe treatment option for patients with unresectable, advanced, programmed cell death ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC).
“Administration of durvalumab after concurrent chemoradiotherapy is the standard treatment of unresectable, locally advanced [NSCLC]; however, 20% to 30% of patients do not receive durvalumab because of adverse events during concurrent chemoradiotherapy,” stated Motoko Tachihara, MD, PhD, Kobe University Graduate School of Medicine, Kobe, Japan, and coauthors.
This multicenter, single-arm, nonrandomized, controlled trial, enrolled 35 patients with unresectable, advanced, PD-L1-positive NSCLC. Patients received 60 Gy of radiotherapy plus 10 mg/kg of concurrent and maintenance durvalumab every 2 weeks for up to 1 year. The primary end point was 12-month progression-free survival (PFS) rate. Key secondary end points included PFS, objective response rate (ORR), treatment completion rate, and adverse events.
At a median follow-up of 22.8 months, the 12-month PFS rate was 72.1%. Median PFS was 25.6 months and confirmed ORR was 90.9%. Scheduled radiotherapy was completed by 97.1% of patients and treatment completion rate was 57.6%. Patients experienced both grade 3/4 (n = 18) and grade 5 (n = 2) adverse events. Any grade pneumonitis or radiation pneumonitis occurred in 23 patients. Grade 3/4 pneumonitis or radiation occurred in 4 patients.
Study results “indicate that durvalumab immunotherapy combined with curative radiotherapy for patients with PD-L1–positive, unresectable, locally advanced NSCLC is a promising treatment with tolerable adverse events and is appropriate as a study treatment for phase 3 clinical trials,” concluded Dr Tachihara and coauthors.
Source:
Tachihara M, Tsujino K, Ishihara T, et al. Durvalumab plus concurrent radiotherapy for treatment of locally advanced non–small cell lung cancer. JAMA Oncol. Published online September 7, 2023. doi: 10.1001/jamaoncol.2023.3309
