Concurrent Durvalumab With Chemoradiotherapy Did Not Improve Outcomes Among Patients With Unresectable Stage III NSCLC
According to a phase 3 study, starting durvalumab concurrent with chemoradiotherapy (CRT) and continuing as consolidation did not improve overall survival (OS) among patients with unresectable stage III non-small cell lung cancer (NSCLC), compared to consolidation durvalumab alone.
These data were first presented by John Varlotto, MD, Edwards Comprehensive Cancer Center at Marshall University, Huntington, West Virginia, United States, at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer (WCLC) in Barcelona, Spain.
This study enrolled 662 patient with unresectable stage IIIA to IIIC NSCLC (n = 635) or mediastinal node recurrence following surgery (n = 27). Patients were randomized to receive either concurrent durvalumab with chemotherapy and radiotherapy (Arm A, n = 335) or to CRT alone (Arm B, n = 327). Patients in either arm who completed CRT, did not progress, had a treatment-related toxicity lower than grade 1 within 45 days of CRT and did not develop pneumonitis were assigned to receive 1 year of durvalumab (Arm C). The primary end point was OS in the intention-to-treat population, with secondary end points including progression-free survival (PFS), objective response rate (ORR), and toxicity.
With a median follow-up duration was 29.9 months, 227 patients in Arms A (82.7%) and B (84.7%) went on to start Arm C. The median OS for Arm A was 41.5 months compared to 39.4 months in Arm B (hazard ratio [HR], 1.03; P = .83). There were 152 patients in Arm C from Arm A who progressed, and 144 patients in Arm C from Arm B. The median PFS was 15.5 months vs 16.8 months, respectively (HR, 1.05; P = .65). At step 1, the overall response rate in Arm A was 51.3% and 47.1% (P = .28). There were no significant differences in grade 3 to grade 5, or grade 2 to grade 5 cardiac or pulmonary events per arm in either step 1 or step 2.
As Dr Varlotto et al concluded, “concurrent and consolidation durvalumab with CRT…did not improve OS to consolidation durvalumab alone,” and “there were also no differences in ORR, PFS, failure patterns nor toxicity between arms.”
Source:
Varlotto JM, Xie Y, Pennell N, et al. Phase 3 trial of concurrent and consolidative durvalumab vs consolidative durva alone for unresectable stage 3 NSCLC. Presented at IASLC 2025 WCLC. September 6-9, 2025; Barcelona, Spain. Abstract PL03.06