Durvalumab consolidation after chemoradiotherapy in unresectable stage III non–small cell lung cancer: A real-world experience from the Australian subset of PACIFIC-R

Australian subset of the multicentric PACIFIC-R study (NCT03798535) in patients with unresectable, stage III non-small cell lung cancer without progression following chemoradiotherapy, found a median progression-free survival of 22.4 months (95% confidence interval, 17.5 to 30.8) confirming clinical benefit of durvalumab consolidation post-chemoradiotherapy in the real-world setting. The Phase 3 PACIFIC trial established post-chemoradiotherapy (CRT) durvalumab consolidation as standard treatment for patients with unresectable, stage III non-small cell lung cancer (NSCLC). We present the results from the Australian subset of the multicentric PACIFIC-R study (NCT03798535) assessing the effectiveness of durvalumab in the real-world setting. Patients with unresectable, stage III NSCLC without progression following CRT, receiving at least 1 dose of durvalumab (10 mg/kg intravenously, every 2 weeks) through an early access program (EAP) between September 2017 and December 2019, were enrolled. Primary endpoints, progression-free survival (PFS) and overall survival (OS) were analyzed by Kaplan–Meier method. 67.0 years) with a median follow-up of 34.7 months were enrolled. Most received last radiation ≥42 days before durvalumab initiation (126, 79.2%) at a dose of 54 to 60 Gy (141, 88.7%). Median PFS was 22.4 months (95% confidence interval CI, 17.5 to 30.8). The 3-year PFS and OS rates were 38.9% (95% CI, 31.0 to 46.7) and 59.1% (95% CI, 51.2 to 66.2). Pneumonitis was the most frequent adverse events of special interest (27, 16.4%); which led to treatment discontinuation in 19 (11.5%) patients. The real-world results from the Australian PACIFIC-R subset confirm translation of the clinical benefit of post-CRT durvalumab consolidation in the pivotal PACIFIC trial to the real-world setting, showing favorable survival outcomes, irrespective of delays in durvalumab initiation post-radiation. • This PACIFIC-R Australian subset data confirms the clinical effectiveness of durvalumab consolidation after CRT to be safe with favorable PFS and OS rates in a more diverse group of patients with stage III, unresectable NSCLC. • The median time to initiation of durvalumab after completing RT was 60.0 days (range, -14 to 346), unlike the PACIFIC trial where patients were required to start durvalumab within 42 days of completing radiation. • The median durvalumab treatment duration was 337 days (∼48 weeks), with 29 patients continuing durvalumab treatment beyond the 12 months stipulated by the trial. • At baseline (before initiation of durvalumab), 11.7% patients had achieved a complete response, 41.6% a partial response and 45.5% had stable disease post-CRT. • The real-world median PFS was 22.4 months, with a 3-year PFS rate of 38.9% and 3-year OS rate of 59.1%. • The safety profile was in line with what was observed in the PACIFIC trial, with 16.4% of patients discontinuing treatment due to AEs. Pneumonitis was the most frequent AESI affecting 16.4% of patients and leading to treatment discontinuation in 11.5% patients. • The PFS and OS benefit remained consistent irrespective of delays (>42 days) in durvalumab initiation post-radiation.