Neoadjuvant durvalumab plus chemotherapy in resectable or borderline resectable non-small-cell lung cancer: the phase...

The phase 2 MDT-BRIDGE study is investigating perioperative durvalumab plus neoadjuvant chemotherapy (AEGEAN regimen) in resectable and borderline resectable non-small-cell lung cancer and chemoradiotherapy (CRT) followed by consolidation durvalumab (PACIFIC regimen) in patients who become unresectable after neoadjuvant chemoimmunotherapy guided by multidisciplinary team assessments during the neoadjuvant period. The primary endpoint was the overall resection rate (descriptive with no formal hypothesis testing). Secondary endpoints included event-free survival, progression-free survival, pathological complete response rate (resectable patients cohort), circulating tumor DNA clearance between baseline and presurgery/pre-CRT and safety. Overall, 142 patients received neoadjuvant treatment; 64.8% and 35.2% were deemed resectable and borderline resectable at baseline, respectively. The overall resection rate (95% confidence interval) was 74.6% (66.7‒81.6) in a population that included more than one-third of patients with borderline resectable disease. R0 resection rate was 96.2% (90.6‒99.0) in those who underwent surgery. Overall, 131 (92.3%) patients had surgery (n = 106) or CRT (n = 25) after neoadjuvant treatment, and 117 (82.4%) patients received adjuvant (n = 94) or consolidation (n = 23) durvalumab. During adjuvant or consolidation durvalumab, maximum grade 3/4 adverse events occurred in 7.4% of resected patients and 17.4% of CRT-treated patients, with 8.5% and 13.0% discontinuing treatment due to adverse events. This multidisciplinary team-guided approach was feasible and enabled delivery of curative-intent treatment (surgery or CRT), followed by durvalumab in most patients, and demonstrated encouraging preliminary efficacy with a manageable adjuvant or consolidation safety profile that was consistent with prior studies. ClinicalTrials.gov identifier: NCT05925530 .