297P Novel intratumoral radioenhancer (JNJ-1900) with chemoradiation and consolidative immunotherapy for stage III unresectable non-small cell lung cancer (NSCLC): Early outcomes from the phase II CONVERGE study

Background: We report preliminary findings from an intratumoral (IT)/intranodal (IN) injection of the novel nanoparticle radioenhancer JNJ-1900 (NTBXR3), followed by concurrent chemoradiotherapy (cCRT) and consolidation immunotherapy (cIT) in stage III unresectable NSCLC. Methods: CONVERGE is a two-part Phase II, open-label study of JNJ-1900.Part 1 evaluated two dose levels (Cohorts A; 22% gross tumor volume [GTV] & B [33% GTV]) to assess antitumor response and safety, leading to a randomised Part 2. Part 1 patients received a single administration of JNJ-1900 into at least one target lesion, followed by cCRT (60 Gy in 30 fractions; Carboplatin/Paclitaxel weekly for 6 weeks), and if no evidence of progressive disease (PD) per RECIST v1.1, cIT (durvalumab).Post-cCRT computed tomography scans were performed within 4 weeks of cCRT.Primary endpoint was objective response rate (ORR), and secondary were disease control rate (DCR) and safety.Results: Part 1 enrolled 7 patients (A=3 & B=4 with median [range] age of 67 [60][61][62][63][64][65][66][67][68][69][70][71][72][73][74][75][76] yrs; 85.7% male) with 16 lesions injected (11 target; 5 non-targets), involving 7 lung tumors (median: 35 [12-74] mm) and 9 lymph nodes (median: 13 [10-22] mm).All injections were performed bronchoscopically.Per lesion, median total GTV planned for injection was 5.8 mL (1.4-134.8)(primary [19 (1.4-134.8)mL] and lymph node [3.6 (1.6-22.7)mL]).Median injection volume and duration were 1.75 (0.36-30) mL and 5 (1-60) mins per lesion.First disease evaluation post-cCRT had ORR = 71.4% (5/7) and DCR = 100%.Median target lesion change in sum of diameters from baseline was -44.6% (0--76%).All injections were completed per plan.One patient reported non-serious, procedure-related adverse events (AEs: Grade 1 hypokalaemia; Grade 3 non-cardiac chest pain).All patients completed cCRT, with one serious AE (Grade 2 hypokalaemia) unrelated to JNJ-1900 and cCRT.All patients have initiated cIT therapy.Conclusions: CONVERGE demonstrates the feasibility and safety of bronchoscopic IT/ IN injection of JNJ-1900.Early findings are encouraging for response and safety outcomes.