69P First-line pumitamig (PD-L1 × VEGF-A bsAb) monotherapy in PD-L1+ non-squamous and squamous non-small cell lung cancer: Data from a phase Ib/IIa trial in China

Background: Patients with metastatic non-small cell lung cancer (mNSCLC) progressing after standard therapies have limited options.In the phase III TROPION-Lung01 trial, datopotamab deruxtecan (Dato-DXd) improved progression-free survival (PFS) versus docetaxel, mainly in nonsquamous disease.Dato-DXd was temporarily available through a European expanded access program (EAP).We evaluated real-world outcomes of Dato-DXd in mNSCLC patients treated at a comprehensive cancer center. Methods:Multicenter retrospective cohort including adults with nonsquamous mNSCLC and 1 prior systemic therapy.Patients received Dato-DXd through an EAP in 3 centers at the Catalan Institute of Oncology.Endpoinits were PFS, overall survival (OS), and safety (CTCAE v.5.0).Survival was estimated by Kaplan-Meier and compared across predefined subgroups using log-rank tests (sex, prior lines 2 vs. >2 and molecular alterations).Results: From June to December 2024, 43 patients received Dato-DXd 6 mg/kg once every 3 weeks (median age 63 years [range 46-77]; 60.5% female; 88.4% ECOG 1; 53.5% with actionable molecular alterations, 34.9% EGFR; PD-L1 expression <1% 34.9%, 1-49% 32.6% and 50% 23.3%).Mean number of previous lines was 2 (1-6).At data cut-off (09-Dec-2025), 6 patients remained on treatment.The median followup for PFS was 8.6 months (SD 4.8).Median PFS was 4.6 months (95% CI 2.7-6.4) and median OS was 9.4 months (95% CI 5.9-NR) No significant differences in PFS were observed by sex (p=0.92),prior lines (p=0.071) or molecular status (p=1), nor in OS (p=0.061;p=0.061; p=0.26, respectively).No differences were identified in EGFR-mutant patients, with a median PFS of 2.7 months (95% CI 1.8-6.4).Median treatment duration was 3.6 months (IQR 2.0-6.3).Adverse events (AE) occurred in 88.4%, including 60.5% grade 3.The most frequent were stomatitis (73.7%; grade 3 32.1%), asthenia (60.5%; grade 3 65.2%) and ocular toxicity (36.8%; grade 3 35.7%).Interstitial lung disease/pneumonitis occurred in 2 patients (5.3%, both grade 3).Non grade 5 AE were observed.Conclusions: Patients treated with Dato-DXd in the EAP showed similar PFS to that of TROPION-Lung01 trial patients, with manageable toxicity.