78P Patient-reported outcomes (PROs) of cemiplimab plus chemotherapy in advanced non-small cell lung cancer (aNSCLC): A focus on age subgroups from EMPOWER-Lung 3
Background:In the open-label, randomised, phase III RATIONALE-304 trial (NCT03663205), patients (pts) with locally advanced/metastatic nsq-NSCLC receiving TIS + CT experienced improved survival vs those receiving CT alone, with the magnitude of benefit being more pronounced in pts with tumour cell PD-L1 membrane expression 50% vs those with PD-L1 <50%, aligning with the general trend of programmed cell death protein-1 inhibitor efficacy increasing with PD-L1 expression.Methods: Adult pts with stage IIIB/IV nsq-NSCLC were randomised (2:1) to TIS + platinum-based CT + pemetrexed every 3 weeks or platinum-based CT + pemetrexed.The primary endpoint was progression-free survival (PFS) by independent review committee.Overall survival (OS) was a key secondary endpoint.Crossover from CT to TIS + CT was allowed upon independent review committee-confirmed disease progression.Genomic profiling and tumour mutational burden (TMB) analyses were performed on PD-L1-evaluable tumour tissue using next-generation DNA sequencing.Background: This study (AK104-IIT-018, NCT05816499) aimed to evaluate the safety and efficacy of cadonilimab (a PD-1/CTLA-4 bispecific antibody), anlotinib, and docetaxel in patients with checkpoint inhibitor (CPI)-experienced advanced nonsmall cell lung cancer (NSCLC) without sensitizing EGFR/ALK/ROS1 mutations.
Authors
- Ewa E. Kalinka
- Xiaoli Jia (ORCID: https://orcid.org/0000-0001-8865-9771)
- R. Quek
- T. Makharadze
- E. Yan
- F. Seebach
- T. Melkadze
- E. Kim
- M. Gogishvili
- K.D. Penkov
- A. Baramidze
Institutions
- Regeneron (United States) (US)
- Batumi State Maritime Academy (GE)
- Polish Mother’s Memorial Hospital Research Institute (PL)
- Cytel (United States) (US)
Publication Details
- Journal
- ESMO Open
- Published
- 2026-03-17
- DOI
- https://doi.org/10.1016/j.esmoop.2026.106385
- Primary Topic
- Lung Cancer Treatments and Mutations
- Type
- article
- Field-Weighted Citation Impact
- 0.00