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March 21, 2026ESMO Open0 citationsOpen Access

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

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ABA. BaramidzeMGM. GogishviliTMT. Makharadze

Key Points

  • This study examines the impact of cemiplimab combined with chemotherapy on patient-reported outcomes across different age groups in advanced non-small cell lung cancer.
  • Open-label, randomized phase III trial design
  • Patients with stage IIIB/IV non-small cell lung cancer were randomized to receive treatment
  • Assessment of progression-free survival and overall survival as primary endpoints
  • Utilization of next-generation DNA sequencing for genomic profiling
  • Cemiplimab combined with chemotherapy significantly improved progression-free survival compared to chemotherapy alone
  • The efficacy of treatment varied with PD-L1 expression levels
  • Older patients exhibited distinctive patient-reported outcomes compared to younger patients

Abstract

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.

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Cite This Study

Baramidze et al. (2026) studied this question.

synapsesocial.com/papers/69be34af6e48c4981c672caehttps://doi.org/10.1016/j.esmoop.2026.106385
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 180P A phase Ib/II study of second-line cadonilimab, anlotinib and docetaxel in patients with checkpoint inhibitor (CPI)-experienced advanced non-small cell lung cancer2026
  2. 264P Patient-reported outcomes (PROs) of cemiplimab (CEMI) + platinum doublet chemotherapy (CHEMO) + ipilimumab (IPI) for first-line (1L) treatment of advanced non-small cell lung cancer (aNSCLC): EMPOWER-lung 3 part 12024
  3. 3Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer with PD-L1 ≥ 1 %: A subgroup analysis from the EMPOWER-Lung 3 part 2 trial2024 · 10 citations
  4. 4A phase 2/3 study of fianlimab, cemiplimab, plus chemotherapy versus cemiplimab plus chemotherapy in first-line treatment of advanced non-small cell lung cancer.2024 · 3 citations
  5. 572P Cemiplimab monotherapy for first-line advanced NSCLC patients with PD-L1 expression ≥50%: 6-y outcomes of EMPOWER-Lung 12026