Data on RNA-Based Cancer Vaccine Plus Cemiplimab for NSCLC Presented at AACR 2025

Combining an RNA-based lipoplex cancer vaccine with cemiplimab showed “promising anti-tumor activity” in patients with advanced non-small cell lung cancer (NSCLC) who are classified as frail, according to research presented at the American Association for Cancer Research (AACR) Annual Meeting 2025.

Rafal Dziadziuszko, MD, PhD, of the Medical University of Gdansk, presented preliminary results of the open-label, multiple cohort phase 1 LuCa-MERIT-1 trial during the AACR clinical trials minisymposium on antibody-drug conjugates and immunooncology-focused biological approaches.

It was important to research because “many patients with considerable comorbidities or older age are unable to tolerate” first-line platinum-based chemotherapy for NSCLC. However, BNT116, an unmodified RNA-based lipoplex cancer vaccine, has shown “a favorable safety profile alone or in combination with cemiplimab” in early studies.

The Phase 1 LuCa-MERIT-1 Trial: Study Design and Patient Population

The phase 1 trial evaluates dose-limiting toxicities and treatment-emergent adverse events, as well as the clinical activity of monotherapy and combination therapies.

The study investigators explained that the data presented at the AACR Annual Meeting is from a cohort of patients who have an Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2 and are not candidates for first-line chemotherapy. All patients had a PD-L1 tumor proportion score of at least 1% on tumor cells. The biomarker analysis evaluated immunogenicity, cytokines, circulating tumor DNA, and PD-L1.

The analysis included 20 patients with a median age of 69.5 years, with 30% having an ECOG performance status of 0, 60% having a performance status of 1, and 10% having a performance status of 2.

Safety Data on BNT116 and Cemiplimab in NSCLC

The researchers reported that all patients experienced treatment-related adverse events (TRAEs) to BNT116 and that 65% experienced TRAEs to cemiplimab. TRAEs of grade 3 or higher with BNT116 occurred in 15% of patients, including one case of supraventricular tachycardia, one case of hypoxia, and one case of hypertension. Serious TRAEs occurred in 35% of patients, with 15% of those only related to BNT116 and 15% of those only related to cemiplimab, with no fatal TRAEs reported.

Efficacy Data on BNT116 and Cemiplimab in NSCLC

The best overall response was a partial response in 45% of patients, and stable disease in 35% of patients. Among the nine patients who had a partial response, two had a PD-L1 tumor proportion score of less than 50%.

The confirmed objective response rate was 45%, with a disease control rate of 80%. The median progression-free survival was 9.9 months (95% CI, 2.4, not estimable), and a ctDNA analysis “revealed strong molecular responses following treatment evidenced as early as week 3,” according to study investigators.

Source:

American Association for Cancer Research 2025. Abstract #CT013. https://www.abstractsonline.com/pp8/#!/20273/presentation/10400