BioNTech BNT116 Cancer Vaccine Shows Promising Early Activity in Resectable NSCLC

Preliminary results from the LuCa-MERIT-1 trial (NCT05142189) were presented by Dr. Rafal Dziadziuszko from the Medical University of Gdańsk, Poland in the WCLC 2026. The study is evaluating BNT116 in patients with resectable NSCLC, including a cohort receiving BNT116 together with the immunotherapy cemiplimab and the chemotherapy drugs carboplatin and paclitaxel. 

Important note: This is not the RET-positive lung cancer cohort of the LuCa-MERIT-1 trial. The cohort presented here is evaluating the investigational BNT116 cancer vaccine in combination with chemotherapy and immunotherapy in patients with resectable early-stage NSCLC, regardless of specific oncogenic driver. The presentation does not report RET-specific results for this cohort.

BNT116 is an investigational RNA-based cancer vaccine designed to stimulate the immune system to recognize proteins associated with cancer cells. It uses an RNA-lipid nanoparticle approach to deliver its payload to antigen-presenting cells, helping activate tumor-antigen-specific T cells. 

In this study, patients received BNT116 weekly for seven initial treatments, followed by every-three-week maintenance treatment, along with cemiplimab and carboplatin/paclitaxel before surgery. Researchers also collected blood and tumor samples to study immune responses and potential biomarkers. 

Results

The preliminary analysis included 20 patients with resectable stage II or III NSCLC. The median age was 65.5 years, and 60% of participants were women. Forty-five percent had tumors with PD-L1 expression of at least 50%. 

Among the 20 patients:

• 13 (65%) experienced a partial response before surgery
• 7 (35%) had stable disease
• No patients experienced progressive disease during neoadjuvant treatment

This resulted in an objective response rate of 65% and a disease control rate of 100%. 

The estimated event-free survival at 24 months was 50.8%, although the median event-free survival had not yet been reached. Median follow-up was 14.5 months. 

The researchers also examined pathological responses (how much of a tumor is still alive when doctors examine the tissue removed during surgery, major pathological response means very little viable cancer remains) in tumors removed during surgery. Among the 15 patients with available pathological response data, eight (53%) achieved at least a major pathological response, including six patients (40%) with a complete pathological response. 

Activation of the immune system

Another important finding was evidence that BNT116 was activating the immune system. After six to eight BNT116 treatments, 8 of 12 patients (67%) with available data developed a treatment-induced immune response against at least one tumor-associated antigen. Responses were detected against five of six targeted antigens, most frequently CLDN6 and KK-LC-1. 

Safety

The safety findings were also closely monitored. All 20 patients experienced at least one treatment-emergent adverse event. The most common were fever (80%), chills (70%), neutropenia (45%), fatigue (45%), and nausea (40%). Cytokine release syndrome occurred in 30% of patients. There were no fatal treatment-emergent adverse events and no dose-limiting toxicities. 

Importantly, no treatment-related delays to surgery occurred, and adverse events did not prevent any patient from undergoing surgery. 

Conclusions

BNT116 is an investigational cancer vaccine that aims to train the immune system to recognize and attack tumor-associated targets. These early results suggest that BNT116 can generate measurable tumor-antigen-specific immune responses while being given alongside chemotherapy and immunotherapy, with encouraging tumor responses. Longer follow-up and larger clinical trials will be needed to determine whether these early responses translate into improved long-term outcomes. These preliminary results support continued investigation of BNT116 in early-stage NSCLC.