Tali Azenkot, MD, is a fellow of hematology and oncology at the University of California San Diego Health.

Dr Azenkot on Dupilumab Plus Cemiplimab in Early-Stage, Resectable NSCLC

“[This is] a different strategy than what has been used before. We are looking at dupilumab in [patients with] NSCLC to see how it can be synergistic with cemiplimab.”

Tali Azenkot, MD, a fellow of hematology and oncology at the University of California San Diego Health, discussed the rationale for an ongoing phase 1/2 study (NCT06088771) of dupilumab (Dupixent) plus cemiplimab (Libtayo) in patients with early-stage, resectable non–small cell lung cancer (NSCLC). Notably, the design of this trial was presented at the 

® Fellows Forum on Thoracic Oncology, which took place during the 

The phase 1/2 trial is combining the anti–interleukin (IL)-4Rα agent dupilumab with the anti–PD-1 drug cemiplimab in the neoadjuvant setting, Azenkot began. The approach being examined in the trial is unique, as dupilumab has previously been used to treat patients with asthma and allergic rhinitis, she added.

Data from preclinical research have shown that the blocking of IL-4 signaling by dupilumab can reduce lung tumor burden by activating dendritic cells and T effector cells. Dupilumab has also been shown to have a synergistic effect when combined with PD-1 blockade.

The single-arm study is enrolling patients with early-stage (≥ T1b) resectable NSCLC of any histology. Patients are also required to be candidates for surgery and be able to undergo pre-operative fresh tissue biopsy. Those with autoimmune conditions, confirmed metastatic disease, or 

 rearrangements will be excluded. Additionally, patients cannot have metastatic disease or have received an immunomodulatory prescription within 8 weeks prior to enrollment.

The study will enroll approximately 12 to 21 patients. All patients will undergo 3 to 6 core needle biopsies and stool sampling at screening. Patients will then receive cemiplimab at 350 mg and dupilumab at 600 mg on day 1 and will undergo surgery within 7 days of day 15. The post-operative follow-up is approximately 30 days after surgery, and patients will received standard-of-care follow-up.

The primary end points are safety and feasibility and major pathological response rate. Secondary end points include time to surgery, pathological complete response rate, event-free survival, and overall survival.

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Tali Azenkot, MD, discusses the rationale for combining dupilumab with cemiplimab in early-stage, resectable non–small cell lung cancer.

Tali Azenkot, MD

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Dr Azenkot on Dupilumab Plus Cemiplimab in Early-Stage, Resectable NSCLC