2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.12A.35 A Phase I Open-label Study Ofnimotuzumab with Nivolumab in Advanced Non-Small Cell Lung Cancer or Head and Neck Squamous Cell Cancer

EP.12A.35 A Phase I Open-label Study Ofnimotuzumab with Nivolumab in Advanced Non-Small Cell Lung Cancer or Head and Neck Squamous Cell Cancer

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This Phase I open-label study, led by Dr. Syed Ather Hussain and team, investigates the combination of Nimotuzumab, an EGFR-targeting antibody, and Nivolumab, an anti-PD-1 agent, in patients with advanced non-small cell lung cancer (NSCLC) or head and neck squamous cell cancer (HNSCC). NSCLC is characterized by overexpression of EGFR, contributing to poor prognosis with a 5% five-year survival rate. The rationale for this study is rooted in preclinical findings suggesting a link between EGF and PD-L1 signaling pathways.<br /><br />Eligible participants had unresectable NSCLC or HNSCC and had undergone prior treatment with platinum-based chemotherapy, with or without immune-oncology (IO) or targeted therapies. The trial, conducted at a single center using a single-arm, non-randomized 3+3 dose escalation design, involved administering increasing doses of Nimotuzumab (200-400 mg) alongside a consistent 240 mg dose of Nivolumab biweekly in 28-day cycles. Treatment was pursued until disease progression, unacceptable toxicity, or patient withdrawal.<br /><br />The study's disease control rate (DCR) was 42.9%, with stable disease as the best outcome, a decrease from 64.1% seen in prior, IO-naïve settings. Notably, 71.4% of participants had received prior IO, influencing results. The study identified that 57.1% of patients had elevated troponin levels, potentially indicating a novel toxicity, although most were asymptomatic. The only symptomatic patient experienced angina pectoris. Given the competitive therapeutic landscape and lack of strong efficacy signals, further development of this treatment combination was halted.<br /><br />The research provides insights into treatment tolerability and potential new toxicities but suggests limited efficacy in previously IO-exposed patient populations.

Asset Subtitle

Ather Hussain Syed

Meta Tag

Speaker Ather Hussain Syed

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

Phase I study

Nimotuzumab

Nivolumab

NSCLC

HNSCC

EGFR

PD-1

disease control rate

troponin levels

treatment toxicity