2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.12H.02 Amivantamab, An EGFR-MET Bispecific Antibody, with Cetrelimab, An Anti-PD-1 Antibody, In Advanced NSCLC: Phase 1/2 Polydamas

EP.12H.02 Amivantamab, An EGFR-MET Bispecific Antibody, with Cetrelimab, An Anti-PD-1 Antibody, In Advanced NSCLC: Phase 1/2 Polydamas

Back to course

Pdf Summary

The document pertains to the Phase 1/2 PolyDamas study evaluating amivantamab, an EGFR-MET bispecific antibody, in combination with cetrelimab, an anti-PD-1 antibody, in patients with advanced non-small cell lung cancer (NSCLC). This study addresses potential resistance mechanisms in EGFR-mutated NSCLC, where PD-1/PD-L1 pathways become upregulated, diminishing treatment effectiveness. The combination of amivantamab and cetrelimab targets both the innate and adaptive immune responses, aiming to improve antitumor activity.<br /><br />The PolyDamas study is an open-label, multicenter clinical trial designed with two phases: a combination dose selection phase (Phase 1) and an expansion phase (Phase 2). This trial is conducted across locations in Brazil, Malaysia, the Republic of Korea, Turkey, and the United States, with a total enrollment target of 80 patients. Phase 1 involves dose escalation to determine the recommended phase 2 combination dose (RP2CD), using Bayesian optimal interval design to manage dose-limiting toxicities. Phase 2 aims to assess the antitumor efficacy of the determined dose.<br /><br />The study includes specific inclusion and exclusion criteria, such as confirmed metastatic NSCLC for participants and no previous anti-PD-1/PD-L1 treatment, especially for those with EGFR mutations. Important exclusion criteria involve existing uncontrolled illnesses, previous relevant therapies, and significant cardiovascular diseases.<br /><br />The primary objective for Phase 1 is identifying the RP2CD while evaluating safety and tolerability. Phase 2 focuses on assessing the antitumor impact using objective response rate (ORR) metrics and secondary endpoints such as progression-free survival (PFS) and overall survival (OS). The study’s exploratory nature means it is hypothesis-generating with no formal statistical hypotheses, and data from each phase are analyzed separately, using time-to-event variables like Kaplan-Meier methods.<br /><br />The PolyDamas study is registered under ClinicalTrials.gov with Identifier NCT05908734, supported by Janssen Research & Development, LLC, and ongoing recruitment aims to deliver new insights into treatment regimens for NSCLC.

Asset Subtitle

Joshua Bauml

Meta Tag

Speaker Joshua Bauml

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

PolyDamas study

amivantamab

cetrelimab

EGFR-MET bispecific antibody

non-small cell lung cancer

PD-1/PD-L1 pathways

clinical trial

dose escalation

antitumor efficacy

Janssen Research & Development