A Phase 3 study evaluating amivantamab and lazertinib combination therapy for non-small cell lung cancer (NSCLC) reached primary completion on 2023-08-11, with results showing a median progression-free survival of 23.72 months for the combination compared to 16.59 months for osimertinib. The trial demonstrated a statistically significant improvement in PFS, with a hazard ratio of 0.7 (p=0.0002).
Background
The study investigated amivantamab and lazertinib combination therapy for participants with epidermal growth factor receptor (EGFR) mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). Specifically, it targeted patients with Exon 19 deletions or Exon 21 L858R substitution mutations. The combination was compared against osimertinib, an established therapy for this patient population.
Trial design
The Phase 3 study (NCT04487080) enrolled 1074 participants with non-small cell lung cancer. The trial's primary objective was to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with EGFR mutation (Exon 19del or Exon 21 L858R substitution) positive, locally advanced or metastatic NSCLC. The study included an experimental arm of amivantamab + lazertinib, an active comparator arm of osimertinib + placebo, and another experimental arm of lazertinib + placebo.
Key results
The trial reported key results for Progression-Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST Version 1.1:
- In the Experimental: Arm A (Open-label): Amivantamab + Lazertinib group, the median PFS was 23.72 Months.
- In the Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib group, the median PFS was 16.59 Months.
- In the Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib group, the median PFS was 18.46 Months.
What this means
The primary completion of this Phase 3 study indicates that the combination of amivantamab and lazertinib significantly extended progression-free survival in patients with EGFR mutation-positive, locally advanced or metastatic non-small cell lung cancer compared to osimertinib. The median PFS of 23.72 months for the combination versus 16.59 months for osimertinib, coupled with a statistically significant hazard ratio of 0.7 (p=0.0002), suggests a meaningful clinical benefit. This outcome could potentially offer a new treatment option for this patient population, warranting further evaluation for regulatory consideration.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The primary completion status for the study NCT04487080, titled 'A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer', was updated on 2023-08-11 on clinicaltrials.gov.