A Phase 3 study evaluating amivantamab in combination with chemotherapy for participants with advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20 insertions reached its primary completion on 2023-05-03. The trial demonstrated a significant improvement in progression-free survival (PFS), with the amivantamab combination arm achieving a median PFS of 11.37 Months compared to 6.70 Months for chemotherapy alone, corresponding to a hazard ratio of 0.395 (p=0.0001).
Background
This study investigated amivantamab, a therapeutic agent, in participants diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC). The specific patient population for this trial was characterized by the presence of epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.
Trial design
The Phase 3 study (NCT04538664) enrolled 308 participants with Carcinoma, Non-Small-Cell Lung. The trial's primary objective was to compare the efficacy of amivantamab in combination with carboplatin-pemetrexed therapy against carboplatin-pemetrexed therapy alone. The primary endpoint for efficacy assessment was Progression-Free Survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, evaluated by Blinded Independent Central Review (BICR).
Key results
The trial reported the following key measurements for progression-free survival:
- For participants in the Arm A: Amivantamab + Chemotherapy group, the median Progression-Free Survival (PFS) was 11.37 Months.
- For participants in the Arm B: Chemotherapy Alone group, the median Progression-Free Survival (PFS) was 6.70 Months.
A key analysis using the Log Rank method determined a Hazard Ratio (HR) of 0.395, with a 95.0% Confidence Interval ranging from 0.296 to 0.528. The p-value for this analysis was 0.0001.
What this means
The results indicate that the combination of amivantamab with chemotherapy significantly extends progression-free survival for patients with advanced or metastatic non-small cell lung cancer characterized by EGFR Exon 20 insertions. The median PFS of 11.37 Months with the combination therapy, compared to 6.70 Months with chemotherapy alone, along with a statistically significant hazard ratio of 0.395 (p=0.0001), suggests a substantial clinical benefit. This finding could support amivantamab as an important treatment option for this specific patient population.
Source
The information regarding this trial's primary completion and results was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT04538664, titled "A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions", was updated on 2023-05-03 on clinicaltrials.gov.