Primary completion results for a Phase 3 study evaluating amivantamab and lazertinib in combination with platinum-based chemotherapy for EGFR-mutated non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2023-07-10. The data showed that the combination of lazertinib, amivantamab, and chemotherapy achieved a median progression-free survival (PFS) of 8.31 months, compared to 4.17 months for chemotherapy alone.
Background
The study investigated amivantamab, a bispecific antibody, and lazertinib, a third-generation EGFR tyrosine kinase inhibitor, in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). Specifically, the trial focused on patients with EGFR Exon 19del or Exon 21 L858R substitution mutations who had experienced disease progression after prior treatment with osimertinib.
Trial design
The Phase 3 study (NCT04988295) enrolled 776 participants with Carcinoma, Non-Small-Cell Lung. The trial's primary purpose was to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies), or amivantamab, carboplatin, and pemetrexed (ACP), compared with carboplatin and pemetrexed (CP) alone. The primary outcome measure was Progression-free Survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as assessed by Blinded Independent Central Review (BICR).
Key results
The trial reported the following median progression-free survival (PFS) results:
- For the Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L) arm, the median PFS was 8.31 months.
- For the Amivantamab + Carboplatin + Pemetrexed (ACP) arm, the median PFS was 6.28 months.
- For the Carboplatin + Pemetrexed (CP) arm, the median PFS was 4.17 months.
Key analyses demonstrated significant improvements in PFS:
- Comparing LACP/ACP-L to CP, the Hazard Ratio (HR) was 0.44 (95% Confidence Interval: 0.35 to 0.56), with a p-value of 0.0001.
- Comparing ACP to CP, the Hazard Ratio (HR) was 0.48 (95% Confidence Interval: 0.36 to 0.64), with a p-value of 0.0001.
What this means
These results indicate that both regimens containing amivantamab, particularly the triple combination with lazertinib, significantly improved progression-free survival compared to standard platinum-based chemotherapy in patients with EGFR-mutated NSCLC after osimertinib failure. The median PFS of 8.31 months for the amivantamab and lazertinib combination arm represents a substantial increase over the 4.17 months observed with chemotherapy alone, suggesting a clinically meaningful benefit for this challenging patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04988295, titled "A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure", were posted on 2023-07-10 on clinicaltrials.gov.