Summary

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• This summary is based on the review of two randomized controlled trial(s). ^[1-2]
• Amivantamab-containing regimens significantly improved PFS (Progression-Free Survival) compared to chemotherapy alone. One study reported hazard ratios (HR) for disease progression or death of 0.48 and 0.44 (P < 0.001), with median PFS of 6.3 and 8.3 months, respectively, compared to 4.2 months for chemotherapy alone. Another study reported a median PFS of 11.4 months for amivantamab-chemotherapy versus 6.7 months for chemotherapy alone (HR: 0.40, 95% CI (33% maturity): 0.30-0.53, P < 0.001).
• ORR (Overall Response Rate) was significantly higher in amivantamab-containing regimens. One study reported ORRs of 64% and 63% for amivantamab-chemotherapy combinations compared to 36% for chemotherapy alone (P < 0.001). Another found a response rate of 73% for amivantamab-chemotherapy compared to 47% for chemotherapy alone (rate ratio: 1.50, 95% CI: 1.32-1.68, P < 0.001).
• Amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy also prolonged intracranial PFS. One study reported median intracranial PFS of 12.5 and 12.8 months, respectively, compared to 8.3 months for chemotherapy alone. The HR for intracranial disease progression or death was 0.55 and 0.58, respectively.
• Hematologic and EGFR (Funded by Janssen Research and Development; PAPILLON ClinicalTrials.gov number, NCT04538664.)-related toxicities were predominant in amivantamab-containing regimens. In one study, the amivantamab-lazertinib-chemotherapy group had higher hematologic adverse events (AEs) than the amivantamab-chemotherapy group, but both groups experienced significant toxicities. Another study reported that 7% of patients discontinued amivantamab due to adverse reactions, with reversible hematologic and EGFR-related toxicities being the most common.
• Amivantamab-containing regimens had more toxicities compared to chemotherapy alone. Specifically, one study highlighted that significant hematologic toxicities in the amivantamab-lazertinib-chemotherapy group necessitated a regimen change.
• One study included patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) (exon 19 deletions or L858R). Consistent progression-free survival (PFS) outcomes were observed in patients with a history of brain metastases and prior brain radiation. Another study focused on patients with advanced NSCLC harboring EGFR exon 20 insertions, who had not received prior systemic therapy. No specific subgroup findings were highlighted.