Sie sind bereits registriert?
Loggen Sie sich mit Ihrem Universimed-Benutzerkonto ein:
Sie sind noch nicht registriert?
Registrieren Sie sich jetzt kostenlos auf universimed.com und erhalten Sie Zugang zu allen Artikeln, bewerten Sie Inhalte und speichern Sie interessante Beiträge in Ihrem persönlichen Bereich zum späteren Lesen. Ihre Registrierung ist für alle Unversimed-Portale gültig. (inkl. allgemeineplus.at & med-Diplom.at)
Amivantamab plus Chemotherapy: New Standard for EGFR Exon 20–Mutated NSCLC
Amivantamab monotherapy has been approved for the treatment of patients with advanced non–small-cell lung cancer (NSCLC) with EGFR exon 20 insertions who have had disease progression after platinum-based chemotherapy. In the industry-supported, international, randomized, phase 3 PAPILLON trial, researchers compared first-line therapy with amivantamab plus platinum-based chemotherapy versus chemotherapy alone in 308 patients with EGFR exon 20 insertion–mutated advanced NSCLC.
Amivantamab was given weekly for 4 weeks then every 3 weeks until disease progression. Chemotherapy consisted of carboplatin and pemetrexed given for 4 cycles followed by maintenance pemetrexed given every 3 weeks until disease progression.
At a median follow-up of 14.9 months, median progression-free survival (PFS) — the primary outcome — was 11.4 months with amivantamab–chemotherapy versus 6.7 months with chemotherapy alone (hazard ratio, 0.40; 95% CI 0.30–0.53; P< 0.001). PFS rates were higher with combination therapy at 6 months (77% vs. 51%), 12 months (48% vs. 13%), and 18 months (31% vs. 3%,). The objective response rate was also significantly improved with amivantamab–chemotherapy compared with chemotherapy alone (73% vs. 47%; rate ratio 1.5; P<0.001). Overall survival was not yet mature at the time of the interim analysis.
The predominant adverse events associated with amivantamab–chemotherapy were reversible hematologic and EGFR-related toxic events that required frequent dose interruptions and led to discontinuation of therapy in 7% of patients.
Based on the findings of improved response rate and PFS with first-line amivantamab–chemotherapy compared with chemotherapy alone, this combination therapy represents a new standard of care for patients with EGFR exon 20–mutated NSCLC. However, there are significant toxicities associated with this regimen and adverse effects must be managed aggressively. With amivantamab moving to first-line use and with the withdrawal of mobocertinib from the market, the optimal second-line therapy for these patients remains unknown.
Zhou C et al.
Title: Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions.
Source: N Engl J Med 2023 Oct 21; [e-pub]. (Abstract/FREE Full Text)