Amivantamab-vmjw shows durable activity in subgroup of patients with advanced NSCLC
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Amivantamab-vmjw conferred long-term clinical response in patients with advanced non-small cell lung cancer and EGFR exon 20 insertion mutations, according to data from the agent’s manufacturer.
Researchers observed the benefit with amivantamab-vmjw (Rybrevant, Janssen), an EGFR and MET bispecific antibody, specifically among patients whose disease had progressed on previous platinum-based chemotherapy. The agent previously received FDA accelerated approval for this indication.
The long-term results of the open-label, multicenter, ongoing phase 1 CHRYSALIS study, presented at 2023 European Lung Cancer Congress, also showed no new safety signals.
“With these new data, amivantamab showed long-term consistent efficacy regardless of prior therapies or response to prior platinum chemotherapy,” Pilar Garrido, MD, associate professor of medical oncology at Universidad de Alcalá, head of medical oncology department at the University Hospital Ramón y Cajal in Madrid and principal investigator, said in a Janssen press release. “Due to the aggressive nature of NSCLC with EGFR exon 20 insertion mutations, treatment with targeted therapies is an important consideration when identifying a treatment option for patients.”
The CHRYSALIS trial evaluated the safety, pharmacokinetics and preliminary efficacy of amivantamab-vmjw as both monotherapy and in combination with the third-generation EGFR tyrosine kinase inhibitor lazertinib (Janssen) for patients with advanced NSCLC and EGFR exon 20 mutations who had progressed on prior platinum-based chemotherapy.
The current analysis included 114 patients with NSCLC and EGFR exon 20 mutations who received amivantamab-vmjw monotherapy at the approved phase 2 doses of 1,050 mg for patients weighing below 80 kg and 1,400 mg for patients weighing 80 kg or more.
Overall response rate served as the primary endpoint. Secondary endpoints included duration of response, clinical benefit rate, PFS and OS.
Median follow-up was 19.2 months.
Results showed an investigator-assessed ORR of 37% (95% CI, 28-46), median duration of response of 12.5 months (95% CI, 6.9-19.3), median PFS of 6.9 months (95% CI, 5.6-8.8), median OS of 23 months (95% CI, 18.5-29.5) and a 2-year OS rate of 47%.
Forty-eight patients (42%) experienced sustained clinical response measured by ORR on amivantamab-vmjw through at least 12 treatment cycles.
Researchers reported a median duration of treatment of 7.5 months, and 15 patients (13%) have remained on treatment for a median 2.6 years.
The most common treatment-emergent adverse events included rash (89%), infusion-related reactions (67%) and paronychia (58%).
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