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Long-term Benefit of Amivantamab Continues in Postplatinum NSCLC

*May 2023*

Long-term data from the CHRYSALIS trial (NCT02609776) continued to demonstrate clinical benefit for amivantamabvmjw (Rybrevant), according to findings presented at the European Lung Cancer Congress 2023 in Copenhagen, Denmark.1

At a median follow-up of 19.2 months, median progression-free survival (PFS) with the agent was 6.9 months (95% CI, 5.6-8.8), and the 2-year PFS rate was 13.7%. Median overall survival (OS) was 23 months (95% CI, 18.5-29.5), and the 2-year landmark OS rate was 47.2%.

Moreover, amivantamab elicited an objective response rate (ORR) of 37% (95% CI, 28%-46%) per investigator assessment, with a median duration of response (DOR) of 12.5 months (95% CI, 6.9-19.3). Notably, its efficacy was consistent irrespective of previous therapies or response to prior platinum chemotherapy.

Forty-two percent of patients (n = 48/114) were reported to have sustained clinical benefit with amivantamab, having received it for 12 or more cycles. Thirteen percent of these patients had been receiving the agent for a median of 2.6 years and were still receiving it. At the time of data cutoff (September 12, 2022), 7 patients were progression free and 8 were receiving treatment beyond disease progression.

“Sustained clinical benefit with [amivantamab]…for 12 cycles [or more] was associated with having a good performance status, [namely an] ECOG [of 0]…a response according to RECIST criteria, and not having a baseline alteration in the RAS/RAF/MEK pathway,” said Pilar Garrido López, MD, PhD, lead study author and associate professor of medical oncology at Universidad de Alcalá, in Madrid, Spain, at the meeting.

In May 2021, the FDA granted accelerated approval to amivantamab for use in adults with NSCLC whose tumor harbors EGFR exon 20 insertion mutations and whose disease had progressed on platinum-based chemotherapy.2 The decision was based on earlier data from CHRYSALIS (n = 81), in which the agent induced an ORR of 40% (95% CI, 29%-51%) with a median DOR of 11.1 months (95% CI, 6.9-not evaluable).

The open-label, phase 1 study enrolled patients with metastatic or unresectable NSCLC who had an ECOG performance status of 0 or 1 and had progressed on or were not able to receive standard treatment.3 For the dose-expansion phase of the trial, patients were required to have measurable disease and qualifying EGFR or MET mutations identified via next-generation sequencing. Those with untreated or active brain metastases were excluded. Read more.