Johnson & Johnson announces dexamethasone reduces infusion-related reactions in patients with EGFR-mutated non-small cell lung cancer treated with intravenous Rybrevant (amivantamab-vmjw)

The study, which included 40 patients, showed that prophylaxis with 8-mg dexamethasone taken for two days prior to the first infusion met the primary endpoint of incidence of IRRs at Cycle 1 Day 1 (C1D1), with an all-grades IRR rate for IV Rybrevant of 22.5 percent.  This represents a three-fold reduction in the incidence of IRRs compared to standard management of IRRs with IV Rybrevant, where historic data has observed an all-grades incidence rate of 67.4 percent.  Data were presented as a mini-oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC).

“These data offer important insights that may help improve the patient experience with intravenous amivantamab treatment,” said Gilberto Lopes, M.D., associate director of global oncology at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, and presenting author. “This study shows us that an easily accessible approach of an increased dose regimen of dexamethasone as a pre-treatment prophylaxis can potentially help lower IRRs. It is encouraging to see a three-fold decrease in IRRs, when comparing the rates in SKIPPirr to historical data.”

In the study, patients received an at-home regimen of oral dexamethasone, taking an 8-mg dose twice daily on the two prior days and one hour prior to receiving IV Rybrevant.  The Rybrevant treatment was combined with Lazcluze (lazertinib). All IRRs were Grade 1 or 2 with no patients requiring hospitalization due to IRRs. There were no Grade 3 or higher IRR events reported. The safety profile of Rybrevant and Lazcluze with prophylactic dexamethasone at the initiation of treatment is consistent with previous studies, showing no significant increase in adverse events. The most common IRR-related symptoms observed in the study were nausea (8 percent), dyspnea (5 percent) and hypotension (5 percent).

“Reducing the risk of IRRs is a critical aspect of improving the overall treatment experience for patients receiving intravenous Rybrevant and oral Lazcluze,” said Mark Wildgust, Ph.D., Vice President of Oncology Global Medical Affairs, Johnson & Johnson Innovative Medicine. “Incorporating oral dexamethasone into the treatment regimen suggests we can help mitigate this risk, with the goal of allowing patients to continue their therapy with fewer interruptions.”

Additional studies are ongoing to evaluate prophylactic strategies to reduce IRRs for patients receiving IV Rybrevant.