The results from the open-label Phase 2 SKIPPirr study have been announced, which evaluated additional prophylactic strategies to reduce the incidence of infusion-related reactions (IRRs) with intravenous (IV) amivantamab-vmjw in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.

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 amivantamab-vmjw of 22.5 percent.

This represents a three-fold reduction in the incidence of IRRs compared to standard management of IRRs with IV amivantamab-vmjw, where historic data has observed an all-grades incidence rate of 67.4 percent.1,2 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 amivantamab-vmjw. The amivantamab-vmjw treatment was combined with 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 amivantamab-vmjw and lazertinib 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 amivantamab-vmjw and oral lazertinib," 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 amivantamab-vmjw. For more details and to view an infographic summarizing the study's findings and dosing regimen, click here.

Source: Johnson & Johnson