Johnson & Johnson announces SKIPPirr study meets primary endpoint

Johnson & Johnson announced results from the open-label Phase 2 SKIPPirr study, which evaluated additional prophylactic strategies to reduce the incidence of infusion-related reactions, or IRRs, with intravenous, or IV, Rybrevant in patients with advanced non-small cell lung cancer, or NSCLC, with epidermal growth factor receptor, or EGFR, exon 19 deletions 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, or C1D1, with an all-grades IRR rate for IV Rybrevant of 22.5%. 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%. 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. 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, dyspnea and hypotension.