J&J's Dexamethasone Regimen Reduces Infusion Reactions In EGFR-Mutated NSCLC Patients On RYBREVANT

(RTTNews) - Janssen-Cilag International NV, a Johnson & Johnson company (JNJ), announced results from the open-label Phase 2 SKIPPirr study, which evaluated additional prophylactic strategies to reduce the incidence of infusion-related reactions (IRRs) with intravenous (IV) RYBREVANT (amivantamab) in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutation.

According to the company, the 8 mg pre-medication regimen showed an infusion-related reaction rate of 22.5 percent with intravenous amivantamab, a three-fold reduction from 67.4 percent historically seen with standard IRR management.

Many monoclonal antibodies are associated with increased rates of IRRs and IRRs with amivantamab are of special interest to the European Medicines Agency (EMA).

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 of 22.5 percent.

There were three additional arms to the study exploring different prophylactic regimens: group 1 (dexamethasone 4 mg, one dose taken orally twice daily on the day before treatment ), group 3 (montelukast 10 mg, five doses starting four days before treatment and continuing through the day of treatment) and group 4 (methotrexate 25 mg subcutaneous injection, administered between days 7 and 3 before treatment). Group 1, 3 and 4 were stopped for futility.

The results of group 2 (dexamethasone 8 mg, taken for two days prior to infusion) showed a three-fold reduction in the incidence of IRRs compared to standard management of IRRs with IV amivantamab, where historic data has observed an all-grades incidence rate of 67.4 percent.

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