SKIPPirr Study: Dexamethasone Pre-med Cuts Infusion Reactions with Amivantamab
New results from the SKIPPirr trial show that giving an 8 mg pre-medication dose of dexamethasone before intravenous amivantamab significantly lowers infusion-related reactions (IRRs) in people with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. With this approach, the IRR rate dropped to 22.5 percent—far below the 67.4 percent historically seen with prior standard management.
Amivantamab at a Glance
Amivantamab is a fully human bispecific antibody designed to target tumors with activating and resistance mutations of EGFR, as well as MET mutations and amplifications. While it has drawn attention for its clinical activity, infusion-related reactions have been a known concern, a point also noted by the European Medicines Agency (EMA). Reducing those reactions—without compromising treatment—has remained a practical priority for clinicians and patients alike.
What the SKIPPirr Trial Tested
SKIPPirr was an open-label Phase 2 study evaluating added prophylactic strategies to curb IRRs with IV amivantamab. Participants received oral dexamethasone over the two days leading up to their first infusion; pairing that with an 8 mg pre-medication dose produced a marked cut in IRRs. The trial also explored three other arms—lower-dose 4 mg dexamethasone, montelukast, and methotrexate—but those groups were discontinued for lack of efficacy.
What the Results Mean
All IRRs recorded in the study were Grade 1 or 2. No hospitalizations occurred. Symptoms, when present, were mild and included effects such as nausea and hypotension. In plain terms, the regimen not only reduced how often reactions happened but also kept them on the mild end of the spectrum.
Expert Perspective
Dr. Gilberto Lopes, Associate Director of Global Oncology at the Sylvester Comprehensive Cancer Center, expressed optimism about these findings. He noted that using a higher dose of dexamethasone improved the treatment experience and substantially lowered the expected IRR rate. The result aligns with Johnson & Johnson’s ongoing focus on improving care quality for people living with EGFR-mutated NSCLC.
Where Research Goes Next
Work continues to identify and test additional prophylactic strategies for patients receiving amivantamab. The aim is straightforward: fewer side effects, fewer interruptions, and a smoother course of care.
Continued Commitment to Better Treatment
Across teams at Johnson & Johnson, there’s a clear emphasis on patient-centered research. Studies like SKIPPirr help refine how therapies are delivered and minimize adverse reactions, so patients can stay on treatment with greater confidence and comfort.
Frequently Asked Questions
What is the SKIPPirr study?
SKIPPirr is a Phase 2, open-label clinical trial that assessed prophylactic strategies to reduce infusion-related reactions in patients treated with intravenous amivantamab. It focused on practical measures that could be used right before and around the first infusion.
What are infusion-related reactions (IRRs)?
IRRs are unwanted responses that occur during or after an IV infusion. They can include symptoms such as fever, chills, nausea, and hypotension. Most reactions seen in this study were mild (Grade 1–2).
What was the primary finding?
An 8 mg prophylactic dose of dexamethasone, given before amivantamab, substantially reduced IRRs—from a historically reported 67.4% down to 22.5% in this setting. Notably, no patients required hospitalization for these reactions.
Who may benefit from this approach?
Patients with advanced non-small cell lung cancer who have EGFR mutations and are receiving intravenous amivantamab may benefit from this dexamethasone pre-medication regimen. The goal is fewer reactions and a smoother start to therapy.
What is Johnson & Johnson’s role here?
Johnson & Johnson supports research to improve cancer care and reduce complications from treatment. Through efforts like the SKIPPirr study, teams explore practical ways to deliver therapies while minimizing infusion-related reactions.
