Johnson & Johnson's Mid-Stage Lung Cancer Trial Reveals Fewer Infusion-Related Reactions

Tuesday, Johnson & Johnson 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-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.

Data were presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC).

The 40-patient study showed that prophylaxis with 8-mg dexamethasone taken for two days before 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%.

This represents a three-fold reduction in the incidence of IRRs compared to standard management of IRRs with IV Rybrevant, where historical data has observed an all-grades incidence rate of 67.4%.

All IRRs were mild or moderate (Grade 1 or 2), with no patients requiring hospitalization due to IRRs. No Grade 3 or higher IRR events were reported.

Over the last weekend, Johnson & Johnson presented longer follow-up data from the landmark Phase 3 MARIPOSA study which showed first-line treatment with Rybrevant combined with Lazcluze (lazertinib) provided consistent benefit across long-term outcomes compared to osimertinib monotherapy in adult NSCLC patients with EGFR exon 19 deletions or L858R substitution mutations.

The data show a strong and improving overall survival (OS) trend favoring Rybrevant plus Lazcluze at approximately three years of follow-up.

• 61% of patients receiving Rybrevant plus Lazcluze were alive compared to 53% of those treated with osimertinib (Median OS not estimable vs 37.3 months).

Overall survival will continue to be assessed with longer term follow-up as a key secondary endpoint.

Results further showed Rybrevant plus Lazcluze demonstrated a trend toward improved central nervous system disease control compared to osimertinib at three years.

• Intracranial PFS was double for Rybrevant plus Lazcluzeversus osimertinib (38% vs. 18%, respectively).

More patients remained on treatment with the Rybrevant plus Lazcluze combination compared to osimertinib (40% vs. 29%).

Additionally, more patients receiving Rybrevant plus Lazcluze at the three-year follow-up had not started a subsequent therapy versus osimertinib (45% vs. 32%).

Progression-free survival after the first subsequent therapy was 57% for Rybrevant plus Lazcluze combination compared to 49% for osimertinib.

In August 2024, the FDA approved Rybrevant plus Lazcluze following a Priority Review as a first-line therapy for patients with EGFR-mutated NSCLC based on the favorable efficacy and safety profile demonstrated in this study.

Price Action: JNJ stock is up 0.09% at $167.53 during the premarket session at last check Wednesday.

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