Johnson & Johnson (JNJ) has announced encouraging results for its lung cancer treatment, Rybrevant (amivantamab-vmjw), showcasing its potential to revolutionize the fight against this deadly disease.
In a recent open-label Phase 2 study, known as SKIPPirr, researchers evaluated strategies to reduce infusion-related reactions (IRRs) experienced by patients receiving IV Rybrevant. The study, presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC), involved 40 patients with advanced non-small cell lung cancer (NSCLC) harboring specific mutations. The primary endpoint, the incidence of IRRs at the first infusion, was met when a prophylactic regimen of 8 mg dexamethasone taken for two days prior to the first infusion led to a significant reduction in IRRs. The all-grades IRR rate for IV Rybrevant decreased to 22.5%, representing a three-fold reduction compared to historical data showing a 67.4% incidence rate. Importantly, all IRRs were mild or moderate, with no patients requiring hospitalization.
Building upon these promising results, Johnson & Johnson also presented longer follow-up data from the landmark Phase 3 MARIPOSA study. This study evaluated Rybrevant in combination with Lazcluze (lazertinib) as a first-line treatment for NSCLC patients with EGFR exon 19 deletions or L858R substitution mutations, comparing it to osimertinib monotherapy.
The long-term data, encompassing approximately three years of follow-up, revealed compelling results. Patients receiving Rybrevant plus Lazcluze exhibited a consistent benefit across various outcomes, including overall survival (OS). At three years, 61% of patients treated with the combination were still alive, compared to 53% of those receiving osimertinib. While the median OS was not estimable for the Rybrevant plus Lazcluze group, it was 37.3 months for the osimertinib group. This data underscores the potential of Rybrevant plus Lazcluze to significantly extend the lives of patients with this form of lung cancer.
The study also indicated a trend toward improved central nervous system disease control with Rybrevant plus Lazcluze compared to osimertinib. The intracranial progression-free survival (PFS) was double for the combination therapy (38%) compared to osimertinib (18%). Furthermore, a greater proportion of patients remained on treatment with Rybrevant plus Lazcluze (40%) compared to osimertinib (29%), highlighting the combination’s potential for sustained therapeutic benefit.
These encouraging results led the FDA to approve Rybrevant plus Lazcluze as a first-line therapy for patients with EGFR-mutated NSCLC in August 2024, following a Priority Review. This approval underscores the significance of these findings and the potential of this combination therapy to significantly improve treatment outcomes for this patient population.
The ongoing positive results for Rybrevant, both as a single agent and in combination with Lazcluze, position it as a promising treatment option for patients with EGFR-mutated NSCLC. The data suggests that Rybrevant can effectively target the disease, improve survival, and enhance quality of life for patients. As research continues, we can anticipate further breakthroughs and advancements in lung cancer treatment, offering hope to millions of individuals facing this challenging disease.
