Johnson & Johnson (J&J) has shared positive longer-term data for its chemotherapy-free combination, Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib), in adults with non-small cell lung cancer (NSCLC).
The announcement comes less than three weeks after the regimen was approved by the US Food and Drug Administration as a first-line therapy for NSCLC patients with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
The phase 3 MARIPOSA trial, which supported the regulator’s decision, has been evaluating Rybrevant, an EGFRxMET bispecific antibody, plus Lazcluze, a third-generation EGFR tyrosine kinase inhibitor (TKI), compared to AstraZeneca’s own third-generation EGFR-TKI Tagrisso (osimertinib) in this patient population.
According to new results presented at this year’s World Conference on Lung Cancer, 61% of patients receiving Rybrevant plus Lazcluze were alive, compared to 53% of those randomised to receive Tagrisso, after a median follow-up of 31.1 months.
J&J’s combination also demonstrated a trend toward improved central nervous system disease control compared to Tagrisso, and more patients receiving the regimen remained on treatment and had not started subsequent therapy at the three-year follow-up.
Overall survival will continue to be assessed with longer term follow-up as a key secondary endpoint, the company said.
NSCLC accounts for up to 85% of all lung cancer cases, and alterations in EGFR are among the most common actionable driver mutations in patients with this form of the disease.
Up to 39% of those with EGFR-mutated NSCLC never receive second-line therapy due to disease progression and lack of treatment options, with acquired resistance mechanisms after standard of care TKI monotherapy making subsequent treatment more difficult.
“By combining the multi-targeted mechanism of Rybrevant with Lazcluze, a central nervous system-penetrant third-generation TKI, we are advancing a chemotherapy-free regimen for the first-line treatment of patients with EGFR-mutant NSCLC,” said presenting author Shirish Gadgeel, Henry Ford Cancer Institute. “This approach blocks EGFR and MET pathways and leverages the immune system, offering patients an opportunity for prolonged benefits.”
Joshua Bauml, vice president, lung cancer disease area stronghold leader, J&J Innovative Medicine, added that company is “encouraged” by the favourable overall survival trend observed with Rybrevant plus Lazcluze and is “eager” to see how the data evolves over time.