Lazcluze

Oncology· 872 cited findings· 1 source document

What the regulatory reviews say

Lazcluze is indicated in combination with amivantamab for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. A Marketing Authorisation Application was submitted on 21 December 2023, and a positive opinion was issued by the CHMP on 14 November 2024, recommending marketing authorisation.

In a pivotal study (73841937NSC3003 (MARIPOSA)) with a total enrolment of 1074 patients, the combination of amivantamab + lazertinib demonstrated a median PFS of 23.72 months, compared to 16.59 months for the osimertinib arm (PFS HR: 0.70; 95% CI: 0.58, 0.85; p-value: 0.0002). When compared to the lazertinib arm, which had a median PFS of 18.46 months, the combination showed a PFS HR of 0.72 (95% CI: 0.57, 0.90; p-value: 0.0046).

Safety findings include a human steady-state AUC0-24h at the recommended dose of 6541.96 h.ng/mL. The qualified level for the JNJ-75182640 impurity is 6.0%. In toxicology studies, the single dose toxicity (MTD) was 600 mg/kg/day, and mortality was observed at 2000 mg/kg/day. Mortality in female rats occurred at doses of 50 and 100 mg/kg/day, and in male dogs at 8 and 20 mg/kg/day. The NOAEL for male and female rats in 4-week toxicity studies was 25 mg/kg/day.

Key figures — cited to the source page

PFS HR (amivantamab + lazertinib vs osimertinib)	0.70	Johnson & Johnson — Lazcluze EMA EPAR public assessment repo, p.92
PFS 95% CI (amivantamab + lazertinib vs osimertinib)	0.58, 0.85	Johnson & Johnson — Lazcluze EMA EPAR public assessment repo, p.92
PFS p-value (amivantamab + lazertinib vs osimertinib)	0.0002	Johnson & Johnson — Lazcluze EMA EPAR public assessment repo, p.92
Median PFS (amivantamab + lazertinib arm)	23.72	Johnson & Johnson — Lazcluze EMA EPAR public assessment repo, p.91
Median PFS (osimertinib arm)	16.59	Johnson & Johnson — Lazcluze EMA EPAR public assessment repo, p.91
human steady-state AUC0-24h at recommended dose	6541.96	Johnson & Johnson — Lazcluze EMA EPAR public assessment repo, p.36
JNJ-75182640 impurity qualified level	6.0	Johnson & Johnson — Lazcluze EMA EPAR public assessment repo, p.37
CHMP Positive Opinion Date	14 November 2024	Johnson & Johnson — Lazcluze EMA EPAR public assessment repo, p.9

Source documents

Johnson & Johnson — Lazcluze EMA EPAR public assessment report (EMEA/H/C/006074, 2025) (2025)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.