FDA Approves Lazcluze Plus Rybrevant for Lung Cancer Subset

The Food and Drug Administration (FDA) approved Lazcluze (lazertinib) plus Rybrevant (amivantamab-vmj) for the frontline treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test, the agency announced.

The approval is based on findings from the randomized MARIPOSA trial, which included 1,074 patients who were randomly assigned to receive Lazcluze plus Rybrevant; Tagrisso (osimertibib) alone; or Lazcluze given alone until their disease progressed or they experienced unacceptable side effects.

READ MORE: Rybrevant Combo Improves Survival in EGFR-Mutated, Advanced NSCLC

The main goal of the trial was progression-free survival (PFS; time patients live after treatment without their disease worsening). The researchers also analyzed overall survival (OS; time from treatment until death of any cause).

Findings showed that Lazcluze plus Rybrevant led to a statistically significant improvement in PFS compared to Tagrisso. The median PFS was 23.7 months in the group of patients who received the drug duo, compared to 16.6 months in the Tagrisso group.

OS data were not quite ready at the time of the current analysis, meaning that not enough patients had died for the researchers to calculate averages.

The most common side effects that occurred in 20% of patients treated with Lazcluze and Rybrevant were: rash, nail toxicity, infusion-related reactions (from Rybrevant), musculoskeletal pain, swelling, stomatitis, venous thromboembolism, feelings of tingling or pins and needles, fatigue, diarrhea, constipation, COVID-19 infection, hemorrhage, dry skin, decreased appetite, itching, nausea and ocular toxicity.

A serious safety issue of venous thromboembolic events (VTE) was observed with Lazcluze in combination with Rybrevant and preventative anticoagulation should be administered for the first four months of therapy, according to the release.

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