New clinical data presented at the World Lung Cancer Society (WCLC) in San Diego reveals promising results for Leclaza (lazertinib) as a monotherapy in non-small cell lung cancer (NSCLC) patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutations. The data, a follow-up from the Phase 3 MARIPOSA study initially presented at ESMO 2023, compares Leclaza monotherapy to Tagrisso (osimertinib).
The study involved 1,074 patients, with 216 receiving Leclaza and 429 receiving Tagrisso. Results indicated a progression-free survival (PFS) of 18.5 months for Leclaza, compared to 16.6 months for Tagrisso. The objective response rate (ORR) was 83% for Leclaza and 85% for Tagrisso, showing similar efficacy in tumor size reduction.
Impact on Brain Metastasis
Notably, Leclaza demonstrated a PFS of 16.4 months in patients with brain metastasis, compared to 13 months for Tagrisso. This suggests a potential advantage for Leclaza in treating NSCLC patients with brain metastasis, a particularly challenging subgroup.
Current FDA Approval and Future Prospects
Leclaza, developed by Yuhan Corporation, recently received FDA approval as a combination therapy with Johnson & Johnson's Rybrevant (amivantamab-vmjw) for first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. The current approval is contingent on its use in combination with Rybrevant.
The prospect of Leclaza monotherapy approval could significantly expand its market potential. Some analysts predict potential annual sales exceeding $5 billion if approved as a monotherapy, positioning it as a potential alternative to Tagrisso. Yuhan Corporation is actively consulting with Johnson & Johnson to pursue approval for Leclaza monotherapy.
Cho Wook-je, president of Yuhan Corporation, has expressed optimism about the future of Leclaza, emphasizing ongoing discussions with Johnson & Johnson regarding monotherapy approval. Johnson & Johnson has set a US sales target of $5 billion for the Leclaza combination therapy.
