Leclaza Combination Therapy Study Published in NEJM, Raising Expectations for FDA Approval

A study demonstrating the superior efficacy of the combination therapy of Yuhan Corporation’s non-small cell lung cancer (NSCLC) treatment, Leclaza (ingredient name: lazertinib), over the monotherapy of Tagrisso (ingredient name: osimertinib) has been published in the prestigious medical journal, the New England Journal of Medicine (NEJM). This positive news has heightened expectations for the FDA’s upcoming review of the combination therapy, with a decision anticipated in August.

On the 26th (local time), a study led by Professor Cho Byoung-chul of Yonsei University College of Medicine (Oncology Department) featuring the combination of Leclaza and Rybrevant (amivantamab) was published in NEJM.

The study presents the results of a Phase 3 clinical trial comparing the combination therapy of Leclaza and Tagrisso to Tagrisso alone in patients with previously untreated locally advanced or metastatic EGFR mutation (exon 19 deletion or L858R substitution) NSCLC. This follows Professor Cho’s presentation of the findings at the European Society for Medical Oncology (ESMO) last year.

Among the 1,074 patients, 429 were randomly assigned to the combination therapy group, 429 to the Tagrisso group, and 216 to the Leclaza group. The results showed that the progression-free survival (PFS) for the Leclaza and Rybrevant combination therapy group was 23.7 months, compared to 16.6 months for the Tagrisso group. The objective response rate (ORR) was 86% in the combination therapy group and 85% in the Tagrisso group.

The research team stated, “The combination therapy of amivantamab and lazertinib demonstrated superior efficacy compared to osimertinib as a first-line treatment for advanced EGFR-mutated NSCLC.”

The industry views the publication of this study as bringing FDA approval one step closer. NEJM is regarded as one of the most authoritative journals in medical research, with studies published in it being widely read, cited globally, and often applied in clinical practice.

Janssen, which holds the global rights to Leclaza, submitted a New Drug Application (NDA) to the FDA last December. With the combination therapy designated for priority review, the FDA’s decision on approval is expected to be announced by August 21.

If the Leclaza combination therapy is approved and launched in the U.S. market, Yuhan Corporation is expected to receive a milestone payment of $60 million (approximately KRW 83 billion) from Janssen. This would mark a significant milestone as the first instance of a new drug developed by a Korean pharmaceutical company through technology transfer being commercialized.