Yuhan Corporation announced that it would apply for approval of ‘Leclaza (active ingredient: Lazertinib), new drug for non-small cell lung cancer, as the first-line treatment early next year based on the results of its global phase 3 clinical trial. Leclaza is a second-line treatment and can be prescribed only when patients diagnosed with lung cancer show resistance to the first-line treatment.

Yuhan Corporation explained at a press conference announcing the results of the 'Leclaza Global Phase 3 Clinical Trial (LASER301)' held at The Plaza Hotel Seoul on December 6th, "We plan to submit a request for the review of the addition of the first-line treatment indication for Leclaza to the Ministry of Food and Drug Safety within the first quarter of next year.“

This phase 3 clinical trial was conducted on 393 patients (258 Asians, 135 non-Asians) with active EGFR mutation-positive locally progressive or metastatic non-small cell lung cancer who had no treatment history. It was a randomized, double-blind, multinational phase 3 clinical trial to evaluate the efficacy and safety of lazertinib compared to gefitinib, a first-line treatment.

In the analysis of the primary endpoint, progression-free survival (PFS), the lazertinib-administered group showed the PFS period of 20.6 months, a statistically significant improvement compared to the gefitinib-administered group's 9.7 months.
In the analysis of the PFS subgroups by race, in Asians, the Lazertinib administered group showed 20.6 months and the gefitinib administered group 9.7 months. In non-Asians, the lazertinib administered group has not reached the median yet while the gefitinib administered group showed 9.7 months, demonstrating antitumor efficacy in both Asians and non-Asians.

Significant results were also obtained in non-small cell lung cancer, which is known to have a poor treatment prognosis. In the exon 19 deletion mutation (Ex19del), the lazertinib administered group showed 20.7 months and the gefitinib administered group showed 10.9 months, while in the exon 21 L858R substitution mutation, the lazertinib administered group showed 17.8 months and the gefitinib administered group showed 9.6 months.

The objective response rate, which is the secondary endpoint, in both lazertinib and gefitinib administered groups was confirmed to be 76%. However, lazertinib had a better response duration of 19.4 months than gefitinib’s 8.3 months.

The interim analysis of overall survival showed that the risk ratio of death was 0.74, and at 18 months of administration, the survival rate of the lazertinib-administered group was 80% while the gefitinib-administered group was 72%.

The most frequently reported adverse reactions in the lazertinib administered group wase paresthesia (39%), followed by rash (36%) and pruritus (26%). Most were grade 1 or 2 mild reactions, and the incidence of adverse effects such as interstitial lung disease and grade 3 or higher QTc prolongation was 2.5% and 1%, respectively.

Mr. Cho Wook-Je, CEO of Yuhan Corporation, said, “With this clinical success, we will be able to provide a new first-line treatment option for patients with EGFR-mutated non-small cell lung cancer around the world. We plan to apply to the Ministry of Food and Drug Safety for a change in product approval of Leclaza and to go through approval procedures with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).”

[WIKI KOREA=Cho Eun, Reporter]

choeun@wikileaks-kr.org

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