Yuhan Yanghang "Rekrazza Phase 3 Results Published in International Journal JCO"

Yuhan Corporation announced on the 29th that the results of the multinational Phase 3 clinical trial of Reclarza (active ingredient: Lazertinib Mesylate Monohydrate), a treatment for epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer, have been published in the international journal Journal of Clinical Oncology (JCO).

Yuhan Corporation Lekraza. [Image provided by Yuhan Corporation]

JCO is an international journal published by the American Society of Clinical Oncology (ASCO) and is a globally authoritative journal in the field of oncology, with a global citation index of 50.739.

The paper contains the main results of the Phase 3 clinical trial (LASER301) of Reclarza. Analysis of the primary endpoint, progression-free survival (PFS) based on investigator assessment, showed that the median PFS was 20.6 months in the Lazertinib group and 9.7 months in the Gefitinib group. Lazertinib administration was confirmed to statistically significantly improve progression-free survival compared to Gefitinib administration.

In the interim analysis of overall survival (OS), the median was not reached (data maturity 29%), and the hazard ratio for death was confirmed to be 0.74.

The clinical benefits of Lazertinib were also observed in various pre-planned subgroup analyses. In particular, the median PFS in the subgroups of Asians, L858R mutation type, and those with brain metastases at enrollment were 20.6 months, 17.8 months, and 16.4 months respectively, showing statistically significant improvement in hazard ratios compared to the control group.

Adverse reactions occurring after drug administration were observed in approximately 96% of the Lazertinib group and about 95% of the Gefitinib group. Most adverse reactions were mild to moderate, and no significant differences were observed between the groups in other categories. These results were previously disclosed at the European Society for Medical Oncology Asia Congress (ESMO Asia) held in Singapore last December.

Professor Byung-Chul Cho, Global Clinical Trial Coordinator (CI) and oncologist at Yonsei Cancer Hospital, stated, "It is very encouraging that the main results of LASER301 were published in such a prestigious journal as JCO in an unusually short period of time," adding, "We hope that Reclarza will establish itself as a new first-line treatment option for EGFR mutation-positive non-small cell lung cancer patients worldwide."

Yuhan Corporation’s Head of Research and Development (R&D), Yeol-Hong Kim, said, "Reclarza is expected to offer hope for lung cancer treatment to patients through its strengths, including a 58% reduction in disease progression risk in patients with brain metastases, extension of progression-free survival in the EGFR L858R substitution mutation known for poor prognosis, and consistent efficacy in the Asian subgroup with a high frequency of EGFR mutations, which are major unmet needs for clinicians."

Reclarza was approved by the Ministry of Food and Drug Safety on January 18, 2021, as a second-line treatment for EGFR T790M mutation-positive patients. In March, an application was submitted to expand its indication to first-line treatment for EGFR mutation-positive patients.

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