Encouraged by Lecraza phase 3 results, Yuhan Corporation “expects to advance to US”

Yuhan Corp. expressed (CEO Cho Wook-je) high expectations for the US approval of its domestic anti-cancer drug ‘Rexraza’ (ingredient: Lazertinib).

On the 6th, Yuhan held a press conference at the Plaza Hotel in Seoul to present the results of the phase 3 clinical trial of Lexraza, which was revealed at ESMO Asia. In particular, Yuhan Corporation CEO Cho Wook-je drew attention by announcing that he would advance the US approval of Rexraza early next year.

“The announcement of phase 3 results in Singapore was well received,” said CEO Cho Wook-je. Accordingly, early next year, we plan to change the approval to first-line treatment in Korea, and at the same time proceed with approval from the US Food and Drug Administration (FDA). “

Professor Cho Byeong-cheol, director of the Lung Cancer Center at Yonsei Cancer Center, who announced the results of a phase 3 clinical trial of Lexraza at the meeting, also weighed in on the possibility of US approval for Lexraza.

Professor Cho Byeong-cheol said, “There is no requirement that clinical trials be conducted in the United States under the conditions of FDA approval. It is important that the design of the clinical trial matches the composition of the US population,” he said. This composition is similar to the composition of clinical trials of other new drugs approved in the United States.

On this day, Professor Cho asserted that Lexraza would be the third generation EGFR TKI that has undergone the second and final global phase 3 trial, showing strong confidence in its efficacy and safety.

According to Professor Cho, as a result of analysis of the primary endpoint, progression-free survival (PFS), the group treated with Lazertinib showed 20.6 months and the group treated with Gefitinib (trade name: Iresajeong ) for 9.7 months, showing that the group treated with Lazertinib was 20.6 months. The group treated with Lazertinib was the group treated with Gefitinib. Statistically, a significant improvement in progression-free survival was observed compared to .

In addition, as a result of subgroup analysis by race, in the Asian patient group, the group treated with Lazertinib showed a difference of 20.6 months and the group treated with Gefitinib 9.7 months.

In the results of subgroup analysis according to EGFR mutation type, in the patient group with exon 19 deletion mutation (Ex19del), the Lazertinib treatment group took 20.7 months, the gefitinib treatment group took 10.9 months, and the patient group with the exon 21 L858R substitution mutation (L858R) received Lazertinib.17.8 months in the administration group and 9.6 months in the gefitinib administration group.

In this study, the most frequently reported adverse reactions in the Lazertinib group were paresthesia (39%), rash (36%), and pruritus (26%). The incidence of adverse events such as interstitial lung disease and QTc prolongation grade 3 or higher was very low, at 2.5% and 1%, respectively. Also, no clinically significant reduction in left ventricular ejection fraction was observed.