[의학신문·일간보사=김영주 기자]’Recraza’ (ingredient name: Razertinib), which was licensed as a new drug in Korea by the Ministry of Food and Drug Safety on the 18th, has a meaning of the birth of a new drug in Korea after 3 years, but it has a greater meaning in taking the first step toward a global innovative new drug It is an evaluation to have. As the US FDA is on the verge of entering the third phase, the approval in Korea is said to have passed the primary verification of efficacy and safety, revealing the prospect of FDA approval in the future. We analyzed the innovativeness of Rekraza and its contribution to patients through clinical trials.
Non-squamous cell patients, 30-40% of non-small cell lung cancer patients
Rekraza is an oral third-generation tyrosine kinase inhibitor (TKI) that has high selectivity for epithelial cell EGFR (epithelial growth factor receptor) T790M-resistant mutations.
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| Recraza product photo |
Lung cancer is a fatal cancer with the highest mortality rate in Korea, and it is classified into small cell lung cancer and non-small cell lung cancer according to tissue type, and 85% of all lung cancers are non-small cell lung cancer. EGFR mutations are common in non-squamous cell lung cancer among non-small cell lung cancer and are diagnosed in about 30-40%. In other words, Rekraza is a new drug targeting non-squamous cell lung cancer patients, which account for 30-40% of non-small cell lung cancer patients, which account for 85% of all lung cancer patients.
According to domestic and international guidelines, it is recommended to administer 1st to 3rd generation EGFR TKI as the first line therapy for advanced or metastatic non-small cell lung cancer with positive EGFR mutations. However, in most patients using the 1st and 2nd generation EGFR TKI, there is a limitation that the disease is inevitably progressed by acquiring resistance, and resistance due to the T790M mutation occurs in about 50-60% of the related resistances.
Significant results in terms of progression-free survival and safety in clinical trials administered as a secondary treatment
This approval of the third generation EGFR TKI’Recraza’ is based on data derived from patients who received Rekraza as a second-line treatment in a clinical trial of LASER201 (YH25448-201) in patients with advanced non-small cell lung cancer with positive EGFR mutations. do.
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| Recraza development process |
In the total dose group T790M mutation-positive patients (162 patients), the objective response rates according to independent median review and investigator evaluation were 59% and 68%, and the median progression free survival was 10.9 months and 11.0 months. Of the patients (78) assigned to the 240 mg dose group, the objective response rates according to independent central review and investigator evaluation of T790M mutation-positive patients (76) were 58% and 72%, and the median progression-free survival was 11.0 months and 13.2. It was months. On the other hand, the intracranial objective response rate of patients with measurable brain metastases in the entire dose group was 55% in the independent central review (22 patients), 64% in the investigator evaluation (22 patients), and the patients with assessable brain metastases. The median progression-free survival period in the cranial cavity has not yet been reached in both the independent central review (64 persons) and the investigator evaluation (89 persons) (median follow-up period of 10.9 months).
The intracranial objective response rate of patients with measurable brain metastases in the 240mg dose group was 71% in the independent central review (7 patients), 78% in the investigator’s evaluation (9 patients), and intracranial in patients with assessable brain metastases. The median progression-free survival was 16.4 months in the independent central review (24 subjects) and the investigator evaluation (40 subjects) has not yet reached the median value.
Most of the adverse reactions that occurred in the total dose group (181 patients) were grade 1 and 2 mild, and the most frequently reported adverse reactions were rash (29%), itchiness (28%), and constipation (22%).
In 13% of patients, the dose was lowered due to an adverse reaction, and in 5%, the drug was discontinued due to an adverse reaction. Interstitial pneumonia was reported in 1% (2) of patients, of which 1 was reported as a serious adverse reaction. The ECG QTc interval prolongation was found in 3% (6 patients) in the total dose group and 5% (4 patients) in the 240mg dose group, but all were mild, grade 1, and clinically significant decrease in left ventricular ejection rate (more than 10%). Decreased, and the absolute value was less than 50%) did not occur. As a result, Rekraza was evaluated to show a significant therapeutic effect and safety profile as a second-line treatment for EGFR T790M mutation-positive non-small cell lung cancer.
Professor Ahn Myung-joo of the Department of Hematology and Oncology, Samsung Medical Center said, “Recraza is the first new drug developed in Korea to be published in the world-renowned journal, Lancet Oncology, and has been recognized for its efficacy and safety. “This approval is expected to be a suitable treatment option for non-small cell lung cancer patients with positive EGFR T790M mutations.” Professor Ahn Myung-Joo is the first author of the clinical thesis behind the approval.
In addition, Professor Byeong-cheol Cho, director of the Lung Cancer Center at Yonsei Cancer Hospital, said, “The domestic approval of Rekraza has great implications.” “It will be a good treatment alternative for Korean lung cancer patients through clinically meaningful antitumor effects and safety. It is expected to be the hope of lung cancer patients around the world through clinical trials.” Professor Byeong-cheol Cho leads the licensed clinical trials of Rekraza and leads the study of multinational phase 3 clinical trials.
Lee Jung-hee, CEO of Yuhan Corporation, said, “Recraja is an innovative new drug born with Yuhan’s new drug development capabilities and the dedication of domestic researchers. “We are very pleased to be able to provide new treatment options for lung cancer patients in Korea with this permission.”