Prof. Seonmin Lim and Byungcheol Ahn, Recraza’s first RWD announcement “confirmed similarity to LASER201 approved clinical results”
The first Real World Data (RWD) of Yuhan Corporation’s Lexraza (ingredient: Lazertinib) in the second-line treatment of patients with EGFR mutation-positive non-small cell lung cancer was announced.
Professor Lim Seon-min of the Department of Oncology at Yonsei Cancer Center and Professor Byung-Chul Ahn of the Department of Oncology at the National Cancer Center from January 2021 to August 2022 at Yonsei Cancer Hospital and National Cancer Center in EGFR mutation-positive non-small cell lung cancer patients who had previously used EGFR-TKI treatment. RWD, which analyzed efficacy and safety data through a retrospective study of 103 patients who received Lexraza among T790M-positive patients who developed resistance, was published in the Lung Cancer Journal.
The research team announced that through this RWD study, they reconfirmed the consistent efficacy and safety of Lexraza in the second-line treatment of patients with EGFR T790M-mutated non-small cell lung cancer in actual clinical settings.
Of the 103 patients analyzed, 90 received Rexraza as a second-line or third-line treatment. The primary endpoint of the study was the median progression-free survival (mPFS), which was 13.9 months (95% CI 11.0 – NR), consistent with the progression-free survival of 11.1 months confirmed in LASER201, a licensed clinical trial of Lexraza. . The objective response rate (ORR) was also 62.1%, similar to the 55.3% observed in the LASER201 clinical trial. The safety profile also showed good tolerability, similar to previous clinical trials.
Professor Lim Seon-min of the Department of Oncology at Yonsei Cancer Center said, “This study is meaningful in that it is the first real-world study to confirm the efficacy and safety profile of Lexraza in non-small cell lung cancer patients in an actual domestic prescription environment.
“As a result of the analysis, we confirmed data consistent with LASER201, which was a licensed clinical trial for Lexraza, and this RWD result, along with other clinical data, will be actively used as a basis for prescribing Lexraza to patients in the field of care,” he added. It showed similar efficacy in patients with Exon19 deletion mutation (Exon19del) and L858R substitution mutation (L858R), and the efficacy did not decrease even in patients who underwent dose reduction.”
The treatment effect of Lexraza for patients with brain metastasis in RWD also showed the same significant effect as the LASER201 clinical trial. In 33 patients with brain metastases with analyzable intracranial lesions, mIPFS (median intracranial progression-free survival) was 17.1 months (95% CI 13.9–NR) and ORR was 57.6%.
Professor Ahn Byeong-cheol of the Department of Oncology at the National Cancer Center said, “When non-small cell lung cancer is diagnosed, brain metastasis is found in about 25% of patients, and it is so common that 50% of patients eventually experience brain metastasis during the disease progression. The effect of brain metastasis of drugs used in actual prescription situations is a very important consideration,” he said. “Through this real-world study, Lexraza consistently demonstrated antitumor effects in brain metastasis, and the basis for prescription of Lexraza for non-small cell lung cancer patients in Korea. are building up,” he said.
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