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Background <p>Selpercatinib is the current standard of care for patients with recurrent or advanced RET fusion-positive non-small cell lung cancer (RET-NSCLC). However, real-world data on selpercatinib for RET-NSCLC are extremely limited, particularly in the Japanese population.</p> Methods <p>This retrospective multicenter study enrolled 27 patients who were pathologically diagnosed with RET-NSCLC and started selpercatinib treatment between September 2021 and June 2024. Patients who had previously received other molecular-targeted drugs were excluded. Of the patients, 10 had received prior treatment and 17 had not.</p> Results <p>As of August 31, 2024, the median follow-up period was 12.0&#xa0;months (range 0.5–31.5&#xa0;months). The objective response rate (ORR) was 100% (8/8 cases) in the previously treated group and 81% (13/16 cases) in the treatment-naïve group. The median progression-free survival (PFS) was 13.3&#xa0;months (95% confidence interval [CI] 0.5-not evaluable [NE]) in the previously treated group and 23.5&#xa0;months (95% CI 5.7-NE) in the treatment-naïve group. The median overall survival was 25.4&#xa0;months (95% CI 0.5-NE) in the previously treated group and not reached (95% CI NE-NE) in the treatment-naïve group. No significant differences were observed in any of these comparisons. The most frequent grade 3 adverse event (AE) was increased ALT (<i>n</i> = 11, 41%), followed by increased AST (<i>n</i> = 7, 26%).</p> Conclusions <p>In Japanese patients treated with selpercatinib, efficacy in whole patients was similar to the worldwide population, whereas AEs (especially liver dysfunction) was more severe than worldwide population. This result highlights the need for careful dose management strategies for Japanese patients.</p>

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Multicenter retrospective study of selpercatinib treatment for advanced or recurrent RET fusion-positive non-small cell lung cancer in Japan

  • 期刊论文

  • 发表日期：

    2025年11月22日

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  • Yasuhiro Mihashi,
  • Kiyohide Komuta,
  • Akihiro Tsukaguchi,
  • Reiko Inada,
  • Atsushi Yanagisawa,
  • Yuhei Shimizu,
  • Ken Yamamoto,
  • Satoshi Tanaka,
  • Naoko Katsurada,
  • Takeshi Nakatani,
  • Yuki Takeyasu,
  • Taiichiro Otsuki,
  • Satoshi Tetsumoto,
  • Akihiro Tamiya,
  • Takayuki Shiroyama,
  • Motoko Tachihara,
  • Kazumi Nishino,
  • Takayasu Kurata,
  • Masahide Mori

摘要

Background

Selpercatinib is the current standard of care for patients with recurrent or advanced RET fusion-positive non-small cell lung cancer (RET-NSCLC). However, real-world data on selpercatinib for RET-NSCLC are extremely limited, particularly in the Japanese population.

Methods

This retrospective multicenter study enrolled 27 patients who were pathologically diagnosed with RET-NSCLC and started selpercatinib treatment between September 2021 and June 2024. Patients who had previously received other molecular-targeted drugs were excluded. Of the patients, 10 had received prior treatment and 17 had not.

Results

As of August 31, 2024, the median follow-up period was 12.0 months (range 0.5–31.5 months). The objective response rate (ORR) was 100% (8/8 cases) in the previously treated group and 81% (13/16 cases) in the treatment-naïve group. The median progression-free survival (PFS) was 13.3 months (95% confidence interval [CI] 0.5-not evaluable [NE]) in the previously treated group and 23.5 months (95% CI 5.7-NE) in the treatment-naïve group. The median overall survival was 25.4 months (95% CI 0.5-NE) in the previously treated group and not reached (95% CI NE-NE) in the treatment-naïve group. No significant differences were observed in any of these comparisons. The most frequent grade 3 adverse event (AE) was increased ALT (n = 11, 41%), followed by increased AST (n = 7, 26%).

Conclusions

In Japanese patients treated with selpercatinib, efficacy in whole patients was similar to the worldwide population, whereas AEs (especially liver dysfunction) was more severe than worldwide population. This result highlights the need for careful dose management strategies for Japanese patients.