Pan-cancer efficacy of pralsetinib in patients with RET fusion–positive solid tumors from the phase 1/2 ARROW trial

Vivek Subbiah, Philippe A. Cassier, Salvatore Siena, Elena Garralda, Luis Paz-Ares, Pilar Garrido, Ernest Nadal, Jacqueline Vuky, Gilberto Lopes, Gregory P. Kalemkerian, Daniel W. Bowles, Mahesh Seetharam, Jianhua Chang, Hui Zhang, Jennifer Green, Alena Zalutskaya, Martin Schuler, Yun Fan, Giuseppe Curigliano

Research output: Contribution to journalArticlepeer-review

34 Scopus citations


Oncogenic RET fusions occur in diverse cancers. Pralsetinib is a potent, selective inhibitor of RET receptor tyrosine kinase. ARROW (NCT03037385, ongoing) was designed to evaluate pralsetinib efficacy and safety in patients with advanced RET-altered solid tumors. Twenty-nine patients with 12 different RET fusion–positive solid tumor types, excluding non-small-cell lung cancer and thyroid cancer, who had previously received or were not candidates for standard therapies, were enrolled. The most common RET fusion partners in 23 efficacy-evaluable patients were CCDC6 (26%), KIF5B (26%) and NCOA4 (13%). Overall response rate, the primary endpoint, was 57% (95% confidence interval, 35–77) among these patients. Responses were observed regardless of tumor type or RET fusion partner. Median duration of response, progression-free survival and overall survival were 12 months, 7 months and 14 months, respectively. The most common grade ≥3 treatment-related adverse events were neutropenia (31%) and anemia (14%). These data validate RET as a tissue-agnostic target with sensitivity to RET inhibition, indicating pralsetinib’s potential as a well-tolerated treatment option with rapid, robust and durable anti-tumor activity in patients with diverse RET fusion–positive solid tumors.

Original languageEnglish (US)
Pages (from-to)1640-1645
Number of pages6
JournalNature medicine
Issue number8
StatePublished - Aug 2022

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)


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