JICC01.14 Efficacy and Safety of Pralsetinib in Chinese Patients with Advanced RET Fusion+ Non-Small Cell Lung Cancer after Platinum-Based Chemotherapy

Zhou, Q.; Wu, Y.; Chang, Jian; Fan, Yixing; Zhao, Jun; Wu, G.; Sun, Ying; Wang, X.; Nian, Weiqi; Wang, K.; Zheng, X.; Qu, L.; Yao, S.; Liu, K.; Li, P.; Yang, J.

doi:10.1016/j.jtho.2021.01.164

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“…18 The results of cohort 8 have been presented at the 2020 World Conference on Lung Cancer. 19 The preliminary and updated results of both previously mentioned cohorts have been presented at the 2021 World Conference on Lung Cancer and ESMO Asia Congress 2022, respectively. 20,21 Here, we report the efficacy and safety data of pralsetinib in Chinese patients with advanced RET fusion-positive NSCLC enrolled in both previously mentioned cohorts.…”

Section: Introductionmentioning

confidence: 99%

“…Based on consistent findings from the global and Chinese populations, the National Medical Products Administration of China approved pralsetinib in 2021 for treating adult patients with locally advanced or metastatic RET fusion–positive NSCLC who previously received platinum‐based chemotherapy 18 . The results of cohort 8 have been presented at the 2020 World Conference on Lung Cancer 19 . The preliminary and updated results of both previously mentioned cohorts have been presented at the 2021 World Conference on Lung Cancer and ESMO Asia Congress 2022, respectively 20,21 .…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of pralsetinib in patients with advanced RET fusion‐positive non–small cell lung cancer

Zhou

Zhao

Chang

et al. 2023

Cancer

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BackgroundPralsetinib is a potent, selective RET inhibitor targeting oncogenic RET alterations. As part of the global, phase 1/2 ARROW trial (NCT03037385), the efficacy and safety of pralsetinib in Chinese patients with advanced RET fusion‐positive non–small cell lung cancer (NSCLC) were evaluated.MethodsAdult patients with advanced, RET fusion–positive NSCLC with or without prior platinum‐based chemotherapy were enrolled into two cohorts receiving 400‐mg once‐daily oral pralsetinib. Primary end points were objective response rates assessed by blinded independent central review and safety.ResultsOf 68 patients enrolled, 37 had received prior platinum‐based chemotherapy (48.6% with ≥3 prior systemic regimens) and 31 were treatment‐naïve. As of March 4, 2022 (data cutoff), of the patients with measurable lesions at baseline, a confirmed objective response was observed in 22 (66.7%; 95% confidence interval [CI], 48.2–82.0) of 33 pretreated patients, including 1 (3.0%) complete response and 21 (63.6%) partial responses; and in 25 (83.3%; 95% CI, 65.3–94.4) of 30 treatment‐naïve patients, including two (6.7%) complete responses and 23 (76.7%) partial responses. Median progression‐free survival was 11.7 months (95% CI, 8.7–not estimable) in pretreated patients and 12.7 months (95% CI, 8.9–not estimable) in treatment‐naïve patients. The most common grade 3/4 treatment‐related adverse events in 68 patients were anemia (35.3%) and decreased neutrophil count (33.8%). Eight (11.8%) patients discontinued pralsetinib because of treatment‐related adverse events.ConclusionPralsetinib showed robust and durable clinical activity with a well‐tolerated safety profile in Chinese patients with RET fusion‐positive NSCLC.Clinical trial registration: NCT03037385.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%