CStone Pharmaceuticals, a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology (IO) therapies and precision medicines, today announced that results from a cohort of Chinese patients in the global phase I/II ARROW trial of pralsetinib were presented in an oral presentation at the IASLC 2020 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer. The results showed that pralsetinib has robust and durable anti-tumor activity and a well-tolerated safety profile in patients that enrolled at China sites who had advanced RET fusion-positive non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.
Pralsetinib is a selective and potent RET inhibitor developed by CStone's partner Blueprint Medicines. CStone has an exclusive collaboration and license agreement with Blueprint Medicines for the development and commercialization of pralsetinib in Greater China, which encompasses Mainland China, Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China.
Date: January 28th, 2021
Presentation Type: Oral Presentation
Title: Efficacy and Safety of Pralsetinib in Chinese Patients with Advanced RET Fusion+ Non-Small Cell Lung Cancer after Platinum-Based Chemotherapy
Presentation #: JICC01.14
Leading Principal Investigator in China: Professor Yi-long Wu
Presenter: Professor Qing Zhou
The ARROW trial (ClinicalTrials.gov identifier: NCT03037385) is a global phase I/II clinical study designed to evaluate the safety, tolerability and efficacy of pralsetinib in patients with RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC) and other advanced solid tumors with RET fusions. Data from the ARROW study showed that pralsetinib had robust and durable anti-tumor activity in multiple advanced RET-altered solid tumors, including RET fusion-positive NSCLC. For ARROW trial patients with RET fusion-positive NSCLC previously treated with platinum-based chemotherapy, this presentation illustrated that the efficacy and safety results of pralsetinib (400 mg once daily) from China sites were consistent with previously reported data from the global patient population. These results mark the first medical conference presentation of data for pralsetinib in Chinese patients with RET fusion-positive NSCLC previously treated with platinum-based chemotherapy.
As of a data cutoff date of May 22, 2020, a total of 37 patients with advanced RET fusion-positive NSCLC from 10 China sites were enrolled in the global ARROW study, and received a starting pralsetinib dose of 400 mg once daily. All patients had received at least one platinum-based chemotherapy regimen, approximately half (49%) had received ≥3 systemic treatment options, and 32% had received ≥3 chemotherapy regimens. Tumor response was assessed by blinded, independent central review using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Efficacy: Pralsetinib showed robust clinical activity in patients with RET fusion-positive NSCLC after platinum-based chemotherapy
In 32 patients who had measurable disease at baseline per blinded, independent central review, the confirmed overall response rate (ORR) was 56% (95% CI: 38-74%), including 1 complete response (CR) and 17 partial responses (PR). In addition, 2 patients achieved PR pending confirmation. The disease control rate (DCR) reached 97% and 1 patient was not evaluable.
Among 18 patients with confirmed response, the median time to first response was 1.9 months.
As of the data cutoff date, 89% (16/18) of confirmed responders have remained on treatment.
The median duration of response (DOR) was not reached, and the 6-m...
Read More
(All Rights Reserved)