CStone Pharmaceuticals, a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, today announced data from the China registrational study of the global pivotal Phase 1/2 ARROW trial. The results demonstrated deep and durable clinical activity of GAVRETO® (pralsetinib) for the first-line treatment of Chinese patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), which is consistent with the global population. The overall safety is manageable, no new safety signal detected. GAVRETO is a potent and selective RET inhibitor discovered by CStone's partner Blueprint Medicines.
"Platinum-based chemotherapy is recommended as the standard first-line treatment for patients with RET fusion-positive NSCLC in China, but there is a need for new treatment options," said Professor Yi-long Wu of Guangdong Provincial People's Hospital, and Principal Investigator on the ARROW study China cohort, "The initial approval of GAVRETO in China heralds a new era for RET inhibitors in the treatment of RET fusion-positive NSCLC after platinum-based chemotherapy. With the promising data shown in the registrational study where GAVRETO is studied as a potential first-line treatment for Chinese patients with RET fusion-positive NSCLC, we very much look forward to the potential approval of broader indications in China."
"We are glad to see that the registrational study of GAVRETO for the first-line treatment of RET fusion-positive NSCLC patients in China has shown promising efficacy results and safety is manageable, adding more clinical evidence for GAVRETO," said Dr. Jason Yang, Chief Medical Officer of CStone. "We would like to thank all the investigators, patients and their families involved in this clinical study. We will initiate regulatory discussions with the China NMPA and look forward to potentially benefiting more patients soon."
CStone plans to submit new indication application to the China NMPA for GAVRETO as a first-line treatment for patients with RET fusion-positive NSCLC soon. Detailed study data will be presented at a future international academic conference.
In March 2021, GAVRETO was granted as one of new care medical supplies approval by the China NMPA as China's first selective RET inhibitor for the treatment of adult patients with locally advanced or metastatic RET fusion-positive NSCLC after platinum-based chemotherapy. The first batch of prescriptions was issued across multiple cities in China this month, benefiting Chinese patients. Additionally, in the recently published "2021 Clinical Guidelines for Molecular Pathological Detection of Non-small Cell Lung Cancer," RET testing was granted a recommendation for the detection of RET fusion-positive NSCLC patients. GAVRETO was included in the 2021 Chinese Medical Association guidelines for clinical diagnosis and treatment of lung cancer as the only recommended second-line or later therapy for RET fusion-positive stage IV non-squamous NSCLC that has progressed following platinum-based chemotherapy. In April 2021, the China NMPA accepted the supplemental new drug application of GAVRETO with priority review designation for the treatment of patients with advanced or metastatic RET-altered thyroid cancers. Following a regulatory review by the NMPA of China, the labeled indications for GAVRETO in China may be expanded to include advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and advanced or metastatic RET fusion-positive thyroid cancers who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate), if approved.
CStone has an exclusive collaboration and license agreement with Blueprint Medicines for the development and commercialization of GAVRETO in Greater China, which encompasses Mainland China, Hong Kong, S.A.R., China, Macau, S.A.R., China, and Taiwan, China.
About the ARROW Study
The ARROW study is a global phase I/II clinical study designed to evaluate the safety, tolerability and efficacy of GAVRETO 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 st...
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