CStone Pharmaceuticals, a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, today announced positive results from China registrational study of the global pivotal Phase 1/2 ARROW clinical trial of the RET inhibitor GAVRETO® (pralsetinib), showing deep and durable anti-tumor activity in Chinese patients with advanced or metastatic RET-mutant- MTC, consistent with previously reported results in the global ARROW study. The safety data observed in Chinese patients is similar with results shown in global patients. This marks another milestone for GAVRETO in the field of RET-altered thyroid cancer, following the medicine's approval in China in March this year for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) after platinum-based chemotherapy. GAVRETO is a potent and selective RET inhibitor discovered by CStone's partner Blueprint Medicines.
"In recent years, there is an increasing incidence of thyroid cancer, but treatment options are extremely limited for patients with RET-mutant MTC. RET-targeting precision therapies in thyroid cancer indication have not been approved in China yet." Professor Ming Gao, Principal Investigator of the ARROW study and President of Tianjin Union Medical Center, said. "We are very glad that the pivotal clinical study of GAVRETO in Chinese patients with RET-mutant MTC has achieved positive results. We look forward to GAVRETO potentially addressing unmet medical needs and benefiting patients with thyroid cancer."
"We are pleased to see the excellent efficacy and safety profiles of GAVRETO in Chinese thyroid cancer patients with RET-mutant MTC," Dr. Jason Yang, Chief Medical Officer of CStone, said. "The NMPA of China accepted the NDA of GAVRETO with priority review designation for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer in April 2021. We look forward to the potential approval of GAVRETO for this indication, so the treatment may benefit Chinese patients with thyroid cancer soon."
Detailed study data will be presented at a future international academic conference. GAVRETO has previously been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation, the NMPA of China, for the treatment of advanced or metastatic RET-mutant MTC. The NMPA of China has previously accepted the New Drug Application (NDA) of GAVRETO with Priority Review Designation on a rolling submission basis for the treatment of patients with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer.
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 MTC and other advanced solid tumors with RET fusions.
Results from the ARROW trial in global patients with RET-mutant MTC were presented at the European Society for Medical Oncology Virtual Congress in September 2020. As of a data cutoff date of February 13, 2020, the results showed that GAVRETO had robust and durable anti-tumor activity in response-evaluable patients who received a starting dose of 400 mg once daily. In 53 patients previously treated with cabozantinib or vandetanib, the overall response rate (ORR) was 60 percent (95% CI: 46%, 74%) with one response pending confirmation, and the median duration of response (DOR) was not reached (95% CI: not reached, not reached). In 19 systemic treatment-naïve patients who were ineligible for standard therapy per the study protocol, the confirmed ORR was 74 percent (95% CI: 49%, 91%), and the median DOR was not reached (95% CI: 7 months, not reached). In 438 ARROW trial patients across RET-altered tumor types, the most common treatment-related adverse events reported by investigators (≥ 15 percent) were increased aspartate aminotransferase, anemia, increased alanine aminotransferase, constipation, hypertension...
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