Suzhou, China, December 28th, 2022-CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that results from the NAVIGATOR China Bridging Study of AYVAKIT® (avapritinib) have been published in The Oncologist. The results showed that AYVAKIT was generally well-tolerated, had marked anti-tumor activity in Chinese patients with gastrointestinal stromal tumor (GIST) harboring a PDGFRA D842V mutation, and highlighted efficacy data as a fourth- or later-line treatment.
AYVAKIT is a potent, selective and orally available inhibitor of KIT and PDGFRA mutant kinases, discovered by CStone’s partner Blueprint Medicines. CStone has an exclusive collaboration and license agreement with Blueprint Medicines for the development and commercialization of AYVAKIT in Mainland China, Hong Kong, Macau and Taiwan.
The study is an open-label, multicenter phase 1/2 clinical trial designed to evaluate the safety, pharmacokinetics and anti-tumor activity of AYVAKIT in Chinese patients with unresectable or metastatic GIST. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and all responses were confirmed.
Professor Shen Lin, Principal Investigator of the NAVIGATOR China Bridging Study, corresponding author of the published paper, and vice president of Peking University Cancer Hospital, said, “The results from the NAVIGATOR China Bridging Study published in The Oncologist further demonstrated that AYVAKIT had impressive response rates in Chinese patients with advanced GIST harboring a PDGFRA exon 18 mutation and had anti-tumor activity in GIST patients receiving fourth-line or later-line treatment. The results show that AYVAKIT, as a precision medicine, brings important benefits to GIST patients, even in later-line settings. We are optimistic that AYVAKIT will benefit more Chinese patients in the future.”
Dr. Jason Yang, Chief Executive Officer of CStone, said, “We are delighted that the updated data from the phase 1/2 bridging study of AYVAKIT in Chinese patients have been published in The Oncologist. The results demonstrated that AYVAKIT was generally well-tolerated in Chinese patients. AYVAKIT had showed impressive efficacy data in Chinese patients with GIST harboring a PDGFRA D842V mutation and notable response rates in Chinese GIST patients receiving fourth-line or later-line treatment. CStone is committed to the development of innovative oncology medicines. Moving forward, we aim to continue bringing more breakthrough therapies to patients in China and worldwide.”
AYVAKIT has been approved in Mainland China, Taiwan, China and Hong Kong, China. CStone is pursuing a broad commercialization program by working with healthcare professionals, industry associations and diagnostics companies to potentially transform the landscape for precision medicine. In addition, AYVAKIT has been listed in more than 80 commercial insurance and government-led insurance programs in Greater China, further improving the drug’s accessibility and affordability.
About AYVAKIT (avapritinib)
AYVAKIT (avapritinib) is a kinase inhibitor approved by the National Medical Products Administration (NMPA) of China for the treatment of adults with unresectable or metastatic GIST harboring the PDGFRA exon 18 mutation, including PDGFRA D842V mutations. AYVAKIT was approved by the Department of Health (DOH), Hong Kong, China, and Taiwan Food and Drug Administration (TFDA) for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA D842V mutation.
The U.S. Food and Drug Administration (FDA) has approved AYVAKIT for the treatment of two indications: adults with advanced systemic mastocytosis (Advanced SM), including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL), and adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. This medicine is approved by the European Commission under the brand name AYVAKYT for the treatment of adults with ASM, SM-AHN or MCL, after at least one systemic therapy, and adults with unresectable or metastatic GIST harboring the PDGFRA D842V mutation.
AYVAKIT/AYVAKYT is not approved for the treatment of any other indication in the U.S., Europe or Greater China.. The FDA granted breakthrough therapy designation to AYVAKIT for the treatment of moderate to severe indolent SM.
CStone (HKEX: 2616) is a biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received nine NDA approvals for its four drugs. Multiple late-stage drug candidates are now under pivotal clinical trials or registration. CStone's vision is to become globally recognized as a world-renowned biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.
For more information about CStone, please visit www.cstonepharma.com.
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