CStone Announces Acceptance of New Drug Application for Pralsetinib for the Treatment of RET Fusion Non-Small Cell Lung Cancer in Hong Kong, China

Jianxin Yang, Chief Medical Officer of CStone, said: "Following the approval of the first-in-class precision targeted drug AYVAKIT ^® (avapritinib) in Hong Kong, China in December 2021 for the treatment of patients with PDGFRA D842V mutant gastrointestinal stromal tumors, we We are delighted that another precision targeted drug, pralsetinib, has successfully submitted a new drug application for non-small cell lung cancer

The new drug application for pralsetinib in Hong Kong, China was accepted based on a global Phase I/II ARROW clinical study

Results of the ARROW study in patients with RET fusion-positive NSCLC worldwide were presented at the June 2021 American Society of Clinical Oncology (ASCO) annual meeting

- In 68 patients without systemic therapy, the overall response rate (ORR) was 79% (95% CI: 68%, 88%)

- Among 126 patients who had previously received platinum-based chemotherapy, the ORR was 62% (95% CI: 53%, 70%)

-As of the data cutoff date, a total of 471 patients with different tumor types were enrolled, the most common adverse events (AEs) were neutropenia, increased aspartate aminotransferase, anemia, decreased white blood cell count, alanine Elevated aminotransferases, high blood pressure, constipation, and fatigue

About RET fusion-positive non-small cell lung cancer 

In recent years, the incidence of lung cancer has continued to increase in China

In the field of lung cancer, driver gene mutations such as EGFR, ALK, and ROS1 have been widely popularized, and targeted drugs for these driver genes have been approved for marketing

About Pralsetinib

Pralsetinib, an oral, once-daily, potent and highly selective RET inhibitor, has been approved by the China National Medical Products Administration for the treatment of patients with positive transfection rearrangement (RET) gene fusions who have previously received platinum-containing chemotherapy Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), adults with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) requiring systemic therapy, and children 12 years of age and older, and those requiring systemic therapy and radiation therapy Advanced or metastatic RET fusion-positive thyroid cancer (TC) in adults and children 12 years of age and older with iodine-refractory (if radioactive iodine is available)

The U.

The European Commission (EC) has granted conditional marketing authorization to GAVRETO as a monotherapy for the treatment of adult patients with RET fusion-positive advanced NSCLC who have not received prior RET inhibitor therapy

In addition to the above, pralsetinib has not been approved for other indications in China, the United States, and Europe

Pralsetinib is designed to selectively and effectively target oncogenic RET mutations, including secondary RET mutations that may lead to treatment resistance

Pralsetinib was developed by CStone partner Blueprint Medicines

Blueprint Medicines and Roche are jointly developing GAVRETO globally (excluding Greater China) for the treatment of patients with RET-mutant NSCLC, thyroid cancer and other solid tumors

About CStone

CStone Pharmaceuticals (SEHK : 2616) is a biopharmaceutical company focused on the research, development and commercialization of innovative immuno-oncology and precision medicines to meet the high medical needs of cancer patients in China and around the world
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Founded in late 2015, CStone has assembled a world-class management team with extensive experience in new drug R&D, clinical research and commercial operations
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With tumor immunotherapy combination therapy as the core, the company has established a rich product pipeline consisting of 15 tumor candidates
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At present, CStone Pharmaceuticals has obtained the approval of 7 new drug marketing applications for 4 innovative drugs
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Several late-stage drug candidates are in pivotal clinical trials or registration stages
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CStone's vision is to become a world-renowned biopharmaceutical company leading the way in the fight against cancer
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