July 5, 2019，Recently, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. obtained the drug registration certificate for Anlotinib Hydrochloride Capsules for the treatment of soft tissue sarcoma. Anlotinib has thus become the first approved targeted drug for soft tissue sarcoma in China. As a monotherapy, this product is indicated for patients with alveolar soft part sarcoma, clear cell sarcoma, and other advanced soft tissue sarcoma patients whose disease has progressed or relapsed after at least one prior anthracycline-containing regimen. This marks the second approved indication for Anlotinib, following its approval for advanced non-small cell lung cancer. Anlotinib will provide a brand-new treatment option for soft tissue sarcoma patients and improve their quality of life.
Soft Tissue Sarcoma: A Rare Tumor with High Clinical Treatment Challenges
Soft tissue sarcoma (STS) refers to a group of malignant tumors originating from mesenchymal tissues. According to statistics from the National Cancer Center, the incidence rate of soft tissue sarcoma in the Chinese population was approximately 2.38 per 100,000 in 2017. STS encompasses more than 50 histological subtypes, each with distinct genetic characteristics, necessitating targeted treatment strategies. Coupled with its high malignancy and poor prognosis, STS poses extreme complexity and challenges in clinical management.
Currently, the main drugs for treating advanced soft tissue sarcoma are cytotoxic antineoplastic agents, with anthracyclines and ifosfamide serving as first-line chemotherapy drugs. In China, there is no standard treatment regimen for STS patients who fail first-line chemotherapy. Compared with chemotherapy, targeted therapy has fewer side effects and can improve patients' quality of life, making the exploration of targeted drug therapy a crucial research direction for this rare tumor type.
Anlotinib: China’s First Targeted Drug for Soft Tissue Sarcoma
Anlotinib is a novel small-molecule multi-targeted tyrosine kinase inhibitor (TKI). It potently inhibits multiple kinases associated with angiogenesis and tumor growth, including VEGFR, FGFR, PDGFR, and c-Kit, exerting dual effects of anti-tumor angiogenesis and tumor growth inhibition.
In June 2017, Anlotinib was granted orphan drug designation for the treatment of soft tissue sarcoma by the U.S. Food and Drug Administration (FDA). Adhering strictly to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Chia Tai Tianqing has advanced the research and development of Anlotinib with innovative approaches. Domestic clinical data of Anlotinib has been accepted by the U.S. FDA, allowing the drug to proceed directly to Phase 1b/2a clinical trials. The clinical research findings of Anlotinib for soft tissue sarcoma have been repeatedly selected for oral presentations at the American Society of Clinical Oncology (ASCO), a top-tier international academic conference. Its Phase II clinical study (NCT01878448) was also published in Clinical Cancer Research, a prestigious international oncology journal.
Clinical trial results demonstrated that, compared with the placebo group, the Anlotinib treatment group prolonged progression-free survival (PFS) of advanced soft tissue sarcoma patients by 4.84 months and reduced the risk of tumor recurrence by 67%. Additionally, Anlotinib featured a low incidence of adverse reactions with mild severity, which were well-tolerated by patients and manageable in the vast majority of cases.
Owing to its definite efficacy, Anlotinib was included in the 2019 edition of the CSCO Guidelines for the Diagnosis and Treatment of Soft Tissue Sarcoma in April 2019. The guidelines recommend Anlotinib as a Grade III recommendation (Category 2B evidence) for second-line treatment of advanced or unresectable soft tissue sarcoma, and as a Grade II recommendation (Category 2B evidence) for first-line treatment of alveolar soft part sarcoma, fully affirming its therapeutic value.
Targeted Therapy: Ushering in a New Era for Soft Tissue Sarcoma Treatment
Chia Tai Tianqing has consistently responded to national initiatives and strived to effectively reduce the medical burden on cancer patients in China. The pricing of Anlotinib is only 50% to 60% of that of similar imported drugs. Since its launch in May 2018, Anlotinib has alleviated pain and delayed disease progression for countless advanced lung cancer patients.
As China’s first approved targeted drug for soft tissue sarcoma, the approval of Anlotinib for this new indication will undoubtedly usher in a new era of targeted therapy for soft tissue sarcoma in the country. Compared with similar domestic and international drugs, both the active pharmaceutical ingredient (API) and preparation of Anlotinib Hydrochloride have obtained marketing approval, boasting mature production processes and quality control technologies, as well as stable product quality. Furthermore, Anlotinib offers advantages such as low dosage and convenient administration, providing clinicians with more treatment options and significantly improving patients' quality of life.
It is reported that tyrosine kinase inhibitors, as molecular targeted drugs, are emerging as a hot area in anti-tumor drug research and development. As a landmark blockbuster innovative drug of Chia Tai Tianqing, Anlotinib holds broad prospects for clinical application, with comprehensive research underway for more cancer types. Research findings indicate that beyond advanced non-small cell lung cancer and soft tissue sarcoma, Anlotinib has achieved significant progress in the treatment of esophageal squamous cell carcinoma, medullary thyroid carcinoma, small cell lung cancer, renal cell carcinoma, ovarian cancer, and other malignancies. The R&D team is actively conducting multicenter clinical trials, including those in the United States.
