Key Takeaways
- Small cell lung cancer patients may soon benefit from HANSIZHUANG, the first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive-stage SCLC, as new results were presented at the 2024 ESMO Congress.
- The ASTRUM-005 study demonstrated that HANSIZHUANG, in combination with chemotherapy, offers a promising treatment option for SCLC patients, with genomic mutation patterns showing consistent benefits regardless of smoking history.
- Henlius continues to expand its global reach with HANSIZHUANG and HANQUYOU, focusing on making life-saving treatments for various cancers, including SCLC and HER2-positive cancers, more accessible worldwide.
Shanghai Henlius Biotech, Inc. has unveiled new results for its first innovative anti-PD-1 monoclonal antibody, HANSIZHUANG (serplulimab) for small cell lung cancer (SCLC), as well as its trastuzumab biosimilar, HANQUYOU, at the 2024 European Society of Medical Oncology (ESMO) Congress. These findings were presented as poster presentations, highlighting the company’s progress in developing groundbreaking cancer treatments.
HANSIZHUANG (serplulimab) is a recombinant humanized anti-PD-1 monoclonal antibody injection, independently developed by Henlius. It holds the distinction of being the world’s first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer. This innovative product has already been approved in China, Indonesia, Cambodia, and Thailand, and has significantly benefited around 80,000 patients to date.
In addition to treating small cell lung cancer, HANSIZHUANG has also been approved by China’s National Medical Products Administration (NMPA) for a range of indications, including microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC), and esophageal squamous cell carcinoma (ESCC). Henlius continues to push the boundaries of cancer treatment through ongoing clinical trials exploring immuno-oncology combination therapies, including HANSIZHUANG plus bevacizumab and chemotherapy for metastatic colorectal cancer (mCRC) and neoadjuvant/adjuvant therapy for gastric cancer (GC).
HANSIZHUANG’s MAA for Lung Cancer Validated by EMA as Henlius Expands Global Reach in Cancer Therapy
HANSIZHUANG’s Marketing Authorisation Application (MAA) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) has been validated by the European Medicines Agency (EMA) and is expected to be approved in 2024. These ongoing developments position HANSIZHUANG as a pivotal treatment option in global cancer therapy.
HANQUYOU, Henlius’ trastuzumab biosimilar, has gained approval in China, Europe, the U.S., and other major markets, making it a valuable tool in the treatment of HER2-positive cancers. The biosimilar is indicated for the treatment of HER2-positive early and metastatic breast cancer as well as metastatic gastric cancer, corresponding to all the approved indications of the trastuzumab originator. HANQUYOU’s broad market reach now extends to 48 countries and regions, benefiting over 210,000 patients. It is recognized as a high-quality, affordable option for cancer treatment, contributing to Henlius’ goal of making life-saving therapies more accessible worldwide.
One of the major highlights of the ESMO Congress was the presentation of findings from the ASTRUM-005 study, a global, phase 3 clinical trial evaluating HANSIZHUANG as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). The trial, which included 585 patients from 128 sites across countries such as China, Poland, Turkey, and Georgia, provided a comprehensive analysis of genomic mutations related to smoking in patients with SCLC.
Serplulimab Mitigates Smoking-Related Mutations in Lung Cancer as Henlius Expands Global Reach
Results showed that the genomic mutation patterns were similar across smoking and non-smoking patients with SCLC, despite differences in smoking history. The study confirmed that patients with higher transversion/transition ratio (TTR) values showed shorter median overall survival (OS) when treated with chemotherapy alone. However, patients in both the chemotherapy and serplulimab groups saw similar benefits in progression-free survival (PFS), suggesting that serplulimab could help mitigate the impact of smoking-related genomic mutations in SCLC.
Henlius is committed to further expanding the use of HANSIZHUANG in multiple cancer types. The company is actively conducting several phase 3 international trials, including one that combines HANSIZHUANG with chemotherapy and radiotherapy for limited-stage small cell lung cancer (LS-SCLC). In the U.S., Henlius is also running a head-to-head trial comparing HANSIZHUANG with atezolizumab, a standard-of-care treatment, for ES-SCLC, to gain approval in the U.S. market.
Beyond lung cancer, Henlius is working to solidify the global presence of HANSIZHUANG in the field of oncology. The company recently received European Union Good Manufacturing Practice (EU GMP) certificates for its production facilities, and the first overseas shipment of HANSIZHUANG was completed in early 2024. This marked HANSIZHUANG’s entry into Southeast Asia, making it the first Chinese anti-PD-1 mAb to reach the region.
Resource: Shanghai Henlius Biotech, September 18, 2024
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