Shanghai, China, December 15th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the European Commission (EC) has granted Orphan Drug Designation (ODD) for HANSIZHUANG (serplulimab) for the treatment of small cell lung cancer (SCLC). This is the second ODD that HANSIZHUANG has been granted for the treatment of SCLC following the one granted by the United States Food and Drug Administration (FDA). At present, there is no anti-PD-1 mAb approved for the first-line treatment of SCLC worldwide. HANSIZHUANG is expected to become the world's first anti-PD-1 mAb for the first-line treatment of SCLC and to fill the clinical gap in the next five years.
Based on the results of ASTRUM-005, an international multi-centre phase 3 study conducted in various countries including China, Poland, Turkey, and Georgia, the New Drug Application (NDA) of HANSIZHUANG in combination with chemotherapy for the first-line treatment of extensive stage small cell lung cancer (ES-SCLC) has been accepted by the National Medical Products Administration (NMPA). Henlius also plans to file marketing authorisation applications (MAA) on ES-SCLC in the EU. Moreover, the first patient has been dosed in a bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC. Henlius plans to recruit 100 pairs of US patients with ES-SCLC to further evaluate the efficacy of HANSIZHUANG.
This ODD granted by EC follows the positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). According to the EC, orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the EU. The EU Regulation on orphan medicinal products establishes a centralised procedure for the designation of orphan medicinal products and puts in place incentives for their research, development and marketing, certain policy support, including but not limited to 1) protocol assistance for clinical studies; 2) access to the centralised authorization procedure; 3) ten years of protection from market exclusivity once approved for marketing; 4) fee reductions for regulatory activities.
According to GLOBOCAN 2020, lung cancer (LC) is the second most common cancer around the world. There were 2.2 million new LC cases and 1.8 million new deaths in 2020 worldwide, and LC is the leading cause of cancer deaths [1]. SCLC accounts for 15%–20% of all cases and is the most aggressive type of LC. It is classified into two stages: limited stage (LS-SCLC) and ES-SCLC, with both exhibiting high malignancy, strong invasiveness, early metastasis, fast disease progression, and a poor prognosis. The advent of immune checkpoint inhibitors has been proved to bring hope to patients and anti-PD-L1 mAb has been recommended by the latest NCCN guidelines and CSCO guidelines as the first-line treatment for ES-SCLC. In recent years, however, a number of PD-1 mAbs have failed in this indication. On the other hand, the standard treatment regimens for LS-SCLC are surgery, chemotherapy, and concurrent radiotherapy. Traditional chemotherapeutic drugs did not exhibit significant progress in patients with LS-SCLC, and most patients tend to develop drug resistance or rapid relapse [2-4].
Based on the unmet clinical needs, Henlius promotes a series of immunotherapy studies in the field of SCLC, with the goal of providing more effective treatment approaches for patients. As for the first-line treatment of ES-SCLC with HANSIZHUANG, the results of ASTRUM-005 were presented for the first time in an oral report at the 2022 ASCO annual meeting, and ASTRUM-005 went on to become the first immunotherapy clinical study of SCLC to be published in The Journal of the American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world. Recently, the updated results of ASTRUM-005 has released in the European Society for Medical Oncology Asia (ESMO Asia) Congress. As of data cutoff date (June 13, 2022), median overall survival (OS) was significantly longer in the serplulimab group (15.8 months) than in the placebo group (11.1 months), forming a new world record with good safety and consistent efficacy over time. For the first-line treatment of LS-SCLC with HANSIZHUANG, the company has carried out an international multi-centre phase 3 study with the first patient dosed in China and has obtained clinical approvals in countries and regions including Australia and Spain.
In the future, Henlius will continue to emphasize unmet clinical needs and actively promote the combination immunotherapy of HANSIZHUANG and international regulatory registration to benefit more patients around the world.
About HANSIZHUANG
HANSIZHUANG (recombinant humanised anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 2 indications are approved for marketing in China, 2 NDAs have been accepted by the NMPA, and more than 10 clinical trials are ongoing across the world.
HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours and squamous non-small cell lung cancer (sqNSCLC). Its synergy with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 12 clinical trials on immuno-oncology combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,100 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDAs of the first-line treatment for squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) have been accepted by the NMPA, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Furthermore, HANSIZHUANG was recommended for the treatment of ES-SCLC in the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC), and the associated clinical trial became the first study published in JAMA on SCLC immunotherapy. Serplulimab was also granted orphan drug designations by the FDA and EC for the treatment of SCLC, and the first patient has been dosed in a bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC.