First Patient in Overseas Trial Site Dosed in an International Multi-centre Phase 3 Study of Henlius Anti-PD-1 mAb HLX10 in ES-SCLC
Shanghai, China, April 24, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient in overseas trial site was dosed in Turkey in a randomised, double-blind, international multi-centre, Phase 3 clinical trial (NCT04063163), which aims to compare the clinical efficacy, safety and tolerability of HLX10, a recombinant anti-programmed death-1 (PD-1) humanised monoclonal antibody (mAb) injection, in combination with chemotherapy (Carboplatin-Etoposide) versus placebo in combination with chemotherapy (Carboplatin-Etoposide) in previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC). This is the second international Phase 3 trial of Henlius HLX10 in lung cancer that has completed dosing of first patient in overseas trial site. The pace of HLX10 to enter global market has been accelerated by the smooth progression of its international pivotal trials.
Previously, first patient has been dosed in this international multi-centre phase 3 clinical study in ES-SCLC in China, and Henlius will continue patient enrollment in China, Turkey and other countries of the study. Recently, the first patient in overseas trial site has also been dosed in another international multi-centre phase 3 clinical study of HLX10 combined with chemotherapy as first-line treatment of squamous non-small cell lung cancer (sqNSCLC). In addition to the above-mentioned two studies, in the field of lung cancer treatment, the study of HLX10 combined with HLX04 (a biosimilar bevacizumab) as first-line treatment of non-squamous NSCLC has also entered pivotal phase 3. With these studies, HLX10 combination therapies have the potential to achieve a broad coverage of first-line lung cancer patients.
According to GLOBOCAN data, lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death in the world, and there are about 2.09 million new cases each year [1]. Among all lung cancer cases, small cell lung cancer (SCLC) accounts for about 15% [2]. SCLC is extremely aggressive and is characterized by early metastatic spread and poor prognosis [3]. Most SCLC patients are diagnosed with extensive-stage diseases. Available treatment options for ES-SCLC patients are quite limited and chemotherapy has been the main treatment method before the era of immuno-oncology therapies. There has been some clinical data suggesting that PD-1 inhibitor combined with chemotherapy has the potential to significantly improve the treatment outcome of ES-SCLC patients.
With the initiation of multiple international clinical trials and the enrollment of patients, Henlius will continue exploring the potential of HLX10 in developing countries to provide cancer patients in these countries with effective and accessible immunotherapy options. At the same time, Henlius also plans to develop HLX10 in the United States, Europe and other developed countries and regions to benefit more patients all over the world.
Reference Notes:
[1] Freddie Bray, Jacques Ferlay, Isabelle Soerjomataram et al. Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries[J]. CA CANCER J CLIN. 2018;68(6): 394–424.
[2] Bender, E. Epidemiology: The dominant malignancy[J]. Nature. 2014;513, S2 - S3.
[3] Santarpia M, Daffinà MG, Karachaliou N, et al. Targeted drugs in small-cell lung cancer. Transl Lung Cancer Res[J]. 2016;5(1): 51-70.
