Shanghai, China, April 23, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient in overseas trial site was dosed in a randomized, double-blind, multi-centre, international Phase 3 clinical trial, which aims to compare the clinical efficacy and safety of HLX10, a recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody (mAb) injection, in combination with chemotherapy (carboplatin nab paclitaxel) versus chemotherapy (carboplatin nab paclitaxel) as first-line treatment in subjects with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) (NCT04033354).
Accelerating HLX10 "Combo plus Global" strategy by international multi-centre studies
HLX10 is an innovative anti-PD-1 mAb independently discovered and developed by Henlius in accordance with international quality standards. To maximize the clinical potential of HLX10, a differentiated strategy of "Combo plus Global" is adopted by Henlius in the development of HLX10. Previously, first patient has been dosed in this international multi-centre phase 3 clinical study in China, and the dosing of the first patient in overseas trial site further advances this "Combo plus Global" strategy. With the initiation of multiple international clinical trials and the enrollment of patients in overseas trial sites, the pace of HLX10 to enter international market will be accelerated. In the future, the position of HLX10 to be a global product and to benefit patients around the world will become a major differentiation advantage of HLX10.
3 pivotal studies covering different types of first-line lung cancer
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]. Of all lung cancer cases, sqNSCLC accounts for about 30%, non-squamous non-small cell lung cancer (nsqNSCLC) accounts for about 55%, and small cell lung cancer (SCLC) accounts for about 15% [2]. Most lung cancer patients are in late stage when diagnosed and lack the opportunity for surgery. In addition, due to the lack of effective therapeutic targets, there is limited treatments available for advanced sqNSCLC and chemotherapy was the main treatment option before the era of immuno-oncology therapies.
Clinical studies suggest that PD-1 inhibitor combined with chemotherapy could bring significant survival benefits to patients with advanced sqNSCLC. In order to improve the treatment modalities of patients with advanced sqNSCLC and to provide novel immuno-oncology treatment options for patients both in China and around the world, Henlius has initiated the international multi-centre phase 3 clinical study (NCT04033354), and will continue patient enrollment in China, Turkey and other countries of the study. In addition to this phase 3 trial in sqNSCLC, there are another two clinical studies of HLX10 combination therapies in lung cancer, i.e. a study of HLX10 combined with HLX04 (a biosimilar bevacizumab) as first-line treatment of nsqNSCLC and a study of HLX10 combined with chemotherapy as first-line treatment of SCLC. Both studies have also entered pivotal phase 3. HLX10 combination therapies have the potential to achieve a broad coverage for first-line lung cancer patients. If the studies of HLX10 go well, they are expected to bring more high-quality immunotherapy options to lung cancer patients.
Expansion of international market via global cooperation
Apart from conducting international trials of HLX10, Henlius also actively seeks for international cooperation opportunities with the aim to benefit more patients in the world, especially patients in emerging markets. Henlius has reached a collaboration agreement with PT Kalbe Genexine Biologics (KG Bio), upon which KG Bio is granted exclusive rights to develop and commercialize HLX10 in relation to its first monotherapy and two combination therapies in 10 Southeast Asian countries. Starting from Southeast Asia, 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 plan 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.