Henlius completed the first patient in the US to administer H drugs for first-line bridging studies in the treatment of extensive-stage small cell lung cancer

On November 29, 2022, Henlius (2696.
HK) announced that a head-to-head bridging study (NCT05468489) of H drug Hans-like (serplulimab) versus first-line standard therapy atezolizumab (PD-L1 ® immunosuppressant) has completed the first subject dosing
in the United States.
Based on the positive feedback from the FDA on the marketing application submitted for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and the discussion results of the FDA Class C Advisory Meeting, the Company intends to recruit 200 US subjects to participate in this bridging clinical trial to evaluate the efficacy
of H drug Hans-like ® in ES-SCLC patients in the United States.

In April 2022, the company announced that H drug Hans-like ® for the treatment of small cell lung cancer (SCLC) has been granted orphan-drug designation by the US Food and Drug Administration (FDA), which will help H drug enjoy certain policy support
in the research and development, registration and commercialization of drug H in the United States.
In China, the marketing application for the first-line treatment of ES-SCLC indications of H drug has been accepted
by the National Medical Products Administration (NMPA).
At present, there is no first-line anti-PD-1 monoclonal antibody for SCLC in the world, and H drug is expected to become the world's first first-line anti-PD-1 monoclonal antibody for SCLC, filling the clinical gap
of PD-1 inhibitors in the first-line treatment of small cell lung cancer in the next five years.

Based on innovation, excellence

Small cell lung cancer accounts for 15%-20% of the total number of lung cancers, which is the most aggressive subtype of lung cancer, divided into limited-stage small cell lung cancer (LS-SCLC) and ES-SCLC, with high malignancy, early metastasis, rapid disease progression, and poor overall prognosis
.
At present, anti-PD-L1 monoclonal antibody combined chemotherapy has been recommended as the first-line treatment for ES-SCLC by the latest version of NCCN guidelines, but in recent years, a number of PD-1 products have been successively broken in the field of ES-SCLC, and have not really benefited
ES-SCLC patients worldwide.

Henlius has conducted an international multi-center phase III clinical study (ASTRUM-005)
for the first-line treatment of ES-SCLC in ® China, Turkey, the European Union, Poland, Georgia and other countries.
A total of 128 trial centers were opened in the trial, enrolling 585 participants, of whom about 31.
5% were white
.
The results of the ASTRUM-005 clinical trial were first released orally at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published online in the Journal of the American Medical Association (JAMA, impact factor: 157.
3), one of the world's top four medical journals, becoming the world's first clinical study
of immunotherapy for small cell lung cancer to be featured in JAMA's main journal 。 As of October 22, 2021, the median overall survival (OS) of the total population in the serplulimab group of the trial reached 15.
4 months, setting a new global record for overall survival of first-line small cell lung cancer and showing good efficacy and safety
.

Extensive layout to accelerate global development

H drug Hans-like is Henlius' first self-developed ® innovative monoclonal antibody, which has been approved for marketing in 2 indications and accepted for marketing for 2 indications
.
Since its approval in March 2022, H has been approved in China for the treatment of microsatellite highly unstable (MSI-H) solid tumors and squamous non-small cell lung cancer, benefiting more than 9,700 Chinese patients
.
Focusing on H drugs, Henlius actively promotes its synergy with other products and the combination of innovative therapies, successively obtaining clinical trial licenses in China, the United States, the European Union and other countries and regions, and simultaneously carrying out 11 clinical trials of tumor immunotherapy around the world, covering lung cancer, esophageal cancer, head and neck squamous cell carcinoma and gastric cancer, and comprehensively covering the first-line treatment
of lung cancer 。 Up to now, H drug has enrolled more than 3,100 people worldwide, including ASTRUM-005, and the proportion of white people enrolled in two international multi-center clinical trials, including ASTRUM-005, is one of the anti-PD-1 monoclonal antibodies with more international clinical data, which is expected to support the application of H drug in overseas markets such as the European Union and lay the foundation
for global clinical application.
The bridging trial in the United States will also further promote the simultaneous development
of H drugs around the world.

In the future, the company will continue to take clinical needs as the core, accelerate the progress of this bridging clinical trial and the global clinical layout of H drug related research, and bring more high-quality, high-cost biological drugs
to patients around the world with continuous innovation and breakthroughs.

About Bridging Research (NCT05468489)

This is a randomized, open-label clinical study
comparing the efficacy and safety of serplulimab in combination with chemotherapy (carboplatin-etoposide) and the PD-L1 immunosuppressant atezolizumab plus chemotherapy (carboplatin-etoposide) in US patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC).
Eligible patients were randomized in a 1:1 ratio to receive intravenous serplulimab (300 mg) or atezolizumab (1200 mg) plus chemotherapy every three weeks
.
The primary objective of this study was to compare the efficacy
of the two dosing regimens in previously untreated US patients with ES-SCLC.
The secondary objective was to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity
of serplulimab in combination with chemotherapy.
The primary endpoint was overall survival (OS).

Secondary endpoints included progression-free survival (PFS), PFS2, objective response rate (ORR), duration of response (DOR), safety, pharmacokinetic profile, and immunogenicity
.