Recently, results from four phase 1/2 clinical trials conducted in patients with advanced solid tumours of Henlius' self-developed novel products, including anti-PD-1 mAb HANSIZHUANG (serplulimab), anti-EGFR mAb HLX07 and anti-LAG-3 mAb HLX26, were released as poster presentations at
The above studies involves HLX10-008-HCC201 led by Professor
HANSIZHUANG (Serplulimab)
HANSIZHUANG (generic name: serplulimab injection) is an innovative anti-PD-1 monoclonal antibody independently developed by Henlius and become the first anti-PD-1 mAb for the first-line treatment of SCLC. Since its first launched in
Title
A phase 2 study of serplulimab (a programmed death-1 inhibitor) with or without HLX04 (a bevacizumab biosimilar) for the treatment of advanced hepatocellular carcinoma
Study design
Patients with advanced HCC who failed prior systemic therapy received serplulimab 3 mg/kg plus HLX04 5 mg/kg (group A), serplulimab 3 mg/kg plus HLX04 10 mg/kg (group B), or serplulimab 3 mg/kg monotherapy (group C). Patients with previously untreated advanced HCC were enrolled in group D and given serplulimab 3 mg/kg plus HLX04 10 mg/kg. All treatments were administered intravenously every 2 weeks. The primary endpoint was safety.
Results
This open-label, multicentre phase 2 study was conducted in
Conclusion
In the first-line and subsequent-line settings, serplulimab plus HLX04 and serplulimab monotherapy, respectively, showed a manageable safety profile together with encouraging efficacy in patients with advanced HCC.
HLX07
HLX07 is an innovative drug targeting EGFR independently developed by Henlius. Adopting the self-developed advanced antibody engineering platform, Henlius re-engineered cetuximab by humanizing its Fab regions and minimizing its glycan contents to generate HLX07 to reduce the immunogenicity and maintain high affinity of the product. As of now, Henlius holds patents of HLX07 in several jurisdictions including
Title
First-line HLX07 Plus Serplulimab With or Without Chemotherapy Versus Serplulimab Plus Chemotherapy in Advanced/Recurrent Squamous Non-small Cell
Study design
This randomised, multicentre phase 2 study consisted of 4 parts and assessed different combinations of HLX07 (at various doses), serplulimab, and chemo. Part 3 explored the preliminary efficacy of the three-drug combination and is presented below. Patients with stage IIIB/IIIC or IV squamous non-small cell lung cancer (sqNSCLC) that could not be treated with surgery or radiation therapy and had not received prior systemic therapy were enrolled and randomised 1:1 to receive intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), combined with serplulimab (300 mg) and chemo (carboplatin and nab-paclitaxel), Q3W. The primary endpoints were
Results
As of
Conclusion
First-line HLX07 plus serplulimab and chemo conferred encouraging antitumour efficacy with a manageable safety profile in patients with advanced sqNSCLC and warrants further investigation.
Title
Efficacy and Safety of HLX07 Monotherapy in Advanced Cutaneous Squamous Cell Carcinoma: an Open-label, Multicentre Phase 2 Study
Study design
This single-arm, open-label, multicentre phase 2 study consisted of 2 parts. Part 1 explored the preliminary efficacy and was presented below; part 2 evaluated the efficacy and safety of HLX07 (at a fixed dose based on part 1) in a larger cohort. Patients with advanced CSCC harbouring lymph node or distant metastasis, or locally advanced CSCC that was not amenable to surgery/radical radiation therapy were enrolled to receive intravenous HLX07 at 1500 mg (group A) or 1000 mg (group B), Q3W in part 1. The primary endpoint was independent radiological review committee (IRRC)-assessed objective response rate (ORR) per RECIST 1.1. Secondary endpoints included other efficacy measures, safety, pharmacokinetics, immunogenicity, and quality-of-life assessment.
Results
As of
Conclusion
HLX07 monotherapy demonstrated encouraging antitumour efficacy and was well-tolerated in patients with advanced CSCC.
HLX26
HLX26 is a human mAb targeting LAG-3 extracellular domains, which developed independently by Henlius. HLX26 can block the LAG-3-mediated signaling pathway to restore the killing function of T cells. Pre-clinical studies proved that HLX26 has the anti-tumour effect and favorable tolerability and safety. Furthermore, in vitro and animal studies showed that HLX26 in combination with serplulimab has a significant synergistic effect in anti-tumour. These results lay the foundation for further clinical studies on combination usage. As of now, the first patients have been dosed in two phase 2 clinical trials of serplulimab in combination with HLX26, respectively for the treatment of metastatic colorectal cancer (mCRC) as well as advanced non-small cell lung cancer (NSCLC).
Title
Safety, Preliminary Efficacy, and Pharmacokinetics of HLX26 plus Serplulimab in Advanced Solid Tumours: an Open-label, Dose-escalation Phase 1 Study
Study design
This was a single-centre, open-label, dose-escalation phase 1 study. Patients with histologically or cytologically confirmed advanced/metastatic solid tumours that had failed or could not receive standard therapies were enrolled and received intravenous HLX26 at three dose levels (500, 800, 1600 mg) plus serplulimab (300 mg) Q3W, following a '3+3' design. The primary endpoint was dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) within three weeks after the first administration of HLX26 (i.e. the DLT observation period). Secondary endpoints included safety, preliminary efficacy, pharmacokinetics, and immunogenicity.
Results
As of
Conclusion
No new safety signals were observed for the different doses of HLX26 in combination with serplulimab. HLX26 plus serplulimab was safe and well tolerated in patients with advanced solid tumours who had failed or could not receive standard therapies.
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