The results of two latest clinical studies of Fuhong Henlius' Slulimumab injection will be released for the first time on ASCO 2021

us" >us" >

On June 7, 2021, Henlius (2696.
HK) announced that the company's self-developed slulimumab (HLX10) is used for the treatment of metastatic and highly microsatellite unstable or mismatch repair defective solid tumors and advanced stages Two phase II clinical trial data for cervical cancer (HLX10-010-MSI201 and HLX10-011-CC201) were released for the first time at the 2021 American Society of Clinical Oncology (ASCO) annual meeting held recently
.

us" >

On June 7, 2021, Henlius (2696.
HK) announced that the company's self-developed slulimumab (HLX10) is used for the treatment of metastatic and highly microsatellite unstable or mismatch repair defective solid tumors and advanced stages Two phase II clinical trial data for cervical cancer (HLX10-010-MSI201 and HLX10-011-CC201) were released for the first time at the 2021 American Society of Clinical Oncology (ASCO) annual meeting held recently
.

us" >

On June 7, 2021, Henlius (2696.
HK) announced that the company's self-developed slulimumab (HLX10) is used for the treatment of metastatic and highly microsatellite unstable or mismatch repair defective solid tumors and advanced stages Two phase II clinical trial data for cervical cancer (HLX10-010-MSI201 and HLX10-011-CC201) were released for the first time at the 2021 American Society of Clinical Oncology (ASCO) annual meeting held recently
.

us" >

On June 7, 2021, Henlius (2696.
HK) announced that the company's self-developed slulimumab (HLX10) is used for the treatment of metastatic and highly microsatellite unstable or mismatch repair defective solid tumors and advanced stages Two phase II clinical trial data for cervical cancer (HLX10-010-MSI201 and HLX10-011-CC201) were released for the first time at the 2021 American Society of Clinical Oncology (ASCO) annual meeting held recently
.

us" >

On June 7, 2021, Henlius (2696.
HK) announced that the company's self-developed slulimumab (HLX10) is used for the treatment of metastatic and highly microsatellite unstable or mismatch repair defective solid tumors and advanced stages Two phase II clinical trial data for cervical cancer (HLX10-010-MSI201 and HLX10-011-CC201) were released for the first time at the 2021 American Society of Clinical Oncology (ASCO) annual meeting held recently
.

    

On June 7, 2021, Henlius (2696.
HK) announced that the company's self-developed slulimumab (HLX10) is used for the treatment of metastatic and highly microsatellite unstable or mismatch repair defective solid tumors and advanced stages Two phase II clinical trial data for cervical cancer (HLX10-010-MSI201 and HLX10-011-CC201) were released for the first time at the 2021 American Society of Clinical Oncology (ASCO) annual meeting held recently
.

On June 7, 2021, Henlius (2696.

Slulimumab injection is an innovative anti-PD-1 monoclonal antibody independently developed by Fuhong Henlius.

It has been approved for clinical trials in China, the United States, the European Union and other countries and regions, and a total of 10 tumor immune clinical trials have been carried out.

Slulimumab injection is an innovative anti-PD-1 monoclonal antibody independently developed by Fuhong Henlius.

It has been approved for clinical trials in China, the United States, the European Union and other countries and regions, and a total of 10 tumor immune clinical trials have been carried out.
Comprehensive coverage of lung cancer, esophageal cancer, hepatocellular carcinoma, gastric cancer, head and neck cancer and other high-incidence large tumors

Slulimumab injection is an innovative anti-PD-1 monoclonal antibody independently developed by Fuhong Henlius.
It has been approved for clinical trials in China, the United States, the European Union and other countries and regions, and a total of 10 tumor immune clinical trials have been carried out.

HLX10-010-MSI201

● Thesis title

The following are the details of the data release of Slulimab (HLX10):

The following is the data publication details of Slulimab (HLX10) : The following is the data publication details of Slulizumab (HLX10):

HLX10-010-MSI201

HLX10-010-MSI201 HLX10-010-MSI201

● Thesis title

● Thesis title ● Thesis titleus" >

Efficacy and safety of HLX10, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: a single-arm, multicenter, phase 2 study.

● Joint principal investigator

Qin Shukui, Nanjing Bayi Hospital of the Chinese People's Liberation Army; Li Jin, Shanghai Oriental Hospital

Efficacy and safety of HLX10, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: a single-arm, multicenter, phase 2 study.

Efficacy and safety of HLX10, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: a single-arm, multicenter, phase 2 study.

● Joint principal investigator

● Joint principal investigator ● Joint principal investigator ● Joint principal investigator

Qin Shukui, Nanjing Bayi Hospital of the Chinese People's Liberation Army; Li Jin, Shanghai Oriental Hospital

Qin Shukui, Nanjing Bayi Hospital of the Chinese People's Liberation Army; Li Jin, Shanghai Oriental Hospitalus" >

● Display form

Abstract and poster

● Abstract number

2566

● Experimental design

This study was conducted in patients with unresectable or metastatic highly microsatellite instability or mismatch repair defect solid tumors that failed standard treatments and was conducted to evaluate the efficacy, safety and tolerability of HLX10.

Open, multi-center, phase II clinical trial
.
The included patients received intravenous injection of 3 mg/kg HLX10 every two weeks for up to two years until the disease progressed, unacceptable toxicity occurred or the patient withdrew
.
The primary endpoint of the trial is the objective response rate (ORR) assessed by the Independent Imaging Evaluation Committee (IRRC) based on the RECIST v1.
1 standard
.

● Test results

1) Effectiveness

a) Primary endpoint

A total of 108 patients were enrolled in this trial, of which 68 patients with MSI-H confirmed by the central laboratory or research center were included in the main efficacy analysis population
.
In the main efficacy analysis population, the ORR assessed by the independent imaging evaluation committee was 38.
2% (95% CI: 26.
7%, 50.
8%; 2 cases had complete remission)
.

b ) secondary end point

Secondary efficacy endpoints include the objective response rate assessed by the investigator, duration of response (DoR), progression-free survival (PFS), and overall survival (OS)
.
The median DoR, PFS and OS have not yet been reached
.

2) Security

The results show that HLX10 has good safety and tolerability
.

● Conclusion

HLX10 has shown significant anti-tumor activity and good safety in patients with MSI-H/dMMR solid tumors who have failed standard treatment
.
As an effective tissue-indeterminate cancer-like drug, HLX10 is expected to improve the clinical efficacy of patients
.

HLX10-011-CC201

● Thesis title

● Display form

● Display form ● Display form ● Display form

Abstract and poster

Abstract and poster

● Abstract number

● Abstract number ● Abstract number

2566

2566

● Experimental design

● Experimental design ● Experimental design

This study was conducted in patients with unresectable or metastatic highly microsatellite instability or mismatch repair defect solid tumors that failed standard treatments and was conducted to evaluate the efficacy, safety and tolerability of HLX10.
Open, multi-center, phase II clinical trial
.
The included patients received intravenous injection of 3 mg/kg HLX10 every two weeks for up to two years until the disease progressed, unacceptable toxicity occurred or the patient withdrew
.
The primary endpoint of the trial is the objective response rate (ORR) assessed by the Independent Imaging Evaluation Committee (IRRC) based on the RECIST v1.
1 standard
.

This study was conducted in patients with unresectable or metastatic highly microsatellite instability or mismatch repair defect solid tumors that failed standard treatments and was conducted to evaluate the efficacy, safety and tolerability of HLX10.
Open, multi-center, phase II clinical trial
.
The included patients received intravenous injection of 3 mg/kg HLX10 every two weeks for up to two years until the disease progressed, unacceptable toxicity occurred or the patient withdrew
.
The primary endpoint of the trial is the objective response rate (ORR) assessed by the Independent Imaging Evaluation Committee (IRRC) based on the RECIST v1.
1 standard
.

● Test results

● Test results ● Test results ● Test results

1) Effectiveness

1) Effectiveness 1) Effectiveness

a) Primary endpoint

a) Primary endpoint a) Primary endpoint

A total of 108 patients were enrolled in this trial, of which 68 patients with MSI-H confirmed by the central laboratory or research center were included in the main efficacy analysis population
.
In the main efficacy analysis population, the ORR assessed by the independent imaging evaluation committee was 38.
2% (95% CI: 26.
7%, 50.
8%; 2 cases had complete remission)
.

A total of 108 patients were enrolled in this trial, of which 68 patients with MSI-H confirmed by the central laboratory or research center were included in the main efficacy analysis population
.
In the main efficacy analysis population, the ORR assessed by the independent imaging evaluation committee was 38.
2% (95% CI: 26.
7%, 50.
8%; 2 cases had complete remission)
.

b ) secondary end point

b ) secondary end point b ) secondary end point ) secondary end point

Secondary efficacy endpoints include the objective response rate assessed by the investigator, duration of response (DoR), progression-free survival (PFS), and overall survival (OS)
.
The median DoR, PFS and OS have not yet been reached
.

Secondary efficacy endpoints include the objective response rate assessed by the investigator, duration of response (DoR), progression-free survival (PFS), and overall survival (OS)
.
The median DoR, PFS and OS have not yet been reached
.

2) Security

2) Security 2) Security 2) Security

The results show that HLX10 has good safety and tolerability
.

The results show that HLX10 has good safety and tolerability
.

● Conclusion

● Conclusion ● Conclusion ● Conclusion

HLX10 has shown significant anti-tumor activity and good safety in patients with MSI-H/dMMR solid tumors who have failed standard treatment
.
As an effective tissue-indeterminate cancer-like drug, HLX10 is expected to improve the clinical efficacy of patients
.

HLX10 has shown significant anti-tumor activity and good safety in patients with MSI-H/dMMR solid tumors who have failed standard treatment
.
As an effective tissue-indeterminate cancer-like drug, HLX10 is expected to improve the clinical efficacy of patients
.

HLX10-011-CC201

HLX10-011-CC201 HLX10-011-CC201

● Thesis title

● Thesis title ● Thesis titleus" >

Efficacy and safety evaluation of HLX10 (a recombinant humanised anti-PD-1 monoclonal antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy: a single-arm, open -label, phase 2 study.

● Principal Investigator

Wu Lingying, Cancer Hospital, Chinese Academy of Medical Sciences

Efficacy and safety evaluation of HLX10 (a recombinant humanised anti-PD-1 monoclonal antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy: a single-arm, open -label, phase 2 study.

Efficacy and safety evaluation of HLX10 (a recombinant humanised anti-PD-1 monoclonal antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy: a single-arm, open -label, phase 2 study.

● Principal Investigator

● Principal Investigator ● Principal Investigator ● Principal Investigator

Wu Lingying, Cancer Hospital, Chinese Academy of Medical Sciences

Wu Lingying, Cancer Hospital, Chinese Academy of Medical Sciencesus" >

● Display form

Summary

● Abstract number

e17510

● Experimental design

This study is a single-arm, open, multi-center, two-phase phase II clinical trial evaluating the efficacy, safety and tolerability of HLX10 combined with albumin paclitaxel in patients with advanced cervical cancer who have failed first-line standard chemotherapy
.
The included patients received intravenous infusion of HLX10 (4.
5 mg/kg) and albumin paclitaxel (260 mg/m ² ) every three weeks .
The primary endpoint of the trial is the objective response rate (ORR) assessed by the Independent Imaging Evaluation Committee (IRRC) based on the RECIST v1.
1 standard .

● Test results

The first phase of the trial was the safety introduction and preliminary efficacy exploration period.
A total of 21 patients were enrolled, and their average composite positive score (CPS) was 39.
33
.
The ORR assessed by IRRC and the investigator were 52.
4% (95% CI: 29.
8%, 74.
3%) and 42.
9% (95% CI: 21.
8%, 66.
0%), respectively
.
Tests show that HLX10 has good safety and tolerance
.

● Conclusion

The results of the first phase of the trial showed that HLX10 combined with albumin paclitaxel showed good efficacy and safety in patients with advanced cervical cancer who failed first-line standard chemotherapy
.

● Display form

● Display form ● Display form ● Display form

Summary

Summary

● Abstract number

● Abstract number ● Abstract number

e17510

e17510

● Experimental design

● Experimental design ● Experimental design

This study is a single-arm, open, multi-center, two-phase phase II clinical trial evaluating the efficacy, safety and tolerability of HLX10 combined with albumin paclitaxel in patients with advanced cervical cancer who have failed first-line standard chemotherapy
.
The included patients received intravenous infusion of HLX10 (4.
5 mg/kg) and albumin paclitaxel (260 mg/m ² ) every three weeks .
The primary endpoint of the trial is the objective response rate (ORR) assessed by the Independent Imaging Evaluation Committee (IRRC) based on the RECIST v1.
1 standard .

This study is a single-arm, open, multi-center, two-phase phase II clinical trial evaluating the efficacy, safety and tolerability of HLX10 combined with albumin paclitaxel in patients with advanced cervical cancer who have failed first-line standard chemotherapy
.
The included patients received intravenous infusion of HLX10 (4.
5 mg/kg) and albumin paclitaxel (260 mg/m ^{2 2} ) every three weeks .
The primary endpoint of the trial is the objective response rate (ORR) assessed by the Independent Imaging Evaluation Committee (IRRC) based on the RECIST v1.
1 standard .

● Test results

● Test results ● Test results ● Test results

The first phase of the trial was the safety introduction and preliminary efficacy exploration period.
A total of 21 patients were enrolled, and their average composite positive score (CPS) was 39.
33
.
The ORR assessed by IRRC and the investigator were 52.
4% (95% CI: 29.
8%, 74.
3%) and 42.
9% (95% CI: 21.
8%, 66.
0%), respectively
.
Tests show that HLX10 has good safety and tolerance
.

The first phase of the trial was the safety introduction and preliminary efficacy exploration period.
A total of 21 patients were enrolled, and their average composite positive score (CPS) was 39.
33
.
The ORR assessed by IRRC and the investigator were 52.
4% (95% CI: 29.
8%, 74.
3%) and 42.
9% (95% CI: 21.
8%, 66.
0%), respectively
.
Tests show that HLX10 has good safety and tolerance
.

● Conclusion

● Conclusion ● Conclusion ● Conclusion

The results of the first phase of the trial showed that HLX10 combined with albumin paclitaxel showed good efficacy and safety in patients with advanced cervical cancer who failed first-line standard chemotherapy
.

The results of the first phase of the trial showed that HLX10 combined with albumin paclitaxel showed good efficacy and safety in patients with advanced cervical cancer who failed first-line standard chemotherapy
.