2021 ASCO summary announced, Chinese pharmaceutical companies have a first look at drug data

The annual global oncology event-the American Society of Clinical Oncology ( ASCO ) annual meeting will be held in the form of an online conference from June 4th to 8th, 2021
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Currently, ASCO's official website has published the summary content of this annual meeting

1.

SHR-1701 is a fusion protein of anti-PD-L1 monoclonal antibody and TGF-β Trap developed by Hengrui
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This phase I clinical trial to be reported at this conference aims to evaluate the safety and preliminary anti-tumor activity of SHR-1701 in patients with refractory solid tumors

As of October 30, 2020, the median duration of exposure to SHR-1701 was 6.

2.

In the forthcoming single-arm, multi-center, open-label Phase 2 study, the efficacy and safety of tislelizumab as a monotherapy for Chinese adult patients were evaluated.
These patients are all previously treated, topical Advanced, unresectable or histologically confirmed metastatic MSI-H/dMMR solid tumor
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From September 2018 to August 2020, a total of 80 patients were enrolled (median age 53 years), of which 74 patients were included in the main efficacy analysis
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At a median follow-up of 11.

3.

HLX10 is an anti-PD-1 monoclonal antibody developed by Henlius.
This is a single-arm, open-label, multi-center phase 2 clinical study.
The enrolled patients were confirmed to be unresectable or unresectable by histology/cytology.
For metastatic MSI-H/dMMR solid tumors, 3 mg/kg HLX10 was injected intravenously every two weeks for 2 years until disease progression, unacceptable toxicity, or patient withdrawal
.
As of January 9, 2021, 108 patients were enrolled, and 68 patients with locally or centrally diagnosed MSI-H were included in the main efficacy analysis population

The IRRC and the ORR assessed by the investigator were 38.

4.

       APG-2575 (lisaftoclax) is a Bcl-2 inhibitor developed by Ascent Pharmaceuticals for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and other blood Patients with malignant tumors
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       In this first global phase I clinical study conducted in humans, it aims to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of APG-2575 in patients with R/R CLL and other HMs , Efficacy and Maximum Tolerated Dose (MTD)/Recommended Dose of Phase II Study (RP2D)
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       As of January 7, 2021, 35 patients were included in the study, and 12 of 14 evaluable R/R CLL/SLL patients achieved partial remission (PR), ORR was 85.
7%, and median (range) response time For 3 (2-7) treatment cycles
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A decrease in the absolute lymphocyte count (ALC) can be observed when the dose of APG-2575 is as low as 20 mg/day
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       APG-2575 is well tolerated and adverse events are controllable
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No dose limiting toxicity (DLT) was observed at the highest dose of 1200 mg
.

       5.
Kelun Pharmaceutical-A166

       A166 is an anti-HER2 antibody-drug conjugate developed by Kelun Pharmaceutical.
The research published this time aims to evaluate the safety, tolerability, and drug safety of A166 in the treatment of patients with locally advanced or metastatic solid tumors expressing HER2.
Dynamics (PK) and preliminary efficacy
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       As of November 30, 2020, a total of 57 patients were enrolled, and the ORRs of 36 patients with HER2-positive breast cancer that could be evaluated for curative effect were 59.
1% (13/22) and 71.
4% (10/14); 4 patients were evaluated for curative effect The results of HER2 low-expressing breast cancer patients were 1 case of PR, 2 cases of SD, and 1 case of PD
.
At present, the median PFS has not yet been reached, and 59% of patients whose data are currently disclosed are still receiving treatment, suggesting that patients are still benefiting
.
One patient in the 4.
8 mg/kg dose group has been treated with A166 for more than 19 months
.

       6.
Genxi Biology——GC012F 

       GC012F is a BCMA/CD19 dual-targeting autologous CAR-T cell therapy developed based on the FasTCAR patented technology platform of Genxi Biosystems
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       In this phase I clinical trial, the data is as of January 12, 2021.
A total of 19 patients with multiple myeloma were included in the three dose groups.
The results showed that the early objective response rate (ORR) was as high as 94.
7% (18/19).
), all responses showed excellent partial remission (VGPR) or even complete remission (sCR) in the strict sense; the data of all dose groups showed rapid, in-depth, and long-lasting therapeutic effects
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All patients (n=9) who received treatment in the highest dose group achieved minimal residual disease negative-strictly complete remission (MRD-sCR)
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       The safety of GC012F is consistent with previous observations.
The main occurrence is low-grade cytokine release syndrome (CRS) (84% of patients are grade 1/2; 11% of patients are grade 3), and there is no grade 4 Or Level 5 CRS
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       As the country attaches great importance to the development of innovative drugs, the development of innovative drugs in China has begun to usher in a golden age and is also recognized by the world
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More and more national innovative drugs have appeared on the international stage one after another, demonstrating huge development potential to the world
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I hope that Chinese medicine will cross mountains and seas, benefit patients all over the world, and usher in the grand feast of China's innovative and international era
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       Reference source:

       1.
2021 ASCO Abstract 2503; 2569; 1024; 

       2.
First-in-human study of lisaftoclax (APG-2575), a novel Bcl-2 inhibitor (Bcl-2i), in patients (pts) with relapsed/refractory (R/R) CLL and other hematologic malignancies (HMs) ;

       3.
PhaseⅠstudy of A166 in patients with HER2expressing locally advanced ormetastatic solid tumors.