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BeiGene, Genxi Biological, Kangfang Biological, Chia Tai Tianqing, etc. announce ASCO clinical data

 Last Update: 2021-06-11
 Source: Internet
 Author: User

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Source: Guanlan Pharmaceutical

On May 20th, the official website of the annual meeting of the American Society of Clinical Oncology (ASCO) officially announced the summary of the conference.

Mechanism of action: PARP inhibitor

Indications: HER2-negative breast cancer

Pamidarib is a PARP1 and PARP2 inhibitor independently developed by BeiGene.

One of them is a phase 2 clinical study of pamidar in the treatment of locally advanced or metastatic HER2-negative breast cancer patients with germline BRCA mutations.

Mechanism of action: ROS1 and NTRK dual target small molecule inhibitor

Indications: ROS1 fusion non-small cell lung cancer (NSCLC)

Talectrectinib is a new generation of selective ROS1 and NTRK dual target small molecule inhibitors, which can cross the blood-brain barrier.

As of January 15, 2021, 22 patients have been treated with taletrectinib, with a median age of 54.

Mechanism of action: pH-dependent humanized antibody that binds to PD-L1

Indications: advanced solid tumors and hematological malignancies

MSB2311 is a humanized antibody that binds to PD-L1 in a pH-dependent manner.

Specifically, among the 17 solid tumor patients with biomarker expression and evaluable efficacy, 6 patients obtained confirmed partial remission (PR) with an ORR of 35%; among them, at 20 mg/kg Q3W (3 weeks of use One time) There were 4 PR patients in the dose group, and the ORR reached 44%.

Mechanism of action: BCMA/CD19 dual-targeting CAR-T therapy

Indications: relapsed/refractory multiple myeloma

GC012F is a BCMA/CD19 dual-targeting autologous CAR-T cell therapy developed based on the FasTCAR patented technology platform of Genxi Biotech.

The results showed that the early ORR was as high as 94.
7% (18/19), and all responses showed excellent partial remission (VGPR), or even complete remission in the strict sense; the data of all dose groups showed rapid, in-depth, and Long-lasting therapeutic effect.
All patients (n=9) who received treatment in the highest dose group achieved negative minimal residual disease-strictly complete remission.
The safety of GC012F is consistent with previous observations.
The main occurrence is low-grade cytokine release syndrome (CRS).
No immune effector cell-related neurotoxicity was observed in 19 patients.
All TEAEs that occurred during treatment, such as decreased blood cell count, were relieved after standard treatment.

5.
Hausen Pharmaceuticals: Ametinib mesylate

Mechanism of action: third-generation EGFR-TKI

Indications: First-line treatment of non-small cell lung cancer

Ametinib is a third-generation EGFR-TKI developed by Hausen Pharmaceuticals and has been approved for second-line use in NSCLC patients in China.
The data of a multi-center, randomized, double-blind, controlled Phase 3 study of this product will be presented in the form of a poster discussion at the conference.
The study aims to evaluate Ametinib versus Gefitinib as the first-line for EGFR-sensitive mutation-positive locally advanced stages.
Or the efficacy and safety of patients with metastatic NSCLC, a total of more than 400 subjects participated.

Studies have shown that compared with the existing first-line standard treatment drugs, the use of amitinib can significantly prolong PFS (mPFS is 19.
3 months vs 9.
9 months), and DoR is also significantly prolonged (mDoR is 18.
1 months vs 8.
3 months) .
Although the ametinib group was used for a longer period of time, the incidence of drug-related skin rashes, diarrhea, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevations, and drug-related serious adverse reactions (SAEs) was lower (4.
2%) vs 11.
2%).
Overall, Ametinib shows good safety, especially in terms of wild-type EGFR-mediated toxicity, indicating that it will bring more survival benefits to patients with advanced lung cancer.

6.
Hengrui Medicine: Carrelizumab

Mechanism of action: PD-1 inhibitor

Indications: First-line treatment of esophageal squamous cell carcinoma

Carrelizumab is a humanized anti-PD-1 monoclonal antibody that has been approved in China for Hodgkin’s lymphoma, advanced hepatocellular carcinoma, non-squamous NSCLC, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, etc.
5 Item indications.
At this conference, the results of a multi-center Phase 3 clinical study called ESCORT-1st will be presented as an oral report.
This study aims to evaluate the effectiveness and safety of placebo combined with paclitaxel and cisplatin, and carrelizumab for injection combined with paclitaxel and cisplatin in the first-line treatment of advanced esophageal cancer.
From December 3, 2018 to May 12, 2020, a total of 596 patients were included in the study.

The data showed that the median follow-up time was 10.
8 months.
Compared with placebo + chemotherapy, carrelizumab + chemotherapy significantly improved OS (median OS was 15.
3 months vs 12.
0 months), and PFS was also prolonged (MPFS is 6.
9 months vs 5.
6 months).
The ORR in the carrelizumab group reached 72.
1% (vs 62.
1%), and the median DoR was 7.
0 months (vs 4.
6 months).
The incidence of treatment-related AEs of grade ≥3 in the two groups was equivalent, and the incidence of serious adverse events related to treatment was 30.
2% and 23.
2%, respectively.
This shows that the addition of carrelizumab to chemotherapy can provide patients with esophageal squamous cell carcinoma with better OS and PFS, and the safety is controllable.

7.
Junshi Bio: Teriprolizumab

Mechanism of action: PD-1 inhibitor

Indications: Mucosal melanoma

Teriprizumab is an anti-PD-1 monoclonal antibody developed by Junshi Biotech.
It has been approved for melanoma, nasopharyngeal carcinoma, and urothelial carcinoma in China for 3 indications.
At this conference, a phase 2 clinical trial of teriprizumab combined with axitinib as a neoadjuvant therapy for resectable mucosal melanoma will be presented in the form of an oral presentation.
From August 2019 to December 2020, a total of 21 patients were included in the study.
The main study endpoint is pathological remission rate (pathological complete remission rate pCR and pathological partial remission rate pPR).

The results showed that the median follow-up time was 59 weeks, and the pathological remission rate was 28.
6% (including 2 cases of pCR and 2 cases of pPR).
No tumor recurrence or metastasis was observed in responding patients, the recurrence-free survival (RFS) was more than 58 weeks, and the median RFS data was immature.
In terms of safety, the combined regimen was well tolerated, and the incidence of grade 3-4 treatment-related adverse events was 23.
8%.
The researchers believe that the neoadjuvant treatment of teriprizumab combined with axitinib in patients with surgically resectable mucosal melanoma can achieve a higher pathological remission rate, indicating that its clinical efficacy is expected and the treatment is well tolerated.
Support further research.

8.
Kangfang Bio: cadonilimab (AK104)

Mechanism of action: PD-1/CTLA-4 double antibody

Indications: First-line treatment of unresectable liver cancer

AK104 is a new and potential next-generation PD-1/CTLA-4 bispecific antibody developed by Kangfang Bio, which is intended to be developed to treat a variety of cancers.
At this conference, Kangfang Bio will announce the Phase 2 clinical study of AK104 combined with tyrosine kinase inhibitor lenvatinib in the first-line treatment of unresectable liver cancer.
The results of the study show that AK104 combined with lenvatinib in the first-line treatment of unresectable liver cancer has shown good anti-tumor activity and acceptable safety, and the toxicity is controllable, and there is no unexpected safety signal.

Specifically, as of February 1, 2021, 30 patients have received AK104+lenvatinib combination therapy.
Among the 18 evaluable patients, the ORR was 44.
4% (8/18), and the disease control rate (DCR) was 77.
8%.
The median progression-free survival has not yet been reached.
Treatment-related adverse events (TRAEs) occurred in 83.
3% of patients.
The most common TRAEs are increased AST/ALT, decreased platelet count, decreased neutrophil count, increased blood bilirubin, and most of them are grade 1 or 2.

9.
Corning Jerry: KN046

Mechanism of action: PD-L1/CTLA-4 double antibody

Indications: First-line treatment of pancreatic ductal adenocarcinoma (PDAC)

KN046 is a recombinant humanized PD-L1/CTLA-4 bispecific antibody.
The results of this product's combined therapy for the first-line treatment of pancreatic ductal adenocarcinoma will be presented in a poster at the conference.
This is a phase 2 clinical study called KN046-IST-04, which is being conducted in China, to evaluate the use of KN046 in combination with albumin paclitaxel/gemcitabine for unresectable locally advanced or metastatic pancreas that have not received systemic treatment in the past.
Efficacy of patients with ductal adenocarcinoma.
As of January 15, 2021, a total of 17 patients have been enrolled.

Among evaluable patients, ORR was 55.
6% and DCR was 88.
9%.
In terms of safety, the overall incidence of KN046-related TRAE was 64.
7%, no grade 4 or 5 TRAE was found, and no patients discontinued KN046 treatment due to TRAE.
This preliminary analysis showed that KN046 combined with albumin paclitaxel and gemcitabine as the first-line therapy for patients with unresectable locally advanced or metastatic PDAC has good activity, safety and tolerability.
The study has confirmed the theoretical basis and feasibility of further evaluation, and further confirmation is required in controlled trials.

10.
Tianyan Pharmaceutical: ADG106

Mechanism of action: CD137 antibody

Indications: Tumor

ADG106 is a fully human ligand-blocking anti-CD137 IgG4 agonistic monoclonal antibody.
It activates CD137 in a natural ligand-like manner while blocking the negative feedback signal mediated by CD137 ligand.
Possess specific Fc receptor cross-linking reaction.
At this conference, Tianyan Pharmaceuticals will publish the data of a phase 1 clinical trial of ADG106 in the form of abstract.

The interim data of this study showed that: ①Retrospective analysis found that 75% of biomarker-positive patients showed more than 30% tumor shrinkage after treatment with ADG106; ②After ADG106 treatment, they showed target-mediated anti-tumor efficacy and The number of dose-related natural killer (NK) cells increased, and the induction rate of soluble CD137 increased in a dose-dependent manner compared to the baseline level; ③The disease control rate of ADG106 monotherapy was 56%, and the highest dose was 10 mg/kg.
The experiment and the dose extension of 3 mg/kg and 5 mg/kg showed good tolerability.
It is reported that clinical trials of ADG106 in the United States and China have successfully recruited nearly 100 patients with advanced solid tumors and/or non-Hodgkin’s lymphoma.
ADG106 is generally safe and tolerated.
Only limited TEAEs including hepatotoxicity or blood have been observed.
Learning abnormality.

11.
Cinda Bio: IBI110, Sintilimab

Mechanism of action: anti-LAG-3 monoclonal antibody, PD-1 inhibitor

Indications: advanced solid tumor

IBI110 is a new type of anti-LAG-3 antibody, and Sintilimab is an innovative PD-1 inhibitor.
Studies have found that simultaneous inhibition of PD-1 and LAG-3 can play a synergistic anti-tumor effect.
At this conference, Innovent will announce a phase 1a/1b dose escalation study of IBI110, which aims to evaluate the effect of IBI110 as a single agent and in combination with sintilimab in patients with advanced solid tumors.
The results of the study showed that: IBI110 monotherapy or the combination of Sintilimab had acceptable toxicity and showed preliminary anti-tumor activity.

Specifically, 21 patients were enrolled in the Phase 1a study: no dose limiting toxicity (DLT) was observed in all dose cohorts; the common TRAE is anemia, and TRAEs≥G3 includes anemia, ascites, and abnormal liver function; Assessed, the best response to monotherapy was 1 confirmed partial remission and 5 stable disease.
In the phase 1b study, 12 patients were enrolled: Except for IBI110 5 mg/kg + sintilimab, all the increased dose groups completed the DLT observation, and no DLT was observed; the common TRAE was an increase in aspartate aminotransferase, and TRAEs≥ Treatment-related adverse events of G3 include hyperglycemia, increased bilirubin binding, and abnormal liver function.
According to the investigator's assessment, the best response was 2 cases of partial remission and 6 cases of stable disease.

12.
Yasheng Pharmaceutical: APG-115

Mechanism of action: MDM2 inhibitor

Indications: Melanoma or advanced solid tumor

APG-115 is an oral and highly selective small molecule MDM2 inhibitor independently developed by Yasheng Pharmaceutical.
At this conference, the preliminary results of a Phase 2 clinical study of APG-115 will be announced as an oral report.
The study aims to evaluate the use of APG-115 combined with pembrolizumab in unresectable/metastatic melanomas that have failed immuno-oncology drug treatment.
Or safety, tolerability, PK, PD and anti-tumor activity in patients with advanced solid tumors.
As of December 25, 2020, a total of 84 patients have been included in the Phase 2 study.

The data showed that the DCR of patients with melanoma resistant to PD-1/PD-L1 inhibitors treated with APG-115 combined with pembrolizumab reached 60.
9%, and the ORR reached 17.
4%.
Conclusions show that APG-115 combined with pembrolizumab is well tolerated, or can restore the anti-tumor effect of patients who are resistant or intolerant to tumor immune drugs.

13.
Chia Tai Sunny: AL2846

Mechanism of action: c-Met inhibitor

Indications: Pancreatic ductal adenocarcinoma

AL2846 is an oral c-Met inhibitor under research by Chia Tai Tianqing, which mainly targets a variety of receptor tyrosine kinases (RTKs).
The conference will show that AL2846 combined with gemcitabine in the treatment of locally advanced or metastatic pancreatic ductal adenocarcinoma phase 1 open, dose escalation study.
As of January 1, 2021, a total of 15 patients with pancreatic ductal adenocarcinoma were enrolled and received different dose levels of AL2846.

The results showed that a patient who experienced grade 3 liver dysfunction experienced dose-limiting toxicity.
The most common drug-related adverse events of grade 3 or above are neutropenia, thrombocytopenia, leukopenia and so on.
Among the 15 patients with evaluable efficacy, 1 patient (6.
6%) achieved partial remission at the 90 mg dose level.
Four patients had PFS for more than 5 months.
The results of the study show that the maximum tolerated dose of AL2846 and gemcitabine is 120 mg, and the researchers have selected 90 mg and 120 mg as the target doses for RP2D.
Currently, further clinical studies of AL2846 for the treatment of pancreatic cancer are underway.

Reference materials:

[1]ASCO21 | Teriprizumab deepens the field of melanoma, nasopharyngeal cancer, head and neck tumors, and radiotherapy to add new colors.
Retreved May 20, 2021, from https://mp.
weixin.
qq.
com/s/yQ8a5smDdWJKkXVGqOmkkQ

[2] mPFS 19.
3 months! The results of the first-line clinical study of Hausen Pharmaceuticals Amelox® will be announced at ASCO.
Retreved May 20, 2021, from https://mp.
weixin.
qq.
com/s/oOZZsncC4hsUgoH8koJACg

[3] Chuangsheng Group announced in ASCO the results of a phase I update of the pH-dependent PD-L1 antibody MSB2311 in the treatment of advanced solid tumors and hematological malignancies.
Retreved May 20, 2021, from https:// story/319173-1.
shtml

[4] Corning Jerry will announce a number of clinical research data at the 2021 American Society of Clinical Oncology (ASCO) annual meeting.
Retreved May 20, 2021, from https:// Hengrui's original research was selected as ASCO Oral's blockbuster research abstract and announced.
Retreved May 20, 2021, from https://mp.
weixin.
qq.
com/s/zRxwTNs4rGL_MBIwVhqhfw

[6] Genxi Bio will announce the latest research results of the BCMA/CD19 dual-targeting CAR-T cell therapy GC012F based on the FasTCAR platform in the treatment of relapsed/refractory multiple myeloma at the 2021 ASCO annual meeting and EHA conference.
Retreved May 20, 2021, from https:// The company's official website and public press releases.

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