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Latest Clinical Data regarding ENDOSTAR and Trilaciclib Presented at the 2022 ASCO

Release time:2022-06-07

The 2022 annual meeting of American Society of Clinical Oncology (ASCO) held in Chicago and online in June 3-7, 2022 (EST) is attracting global attention from oncology academic community. Four studies regarding Simcere’s anti-tumor drug Endostar (recombinant human endostatin) and Trilaciclib (in collaboration with G1 Therapeutics) were selected into abstracts of ASCO 2022, involving tumor types of non-small cell lung cancer (NSCLC), nasopharyngeal cancer, and Small Cell Lung Cancer (SCLC). The latest data were release during the conference.


NSCLC:Endostar three-day infusion pump combined with PD-1

Title: Three days of CIV rh-Endostatin in combination with PD-1 antibody plus chemotherapy as first-line regimen for EGFR/ALK-negative, advanced or metastatic, non-squamous non–small cell lung cancer (NSCLC): A open label, multicenter, phase II and cohort study (ENPOWER).

Author: Dong Wang

Third Military Medical University, Chongqing, China

Report Type: Poster

Abstract No: 9031

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43 subjects were evaluable for efficacy analysis, with 15 in Cohort 1 (PD-1 combination) and 28 in Cohort 2. ORR and DCR was 53% and 93% in Cohort 1 (CR, 0; PR, 8; SD, 6; PD,1) and 39% and 86% in Cohort 2 (CR 0; PR 11; SD, 13; PD, 4), respectively. 50 subjects were included in safety analysis. The overall incidence of AEs of any grade was 89%. 92% of the patients in the cohort 1 and 85% in the cohort 2.


Conclusions:Three days of CIV rh-Endostatin in combination with PD-1 antibody plus chemotherapy for the first line treatment of EGFR/ALK negative, advanced or metastatic, non-squamous NSCLC could obtain the better improvement in the efficacy and result in the higher frequent in some of AEs.

 

NSCLC:Endostar enhances effect of radiotherapy on brain metastases

Title:Efficacy and safety of recombinant human endostatin combined with whole-brain radiotherapy in patients with brain metastases from NSCLC.

Author:Lingjuan Chen

Cancer Center, Union Hospital, Huazhong University of Science and Technology, Wuhan, China

Report Type: Abstract

Abstract No:e21158

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43 NSCLC patients with BMs were divided into two groups randomly. Rh-endostatin combination group (n = 19) received WBRT combined with Rh-endostatin, and radiation group (n = 24) received WBRT alone.


Median progression-free survival (PFS) was 8.1 months in the Rh-endostatin combination group versus 4.9 months in the radiation group (95%CI: 0.2612-0.9583, p= 0·0428). Besides, median iPFS was 11.6 months in Rh-endostatin combination group versus 4.8 months in the radiation group (95%CI:0.2530-0.9504, p= 0·0437). Overall survival (OS) was 14.2 months in the Rh-endostatin combination group versus 6.4 months in the radiation group (95%CI:0.2508-1.026, p= 0·0688). Compared with radiotherapy alone, CBV and CBF in the Rh-endostatin combination group increased more significantly than before radiotherapy, indicating that Rh-endostatin may improve local blood supply and microcirculation.

 

Nasopharyngeal cancer: Endostar combined with IMRT, a promising alternative regimen

 

Title:Recombinant human endostatin combined with intensity-modulated radiotherapy in low-risk locoregionally advanced nasopharyngeal carcinoma: A phase II, randomized, multicenter clinical trial.

Type:Poster

Abstract No:6061

Author:Prof .WANG Rensheng The First Affiliated Hospital of Guangxi Medical University  

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Concurrent chemoradiotherapy (CCRT) is currently considered to be the standard treatment for locoregionally advanced nasopharyngeal carcinoma (LA-NPC), accompanied with non-neglectable toxicity and unsatisfactory compliance.  

A total of 120 patients were included in the trial. After a median follow-up of 71 months (IQR 62-75), the 5-year OS rate was 88.1% in the ERT group and 77.6% in the CCRT group, with a difference of 10.5% (95% CI: -0.03 to 0.24; Pnon-inferiority = 0.002). Patients in the ERT group had better 3-year PFS than that in the CCRT group (89.8% vs 70.6%; HR = 0.362; 95% CI: 0.150-0.873; Plog-rank = 0.018). The overall all-grade toxicity burdens were heavier in CCRT group. No patients died of treatment-related causes.

Conclusions:

Rh-endostatin combined with IMRT had favorable efficacy, fewer toxic effects and more improved quality of life, which might be a promising alternative regimen to CCRT for low-risk LA-NPC in clinic.

 

SCLC:Trilaciclib reduces chemotherapy-induced myelosuppression

Title:Impact of trilaciclib on multilineage chemotherapy-induced myelosuppression events in patients with extensive-stage small cell lung cancer: Post-hoc analyses of data from randomized clinical trials.

Type:Poster

Abstract No:8568

Author : Jerome H. Goldschmidt, Blue Ridge Cancer Care

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Trilaciclib is a short-acting CDK4/6 inhibitor administered prior to chemotherapy for multilineage myeloprotection. In this post-hoc trial analysis, the impact of trilaciclib on the occurrence of single and concurrent multilineage CIM events were assessed.

 

Analyses were conducted separately by line of chemotherapy. In the first-line (1L) setting, pooled data from the G1T28-05 and G1T28-02 trials, in which trilaciclib or placebo was administered prior to chemo. In the 2/3L setting, analyses were based on data from the G1T28-03 trial where patients received trilaciclib or placebo prior to chemo.

 

Compared with placebo, fewer patients receiving trilaciclib had single-lineage CIM events and concurrent events in 2 or 3 lineages during cycles 1–4 of 1L chemotherapy using pooled data from G1T28-05 and G1T28-02. A similar trend was observed in the 2/3L setting. Generally, SN occurred more frequently in earlier cycles, whereas SA and ST tended to occur later. The sensitivity analysis in each individual 1L trial yielded consistent results with the pooled analysis.

Conclusions:

Patients with ES-SCLC receiving trilaciclib prior to chemotherapy had fewer single and concurrent multilineage CIM events than patients receiving placebo.