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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


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


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.


Abstract No:6061

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


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.


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.


Abstract No:8568

Author : Jerome H. Goldschmidt, Blue Ridge Cancer Care


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.


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