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Simcere Will Announce Progress of Multiple Clinical Research on Antitumor Drugs at the 2021 ASCO Annual Meeting

Release time:2021-05-26

The 2021 Annual Meeting of the American Society of Clinical Oncology (ASCO) - Virtual Conference will be held online from June 4th to 8th, 2021 (Eastern Time). It is one of the world’s largest and most influential clinical oncology academic conferences at the highest academic level.

Four clinical studies related to Endostar® (Recombinant Human Endostatin), an innovative antitumor drug of Simcere Pharmaceutical Group LTD. (2096.HK), has been included into the ASCO Conference Abstract. These are namely in the areas of metastatic non-small cell lung cancer, melanoma, and nasopharyngeal carcinoma. Key research data will be published during the conference. 

Furthermore, latest progress on a pivotal trial of envafolimab, the world’s first subcutaneous PD-L1 single-domain antibody injection will also be announced at ASCO annual meeting. The product is currently being developed in China under the strategic alliance of Simcere, 3D Medicines and Alphamab Oncology (9966.HK).

Endostar®(Recombinant Human Endostatin Injection)



Platinum-based chemotherapy combined with Endostar in the treatment of advanced NSCLC: A real world study

Session type: Publication Only

Abstract No.:e21033

Authors:Wei Jiang (Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China) et al.

Study Cases:512

Results: 63.3% pts was diagnosed at stage IV. 40.0% pts was adenocarcinoma and 35.4% pts was squamous cell carcinoma. 81.4% pts received endostar combined with chemotherapy as first-line.292 people were included in the efficacy analysis set. The ORR, DCR and median PFS were 34%, 73% and 8.2 (95% CI 6.0-13.7) months, respectively. There were no significant differences of ORR and DCR among common platinum-based chemotherapy. Conclusions: The real-world data confirmed the superiority of endostar plus platinum-based chemotherapy in Chinese advanced NSCLC pts, with acceptable adverse effects.


Safety and efficacy of nivolumab plus recombinant human endostatin in previously treated advanced non-small cell lung cancer: A prospective and multicenter phase 2 trial

Session type: Publication Only

Abstract No.:e21079

Authors:Weize Lv (The Fifth Affiliated Hospital Sun Yat-sen University, Zhuhai, China) et al.

Study Cases:35

Results: 11 of 33 evaluable patients achieved confirmed partial response with an objective response rate of 33.3% and disease control rate of 60.6%. Median follow-up was 8.2 months. Median progression-free survival was 7.1 months).The 6-month overall survival rate was 54.5%. The first prospective study that assessed nivolumab combined with rh-Endostatin as second-line or later treatment in pretreated patients with advanced NSCLC reveals a promising treatment regimen in this patient population.

Mucosal melanoma


Continuous infusion of Endostar combined with chemotherapy in patients with advanced or recurrent mucosal melanoma: A real-world cohort study

Session type: Publication Only

Abstract No.:e21517

Authors:Xin Liu (Fudan University Shanghai Cancer Center, Shanghai, China) et al.

Study Cases:43

Results:Endostar (105 mg/m2) was administered with continuous infusion for 168 hours (Civ 168h).An objective response was observed in 12 (30.0%) of the 40 evaluable patients, and disease control was achieved in 31 (77.5%) patients.With a median follow-up of 17.6 months, the median progression-free survival (PFS) and overall survival (OS) were 4.9 and 15.3 months, respectively. Multivariate analysis indicated a high lymphocyte-to-monocyte ratio (LMR) was correlated with favorable PFS and OS in this patient population.

Nasopharyngeal carcinoma


Endostar combined with intensity-modulated radiotherapy in low-risk local advanced nasopharyngeal carcinoma: A phase II, randomized, multicentric clinical trial

Session Type: Poster Session

Abstract No.:6050

Authors:Min Kang (The First Affiliated Hospital of Guangxi Medical University, Nanning, China) et al.

Study Cases:120

Results:After a median follow-up of 47 months, 3-year OS rate were 93.2% and 79.3% (p=0.032), 3-year PFS rate were 89.8% and 70.6% (p=0.011), 3-year DMFS rate were 93.2% and 80.7%, in two groups, respectively (P=0.042).For short-term curative effects, CR rate were 71.2% and 60.0% for primary tumor, 74.6%and 63.3%for cervical lymph nodes, in two groups, respectively (P < 0.05). Moreover, the incidences of adverse events were significantly lower in ERT group compared with in CCRT group.

Envafolimab (KNO35)

Soft tissue sarcomas


ENVASARC: A pivotal trial of Envafolimab, and Envafolimab in combination with ipilimumab, in patients with advanced or metastatic undifferentiated pleomorphic sarcoma or myxofibrosarcoma who have progressed on prior chemotherapy

Session Type: Poster Session

NO: TPS11581

Authors: Sandra P. D'Angelo (Memorial Sloan Kettering Cancer Center, New York, NY) et al.