Bevacizumab Biosimilar Candidate TAB008 Compared to Avastin® in Patients With Locally Advanced, Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer: a Randomized, Double-blind, Multicenter Study

In this randomized, double-blind, multicenter, phase III similarity study, treatment naive, EGFR wild-type, locally advanced, metastatic, or recurrent non-squamous, non-small cell, lung cancer (ns-NSCLC) patients were enrolled and randomized (1:1) into TAB008 or Bevacizumab-EU groups. Patients received TAB008 or bevacizumab-EU 15 mg/kg intravenously plus paclitaxel/carboplatin for 4-6 cycles followed by TAB008 or bevacizumab-EU 7.5 mg/kg until disease progression, unacceptable toxicity or death. The primary endpoint compared the objective response rate (ORR) within 6 cycles as read by an independent radiological review committee (IRRC). Secondary endpoints compared disease control rate (DCR) Within 6 cycles, duration of response (DoR), progression free survival (PFS), a year overall survival rate (OSR), overall survival (OS), safety, immunogenicity, and steady state pharmacokinetics.

Start Date20 Oct 2017

Sponsor / Collaborator

Tot Biopharm Co. Ltd.

CTR20170244 / CompletedPhase 3

TAB008对比贝伐单抗联合紫杉醇和卡铂化疗一线治疗晚期或复发性非鳞状细胞、非小细胞肺癌的III期临床研究

[Translation] Phase III clinical study of TAB008 versus bevacizumab combined with paclitaxel and carboplatin chemotherapy as first-line treatment for advanced or recurrent non-squamous cell and non-small cell lung cancer

评价TAB008单抗联合紫杉醇和卡铂化疗对比贝伐珠单抗联合紫杉醇和卡铂一线治疗晚期或复发性非鳞状细胞、非小细胞肺癌的有效性、安全性以及免疫原性，作为生物类似新药获准上市的依据。

[Translation]

To evaluate the efficacy, safety, and immunogenicity of TAB008 combined with paclitaxel and carboplatin chemotherapy versus bevacizumab combined with paclitaxel and carboplatin as first-line treatment for advanced or recurrent non-squamous cell and non-small cell lung cancer, as a basis for the approval of biosimilar new drugs for marketing.

Start Date13 Oct 2017

Sponsor / Collaborator

TOT BIOPHARM International Co. Ltd.

CTR20160522 / CompletedNot Applicable

TAB008单抗注射液和安维汀注射液对于中国健康男性受试者单次给药的随机、双盲、平行对照的PK和安全性的I期研究

[Translation] A randomized, double-blind, parallel-controlled phase I study of the PK and safety of a single-dose combination of TAB008 monoclonal antibody injection and Avastin injection in healthy Chinese male subjects

主要：评价单次给药后TAB008单抗注射液和安维汀注射液的主要PK参数、Cmax、AUC0-t和AUC0-∞的生物相似性次要：评价单次给药后TAB008单抗注射液和安维汀注射液的其他PK参数、安全性和免疫原性的生物相似性

[Translation]

Primary: To evaluate the biosimilarity of the main PK parameters, Cmax, AUC0-t and AUC0-∞ of TAB008 mAb injection and Avastin injection after a single dose Secondary: To evaluate the biosimilarity of other PK parameters, safety and immunogenicity of TAB008 mAb injection and Avastin injection after a single dose

Start Date29 Nov 2016

Sponsor / Collaborator

TOT BIOPHARM International Co. Ltd.

100 Clinical Results associated with Bevacizumab biosimilar (Tot Biopharm)

100 Translational Medicine associated with Bevacizumab biosimilar (Tot Biopharm)

100 Patents (Medical) associated with Bevacizumab biosimilar (Tot Biopharm)

Literatures (Medical) associated with Bevacizumab biosimilar (Tot Biopharm)

01 Aug 2023·Journal of Cancer Research and Clinical Oncology

Bevacizumab biosimilar candidate TAB008 compared to Avastin® in patients with locally advanced, metastatic EGFR wild-type non-squamous non-small cell lung cancer: a randomized, double-blind, multicenter study

Article

Author: Lu, S ; Yang, L ; Chen, P ; Zhou, Z ; Gu, K ; He, J ; Liu, A ; Qin, S ; Sun, Y ; Yu, G ; Sun, P ; Shi, J ; Pan, Y ; Chen, J ; Ma, K

BACKGROUNDBevacizumab (Avastin^®) is a monoclonal antibody targeting the vascular endothelial growth factor (VEGF). Used alone or in combination with chemotherapy and/or immunotherapy, Avastin^® has shown promising efficacy in many cancers. This study compared the efficacy and safety of TAB008 with Avastin^® sourced from the EU (bevacizumab-EU), in patients with non-squamous non-small cell lung cancer (nsNSCLC).METHODIn this randomized, double-blind, multicenter, phase III similarity study, treatment naïve for metastatic lung cancer., EGFR wild-type, locally advanced, metastatic, or recurrent non-squamous, non-small cell, lung cancer (nsNSCLC) patients were enrolled and randomized (1:1) into TAB008 or Avastin^® groups. Patients received TAB008 or Avastin^® 15 mg/kg intravenously plus paclitaxel/carboplatin for 4-6 cycles followed by TAB008 or Avastin^® 7.5 mg/kg until disease progression, unacceptable toxicity or death. The primary endpoint compared the objective response rate (ORR) within 6 cycles as read by an independent radiological review committee (IRRC). Secondary endpoints compared disease control rate (DCR) Within 6 cycles, duration of response (DoR), progression-free survival (PFS), a year overall survival rate (OSR), overall survival (OS), safety, immunogenicity, and steady-state pharmacokinetics.RESULTSA total of 549 nsNSCLC patients were enrolled (277 in TAB008 group and 272 in Avastin^® group). In the full analysis set, ORRs were 55.957% for TAB008 and 55.720% for Avastin^®, and the ORR ratio was 1 (90% CI 0.89-1.14), well within the predefined equivalence margin of 0.75-1.33. No significant differences were found in DCR within 6 cycles (95.703% vs 95.367%, p = 0.8536), DoR (8.17 vs 7.3 months, p = 0.3526), PFS (9.10 vs. 7.97 months, p = 0.9457), 1 year overall survival rate (66.2% vs 68%, p = 0.6793), or OS (20.4 vs 17.6 months, p = 0.6549). Serious adverse events (SAEs) occurred in 37.55% (104/277) of patients in the TAB008 group and 34.32% (93/271) in the Avastin^® group. Anti-drug antibodies were reported in 3 of 277 (1.08%) TAB008 patients, and 5 of 271 (1.85%) Avastin^® patients, neutralizing antibody (Nab) was positive in 1 patient on Avastin^®, which became negative upon follow-up. The steady-state trough concentrations (C_ssmin) were 106.13 μg/mL in TAB008 group and 96.03 μg/mL in Avastin^® groups, with the treatment group ratio of LS geometric means fully contained within the bioequivalence limits of 80.00-125.00% (90% CI was 101.74-120.05%).CONCLUSIONSTAB008 is similar to Avastin^® in terms of efficacy, safety, and pharmacokinetic parameters, with comparable immunogenicity.TRIAL REGISTRATIONClinicalTrials.gov number; NCT05427305.

Frontiers in PharmacologyQ2 · MEDICINE

A Phase I, Randomized, Single-Dose Study Evaluating the Biosimilarity of TAB008 to Bevacizumab in Healthy Volunteers

Q2 · MEDICINE

ArticleOA

Author: Liu, Long ; Tong, Yuanxu ; Lei, Chunpu ; Liu, Ying ; Wang, Yu ; Wang, Jin ; Chen, Gang ; Qi, Lu ; Liu, Huijuan ; Liu, Chen ; Liu, Xiaona ; Wang, Zejuan ; Wang, Xinghe

Objective: This study compared the pharmacokinetics (PK), safety, and immunogenicity of the biosimilar TAB008 monoclonal antibody to bevacizumab (Avastin^®) in normal healthy Chinese male volunteers. Methods: In this randomized, double-blind, parallel controlled study, a total of 100 healthy Chinese male subjects were randomized (1:1) to receive a single 1 mg/kg intravenous dose of TAB008 or Avastin^® over a 90-min infusion. The subjects were followed for 99 days after drug administration. Primary endpoints were bioequivalence of major pharmacokinetic parameters (AUC_0-t and AUC_0-∞) and maximum observed serum concentration (C_max). Secondary endpoints included safety and immunogenicity parameters. Results: The two groups of test subjects (49 subjects in the TAB008 group and 50 subjects in the Avastin^® group) were well matched in regards to all demographic and baseline characteristics. The treatment group ratios of LS geometric means for the three primary PK parameters were fully contained within the bioequivalence limits of 80.00-125.00% (90% CI was 103.66-118.33% for C_max, 94.32-111.72% for AUC_0-t, and 94.69-112.23% for AUC_0-∞). Treatment-emergent adverse events (TEAEs) were reported for 24 (49.0%) subjects in the TAB008 group and 22 (44.0%) subjects in the Avastin^® group. TEAEs related to the study drug were reported for 19 (38.8%) subjects in the TAB008 group and 19 (38.0%) subjects in the Avastin^® group. National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 TEAEs were reported for 1 (2.0%) subject in the TAB008 group and 3 (6.0%) subjects in the Avastin^® group. There were no Grade 4 or 5 TEAEs or serious adverse events (SAEs) during the study. Anti-drug antibody generation was reported once only in each group, and neutralizing antibody (Nab) analysis was negative upon follow-up. Conclusion: TAB008 attained pharmacokinetic similarity to bevacizumab, and was safe and well tolerated.

100 Deals associated with Bevacizumab biosimilar (Tot Biopharm)

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Indication	Country/Location	Organization	Date
Hepatocellular Carcinoma	CN	Tot Biopharm Co. Ltd.	11 Apr 2022
Fallopian Tube Carcinoma	CN	Tot Biopharm Co. Ltd.	09 Mar 2022
Glioblastoma	CN	Tot Biopharm Co. Ltd.	09 Mar 2022
Ovarian Epithelial Carcinoma	CN	Tot Biopharm Co. Ltd.	09 Mar 2022
Primary peritoneal carcinoma	CN	Tot Biopharm Co. Ltd.	09 Mar 2022
Uterine Cervical Cancer	CN	Tot Biopharm Co. Ltd.	09 Mar 2022
Colorectal Cancer	CN	Tot Biopharm Co. Ltd.	01 Dec 2021
Non-Small Cell Lung Cancer	CN	Tot Biopharm Co. Ltd.	01 Dec 2021

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Non-squamous non-small cell lung cancer	Discovery	CN	TOT BIOPHARM International Co. Ltd.	13 Oct 2017

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05427305 (Pubmed)	Phase 3	Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma \| EGFR positive Non-squamous non-small cell lung cancer	549	TAB008	(ngbrjbbznw) = asaliqyveh xmzewaepnb (sitksgyesq, 0.89 - 1.14) View more	-	03 Jan 2023
				Avastin®	(ngbrjbbznw) = chtpkzrdwb xmzewaepnb (sitksgyesq ) View more
ESMO_ASIA_VIRTUAL2020	Phase 3	Advanced Lung Non-Small Cell Squamous Carcinoma	549	TAB008	(szefdopyej) = smbusiatls jaxceycupf (zrgzsfpgmn, 0.89 - 1.14) View more	Positive	22 Nov 2020
				Avastin	(szefdopyej) = rnvpmuvtxq jaxceycupf (zrgzsfpgmn, 0.89 - 1.14) View more

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