Abstract 388P
Background
Bevacizumab (Avastin®) is a monoclonal antibody targeting the vascular endothelial growth factor (VEGF). Used alone or in combination with chemotherapy and/or immunotherapy, there is confirmed efficacy in many cancers.
Methods
In this randomized, double-blind, multicenter, phase III, treatment naive, locally advanced, metastatic, or recurrent EGFR wildtype non-squamous, non small cell lung cancer (nsNSCLC) patients were enrolled and randomized (1:1) into TAB008 or Avastin® groups. Patients received 4-6 (3 week)cycles of paclitaxel/carboplatin plus TAB008 or Avastin® at 15mg/kg intravenously, followed by 7.5mg/kg maintenance dose 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 included disease control rate (DCR), duration of response (DoR), progression free survival (PFS), 1 year overall survival rate (OSR), overall survival (OS), safety, immunogenicity, and pharmacological bio-equivalence of Cmin under steady state conditions.
Results
A total of 549 nsNSCLC patients were enrolled (277 in the TAB008 group, 272 in the Avastin® group). In the full analysis set, ORRs were 55.957% for TAB008, and 55.720% for Avastin®, the 90% CI was 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 (95.7% vs 95.4%, 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 OSR (66.2 vs 68%, p=0.6793), or OS (20.4 vs 17.4 months, p=0.6594). Serious adverse events (AEs) occurred in 37.55% (104/277) and 34.32% (93/271) in the TAB008 and Avastin® groups. Anti-drug antibodies were reported in 3/277 (1.08%) and 5/271(1.85%) in the TAB008 and Avastin® groups. Steady-state trough concentrations (Cmin) were 106.13 and 96.03μg/mL in the TAB008 and Avastin® groups, with the treatment group ratio of LS geometric means is contained within the bioequivalence limits of 80.00–125.00% (90% CI: 101.74%-120.05%).
Conclusions
TAB008 is similar to bevacizumab(Avastin®) in terms of efficacy, safety, and pharmacokinetic parameters.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
TOT BIOPHARM.
Funding
TOT BIOPHARM.
Disclosure
X. Li, L. Wang: Full/Part-time employment: TOT BIOPHARM. All other authors have declared no conflicts of interest.
Resources from the same session
424P - Hippocampus sparing in volumetric modulated arc therapy (VMAT) for brain tumour radiotherapy treatment
Presenter: Eva Yi Wah Cheung
Session: e-Poster Display Session
425P - The impact of obesity on treatment outcomes in patients with solid tumour malignancies treated with first-line (1L) immuno-oncology (IO) agents
Presenter: Chun Loo Gan
Session: e-Poster Display Session
426P - A multicenter, randomized, double-blind, phase II study of lenvatinib (LEN) in patients (pts) with radioiodine-refractory differentiated thyroid cancer (RR-DTC) to evaluate the safety and efficacy of a daily oral starting dose of 18 mg vs 24 mg
Presenter: Marcia S. Brose
Session: e-Poster Display Session
427P - On the clinical implications of systemic and local immune responses in human angiosarcoma
Presenter: Jason Yongsheng Chan
Session: e-Poster Display Session
428P - Prognostic value of clinico-pathological characteristics and peripheral monocyte counts in localised extra-meningeal solitary fibrous tumours treated with surgical resection
Presenter: Ryan Lim
Session: e-Poster Display Session
429P - Demographics, pattern of care, and outcome analysis of malignant melanoma cases from a tertiary care centre in India
Presenter: Anshul Agarwal
Session: e-Poster Display Session
430P - Teenagers and young adult cancers in rural central India: Access to age-appropriate care
Presenter: Runu Sharma
Session: e-Poster Display Session
431P - Quantitative study of two critical lncRNAs in patients with glioma tumours
Presenter: Kamal Mohammadian
Session: e-Poster Display Session
432P - Efficacy and tolerability of vismodegib treatment in locally advanced and metastatic basal cell carcinoma
Presenter: Mustafa Gürbüz
Session: e-Poster Display Session
433P - Association between aspirin and cancer risk: A Mendelian randomization analysis
Presenter: Yu Jiang
Session: e-Poster Display Session