Abstract 1205
Background
SB8 is a proposed biosimilar of the reference bevacizumab (BEV). This study compared the efficacy, safety, pharmacokinetics (PK), and immunogenicity of SB8 to BEV in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
Methods
In this randomised, double-blind, multicentre study, patients were randomised (1:1) to receive SB8 or BEV with paclitaxel and carboplatin Q3W followed by SB8 or BEV maintenance therapy until disease progression, unacceptable toxicity, death, or 1 year from the randomisation of the last patient. The primary endpoint was the best overall response rate (ORR) by 24 weeks of chemotherapy; risk ratio was analyzed in the full analysis set (FAS) and risk difference was analyzed in the per-protocol set (PPS). Secondary endpoints were progression free survival (PFS), overall survival (OS), duration of response (DOR), safety, PK, and immunogenicity.
Results
A total of 763 patients (SB8, n = 379; BEV, n = 384) were randomized. Baseline characteristics were balanced between SB8 and BEV. In the FAS, the best ORR was 47.6% in SB8 and 42.8% in BEV; the risk ratio was 1.11 and its 90% CI was [0.975, 1.269], which was within the pre-defined equivalence margin of [0.737, 1.357]. In the PPS, the best ORR was 50.1% in SB8 and 44.8% in BEV; the risk difference was 5.3% and its 95% CI was [−2.2%, 12.9%], of which the lower margin was contained within and the upper margin was outside the pre-defined equivalence margin of [−12.5%, 12.5%]. The secondary efficacy endpoints in the FAS were comparable between SB8 vs BEV: median PFS (8.50 vs 7.90 months), median OS (14.90 vs 15.80 months), and median DOR (5.60 vs 5.85 months). The overall incidence of treatment-emergent adverse events (TEAEs) was comparable between SB8 vs BEV (92.1% vs 91.1%). The most frequently occurring TEAEs were alopecia, anaemia, and nausea. PK parameters (Ctrough and Cmax) and the incidence of overall anti-drug antibodies (16.1% vs 11.0%) were comparable between SB8 vs BEV.
Conclusions
This study demonstrated equivalence between SB8 and BEV in terms of best ORR risk ratio. Other efficacy endpoints, safety, PK, and immunogenicity were comparable between SB8 and BEV.
Clinical trial identification
NCT02754882.
Editorial acknowledgement
Legal entity responsible for the study
Samsung Bioepis Co., Ltd.
Funding
Samsung Bioepis Co., Ltd.
Disclosure
M. Reck: Honoraria (self), Advisory / Consultancy: Samsung Bioepis Co., Ltd.; Honoraria (self), Advisory / Consultancy: AbbVie; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Roche. J. Choi: Full / Part-time employment: Samsung Bioepis Co., Ltd. D. Shin: Full / Part-time employment: Samsung Bioepis Co., Ltd. All other authors have declared no conflicts of interest.
Resources from the same session
681 - Significance of the red blood cell distribution width in resected pathological stage I non-small cell lung cancer
Presenter: Gouji Toyokawa
Session: Poster Display session 1
Resources:
Abstract
3336 - Survival outcome of non-small cell lung cancer (NSCLC) patients: Comparing results between the database of the Comprehensive Cancer Center Zürich (CCCZ) and the Epidemiological Cancer Registry Zurich and Zug (KKR)
Presenter: Rolf A. Stahel
Session: Poster Display session 1
Resources:
Abstract
2204 - NORA trial (GECP 15/02): Updated results of the Spanish Lung Cancer Group (SLCG) phase II trial of concurrent chemo-radiotherapy (CT-RT) with cisplatin (P) plus metronomic oral vinorelbine (mOV) for unresectable locally advanced non-small cell lung cancer (LA-NSCLC)
Presenter: María Guirado
Session: Poster Display session 1
Resources:
Abstract
1446 - A nomogram to predict outcomes of lung cancer patients after pneumonectomy based on 47 indicators set by principle component analysis
Presenter: Bo Cheng
Session: Poster Display session 1
Resources:
Abstract
1788 - Prognostic and predictive value of 18F-PET/CT on the response to treatment in locally advanced non-small cell lung cancer (NSCLC)
Presenter: Cristina Alfaro Autor
Session: Poster Display session 1
Resources:
Abstract
2299 - Comparison of three different chemotherapy regimens for concomitant chemoradiotherapy in locally advanced non small cell lung cancer
Presenter: Abdurrahman Işıkdoğan
Session: Poster Display session 1
Resources:
Abstract
4211 - Predicting the first failure pattern in patients with inoperable local advanced non-small cell lung cancer (LA-NSCLC) receiving definitive chemoradiotherapy: Establishment and internal validation of a nomogram based on the clinicopathological factors
Presenter: Xueru Zhu
Session: Poster Display session 1
Resources:
Abstract
1550 - Prognostic impact of neutrophil-to-lymphocyte ratio (NLR) pre and post chemoradiotherapy (CRT) in stage III non-small cell lung cancer (NSCLC)
Presenter: Vicente Palomar Abril
Session: Poster Display session 1
Resources:
Abstract
2345 - Meta-analysis evaluating neutropenia incidence with EGFR inhibitors and chemotherapy in patients with NSCLC
Presenter: Bernardo Rapoport
Session: Poster Display session 1
Resources:
Abstract
3747 - Effector CD4+ T-cell induction by thoracic radiotherapy for patients with NSCLC
Presenter: Yu Miura
Session: Poster Display session 1
Resources:
Abstract