Tumori Journal Abstract Book - October 2020 - 7

A - Thoracic Cancers	

RR, % (95% CI)
DCR, % (95% CI)
Tumor size reduction, %

7
Overall (n=116)a

Prior platinum
treatment (n=80)

No prior systemic
treatment (n=26)

65 (55-73)b
93 (87-97)
96

61 (50-72)b
95 (88-99)
95

73 (52-88)
88 (70-98)
100

a

Including n=10 with prior non-platinum treatment; bIncluding n=2 with partial response pending confirmation

A06
A Phase III Study comparing SB8, a
Proposed Bevacizumab Biosimilar,
and Reference Bevacizumab in
Patients with Metastatic or
Recurrent Non-squamous NSCLC
Loupakis F.1, Reck M.2, Luft A.3, Bondarenko I.4, Shevnia S.5, Trukhin
D.6, Kovalenko N.7, Vacharadze K.8, Fülöp A.9, Hontsa A.10, Choi J.11,
Shin D.12
1

Department of Oncology, Istituto Oncologico Veneto, IRCCS, Padova;
Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research
Center North, German Center of Lung Research, Lung Clinic, Grosshansdorf,
Germany; 3Department of Thoracic Surgery, Leningrad Regional Clinical
Hospital, St. Petersburg, Russian Federation; 4Oncology and Medical Radiology
Department, Dnipropetrovsk Medical Academy, Dnipro, Ukraine; 5Department
of Chemotherapy, Podillia Regional Oncology Center, Vinnytsia, Ukraine;
6
Oncology Department, Odessa Regional Oncology Center, Odessa, Ukraine;
7
Oncology, Volgograd Regional Clinical Oncology Dispensary, Volgograd,
Russian Federation; 8Department of Phthisiatry, Research Institute of Clinical
Medicine, Tbilisi, Georgia; 9Department of Pulmonary Class and Bronchology,
Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Hungary; 10Day
Staing Department, Chernivtsi Regional Oncology Center, Chernivtsi, Ukraine;
11
Biometrics, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea; 12Clinical
Development, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea
2

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 antidrug 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. Previously presented at ESMO Congress 2019, "FPN:1565P", "Martin
Reck et al." - Reused with permission.

A07
Low-dose oral etoposide is an
active option for patients with
heavily pre-treated thymic
epithelial tumors
Palmieri G.1, Ottaviano M.2, Tortora M.1, Terracciano D.3, Dolce P.4, Di
Lauro V.5, Picozzi F.5, Parola S.5, Riccio V.5, De Placido P.5, Pietroluongo
E.5, Liotti A.3, La Civita E.3, Guggino G.6, Cicalese M.7, Curcio C.8,
Longo M.3, Botti G.9, Daniele B.2, De Placido S.10, Giuliano M.10
1

CRCTR Rare Tumors Reference Center of Campania region, Naples,
Italy, Napoli; 2Oncology Unit, Ospedale del Mare, Naples, Italy, Napoli;
3
Università degli Studi di Napoli "Federico II", Department of Translational
Medical Sciences, Napoli; 4Università degli Studi di Napoli "Federico II",
Department of Public Health, Napoli; 5Università degli Studi di Napoli
"Federico II", Department of Clinical Medicine and Surgery, Napoli;
6
Thoracic Surgery Unit, Antonio Cardarelli Hospital Naples, Italy, Napoli;
7
Azienda Ospedaliera dei Colli Naples, Italy, Napoli; 8Division of Thoracic
Surgery, Monaldi Hospital Naples, Italy, Napoli; 9Istituto Nazionale Tumori
IRCCS Fondazione "G. Pascale", Naples, Italy, Napoli; 10Università degli
Studi di Napoli "Federico II", Department of Clinical Medicine and Surgery
and CRCTR Rare Tumors Reference Center of Campania region, Naples,
Italy, Napoli
Tumori Journal Abstract Book - October 2020

Table of Contents for the Digital Edition of Tumori Journal Abstract Book - October 2020
