PMID- 30617139
OWN - NLM
STAT- MEDLINE
DCOM- 20200511
LR  - 20200511
IS  - 1557-3265 (Electronic)
IS  - 1078-0432 (Linking)
VI  - 25
IP  - 7
DP  - 2019 Apr 1
TI  - Efficacy and Safety of the Biosimilar ABP 215 Compared with Bevacizumab in 
      Patients with Advanced Nonsquamous Non-small Cell Lung Cancer (MAPLE): A 
      Randomized, Double-blind, Phase III Study.
PG  - 2088-2095
LID - 10.1158/1078-0432.CCR-18-2702 [doi]
AB  - PURPOSE: This phase III study compared clinical efficacy and safety of the 
      biosimilar ABP 215 with bevacizumab reference product (RP) in patients with 
      advanced nonsquamous non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: 
      Patients were randomized 1:1 to ABP 215 or bevacizumab 15 mg/kg every three weeks 
      for 6 cycles. All patients received carboplatin and paclitaxel every three weeks 
      for >/=4 and </=6 cycles. The primary efficacy endpoint was risk ratio of objective 
      response rate (ORR); clinical equivalence was confirmed if the 2-sided 90% 
      confidence interval (CI) of the risk ratio was within the margin of 0.67 to 1.5. 
      Secondary endpoints included risk difference of ORR, duration of response (DOR), 
      progression-free survival (PFS), and overall survival (OS); pharmacokinetics, 
      adverse events (AEs), and incidence of antidrug antibodies (ADAs) were monitored. 
      RESULTS: A total of 820 patients were screened; 642 were randomized to ABP 215 (n 
      = 328) and bevacizumab (n = 314). Overall, 128 (39.0%) and 131 (41.7%) patients 
      in the ABP 215 and bevacizumab groups, respectively, had objective responses [ORR 
      risk ratio: 0.93 (90% CI, 0.80-1.09)]. In the ABP 215 and bevacizumab group, 308 
      (95.1%) and 289 (93.5%) patients, respectively, had at least 1 AE; 13 (4.0%) and 
      11 (3.6%) experienced a fatal AE. Anti-VEGF toxicity was low and comparable 
      between treatment groups. At week 19, median trough serum drug concentration was 
      132 mug/mL (ABP 215 group) and 129 mug/mL (bevacizumab group). No patient tested 
      positive for neutralizing antibodies. CONCLUSIONS: ABP 215 is similar to 
      bevacizumab RP with respect to clinical efficacy, safety, immunogenicity, and 
      pharmacokinetics. The totality of evidence supports clinical equivalence of ABP 
      215 and bevacizumab.
CI  - (c)2019 American Association for Cancer Research.
FAU - Thatcher, Nicholas
AU  - Thatcher N
AD  - The Christie Hospital, Manchester, United Kingdom. Nick.Thatcher@christie.nhs.uk.
FAU - Goldschmidt, Jerome H
AU  - Goldschmidt JH
AD  - Oncology and Hematology Associates of Southwest Virginia, US Oncology Research, 
      McKesson Specialty Health, Blacksburg, Virginia.
FAU - Thomas, Michael
AU  - Thomas M
AD  - Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitatsklinikum, 
      Heidelberg, Translational Lung Research Center, Heidelberg, Germany.
FAU - Schenker, Michael
AU  - Schenker M
AD  - Centrul de Oncologie Sf Nectarie, Craiova, Romania.
FAU - Pan, Zhiying
AU  - Pan Z
AD  - Amgen Inc., Thousand Oaks, California.
FAU - Paz-Ares Rodriguez, Luis
AU  - Paz-Ares Rodriguez L
AD  - Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, 
      Spain.
FAU - Breder, Valery
AU  - Breder V
AUID- ORCID: 0000-0002-6244-4294
AD  - Department of Clinical Biotechnologies, N. N. Blokhin National Medical Research 
      Center of Oncology, Russia.
FAU - Ostoros, Gyula
AU  - Ostoros G
AD  - Koranyi National Institute for TB and Pulmonology, Budapest, Hungary.
FAU - Hanes, Vladimir
AU  - Hanes V
AD  - Amgen Inc., Thousand Oaks, California.
LA  - eng
SI  - ClinicalTrials.gov/NCT01966003
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190107
PL  - United States
TA  - Clin Cancer Res
JT  - Clinical cancer research : an official journal of the American Association for 
      Cancer Research
JID - 9502500
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 2S9ZZM9Q9V (Bevacizumab)
SB  - IM
EIN - Clin Cancer Res. 2019 May 15;25(10):3193. PMID: 31092617
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Bevacizumab/administration & dosage/pharmacokinetics
MH  - Biosimilar Pharmaceuticals/administration & dosage/pharmacokinetics
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/*pathology
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Lung Neoplasms/*drug therapy/mortality/*pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Grading
MH  - Neoplasm Staging
MH  - Odds Ratio
MH  - Treatment Outcome
EDAT- 2019/01/09 06:00
MHDA- 2020/05/12 06:00
CRDT- 2019/01/09 06:00
PHST- 2018/08/17 00:00 [received]
PHST- 2018/09/10 00:00 [revised]
PHST- 2019/01/03 00:00 [accepted]
PHST- 2019/01/09 06:00 [pubmed]
PHST- 2020/05/12 06:00 [medline]
PHST- 2019/01/09 06:00 [entrez]
AID - 1078-0432.CCR-18-2702 [pii]
AID - 10.1158/1078-0432.CCR-18-2702 [doi]
PST - ppublish
SO  - Clin Cancer Res. 2019 Apr 1;25(7):2088-2095. doi: 10.1158/1078-0432.CCR-18-2702. 
      Epub 2019 Jan 7.