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Secondary efficacy results from a phase 3 study comparing efficacy and safety of biosimilar candidate ABP 215 with bevacizumab in patients with non-squamous non-small cell lung cancer (NSCLC)

Date

08 Oct 2016

Session

Poster Display

Presenters

Nicholas Thatcher

Citation

Annals of Oncology (2016) 27 (6): 411-415. 10.1093/annonc/mdw382

Authors

N. Thatcher1, M. Thomas2, G. Ostoros3, J. Pan4, J. Goldschmidt5, V. Hanes4

Author affiliations

  • 1 Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 2 Internistische Onkologie Der Thoraxtumoren, Thoraxklinik Heidelberg, 69126 - Heidelberg/DE
  • 3 3koranyi National Institute For Tb And Pulmonology, National Koranyi Institute of Pulmonology, H-1121 - Budapest/HU
  • 4 Biosimilars, Amgen, Inc., 91320 - Thousand Oaks/US
  • 5 Oncology And Hematology Associates Of Southwest Virginia, Us Oncology Research, Mckesson Specialty Health, Blue Ridge Cancer Care, 24382 - Christianburg/US
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Resources

Abstract 3168

Background

ABP 215 is a biosimilar candidate to bevacizumab, a VEGF inhibitor. Analytical, functional and pharmacokinetic similarity assessments between ABP 215 and bevacizumab have been completed. Here we present results of secondary efficacy variables, focusing on the risk difference (RD) of the overall response rate (ORR) and progression-free survival (PFS). Primary efficacy and safety results from this phase 3 study have been previously reported.

Methods

In this randomized, double-blind, active-controlled study in adults with NSCLC receiving first-line chemotherapy with carboplatin and paclitaxel, patients were randomized (1:1) to receive 15 mg/kg of the investigational product (IP) (ABP 215 or bevacizumab) administered as an IV infusion every 3 weeks for 6 cycles. Patients remained on treatment until 21 days after the last dose of IP or study-specified chemotherapy. Clinical equivalence was demonstrated by comparing the 2-sided 90% confidence interval (CI) of the risk ratio of ORR (primary endpoint) between patients randomized to each study arm with the margin of (0.67, 1.5).

Results

A total of 328 and 314 patients were randomized to ABP 215 (Arm 1) and bevacizumab (Arm 2) groups; the groups were balanced in demographic and baseline characteristics. There were 128 (39.0%) responders in Arm 1 and 131 (41.7%) in Arm 2. The RD for ORR was −2.90% (90% CI: −9.26%–3.45%; 95% CI: −10.48%–4.67%). The PFS analysis included 256 events; 131 patients (39.9%) in Arm 1 and 125 patients (39.8%) in Arm 2 in the intent-to-treat population had progressed or died before the study ended. The estimated hazard ratio from a stratified Cox proportional hazards regression model (Arm 1 relative to Arm 2) was 1.03 (90% CI: 0.83–1.29; 95% CI: 0.80–1.34) ). Safety results were comparable between groups (previously reported). Patients developing binding antibodies were 1.4% in Arm 1 vs 2.5% in Arm 2; no subject tested positive for neutralizing antibodies.

Conclusions

Along with the primary efficacy results of this study, these data are further evidence of clinical equivalence between ABP 215 and bevacizumab in this patient population.

Clinical trial identification

NCT01966003

Legal entity responsible for the study

N/A

Funding

Amgen, Inc.

Disclosure

N. Thatcher: Received honoraria from Lilly, Amgen, Boehringer Ingelheim (BI), Otsuka and Roche. Received consulting/advisory payments from Lilly, Amgen, BI, Otsuka Served on Speaker Bureau for Lilly, BI, Otsuka, Roche Provided paid testimony on behalf of Lilly. M. Thomas: Received honoraria, consulting/advisory payment from BMS, MSD, AZ, Lilly, Novartis, Roche, Celgene, Pfizer Received research funding from BMS, MSD, AstraZeneca Received travel, accomodations, expenses from Pfizer, BMS, Lilly. G. Ostoros: Investigator, Amgen. J. Pan, V. Hanes: Amgen employee and stockholder. J. Goldschmidt: Received honoraria from Roche/Genentech, BMS, Celgene Received consulting/advisory payments from BMS Served on speakers' bureau for Roche, BMS, Celgene Received travel, accomodations, expenses from Roche, BMS.

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