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Attend this session at the
2018 ASCO Annual Meeting!


Session: The Arrival of Biosimilars

Type: Clinical Science Symposium

Time: Monday June 4, 9:45 AM to 11:15 AM

Location: Hall D1

A comparative clinical study of PF-06439535, a candidate bevacizumab biosimilar, and reference bevacizumab, in patients with advanced non-squamous non-small cell lung cancer.

Sub-category:
Metastatic Non-Small Cell Lung Cancer

Category:
Lung Cancer—Non-Small Cell Metastatic

Meeting:
2018 ASCO Annual Meeting

Abstract No:
109

Citation:
J Clin Oncol 36, 2018 (suppl; abstr 109)

Author(s): Mark A. Socinski, Joachim Von Pawel, Kazuo Kasahara, Igor Bondarenko, Konstantinos Syrigos, Vladimir Ivanovich Vladimirov, Maciej Bryl, Manuela Zereu, A H. Bair, Fiona Hilton, Katherine Faye Liau, Roy S. Herbst; Florida Hospital Cancer Institute, Orlando, FL; Pneumology Clinic, Asklepios Fachkliniken, Gauting, Germany; Department of Respiratory Medicine, Kanazawa University Hospital, Kanazawa City, Japan; Dnipropetrovsk Medical Academy, Dnipropetrovsk, Ukraine; Sotiria General Hospital, Athens, Greece; State Medical Institution Pyatigorsk, Pyatigorsk, Russia; E.J. Zeyland Wielkopolska Center of Pulmonology and Thoracic Surgery, Poznan, Poland; Santa Casa de Porto Alegre, Porto Alegre, RS, Brazil; Pfizer, Groton, CT; Yale School of Medicine, New Haven, CT

Abstract Disclosures

Abstract:

Background: This ongoing, double-blind, randomized, global clinical trial (NCT02364999) evaluated the efficacy, safety, and immunogenicity of PF-06439535 vs. reference bevacizumab sourced from the EU (bevacizumab-EU), in combination with paclitaxel (P) and carboplatin (C), as first-line therapy in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Methods: Eligible pts were randomized 1:1 to PF-06439535 or bevacizumab-EU plus P/C on Day 1 of every 3-week (wk) cycle followed by PF-06439535 or bevacizumab-EU blinded monotherapy until disease progression or unacceptable toxicity. The primary objective was to compare objective response rate (ORR) by Wk 19 between treatment arms. Secondary objectives included safety, 1 year (yr) PFS, 1 yr survival rate and immunogenicity. Results: 719 pts were randomized: PF-06439535 (n = 358) and bevacizumab-EU (n = 361). The majority of patients were male (65%) with a median age of 61y and newly diagnosed Stage IV NSCLC (76%). For the primary endpoint, relative risk of ORR was 1.015. The 90% confidence interval (CI), 0.886-1.163, was contained within the FDA pre-specified therapeutic equivalence margin of 0.73–1.37. Secondary endpoints further support similarity between the 2 treatment arms (Table). Incidence of treatment-emergent adverse events (AEs) (all-causality) was similar (PF-06439535: 96.6%) and (bevacizumab-EU: 96.1%). AE results indicate no clinically meaningful differences between the two arms for arterial thromboembolic event (TE)/venous TE events, bleeding events, hypertension, GI perforation, and proteinuria. Conclusions: In patients with advanced non-squamous NSCLC, PF-06439535 and bevacizumab-EU showed similar ORR (primary endpoint) PFS, OS, safety and immunogenicity. Clinical trial information: NCT02364999

Efficacy endpoints.

PF-06439535Bevacizumab-EU
ORR45.3%
(95%: 40.01%, 50.57%)
44.6%
(95%: 39.40%, 49.89%)
1 yr PFS rate29.4%
(95% CI: 23.2%, 35.9%)
29.3%
(95% CI: 23.5%, 35.3%)
1 yr survival rate65.2%
(95% CI: 59.0%, 70.7%)
66.4%
(95% CI: 59.9%, 72.0%)

 
Other Abstracts in this Sub-Category:

 

1. Pembrolizumab (pembro) versus platinum-based chemotherapy (chemo) as first-line therapy for advanced/metastatic NSCLC with a PD-L1 tumor proportion score (TPS) ≥ 1%: Open-label, phase 3 KEYNOTE-042 study.

Meeting: 2018 ASCO Annual Meeting Abstract No: LBA4 First Author: Gilberto Lopes
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

2. Phase 3 study of carboplatin-paclitaxel/nab-paclitaxel (Chemo) with or without pembrolizumab (Pembro) for patients (Pts) with metastatic squamous (Sq) non-small cell lung cancer (NSCLC).

Meeting: 2018 ASCO Annual Meeting Abstract No: 105 First Author: Luis G. Paz-Ares
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

3. IMpower131: Primary PFS and safety analysis of a randomized phase III study of atezolizumab + carboplatin + paclitaxel or nab-paclitaxel vs carboplatin + nab-paclitaxel as 1L therapy in advanced squamous NSCLC.

Meeting: 2018 ASCO Annual Meeting Abstract No: LBA9000 First Author: Robert M. Jotte
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

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