1221TiP - ABOUND.sqm: A phase 3 randomized study of maintenance nab-paclitaxel (nab-P) after induction therapy with nab-P plus carboplatin (C) in patients (p...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Locally Advanced
Presenter David Spigel
Citation Annals of Oncology (2014) 25 (suppl_4): iv417-iv425. 10.1093/annonc/mdu348
Authors D.R. Spigel1, A. Ko2, T.J. Ong2, H. West3, E. Kim4, C. Reynolds5
  • 1Oncology, Sarah Cannon Research Institute, US-37203 - Nashville/US
  • 2Oncology, Celgene Corporation, Summit/US
  • 3Oncology - Medical, Swedish Cancer Institute, Seattle/US
  • 4Oncology, Levine Cancer Institute Carolinas Healthcare System, Charlotte/US
  • 5Oncology, Ocala Oncology Center and US Oncology Research, Houston/US

Abstract

Background

In a phase 3 trial, nab-P/C vs solvent-based paclitaxel + C demonstrated a 68% improvement in ORR (41% vs 24%; P < 0.001) and a trend toward improved overall survival (OS; median 10.7 vs 9.5 months; HR 0.890; P = 0.310) in a subset of pts with advanced SCC NSCLC (Socinski et al. Ann Oncol 2013;24:2390-6). In a subgroup analysis of pts with SCC NSCLC who were progression free after 4 cycles of nab-P/C and received maintenance nab-P/C, the median OS from time of randomization was 13.8 months; no new safety signals were noted (Socinski et al. IASLC 2013 [abstract 3438]). The current phase 3 open-label multicenter crossover study (Albumin-Bound Paclitaxel in an NSCLC Clinical Trial as Squamous Maintenance Therapy [ABOUND.sqm]) will evaluate the efficacy and safety of nab-P maintenance therapy after nab-P/C induction therapy in pts with SCC NSCLC.

Trial design

During induction, ≈ 540 pts will receive nab-P 100 mg/m2 IV (30-min infusion) on days 1, 8, and 15 plus IV C AUC 6 mg·min/mL on day 1 of a 21-day cycle. Eligibility criteria include no prior chemotherapy for metastatic disease, histologically confirmed stage IIIB/IV SCC NSCLC, Eastern Cooperative Oncology Group performance status (PS) ≤ 1, adequate organ function, peripheral neuropathy grade < 2, and absence of brain metastases. Pts with confirmed complete response (CR), partial response (PR), or stable disease (SD) after 4 cycles of nab-P/C will be eligible for maintenance. At the start of maintenance, ≈ 260 pts will be randomized 2:1 to nab-P 100 mg/m2 on days 1 and 8 of each 21-day cycle plus best supportive care (BSC) or BSC alone until progressive disease (PD). Randomization will be stratified by disease stage (IIIB vs IV), response to induction (CR/PR vs SD), and PS (0 vs 1). Crossover to nab-P is allowed if radiologically assessed PD is observed. The primary endpoint is investigator-assessed PFS from time of randomization at the start of maintenance therapy according to RECIST 1.1. Secondary endpoints include OS, ORR, and safety. Exploratory endpoints include tumor biomarker response and healthcare resource utilization. ClinicalTrials.gov number NCT02027428.

Disclosure

A. Ko: Amy Ko is an employee of Celgene and owns stock; H. West: Dr West has participated in advisory boards and received honoraria from the following: Novartis, Genetech/Roche, Foundation Medicine; E. Kim: Dr Kim is an advisor/consultant for the following companies: Celgene Eli Lilly Genentech/Roche; C. Reynolds: Dr Reynolds has participated in Ad Boards and received honoraria for the following: Celgene and Pfizer. All other authors have declared no conflicts of interest.