622PD - nab-Paclitaxel (nab-P) Plus Gemcitabine (G) for Patients (Pts) With Locally Advanced Pancreatic Cancer (LAPC): Interim Efficacy and Safety Results...

Date 11 September 2017
Event ESMO 2017 Congress
Session Gastrointestinal tumours, non-colorectal
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Gastrointestinal Cancers
Presenter Philip Philip
Citation Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369
Authors P.A. Philip1, J. Lacy2, F. Portales3, A. Sobrero4, R. Pazo-Cid5, J.L. Manzano-Mozo6, E.S. Kim7, S. Dowden8, A. Zakari9, C. Borg10, E. Terrebonne11, F. Rivera Herrero12, J. Shiansong Li13, T.J. Ong14, T. Nydam14, P. Hammel15
  • 1Department Of Oncology, Karmanos Cancer Institute, 48201 - Detroit/US
  • 2Medical Oncology, Yale Cancer Center, 06510 - New Haven/US
  • 3Oncologue Digestif, Institut régional du Cancer de Montpellier (ICM), Montpellier/FR
  • 4Medical Oncology, Azienda Ospedaliera Universitaria San Martino, 16132 - Genova/IT
  • 5Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 6Medical Oncology, Hospital Universitari Germans Trias i Pujol, Barcelona/ES
  • 7Medical Oncology, Levine Cancer Institute, Charlotte/US
  • 8Medical Oncology, Tom Baker Cancer Center, T2N 4N2 - Calgary/CA
  • 9Gastro Intestinal Cancer Program, Florida Hospital Cancer Institute, 32804 - Orlando/US
  • 10Medical Oncology, Centre Hospitalier Belfort Montbeliard, Montbeliard/FR
  • 11Medical Oncology, Hospital Haut Leveque, Giround/FR
  • 12Medical Oncology, Hospital Universitario Marques de Valdecilla, 39008 - Santander/ES
  • 13Biostatistics, Celgene Corporation - USA, 07901 - Summit/US
  • 14Medical Affairs, Celgene Corporation - USA, 07901 - Summit/US
  • 15Gastroenterology, Hôpital Beaujon, 92110 - Clichy/FR

Abstract

Background

Treatment options for pts with LAPC are limited. In the phase 3 MPACT trial, nab-P + G treatment (Tx) resulted in a > 3-fold reduction in primary pancreatic tumor burden vs G in pts with metastatic PC, suggesting that the regimen may be effective in LAPC. Interim efficacy and safety results from the international, multicenter, prospective phase 2 LAPACT trial are presented.

Methods

During induction, treatment-naive pts with unresectable LAPC and ECOG PS ≤ 1 received 6 cycles of nab-P 125 mg/m2 + G 1000 mg/m2 on D 1, 8, and 15 of each 28-day cycle. After induction, pts without PD or unacceptable AEs were eligible for the investigator’s choice (IC) of continued Tx with nab-P + G, chemoradiation (CRT), or surgery. Surgery could occur prior to completing 6 cycles if the investigator deemed a sufficient tumor response. The primary endpoint was TTF. A secondary endpoint was disease control rate (DCR = CR, PR, and SD [≥ 16 weeks]) in pts who completed induction and had ≥ 1 postbaseline assessment. Data for pts who received their first dose of Tx by Oct 1, 2016 are reported.

Results

A total of 101 pts with LAPC received nab-P + G induction. Median age was 65 years (range, 42-85), and median time from primary diagnosis to first dose was 27 days. Pts received a median of 5 Tx cycles (range, 1-6). A total of 60 patients (59%) completed induction. Among 93 evaluable patients, the DCR was 82% (76/93; PR, n = 33; SD ≥ 16 wks, n = 43); 12 pts had SD 

Conclusions

The reported DCR of 82% and PR rate of 35% for nab-P + G are promising, and there were no new safety signals compared with previous studies. These interim results suggest that nab-P + G is an appropriate LAPC Tx. NCT02301143.

Clinical trial identification

NCT02301143

Legal entity responsible for the study

Celgene Corporation

Funding

Celgene Corporation

Disclosure

P.A. Philip: Research funding: Celgene, Bayer, Incyte; consultant or advisory role: Celgene; speakers’ bureau: Bayer, Roche, Sanofi, Amgen. J. Lacy, C. Borg: Research funding: Celgene. A. Sobrero: Honoraria: Bayer, Celgene, Merck, Roche, Sanofi. Consulting or advisory role: Amgen, Bayer, Merck, Pfizer; speaker’s bureau: Amgen, BMS, Merck, Sanofi. E.S. Kim: Honoraria, speaker’s bureau, advisory board: GuardantHealth; consultant: Pharmacyclics, Medallion Healthcare; advisory board: Bayer; consultant: Momenta. S. Dowden: Honoraria, advisory role, speaker’s bureau, Amgen, Bayer, Celgene, Lilly, Roche A. Zakari: Speakers bureau, Amgen, Celgene. F. Rivera Herrero: Research funding, Celgene, Bayer, Roche, Amgen, Merck-Serono, MSD, Sanofi, Lilly; consultant or advisory role, Celgene, Bayer, Roche, Amgen, Merck-Serono, MSD, Sanofi, Lilly; speaker’s bureau, Celgene, Bayer, Roche, Sanofi, Amgen, Lilly. J. Shiansong Li, T.J. Ong, T. Nydam: Employment, stock ownership: Celgene. P. Hammel: Consultant or advisory role, honoraria, travel accommodations, expenses: Celgene. All other authors have declared no conflicts of interest.