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Attend this session at the
2017 ASCO Annual Meeting!


Session: Gastrointestinal (Noncolorectal) Cancer

Type: Oral Abstract Session

Time: Sunday June 4, 8:00 AM to 11:00 AM

Location: Hall D2

Nivolumab ± ipilimumab in pts with advanced (adv)/metastatic chemotherapy-refractory (CTx-R) gastric (G), esophageal (E), or gastroesophageal junction (GEJ) cancer: CheckMate 032 study.

Sub-category:
Esophageal or Gastric Cancer

Category:
Gastrointestinal (Noncolorectal) Cancer

Meeting:
2017 ASCO Annual Meeting

Abstract No:
4014

Citation:
J Clin Oncol 35, 2017 (suppl; abstr 4014)

Author(s): Yelena Yuriy Janjigian, Patrick Alexander Ott, Emiliano Calvo, Joseph W. Kim, Paolo Antonio Ascierto, Padmanee Sharma, Katriina Johanna Peltola, Dirk Jaeger, T.R. Jeffry Evans, Filippo G. De Braud, Ian Chau, Marina Tschaika, Christopher T. Harbison, Weiguo Cai, Johanna C. Bendell, Dung T. Le; Memorial Sloan Kettering Cancer Center, New York, NY; Dana-Farber Cancer Institute, Boston, MA; START Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain; Yale Cancer Center, New Haven, CT; Istituto Nazionale Tumori “Fondazione G.Pascale”- IRCCS, Naples, Italy; MD Anderson Cancer Center, Houston, TX; Comprehensive Cancer Center, Helsinki University Hospital, Helsinki, Finland; Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany; Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan, Italy; Royal Marsden Hospital, London, United Kingdom; Bristol-Myers Squibb, Princeton, NJ; Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, TN; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD

Abstract Disclosures

Abstract:

Background: In the phase 3 ONO-12 study, 3rd- or later-line nivolumab (N) monotherapy prolonged OS vs placebo in Asian pts with adv G/GEJ cancer (median OS, 5.3 vs 4.1 mo; HR, 0.63; P< 0.0001; ASCO-GI 2017, Kang YK et al. J Clin Oncol. 2017;35 (suppl 4S) [abstract 2]). The phase 1/2 CheckMate 032 study showed favorable clinical activity of N ± ipilimumab (I) in Western pts with adv CTx-R G/E/GEJ cancer (NCT01928394). We report updated long-term follow-up data of G/E/GEJ pts in CheckMate 032. Methods: Pts received N 3 mg/kg Q2W (N3), N 1 mg/kg + I 3 mg/kg Q3W (N1+I3), or N 3 mg/kg + I 1 mg/kg Q3W (N3+I1). Primary endpoint was ORR. Secondary endpoints included DOR, OS, PFS, and safety. Efficacy in pts by PD-L1 status was assessed. Results: 160 heavily pretreated pts (79% had ≥ 2 prior Tx) were enrolled (N3, n = 59; N1+I3, n = 49; N3+I1, n = 52); 24% had PD-L1+ (≥ 1%) tumors. ORR was 12% in N3, 24% in N1+I3, and 8% in N3+I1. In pts with PD-L1 ≥ 1%, ORR was 19% (3/16) in N3, 40% (4/10) in N1+I3, and 23% (3/13) in N3+I1; in pts with PD-L1 < 1%, ORR was 12% (3/26), 22% (7/32), and 0% (0/30), respectively. Median DOR was 7.1 mo in N3, 7.9 mo in N1+I3, and NA in N3+I1. OS in all pts and in pts with PD-L1 ≥ 1% is in the Table. Grade 3–4 treatment-related AEs reported in ≥ 10% of pts in any treatment arm were diarrhea (N3, 2%; N1+I3, 14%; N3+I1, 2%), ALT increased (N3, 3%; N1+I3, 14%; N3+I1, 4%), and AST increased (N3, 5%; N1+I3, 10%; N3+I1, 2%). Conclusions: N ± I led to durable responses and long-term OS in heavily pretreated Western pts with adv G/E/GEJ cancer, which is consistent with the clinical activity observed in Asian pts in the ONO-12 study. Safety was consistent with prior reports. These data support ongoing investigation of N ± I in pts with adv G/E/GEJ cancer. Clinical trial information: NCT01928394

OS in all pts and pts with PD-L1 ≥ 1%.

All ptsN3N1+I3N3+I1
n = 59n = 49n = 52
 Median (95% CI), mo6.2 (3.4, 12.4)6.9 (3.7, 11.5)4.8 (3.0, 8.4)
 Rate (95% CI), %
  12 mo39 (26, 52)35 (22, 49)24 (13, 37)
  18 mo25 (14, 37)28 (15, 41)13 (5, 24)
  24 mo22 (12, 35)22 (10, 37)
Pts with PD-L1 ≥ 1%n = 16n = 10n = 13
 Median (95% CI), mo6.2 (1.9, 12.4)NA (1.2, NA)5.6 (2.4, 10.9)
 Rate (95% CI), %
  12 mo34 (12, 57)50 (18, 75)23 (6, 47)
  18 mo13 (2, 35)50 (18, 75)15 (2, 39)

 
Other Abstracts in this Sub-Category:

 

1. KEYNOTE-059 cohort 1: Efficacy and safety of pembrolizumab (pembro) monotherapy in patients with previously treated advanced gastric cancer.

Meeting: 2017 ASCO Annual Meeting Abstract No: 4003 First Author: Charles S. Fuchs
Category: Gastrointestinal (Noncolorectal) Cancer - Esophageal or Gastric Cancer

 

2. Perioperative chemotherapy with docetaxel, oxaliplatin, and fluorouracil/leucovorin (FLOT) versus epirubicin, cisplatin, and fluorouracil or capecitabine (ECF/ECX) for resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma (FLOT4-AIO): A multicenter, randomized phase 3 trial.

Meeting: 2017 ASCO Annual Meeting Abstract No: 4004 First Author: Salah-Eddin Al-Batran
Category: Gastrointestinal (Noncolorectal) Cancer - Esophageal or Gastric Cancer

 

3. A randomized phase II pilot study prospectively evaluating treatment for patients based on ERCC1 for advanced/ metastatic esophageal, gastric, or gastroesophageal junction cancer: SWOG S1201.

Meeting: 2017 ASCO Annual Meeting Abstract No: 4009 First Author: Syma Iqbal
Category: Gastrointestinal (Noncolorectal) Cancer - Esophageal or Gastric Cancer

 

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