You are here

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

Yelena Yuriy Janjigian, Patrick Alexander Ott, Emiliano Calvo, Joseph W. Kim, Paolo Antonio Ascierto, Padmanee Sharma, et al.

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

Editorial comment from Prof Lordick & Dr Smyth:
Checkmate 032 shows that the combination of two checkpoint inhibitors with different mechanisms of action (anti-PD1 plus anti-CTLA4: Nivolumab 1mg/kg and Ipilimumab 3mg/kg every three weeks) shows promise for the treatment of advanced and pretreated gastric cancers. Response rates for PD-L1 positive gastric cancers were reported to be as high as 40% for combination therapy in PD-L1 positive patients and survival rates after 18 months of treatment in patients with PD-L1 positive tumors were as high as 50%.    Whether or not this combination will be established as a chemotherapy free option in the treatment algorithm of gastric cancer depends on the results of ongoing randomized controlled trials.



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 6 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.


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.


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, andNA 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%).


N 6 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 6 I in pts with adv G/E/GEJ cancer. Clinical trial information: NCT01928394.

All content © 2017 American Society of Clinical Oncology. All rights reserved.

Search this site

Search form

ECCO2017 symposium webcast: Treatment evolution in advanced GI malignancies

Welcome and introduction - Florian Lordick


Subscribe to our E-Alert to keep up to date with the new items in the Resource Centre

Featured Content

New Book Content

This online Resource Centre has been sponsored by Lilly Oncology

Note that Lilly Oncology has no editorial control over the content of this Resource Centre. The Resource Centre and all content therein has been subject to an independent editorial review.