Safety and activity of nivolumab monotherapy in advanced and metastatic (A/M) gastric or gastroesophageal junction cancer (GC/GEC): Results from the CheckMate-032 study.

Cancers of the Esophagus and Stomach
Session Type and Session Title: 
Oral Abstract Session: Cancers of the Esophagus and Stomach
Poster Session A: Cancers of the Esophagus and Stomach
Abstract Number: 


Poster Board Number: 
Poster Session A Board #F6
J Clin Oncol 34, 2016 (suppl 4S; abstr 6)
Dung T. Le, Johanna C. Bendell, Emiliano Calvo, Joseph W. Kim, Paolo Antonio Ascierto, Padmanee Sharma, Patrick Alexander Ott, Petri Bono, Dirk Jaeger, T.R. Jeffry Evans, Filippo G. De Braud, Ian Chau, Olaf Christensen, Christopher Harbison, Chen-Sheng Lin, Yelena Yuriy Janjigian; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Sarah Cannon Research Institute, Tennessee Oncology, PLLC, Nashville, TN; START Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain; Yale University Medical Center, Yale Cancer Center, New Haven, CT; Istituto Nazionale Tumori, IRCCS, Naples, Italy; The University of Texas MD Anderson Cancer Center, Houston, TX; Dana-Farber Cancer Institute, Boston, MA; Helsinki University Central Hospital, Helsinki, Finland; National Center for Tumor Diseases, University Hospitals Heidelberg, Heidelberg, Germany; Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, United Kingdom; Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy; Royal Marsden Hospital, London, United Kingdom; Bristol-Myers Squibb, Princeton, NJ; Memorial Sloan Kettering Cancer Center, New York, NY

Abstract Disclosures


Background: Patients (pts) with GC/GEC often present with A/M disease, which has a poor prognosis, with 1-year survival < 30%, and few treatment options. Nivolumab is a fully human anti-PD-1 IgG4 monoclonal antibody with a favorable safety profile and efficacy in melanoma, non–small-cell lung cancer, and renal cell carcinoma. The phase I/II, open-label CheckMate-032 study evaluated nivolumab ± ipilimumab in pts with solid tumors. Here, we report initial results for pts with GEC/GC receiving nivolumab monotherapy. Methods: Pts with A/M histologically confirmed GC/GEC, irrespective of PD-L1 status, were assigned to receive nivolumab alone (3 mg/kg IV Q2W) and treated until disease progression (PD) or intolerable toxicity. The primary endpoint was objective response rate (ORR); other endpoints included safety, progression-free survival, overall survival (OS), and biomarker status. Results: 59 pts were enrolled and treated with single-agent nivolumab. Median age was 60 y (range 29–80), and 83% of pts received ≥ 2 prior regimens. At database lock, 10 pts were on active treatment; 49 pts discontinued (PD, n = 40; unrelated adverse events, n = 4; treatment-related adverse events [TRAEs], n = 2; other, n = 3). Pts received a median of 4 doses (range 1–25). ORR was 12% (n = 7/58; 1 complete response, 6 partial responses); 12 pts (21%) had stable disease. Among responders, median duration of response was 7.1 mo (95% CI, 3.0–13.2). Median OS was 6.8 mo (95% CI, 3.3–12.4); 12-mo OS rate was 38% (95% CI, 23.2–52.7). 39% of tumor samples were PD-L1 positive ( ≥ 1% cutoff). ORRs in pts with PD-L1-positive and -negative tumors were 18% and 12%, respectively. TRAEs occurred in 66% of pts; most were Grade 1/2. Grade 3/4 TRAEs occurred in 14% of pts and included pneumonitis, fatigue, diarrhea, vomiting, hypothyroidism, and increased aspartate and alanine aminotransferase and alkaline phosphatase levels. No treatment-related deaths occurred. Conclusions: Nivolumab monotherapy was well tolerated and demonstrated encouraging antitumor activity in heavily pretreated pts with GC/GEC. Objective responses occurred in pts with PD-L1-positive and -negative tumors. Clinical trial information: NCT01928394