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  • / Nivolumab (NIVO) plus chemotherapy (chemo) or ipilimumab (IPI) versus chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): Expanded efficacy and safety analyses from CheckMate 648.

Nivolumab (NIVO) plus chemotherapy (chemo) or ipilimumab (IPI) versus chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): Expanded efficacy and safety analyses from CheckMate 648.

Abstract Video & Slides Poster

Authors

Ian Chau

Ian Chau

Royal Marsden Hospital, London & Surrey, United Kingdom

Ian Chau , Jaffer A. Ajani , Yuichiro Doki , Jianming Xu , Lucjan Wyrwicz , Satoru Motoyama , Takashi Ogata , Hisato Kawakami , Chih-Hung Hsu , Antoine Adenis , Farid El Hajbi , Maria Di Bartolomeo , Maria Ignez Freitas Melro Braghiroli , Eva Holtved , Mariela A. Blum Murphy , Sandzhar Abdullaev , Samira Soleymani , Ming Lei , Ken Kato , Yuko Kitagawa

Organizations

Royal Marsden Hospital, London & Surrey, United Kingdom, University of Texas MD Anderson Cancer Center, Houston, TX, Osaka University Graduate School of Medicine, Osaka, Japan, Affiliated Hospital Cancer Center, Academy of Military Medical Sciences, Beijing, China, Klinika Onkologii i Radioterapii, Narodowy Instytut Onkologii, Warszawa, Poland, Akita University Hospital, Akita, Japan, Kanagawa Cancer Center, Kanagawa, Japan, Kindai University Faculty of Medicine, Osakasayama, Japan, National Taiwan University Hospital, Taipei, Taiwan, Institut du Cancer de Montpellier, Montpellier, France, Centre Oscar Lambret, Lille, France, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy, Institute of Cancer of São Paulo, University of São Paulo, São Paulo, Brazil, Odense University Hospital, Odense, Denmark, Bristol Myers Squibb, Princeton, NJ, National Cancer Center Hospital, Tokyo, Japan, Keio University School of Medicine, Tokyo, Japan

Research Funding

Pharmaceutical/Biotech Company

Background: NIVO + chemo and NIVO + IPI demonstrated significant overall survival (OS) benefit vs chemo in previously untreated patients (pts) with advanced ESCC in the phase 3 CheckMate 648 study. We report expanded results from the primary analysis with 13-month (mo) minimum follow-up. Methods: Pts with previously untreated, unresectable advanced, recurrent, or metastatic ESCC were randomized to NIVO (240 mg Q2W) + chemo (fluorouracil + cisplatin Q4W), NIVO (3 mg/kg Q2W) + IPI (1 mg/kg Q6W), or chemo. Primary endpoints were OS and progression-free survival (PFS) per blinded independent central review (BICR) in pts with tumor cell programmed death ligand 1 (PD-L1) ≥ 1%. Secondary endpoints planned for hierarchical testing included OS, PFS, and objective response rate (ORR) per BICR in all randomized pts. Duration of response (DOR) per BICR and PFS2 per investigator (time from randomization to progression after subsequent systemic therapy, initiation of second subsequent systemic therapy, or death) were exploratory endpoints. Results: Among all pts randomized to NIVO + chemo (n = 321), NIVO + IPI (n = 325), or chemo (n = 324), PFS2 favored NIVO + chemo (HR 0.64, 95% CI 0.54–0.77) and NIVO + IPI (HR 0.74, 95% CI 0.62–0.88) vs chemo. ORR (95% CI) was 47% (42–53), 28% (23–33), and 27% (22–32), respectively. More responders with NIVO + chemo or NIVO + IPI vs chemo had prolonged DOR (≥12 mo; 39%, 48%, and 23%, respectively). Efficacy data by tumor cell PD-L1 and PD-L1 combined positive score will be presented. Grade 3/4 treatment-related adverse events with potential immunologic etiology (select TRAEs) occurred in ≤ 6% of pts with NIVO + chemo and NIVO + IPI, and non-endocrine select TRAEs resolved in 57%–95% of pts across organ categories (Table). Conclusions: NIVO + chemo and NIVO + IPI demonstrated favorable PFS2 and a higher proportion of pts with prolonged DOR vs chemo, as well as acceptable safety profiles. These results provide further support for each regimen as a new potential 1L standard of care in advanced ESCC. Clinical trial information: NCT03143153.

Select TRAEs
NIVO + chemo (n = 310)
NIVO + IPI (n = 322)
Any
grade,
n (%)
Median time to onset (range), wk>
Median time to resolution (range), wk
Any
grade,
n (%)>
Median time to onset (range), wk
Median time to resolution (range), wk
Endocrine
36 (12)
13.0 (5.0–100)
NR (4.1–125.6+)
88
(27)
8.2 (1.9–72.9)
NR (0.4+ to 154.0+)
Gastrointestinal
64 (21)
5.1 (0.3–53.1)
1.5 (0.1–65.9+)
38
(12)
9.1 (0.6–50.3)
2.9 (0.3–79.1+)
Hepatic
32 (10)
7.9
(0.3–84.1)
2.4 (0.4–24.0+)
42
(13)
5.0 (1.0–50.1)
5.1 (1.1–30.9+)
Pulmonary
18 (6)
31.2 (5.0–85.1)
12.1 (1.0–39.9+)
26 (8)
11.9 (1.9–72.3)
12.1 (0.1+ to 119.3+)
Renal
74 (24)
10.1 (0.7–60.7)
17.1 (0.4–128.1+)
8 (2)
7.1 (1.1–47.1)
9.6 (0.7–142.3+)
Skin
54 (17)
5.9 (0.1–61.1)
7.1 (0.1–157.0+)
110
(34)
3.9 (0.1–54.3)
11.4 (0.3–146.6+)

+ indicates a censored value. NR, not reached; wk, weeks.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT03143153

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 4035)

DOI

10.1200/JCO.2022.40.16_suppl.4035

Abstract #

4035

Poster Bd #

23

Abstract Disclosures

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