Nivolumab (NIVO) + low-dose ipilimumab (IPI) in previously treated patients (pts) with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Long-term follow-up.

Authors

null

Michael J. Overman

MD Anderson Cancer Center, Houston, TX

Michael J. Overman , Sara Lonardi , Ka Yeung Mark Wong , Heinz-Josef Lenz , Fabio Gelsomino , Massimo Aglietta , Michael Morse , Eric Van Cutsem , Raymond S. McDermott , Andrew G Hill , Michael B. Sawyer , Alain Hendlisz , Bart Neyns , Magali Svrcek , Ajlan Atasoy , Huanyu Zhao , Ming Lei , Scott Kopetz , Thierry Andre

Organizations

MD Anderson Cancer Center, Houston, TX, Istituto Oncologico Veneto - IRCCS, Padova, Italy, Westmead Hospital, Sydney, Australia, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, University Hospital of Modena, Modena, Italy, Candiolo Cancer Institute and University of Torino Medical School, Candiolo, Italy, Duke University Medical Center, Durham, NC, University Hospitals and KU Leuven, Leuven, Belgium, St Vincent’s University Hospital and Cancer Trials Ireland, Dublin, Ireland, Tasman Oncology Research, Ltd, Southport, Queensland, Australia, Cross Cancer Institute and University of Alberta, Edmonton, AB, Canada, Institut Jules Bordet, Brussels, Belgium, University Hospital Brussels, Brussels, Belgium, Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris and Sorbonne Université, Paris, France, Bristol-Myers Squibb, Princeton, NJ

Research Funding

Pharmaceutical/Biotech Company

Background: In the phase II CheckMate-142 trial, NIVO + low-dose IPI (1 mg/kg) provided meaningful clinical benefit in previously treated MSI-H/dMMR mCRC pts after a median follow-up of 13.4 mo. Here, we present long-term follow-up (median 25.4 mo) of these pts. Methods: Pts received NIVO 3 mg/kg + low-dose IPI Q3W (4 doses) followed by NIVO 3 mg/kg Q2W until disease progression. Primary endpoint was investigator (INV)-assessed objective response rate (ORR; RECIST v1.1). Results: Of 119 treated pts, 76% had ≥ 2 prior lines of therapy. ORR and disease control rates (DCR) were 58 and 81%, respectively (Table). Complete response (CR) rate increased with long-term follow-up from 3 (13.4 mo) to 6% (25.4 mo). Median duration of response (DOR) was not reached, with 68% of responses ongoing at data cutoff. At 24 mo, progression-free survival (PFS) and overall survival (OS) rates were 60 and 74%, respectively; OS rates were 96, 56, and 29% in pts with CR or partial response (PR), stable disease (SD), and progressive disease (PD), respectively. Grade 3–4 treatment-related adverse events (TRAEs) occurred in 31% of pts; 10% (grade 3–4) and 13% (any grade) of pts had TRAEs leading to discontinuation. Conclusions: Long-term follow-up with NIVO + low-dose IPI provides durable clinical benefit with deepening of response and a manageable safety profile with no new safety signals, demonstrating long-term benefit of NIVO + low-dose IPI for previously treated pts with MSI-H/dMMR mCRC. Clinical trial information: NCT02060188

INV-assessed efficacy

NIVO + low-dose IPI (N = 119)
13.4 mo*25.4 mo*
ORR, n (%)65 (55)69 (58)
(95% CI)(45–64)(49–67)
Best overall response, n (%)
CR4 (3)7 (6)
PR61 (51)62 (52)
SD37 (31)33 (28)
PD14 (12)14 (12)
Unknown3 (3)3 (3)
DCR, n (%)95 (80)96 (81)
(95% CI)(72–87)(72–87)
Median time to response, mo (range)3 (1–14)3 (1–24)
Median DOR, mo (range)NR (NE)NR (1+ to 33+)
Median PFS, mo (95% CI)NR (NE)NR (23–NE)
12-mo rate, % (95% CI)71 (61–79)71 (62–78)
24-mo rate, % (95% CI)60 (50–69)
Median OS, mo (95% CI)NR (NE)NR (NE)
12-mo rate, % (95% CI)85 (77–90)85 (77–90)
24-mo rate, % (95% CI)74 (65–81)

*Median follow-up NE = not estimable NR = not reached

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Abstract Details

Meeting

2019 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Cancers of the Colon, Rectum, and Anus

Track

Cancers of the Colon, Rectum, and Anus

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT02060188

Citation

J Clin Oncol 37, 2019 (suppl 4; abstr 635)

DOI

10.1200/JCO.2019.37.4_suppl.635

Abstract #

635

Poster Bd #

K20

Abstract Disclosures