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
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
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 (%) | ||
CR | 4 (3) | 7 (6) |
PR | 61 (51) | 62 (52) |
SD | 37 (31) | 33 (28) |
PD | 14 (12) | 14 (12) |
Unknown | 3 (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 Disclosures
2022 ASCO Annual Meeting
First Author: Michael J. Overman
2023 ASCO Annual Meeting
First Author: Heinz-Josef Lenz
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Thierry Andre
2023 ASCO Annual Meeting
First Author: Dirk Schadendorf