ESMO Supporter 2018

Found 2 Presentations For Request "LBA18_PR"

Proffered paper session - Gastrointestinal tumours, colorectal Proffered Paper session

LBA18_PR - Durable Clinical Benefit With Nivolumab (NIVO) Plus Low-Dose Ipilimumab (IPI) as First-Line Therapy in Microsatellite Instability-High/Mismatch Repair Deficient (MSI-H/dMMR) Metastatic Colorectal Cancer (mCRC)

Presentation Number
LBA18_PR
Lecture Time
09:15 - 09:27
Speakers
  • Heinz-Josef J. Lenz (Los Angeles, US)
Location
Hall A2 - Room 18, ICM München, Munich, Germany
Date
22.10.2018
Time
09:15 - 11:00

Abstract

Background

In previously chemotherapy-treated patients with MSI-H/dMMR mCRC from the phase II CheckMate-142 trial, NIVO + low-dose IPI (1 mg/kg) provided durable clinical benefit (investigator-assessed [INV] objective response rate [ORR] 55%, median duration of response [DOR] not reached, 12-month overall survival [OS] rate 85%) and manageable safety. Here we report the first results of the efficacy and safety of NIVO + low-dose IPI as a first-line (1L) therapy for patients with MSI-H/dMMR mCRC from CheckMate-142.

Methods

Patients with no prior treatment for MSI-H/dMMR mCRC were treated with NIVO 3 mg/kg every 2 weeks (Q2W) + low-dose IPI every 6 weeks (Q6W) until disease progression. The primary endpoint was ORR (INV; RECIST v1.1).

Results

Of 45 patients, 51% were male and median age was 66 years. Median follow-up (time from first dose to data cut-off) was 13.8 months (range 9–19). The ORR and disease control rate (DCR) were 60% and 84%, respectively, with a 7% complete response rate (Table). Median DOR was not reached. At 12 months, progression-free survival (PFS) and OS rates were 77% and 83%, respectively. Grade 3–4 treatment-related adverse events (TRAEs) occurred in 16% of patients and 7% of patients had any grade TRAEs leading to discontinuation. Any grade select immune-mediated TRAEs affecting the hepatic (13%), gastrointestinal (11%), pulmonary (2%), and renal (2%) systems resolved in 100% of patients, while those affecting the skin (33%) and endocrine (24%) systems resolved in 45% and 60% of patients, respectively.

Conclusions

NIVO (Q2W) + low-dose IPI (Q6W) demonstrated robust and durable clinical benefit and was well-tolerated as a 1L treatment for MSI-H/dMMR mCRC. These results suggest that NIVO + low-dose IPI may represent a new treatment option for these patients.

Table. Efficacy and Safety
NIVO + IPI (N = 45)

ORRa, n (%)

(95% CI)

27 (60)

(44–74)

Best overall response, n (%)

CR

PR

SD

PD

Not determined

3 (7)

24 (53)

11 (24)

6 (13)

1 (2)

DCRb, n (%)

(95% CI)

38 (84)

(71–94)
Median time to response, months (range) 2.6 (1.2–13.8)
Median DOR, months (95% CI) NR (11.5–NE)

Median PFS, months (95% CI)

12-month rate, % (95% CI)

NR (14.1–NE)

77 (62.0–87.2)

Median OS, months (95% CI)

12-month rate, % (95% CI)

NR (NE)

83 (67.6–91.7)

TRAEs, n (%)

Any grade

Grade 3–4

35 (78)

7 (16)

TRAEs leading to discontinuation, n (%)

Any grade

Grade 3–4

3 (7)

1 (2)

aPatients with CR or PR divided by the number of treated patients

bPatients with a CR, PR, or SD for ≥12 weeks divided by the number of treated patients

CI = confidence interval; CR = complete response; NE = not estimable; NR = not reached; PD = progressive disease; PR = partial response; SD = stable disease

Clinical trial identification

NCT02060188

Editorial Acknowledgement

Professional medical writing assistance and editorial assistance was provided by Tanmayi Mankame, PhD, and Christine Craig of PAREXEL International, funded by Bristol-Myers Squibb.

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Proffered paper session - Gastrointestinal tumours, colorectal Proffered Paper session

Invited Discussant LBA18_PR and LBA19

Lecture Time
09:39 - 09:54
Speakers
  • Julien Taieb (Paris, FR)
Location
Hall A2 - Room 18, ICM München, Munich, Germany
Date
22.10.2018
Time
09:15 - 11:00