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Safety Profile of Nivolumab + Ipilimumab Combination Therapy in Patients With DNA Mismatch Repair-Deficient/Microsatellite Instability–High (dMMR/MSI-H) Metastatic Colorectal Cancer (mCRC) in CheckMate-142


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Safety Profile of Nivolumab + Ipilimumab Combination Therapy in Patients With DNA Mismatch

Repair-Deficient/Microsatellite-Instability-High Metastatic Colorectal Cancer in CheckMate-142

Edith Brutcher,1 Taline Khoukaz,2 Leighanne Hartman3

1Emory Winship Cancer Institute, Atlanta, GA, USA; 2USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA; 3Duke University Medical Center, Durham, NC, USA


• Nivolumab (NIVO) received accelerated approval for patients with DNA mismatch repair-deficient and/or microsatellite-instability-high (dMMR/MSI-H)

metastatic colorectal cancer (mCRC) that progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan1

• NIVO plus an optimized dose of ipilimumab (IPI) provided durable clinical benefit in patients with pretreated dMMR/MSI-H mCRC2

– High objective response rate (ORR; 55%), with median duration of response

(DOR) not reached, and disease control for ≥12 weeks in 80% of patients2

– Encouraging survival (12-month progression-free survival [PFS] and overall

survival [OS] rates of 71% and 85%, respectively)2

– Manageable safety with low discontinuation rate due to an adverse event

(AE) related to study drug (13%)2

• Consistent with the overall population, patients who discontinued treatment due to AEs achieved high ORR (63%), high disease control for ≥12 weeks

(81%), and a median DOR not reached2

• AEs with checkpoint inhibition often affect the dermatologic, gastrointestinal (GI), pulmonary, renal, endocrine, and hepatic systems and differ from

chemotherapy-related AEs3

• Early AE detection and proper management, including use of systemic corticosteroids, may lead to improved outcomes3

• Here we describe the detailed safety profile of NIVO + IPI and management of AEs from CheckMate-142


Study Design

• CheckMate-142 is an ongoing, multi-cohort, phase 2 study evaluating the efficacy and safety of NIVO-based therapies in patients with mCRC

(NCT02060188) (Figure 1)2

Safety Assessments

• Safety assessments included frequency of treatment-related AEs (TRAEs), TRAEs leading to discontinuation or delay, and frequency, onset, resolution,

and recurrence of select TRAEs (sTRAEs, defined as TRAEs of potential immunologic etiology)3

• Immune-modulating medications (IMMs), including corticosteroids and immunosuppressive agents, were used to manage sTRAEs per protocol-

specified algorithms4

• Time to onset of any grade sTRAEs was defined as the time between the day of the first dose of study treatment and the onset date of the earliest sTRAE

• Time to resolution of sTRAEs was defined as the longest time from onset to complete resolution or improvement to baseline grade

• sTRAEs that occurred after resuming treatment following dose delay are shown

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