Nivolumab plus low-dose ipilimumab as first-line therapy in microsatellite instability-high/DNA mismatch repair deficient metastatic colorectal cancer: Clinical update.

• DOI: 10.1200/jco.2020.38.4_suppl.11
• Publication Date: 2020-02-04T21:41:51Z
• Authors: Heinz-Josef Lenz; Sara Lonardi; Vittorina Zagonel; Eric Van Cutsem; M. Luisa Limon; Ka Yeung Mark Wong; Alain Hendlisz; Massimo Aglietta; Pilar Garcia-Alfonso; Bart Neyns; Andrea Spallanzani; Dana Backlund Cardin; Tomislav Dragovich; Usman Shah; Ajlan Atasoy; Jean-Marie Ledeine; Michael J. Overman
• Keywords: Microsatellite Instability; Discontinuation; Clinical endpoint

11 Background: In the phase 2 CheckMate 142 trial, nivolumab plus low-dose ipilimumab provided robust and durable clinical benefit was well tolerated as first-line therapy for microsatellite instability-high/DNA mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) (Lenz et al. Ann Oncol 2018;29:LBA18). Longer follow-up data will be presented. Methods: Patients with MSI-H/dMMR mCRC no prior treatment disease received 3 mg/kg every weeks 1 6 until progression or discontinuation. The primary endpoint investigator-assessed objective response rate (ORR). Results: For all 45 patients (median 13.8 months), ORR 60% (95% CI 44.3–74.3). Responses were consistent overall population across subgroups including age, Eastern Cooperative Oncology Group (ECOG) performance status, adjuvant/neoadjuvant therapy, mutation status (Table). Seven (16%) had grade 3–4 treatment-related adverse events; (7%) any events leading to Updated response, survival, safety after a longer 19.9 months) Conclusions: Nivolumab demonstrated tolerated. Evaluated responses population. may represent new option mCRC. Clinical trial information: NCT02060188. [Table: see text]