In the phase 2 CheckMate 142 trial, Nivolumab ( Opdivo ) plus low-dose Ipilimumab ( Yervoy ) has provided robust and durable clinical benefit and 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 ).
Patients with MSI-H/dMMR metastatic colorectal cancer and no prior treatment for metastatic disease received Nivolumab 3 mg/kg every 2 weeks plus low-dose Ipilimumab 1 mg/kg every 6 weeks until disease progression or discontinuation.
The primary endpoint was investigator-assessed objective response rate ( ORR ).
For all 45 patients ( median follow-up was 13.8 months ), ORR was 60% ( 95% CI 44.3–74.3 ).
Responses were consistent with the overall population across subgroups including age, ECOG performance status, prior adjuvant / neoadjuvant therapy, and mutation status.
Seven patients ( 16% ) had grade 3-4 treatment-related adverse events; 3 ( 7% ) had any grade treatment-related adverse events leading to discontinuation.
In conclusion, Nivolumab plus low-dose Ipilimumab has demonstrated robust and durable clinical benefit and was well tolerated.
Evaluated subgroups had responses consistent with the overall population.
Nivolumab plus low-dose Ipilimumab may represent a new first-line treatment option for patients with MSI-H/dMMR metastatic colorectal cancer. ( Xagena )
Source: American Society of Clinical Oncology ( ASCO ) Virtual Meeting, 2020