Abstract No : 4040
Indication : MSI-H/dMMR CRC
Intervention : Nivolumab (NIVO) + low-dose ipilimumab (IPI)
Company : Bristol-Myers Squibb
Technology : Monoclonal antibodies
In 45 pts with median follow-up of 29.0 mo, ORR (95% CI) increased to 69% (53–82) (Table) from 60% (44.3–74.3); complete response (CR) rate increased to 13% from 7%. The concordance rate of INV and blinded independent central review was 89%. Median duration of response (DOR) was not reached (Table). Median progression-free survival (PFS) and overall survival (OS) were not reached, and 24-mo rates were 74% and 79%, respectively (Table). Nineteen pts discontinued study treatment without subsequent therapy. An analysis of tumor response post discontinuation will be presented. Ten (22%) pts had grade 3–4 treatment-related adverse events (TRAEs); 3 (7%) had grade 3–4 TRAEs leading to discontinuation.
NIVO + low-dose IPI continued to show robust, durable clinical benefit with a deepening of response, and was well tolerated with no new safety signals identified with longer follow-up. NIVO + low-dose IPI may represent a new 1L therapy option for pts with MSI-H/dMMR mCRC.
Nivolumab + low-dose Ipilimumab continues to show robust, durable clinical benefit with longer duration of response. Among treatment free patients, the majority remained progression free during the treatment free interval. Nivolumab + low-dose Ipilimumab may represent a new 1L therapy option for patients with MSI-H/dMMR mCRC.