Nivolumab (NIVO) plus ipilimumab (IPI) with two cycles of chemotherapy (chemo) in firstline metastatic non-small cell lung cancer (NSCLC): CheckMate 568 Part 2.
Abstract No : 9560
Abstract Type : Poster Session
Indication : Non-Small Cell Lung Cancer
Intervention : Nivolumab (NIVO) plus ipilimumab (IPI) with two cycles of chemotherapy (chemo)
Company : Bristol-Myers Squibb
Technology : Monoclonal antibody
In total, 36 pts received treatment; 97% of pts completed 2 cycles of chemo combined with NIVO + IPI. Three pts discontinued IPI while continuing NIVO. Minimum follow-up was 14.9 months. Only 1 (3%) pt experienced a DLT (transient, asymptomatic grade 3 AST and ALT elevation) within the first 9 weeks. The elevation occurred on cycle 1, day 21 and resolved 2 weeks later with discontinuation of IPI, delay of NIVO, and treatment with prednisone; chemo was continued throughout and NIVO was restarted thereafter without recurrent toxicity. Grade 3–4 TRAEs occurred in 21 (58%) pts. Eight (22%) pts experienced a TRAE leading to discontinuation, most commonly colitis,encephalopathy, pneumonitis, and arthralgia (each in 2 [6%] pts); these events occurred outside of the 9-week window for DLT assessment. The most common select TRAEs (defined as AEs of potential immunologic causes) were skin related (18 [50%] pts); the most common grade 3–4 select TRAEs were endocrine (3 [8%] pts), skin related, gastrointestinal, and pulmonary (each in 2 [6%] pts). No treatment-related deaths occurred. Updated safety in addition to efficacy data will be presented.
In pts with untreated advanced NSCLC, the addition of 2 cycles of platinum-doublet chemo to NIVO + tumor-optimized IPI was tolerable. No unexpected safety signals were observed.
In CheckMate 568 Part 2, the addition of 2 cycles of platinum-doublet chemo to NIVO + tumor-optimized IPI was tolerable and this combo showed encouraging clinical activity with a disease control rate of 89% and median OS was 19.4 months