31May

CheckMate 568 Part 2 data will further support the approval of nivolumab plus ipilimumab with two cycles of chemotherapy combo in firstline NSCLC setting

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


Results:

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.


Conclusion:

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.


Commentary:

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


Refer to Non Small Cell Lung Cancer Market report for detailed Insights.