31May

Finally Opdivo in combination with Yervoy has got success in much awaited lucrative first line NSCLC patients whose tumors express PD-L1≥1% and approval is further supported by long term data

Nivolumab + ipilimumab versus platinum-doublet chemotherapy as first-line treatment for advanced non-small cell lung cancer: Three-year update from CheckMate 227 Part 1.


Abstract No : 9500

Abstract Type : Oral Abstract Session

Indication : Non-Small Cell Lung Cancer

Intervention : Nivolumab + ipilimumab versus platinum-doublet chemotherapy

Company : Bristol-Myers Squibb and Ono Pharmaceutical

Technology : Monoclonal antibody


Results:

After a median follow-up of 43.1 mo (database lock, 28Feb 2020), pts with PD-L1 $ 1% continued to derive OS benefit from NIVO + IPI vs chemo (HR: 0.79; 95% CI, 0.67–0.93); 3-y OS rates were 33% (NIVO + IPI), 29% (NIVO), and 22% (chemo). At 3 y, 18% of pts with PD-L1 $ 1% treated with NIVO + IPI remained progression-free vs 12% with NIVO and 4% with chemo; 38% of confirmed responders remained in response in the NIVO + IPI arm at 3 y vs 32% in the NIVO arm and 4% in the chemo arm. In pts with PD-L1 , 1%, OS HR for NIVO + IPI vs chemo was 0.64 (95% CI, 0.51–0.81); 3-y OS rates were 34% (NIVO + IPI), 20% (NIVO + chemo), and 15% (chemo); 13%, 8%, and 2% of pts remained progression-free; and 34%, 15%, and 0% of confirmed responders remained in response, respectively. Pts with PD-L1 $ 1% with either CR/PR at 6 mo had longer subsequent OS with NIVO + IPI vs chemo; pts with SD or PD at 6 mo had generally similar subsequent OS between treatments (Table); results in PD-L1 , 1% pts will be presented. Any-grade /grade 3–4 treatment-related AEs were observed in 77% / 33% of all pts treated with NIVO + IPI, and 82%/36% with chemo.


Conclusion:

With 3 y minimum follow-up, NIVO + IPI continued to provide durable and long-term OS benefits vs chemo for pts in 1L aNSCLC. Pts with PD-L1 ≥ 1% who achieved CR/PR at 6 mo had marked OS benefit with NIVO + IPI vs chemo. No new safety signals were identified for NIVO + IPI.


Commentary:

Over one third of patients are still alive at 3 years on Opdivo plus Yervoy combo compared to 22% for chemotherapy alone. However, entry of this combo in first line setting will not be a simlple cake walk as duo could cut the risk of death among PD-L1 positive patients by just 21% compared to around 51% by Keytruda


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