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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

ASCO: Nivolumab + ipilimumab versus platinum-doublet chemotherapy

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

Note: The therapeutics segment is experiencing significant NSCLC clinical trial activity, which is further expected to drive Non-Small Cell Lung Caner market growth in the coming years.

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

Executive Summary

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

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