31May

Wthin a space of 11 days, Opdivo-Yervoy with chemo bagged another approval in first line NSCLC irrespective of PD-L1 expression

Nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of platinum-doublet chemotherapy (chemo) vs 4 cycles chemo as first-line (1L) treatment (tx) for stage IV/recurrent non-small cell lung cancer (NSCLC): CheckMate 9LA.


Abstract No : 9501

Abstract Type : Oral Abstract Session

Indication : Non-Small Cell Lung Cancer

Intervention : Nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of platinum-doublet chemotherapy (chemo) vs 4 cycles chemo

Company : Bristol-Myers Squibb and Ono Pharmaceutical

Technology : Monoclonal antibody


Results:

Baseline characteristics were balanced across arms. At a preplanned interim analysis (minimum follow-up 8.1 mo), OS was significantly prolonged with NIVO + IPI + chemo vs chemo (HR 0.69, 96.71% CI: 0.55–0.87; P =0.0006); statistically significant improvements in PFS and ORR were seen. With longer follow-up (minimum 12.7 mo), NIVO + IPI + chemo vs chemo continued to provide longer OS; median 15.6 vs 10.9 mo (HR 0.66, 95% CI: 0.55–0.80); 1-y OS rates were 63 vs 47%. Clinical benefit was consistent across all efficacy measures in key subgroups including by PD-L1 and histology. Grade 3–4 tx-related adverse events were reported in 47 vs 38% of pts in the NIVO + IPI + chemo vs chemo arms, respectively.


Conclusion:

CheckMate 9LA met its primary endpoint: a statistically significant improvement in OS was observed with NIVO + NSCLC-optimized IPI + a limited course of chemo vs chemo (4 cycles) in 1L advanced NSCLC. No new safety signals were reported.


Commentary:

Opdivo-Yervoy combo also approved along with chemo to deliver the expected fast initial response and durable longer term benefit to patients although chemo will also pose expected harmful side effects to the patiens as well.


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