BMS Reports Long-Term Survival Benefits of Opdivo (nivolumab) Plus Yervoy (ipilimumab) in First-Line Metastatic NSCLC from CheckMate-9LA and CheckMate-227 Trials

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Recently, Bristol-Myers Squibb (BMS) announced the 3-year follow-up results of the Phase 3 CheckMate-9LA trial for the first-line treatment of lung cancer with the Opdivo+Yervoy immunotherapy combination, as well as the 5-year follow-up results of Part 1 of the Phase 3 CheckMate-227 trial.

Three-year follow-up results from the Phase 3 CheckMate-9LA trial show that in previously untreated metastatic non-small cell lung cancer (mNSCLC) patients, the immunotherapy combination Opdivo + Yervoy with two cycles of chemotherapy demonstrated durable survival benefits compared to four cycles of chemotherapy. With a minimum follow-up of three years (36.1 months), the combination therapy group continued to show sustained improvement in overall survival (OS). Three years later, 27% of patients in the combination therapy group remained alive, versus 19% in the chemotherapy group (HR=0.74; 95% CI: 0.62-0.87).

Moreover, in patient populations typically associated with poor prognosis, a long-term durable clinical benefit was observed with combination therapy compared to chemotherapy after 3 years, including patients with PD-L1 expression <1% (3-year OS rate: 25% vs 15%) and those with squamous histology (3-year OS rate: 24% vs 11%). An exploratory analysis showed a positive trend in OS benefit with combination therapy in patients harboring certain tumor mutations (e.g., STK11).

Five-year follow-up results from Part 1 of the Phase 3 CheckMate-227 trial showed that, compared with chemotherapy, first-line treatment with Opdivo + Yervoy provided long-term, sustained survival benefits in previously untreated patients with mNSCLC, regardless of PD-L1 expression levels. This represents the longest follow-up time reported for immunotherapy in mNSCLC.

Minimum follow-up of 5 years (61.3 months):

In the patient population with tumor PD-L1 expression ≥1%, the 5-year survival rate was 24% in the Opdivo+Yervoy group and 14% in the chemotherapy group (HR=0.77; 95% CI: 0.66-0.91).

In the patient population with PD-L1 < 1%, the 5-year survival rate in the Opdivo + Yervoy group was nearly three times that of the chemotherapy group (19% vs 7%; HR = 0.65; 95% CI: 0.52-0.81).

In the patient population responding to treatment, more patients in the Opdivo+Yervoy group remained in remission after 5 years (treatment stopped over 3 years ago, with immunotherapy lasting up to 2 years as per protocol), including in the PD-L1≥1% patient group (28% vs 3%) and the PD-L1<1% patient group (21% vs 0%).

Approximately two-thirds (66%) of patients who received Opdivo+Yervoy treatment and survived after 5 years (66% with PD-L1 expression ≥1%, 64% with PD-L1 expression <1%) did not receive any subsequent treatment for more than 3 years after discontinuing therapy.

If left untreated, the prognosis of mNSCLC is very poor, with a 5-year survival rate of approximately 6%. As follow-up time extends, the immunotherapy regimen based on Opdivo + Yervoy has demonstrated impressive and durable clinical benefits, with data clearly confirming its clinical value in first-line mNSCLC.

Besides first-line mNSCLC, Bristol-Myers Squibb also announced post-hoc analysis data from the Phase 3 CheckMate-816 trial of Opdivo in combination with chemotherapy as neoadjuvant (pre-surgery) treatment for early-stage lung cancer. In the neoadjuvant (pre-surgery) treatment of early-stage cancer, there is debate across different tumor types regarding whether the absence of any signs of cancer in the surgically removed tumor tissue (pathological complete response, pCR) can serve as a good indicator that neoadjuvant therapy can prevent cancer recurrence or death (event-free survival, EFS).

Bristol-Myers Squibb's latest post-hoc analysis data supports the connection between the two in early-stage NSCLC treatment. In early-stage NSCLC patients who received Opdivo plus chemotherapy before surgery, those with no evidence of tumors in the surgically removed tissue had an 82% reduction in the risk of disease recurrence or death compared to patients with residual tumors at the time of surgery. Notably, consistent effects were observed across patients with Stage IB to Stage IIIA disease at baseline, regardless of tumor PD-L1 expression.

Reference Source:

1、Three-Year Data from Phase 3 CheckMate -9LA Trial Demonstrate Long-Term, Durable Survival Outcomes of Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Two Cycles of Chemotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

2、Landmark Five-Year Data from Phase 3 CheckMate -227 Trial Demonstrate Long-Term, Durable Survival Outcomes with Opdivo(nivolumab) Plus Yervoy (ipilimumab) in First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer

3、ASCO: Bristol Myers adds to debate with Opdivo's presurgery lung cancer performance