ESMO: Nivolumab combined with chemotherapy and neoadjuvant therapy reduces the risk of EFS by 43% in patients with resectable non-small cell lung cancer (Checkmate-816 study)

The ultimate goal of treatment for early stage cancer is to prevent disease recurrence while working to find a cure for the patient
.

Unfortunately, even with surgery, more than half of patients with resectable non-small cell lung cancer ( NSCLC ) experience disease recurrence and death

The ultimate goal of treatment for early stage cancer is to prevent disease recurrence while working to find a cure for the patient

Results for the event-free survival (EFS) endpoint further disclosed at this year's ESMO

Checkmate-816 is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy of nivolumab in combination with chemotherapy in neoadjuvant therapy in patients with resectable non-small cell lung cancer compared with chemotherapy alone
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In the primary analysis, 358 patients were randomized preoperatively to receive nivolumab (360 mg) in combination with histology-based platinum doublet chemotherapy (every 3 weeks for up to 3 cycles), or platinum alone Double-drug chemotherapy (every 3 weeks for up to 3 cycles)

The CheckMate-816  phase III clinical study expands the enrolled population to a wider range of operable patients (stage IB-IIIA, of which 63% are stage IIIA; 50% PD-L1>1%), and in a larger group (n=358 ) to examine the benefit of nivolumab in combination with neoadjuvant chemotherapy in operable patients
.

The CheckMate-816 study found that preoperative use of nivolumab in combination with chemotherapy resulted in a statistically significant improvement in event-free survival (EFS) compared with chemotherapy alone, with a 37% reduction in the risk of disease progression, recurrence, or death.

 statistics

In the ITT population, the pCR of nivolumab combined with chemotherapy was 24% in the ITT population, and the pCR of chemotherapy was only 2.
2%, an approximately 10-fold improvement (OR=13.
94, 99%CI: 3.
49-55.
75; p<0.
0001 )
.

Moreover, the pCR rate and the depth of pathological response were significantly improved in patients regardless of disease stage

Median event-free survival (EFS) was 31.
6 months (95% CI: 30.
2-not reached) for patients in the nivolumab plus chemotherapy arm and 20.
8 months (95% CI: 14.
0-26.
7) for patients in the chemotherapy arm
.

In a prespecified interim analysis of overall survival, the HR was 0.

Based on the results of this study, on March 4, 2022, the FDA announced the approval of nivolumab in combination with platinum-based doublet chemotherapy for the neoadjuvant treatment of adult patients with resectable NSCLC

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