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Neoadjuvant nivolumab plus chemotherapy improves surgical outcomes in NSCLC

Presented By
Dr Jonathan Spicer, McGill University, Canada
Conference
ASCO 2021
Trial
Phase 3, CheckMate 816
The results from CheckMate 816 showed that patients with resectable non-small cell lung cancer (NSCLC) who were treated with neoadjuvant nivolumab plus chemotherapy had improved pathologic complete response (pCR) rates and improved surgical outcomes.

The randomised, phase 3 CheckMate 816 trial (NCT02998528) evaluates the efficacy and safety of neoadjuvant therapy with nivolumab plus chemotherapy in patients with resectable NSCLC. Recently, results were presented of the first primary endpoint (pCR, defined as 0% viable tumour cells in lung and lymph nodes): median pCR was 24% in patients (n=179) treated with neoadjuvant nivolumab plus chemotherapy versus 2.2% in patients (n=179) treated with neoadjuvant chemotherapy (HR 13.94; 95% CI 3.49–55.75; P<0.0001) [1]. At the ASCO 2021 Annual Meeting, Dr Jonathan Spicer (McGill University, Canada) presented key surgical outcomes from the study [2].

Definitive surgery rates were 83% with nivolumab plus chemotherapy (n=149) versus 75% with chemotherapy alone (n=135). Reasons for cancelled surgery included disease progression (12 and 17 patients, respectively) and adverse events (2 patients in each arm). Adverse events were responsible for delays of surgery in 6 patients in the nivolumab plus chemotherapy arm and 9 patients in the chemotherapy arm. Minimally invasive surgery rates were 30% and 22%, and conversion from minimally invasive to open surgery rates were 11% and 16% for nivolumab plus chemotherapy and chemotherapy, respectively. Lobectomy was performed in 77% and 61% of patients, and pneumonectomy in 17% and 25% for nivolumab plus chemotherapy and chemotherapy, respectively.

A complete resection (R0) was achieved in 83% versus 78% of patients and median residual viable tumour (RVT) cells in the primary tumour bed were 10% versus 74% for nivolumab plus chemotherapy versus chemotherapy. There was no increase in median duration of surgery and length of hospitalisation between the two arms.


    1. Forde PM, et al. Abstract 5218, AACR Annual Meeting 2021, 9–14 April.

    2. Spicer J, et al. Surgical outcomes from the phase 3 CheckMate 816 trial: Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo alone as neoadjuvant treatment for patients with resectable non-small cell lung cancer (NSCLC). Abstract 8503, ASCO 2021 Virtual Meeting, 4–8 June.
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