NADIM II: OS benefit of neoadjuvant nivolumab plus chemotherapy in NSCLC

Neoadjuvant nivolumab plus chemotherapy was superior to chemotherapy alone in patients with resectable stage IIIA–IIIB non-small cell lung cancer (NSCLC) in terms of progression-free survival (PFS) and overall survival (OS). The phase 2 NADIM II trial is therefore the first clinical trial to demonstrate an OS benefit of nivolumab plus chemotherapy over chemotherapy alone in this population [1].

The NADIM II trial (NCT03838159) randomised 90 patients with resectable stage IIIA–IIIB NSCLC 2:1 to neoadjuvant nivolumab plus chemotherapy or chemotherapy alone. The primary analysis showed a benefit of the experimental treatment over chemotherapy alone with regard to pathologic complete response rates (pCR; 36.8% vs 6.9%; 95% CI 1.70–36.51; P=0.0068) [2]. At WCLC 2022, Dr Mariano Provencio (Hospital Universitario Puerta de Hierro-Majadahonda, Spain) presented the PFS and OS results of this trial after a median follow-up of 26.1 months.

The PFS data favoured the combination therapy arm over the monotherapy arm (median PFS not reached vs 18.3 months; HR 0.48; P=0.025), with corresponding PFS rates of 66.6% vs 42.3%. Similarly, patients who received nivolumab plus chemotherapy had an OS benefit over patients who only received chemotherapy (OS rates 84.7% vs 63.4%; HR 0.40; P=0.034). According to Dr Provencio, these results confirm the superiority of neoadjuvant nivolumab plus chemotherapy over chemotherapy alone in patients with resectable stage IIIA–IIIB NSCLC.

1. Provencio M, et al. Progression free survival and overall survival in NADIM II study. PL03.12, WCLC 2022, Vienna, Austria, 06–09 August.
2. Provencio M, et al. Abstract 8501, 2022 ASCO Annual Meeting, Chicago, IL, USA, 03–07 June.

 

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Posted on 23 August, 202223 August, 2022