The Study: We know inhibitors of the PD-1 axis improve outcomes among locally advanced and/or metastatic NSCLC, but can this novel approach be harnessed to enhance the curability of the only “curable” cases of NSCLC? We’re talking, of course, about early stage disease, which still confers a cancer-specific mortality of over one in four. The door has now been cracked with promising results from a pilot study of neoadjuvant nivolumab for resectable (Stage I-IIIA) NSCLC. Unlike durvalumab that was studied following definitive chemoradiation, the neoadjuvant timing makes sense here so that tumor antigens are still around en masse. Nivo (3 mg/kg) every 2 weeks x 2 was administered prior to surgery in 21 patients. A “major” path response was defined as < 10% of tumor cells viable at time of resection and was achieved in 9 (43%) patients, despite only two demonstrating any radiographic tumor shrinkage. And in keeping with its newest marketing strategy, the manuscript highlights that major path response was significantly associated with higher mean tumor mutational burden and not PD-L1 expression. Importantly, no surgery was delayed.
Bottom Line: It’s way too early in the game to call it, but Bristol-Myers Squibb is banking on these promising rates of pathologic response to neoadjuvant nivolumab eventually translating into bigger cure rates (read: market shares) among patients with early-stage NSCLC. | Ford, N Enlg J Med 2018