Dr Mitzman on the Emergence of Immunotherapy in Early-Stage NSCLC

Brian Mitzman, MD, FACS, FCCP, assistant professor, Division of Cardiothoracic Surgery, the University of Utah Huntsman Cancer Institute, discusses the emergence of immunotherapy as a treatment option for patients with early-stage non–small cell lung cancer (NSCLC).

Until recently, the standard of care for patients with stage II or early stage III NSCLC involved resection followed by chemotherapy. However, data from recent clinical trials evaluating immunotherapy in this patient population have paved the way for novel treatment options for patients with early-stage NSCLC, Mitzman says.

In May 2022, the FDA approved nivolumab (Opdivo) plus platinum-doublet chemotherapy in the neoadjuvant setting for adult patients with resectable NSCLC, based on data from the phase 3 CheckMate 816 trial (NCT02998528) trial. Findings showed that nivolumab plus chemotherapy elicited a median event-free survival of 31.6 months (95% CI, 30.2–not reached [NR]) vs 20.8 months (95% CI, 14.0-26.7) with chemotherapy alone (HR, 0.63; 95% CI, 0.45-0.87; P = .0052).

Data from the phase 3 IMpower010 study (NCT02486718) supported the FDA approval in October 2021 of atezolizumab (Tecentriq) for use as an adjuvant treatment following resection and platinum-based chemotherapyin patients with stage II to IIIA NSCLC whose tumors have PD-L1 expression on 1% or more of tumor cells. Results from this study demonstrated that the median disease-free survival (DFS) was NR (95% CI, 36.1–not evaluable [NE]) in patients with stage IB through stage IIIA NSCLC in the atezolizumab arm vs 35.3 months (95% CI: 29.0–NE) for those in best supportive care arm (HR, 0.66; 95% CI, 0.50-0.88; P = .004).

Finally, in January 2023, the FDA approved pembrolizumab (Keytruda) as an adjuvant treatment following resection and platinum-based chemotherapy for patients with stage IB (T2a ≥4 cm), II, or IIIA NSCLC, based on data from the phase 3 KEYNOTE-091 trial (NCT02504372). Findings from this study showed that patients in the pembrolizumab arm experienced a median DFS of 58.7 months (95% CI, 39.2-NR) compared with 34.9 months (95% CI, 28.6-NR) for those in the placebo arm (HR, 0.73; 95% CI, 0.60-0.89).

Within his clinical practice, the approval of neoadjuvant nivolumab plus chemotherapy has had the most impact, Mitzman concludes.