Neoadjuvant Nivolumab Plus Platinum-Doublet Chemotherapy Is Now Approved for Resectable NSCLC

The FDA has approved neoadjuvant nivolumab (Opdivo) plus chemotherapy to treat patients with resectable non–small cell lung cancer (NSCLC). Notably, this combination now represents the first available neoadjuvant immunotherapy combination option for this patient population, according to a news release.¹

The approval is supported by findings from the CheckMate 816 trial (NCT02998528), which showed that the combination elicited a significantly improved survival outcomes in patient with resectable NSCLC. Patients who received this combination experienced a 37% reduction in the risk of progression, recurrence, or death (HR 0.63; 95% CI, 0.45-0.87; P = .0052) compared with those who received chemotherapy alone.

Furthermore, patients in the nivolumab/chemotherapy cohort also reached a median event-free survival (EFS) of 3.6 months (95% CI, 30.2-not reached) compared with 20.7 months (95% CI, 14.0-26.7) in the control group.

In addition, at the 2021 AACR Annual Meeting, data were presented that demonstrated a significantly improved pathological complete response rate with the combination compared with those who received chemotherapy alone (24% vs 2.2%, respectively).² The combination was not associated with an increase in overall toxicity or surgery delays.

Moreover, surgical outcomes revealed that the definitive surgery rates were 83% with nivolumab plus chemotherapy compared with 75% with chemotherapy alone, according to findings presented at the 2022 ASCO Annual Meeting.³ Reasons for surgery cancellation included disease progression, adverse events (AEs), as well as patient refusal, unrespectability, and poor lung function.

“Given the rates of disease recurrence in patients with resectable NSCLC, additional treatment options are needed that can be given before surgery to help improve the chance of successful surgical treatment and support the goal of reducing the risk of cancer returning,” study investigator Mark Awad, MD, PhD, clinical director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said in a statement. “The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC, and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery. Today’s announcement reinforces the need to increase the rates of NSCLC screening and early detection, and for patients to discuss treatment options with their providers.”

The recommended dose is 360 mg of nivolumab along with platinum-doublet chemotherapy on the same day every 3 weeks for 3 cycles.⁴

The most frequently observed adverse events included nausea, constipation, fatigue, decreased appetite, and rash. Notably, the combination did not elicit more delays or cancellations of surgery; the median length of hospital stays following surgery were also found to be similar between both study arms.

References

1. U.S. Food and Drug Administration approves Opdivo (nivolumab) with chemotherapy as neoadjuvant treatment for certain adult patients with resectable non-small cell lung cancer. News release. Bristol Myers Squibb. March 4, 2022. Accessed March 7, 2022. https://bit.ly/3INrdQA
2. Neoadjuvant nivolumab plus chemotherapy increased pathological complete response rate in CheckMate-816 lung cancer trial. American Association for Cancer Research. April 10, 2021. Accessed February 28, 2022. https://bit.ly/3JTLwfw
3. Spicer J, Wang C, Tanaka F, 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). J Clin Oncol. 2021;39(supp 15; abstr 8503). doi:10.1200/JCO.2021.39.15_suppl.8503
4. FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer. FDA. News release. March 4, 2022. Accessed March 7, 2022. https://bit.ly/3Myicx2