Nivolumab Plus Chemo Approved as Neoadjuvant Therapy for Some Patients With Resectable NSCLC

Based on results of the phase 3 CheckMate-816 trial, the FDA granted approval to the combination of nivolumab plus platinum-doublet chemotherapy for the treatment of non–small cell lung cancer prior to surgery.

Nivolumab (Opdivo) in combination with platinum-doublet chemotherapy is now FDA approved for the treatment of certain patients with resectable non–small cell lung cancer (NSCLC) in the neoadjuvant setting, according to Bristol Myers Squibb.

Patients eligible for the therapy are those with either node positive disease or tumors of 4 cm or greater.

The approval was based on the results of the phase 3 CheckMate 816 study (NCT02998528), which demonstrated a statistically significant improvement in event-free survival (EFS) with nivolumab plus chemotherapy vs chemotherapy alone among patients with early NSCLC.

“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,” Mark Awad, MD, PhD, CheckMate-816 study investigator and 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.”

Combination therapy with nivolumab/chemotherapy resulted in a 37% reduction in the risk of progression, recurrence, or death vs the active comparator arm (HR, 0.63; 95% CI, 0.45-0.87; P = .0052), with respective medians of 31.6 months and 20.8 months. Pathological complete responses were achieved in 24% of patients treated with nivolumab (95% CI, 18.0%-31.0%) vs 2.2% with chemotherapy alone (95% CI, 0.6%-5.6%; P <.0001). Interim analysis for overall survival showed a hazard ratio of 0.57 (95% CI, 0.38-0.87), which had not crossed the boundary for statistical significance.

EFS data from the trial are planned for presentation at the upcoming 2022 American Association for Cancer Research Annual Meeting 2022 in April.

Reference

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 4, 2022. https://bit.ly/3INrdQA

Related Videos
An expert from Yale School of Medicine discusses how the approval of adjuvant pembrolizumab expands treatment to include patients with IB, II, III, and IIIA resected, early-stage, non–small cell lung cancer regardless of PD-L1 expression.
Alexander Spira, MD, PhD, FACP, of the Virginia Cancer Specialists, discusses how the FDA approval of adagrasib for KRAS G12C–mutated non–small cell lung cancer can provide benefit for this patient population.
Pooling data with other radiation trials, looking more closely at central non-small cell lung cancer, and exploring secondary outcomes represent the next steps in terms of analyzing stereotactic body radiation (SBRT) vs conventional hypofractionated radiotherapy (CRT), according to Anand Swaminath, MD.
Anand Swaminath, MD, reviews the design of the phase 3 LUSTRE trial comparing a 3-week conventional radiotherapy regimen with stereotactic body radiotherapy among patients with stage I medically inoperable non-small cell lung cancer.
Stereotactic body radiation therapy yielded numerical improvements in terms of local control compared with conventional hypofractionated radiotherapy among patients with stage I medically inoperable non-small cell lung cancer, according to findings from the phase 3 LUSTRE trial.
Data from the phase 3 LUSTRE trial indicated that stereotactic body radiotherapy is a safe and effective alternative to conventional radiation for use in patients with stage I medically-inoperable non-small lung cancer, according to an expert from Juravinski Cancer Centre in Canada.
Hossein Borghaei, DO, MS, discussed where investigators may drive future research following the phase 2 Lung-MAP trial examining pembrolizumab and ramucirumab in previously treated advanced non–small cell lung cancer.
Hossein Borghaei, DO, MS, highlights data that read out of the phase 2 Lung-MAP trial, assessing ramucirumab/pembrolizumab in previously treated advanced non–small cell lung cancer.
Related Content