Neoadjuvant Nivolumab Plus Chemo Approved in Canada for Treatment of Resectable Non-Small Cell Lung Cancer

Nivolumab (Opdivo) plus platinum-doublet chemotherapy has been approved by Health Canada for the treatment of certain patients with resectable non–small cell lung cancer, according to Bristol Meyers Squibb.

The approval was based on results from the phase 3 CheckMate 816 trial (NCT02998528), in which neoadjuvant nivolumab plus chemotherapy resulted in a 37% reduction in risk of disease progression, recurrence, or death vs chemotherapy alone among patients with resectable NSCLC (HR, 0.63; 97.38%, 0.43-0.91; P = .005). The median event-free survival (EFS) with nivolumab/chemotherapy was 31.6 months vs 20.8 months with chemotherapy alone. Improvement in the rate of pathological complete response (pCR) also occurred in patients treated with nivolumab at 24% compared with 2.2% among those treatment with chemotherapy (OR, 13.94; 99% CI, 3.49-55.75; P <.001).

Moreover, EFS for patients without pCR was longer with nivolumab at 26.6 months vs 18.4 months with chemotherapy alone (HR, 0.84; 95% CI, 0.61-1.17). Of the patients treated with nivolumab, 76.1% were estimated to have survived without progression or recurrence at 1 year compared with 63.4% of patients treated with chemotherapy alone. After 2 years, the rates of survival were 63.8% and 45.3%, respectively.

Investigators also noted that the depth of pathological remission in the primary tumor was greater with nivolumab, regardless of baseline disease.

“The approval of nivolumab plus platinum-doublet chemotherapy in the neoadjuvant setting represents a pivotal transformation in the way we can help patients with resectable non–small cell lung cancer,” Jonathan D. Spicer, MD, PhD, associate professor of surgery in the Department of Surgery (Thoracic and Upper GI Surgery) at McGill University, said in an interview. “As thoracic surgeons, despite our best efforts to completely remove lung cancers, we see our patients experience recurrence of their disease all too often. My goal is to cure cancer and this new pre-operative treatment combination is now shown to prolong survival and increase the number of patients who have no signs of cancer in their tissues after surgery.”

In March 2022, the FDA approved neoadjuvant nivolumab plus chemotherapy for the treatment of certain patients with resectable NSCLC. Patients eligible for the treatment include those with either node positive disease or tumors of 4 cm or greater.

Reference

Health Canada approves Opdivo (nivolumab) with chemotherapy as neoadjuvant treatment for adult patients with resectable non-small cell lung cancer. News release. Bristol Myers Squibb. August 23, 2022. Accessed August 23, 2022. https://yhoo.it/3CqtNM9