Bristol Myers Squibb (BMS) has announced that its PD-1 immune checkpoint inhibitor Opdivo (nivolumab) has been approved by the European Commission (EC) as part of a perioperative treatment regimen for a subset of adult lung cancer patients.
The drug has been authorised for use alongside chemotherapy as a neoadjuvant treatment before surgery and as an adjuvant monotherapy after surgery.
Patients eligible for the regimen will have resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and have tumours with PD-L1 expression of at least 1%.
The EC’s decision was supported by results from the late-stage CheckMate-77T trial, in which the risk of disease recurrence, progression or death was reduced by 42% in patients treated with the Opdivo regimen compared to those randomised to receive neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo after a median follow-up of 25.4 months.
Additionally, after two years, event-free survival was seen in 65% of Opdivo-treated patients versus 44% of patients in the chemotherapy and placebo cohort, and BMS’ drug was associated with clinically meaningful improvements in pathologic complete response and major pathologic response.
Lung cancer is the leading cause of cancer deaths worldwide, with NSCLC accounting for up to 84% of all cases. The majority of NSCLC patients are diagnosed with non-metastatic disease and, while many are cured by surgery, up to 55% of these patients develop recurrence and die of their disease despite resection.
Opdivo is designed to use the body’s own immune system to help restore anti-tumour immune response and is already approved in the EU for certain NSCLC indications, as well as tumour types including melanoma, renal cell carcinoma, urothelial cancer and hepatocellular carcinoma.
Dana Walker, vice president, Opdivo global programme lead, BMS, said: “This approval brings another perioperative immunotherapy treatment option for select patients with resectable NSCLC in the EU, helping address an ongoing need for interventions that can meaningfully reduce the risk of cancer returning after initial therapy.
“With this approval, Opdivo with chemotherapy followed by adjuvant Opdivo has the potential to change the course of certain patients’ disease by significantly reducing the risk of cancer recurrence and improving long-term outcomes earlier in the treatment journey.”