- PMLiVE
Bristol Myers Squibb (BMS) has announced that its Opdivo (nivolumab) perioperative treatment regimen has been recommended by the European Medicines Agency’s human medicines committee for adults with non-small cell lung cancer (NSCLC).
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be authorised for use alongside platinum-based chemotherapy as a neoadjuvant treatment before surgical resection and as an adjuvant monotherapy after surgery.
Patients eligible for the regimen would have resectable NSCLC at high risk of recurrence with tumour cell PD-L1 expression of at least 1%, according to the committee’s positive opinion.
Lung cancer is the leading cause of cancer-related deaths globally and NSCLC accounts for up to 84% of all cases. Despite many non-metastatic NSCLC patients being cured by surgery, 30% to 55% will develop recurrence and die of their disease despite resection.
Opdivo is a PD-1 immune checkpoint inhibitor designed to use the body’s own immune system to help restore anti-tumour immune response.
The drug is already approved in the EU for a range of indications, including in combination with platinum-based chemotherapy for adults with resectable NSCLC in the neoadjuvant setting.
The CHMP’s latest decision was supported by positive results from the phase 3 CheckMate-77T trial, in which the Opdivo perioperative regimen was shown to improve event-free survival compared to chemotherapy plus placebo.
BMS’ regimen also demonstrated clinically meaningful improvements in the secondary efficacy endpoints of pathologic complete response and major pathologic response, and its safety profile was consistent with previously reported studies in NSCLC.
Dana Walker, vice president, Opdivo global programme lead, BMS, said: “Preventing disease recurrence and improving long-term outcomes for patients with NSCLC earlier in the treatment journey is critical to addressing unmet needs and is one of our top priorities.
“With [this] positive opinion from the CHMP, we are pleased that our second Opdivo-based regimen for certain patients with resectable NSCLC whose tumours have PD-L1 expression [of at least] 1%, is one step closer to being approved in the EU.”
The European Commission will now review the CHMP’s recommendation as it makes a final decision on Opdivo in this indication, expected within approximately two months.