Bristol Myers Squibb (BMS) has received the European Commission (EC) approval for its perioperative regimen comprising neoadjuvant Opdivo (nivolumab) plus chemotherapy, followed by surgery and adjuvant Opdivo.
The treatment is designed for adults with resectable non-small cell lung cancer (NSCLC) exhibiting PD-L1 expression of 1% or more, addressing the high risk of recurrence.
The EC approval is based on the CheckMate -77T study, which compared the Opdivo regimen with a neoadjuvant platinum-doublet chemotherapy and placebo.
The trial met its primary endpoint of event-free survival (EFS), reducing the risk of disease recurrence, progression, or death by 42% in the Opdivo arm, after 25.4 months of follow-up.
EFS was observed in 65% of patients in the Opdivo arm after 24 months, compared to 44% in the chemotherapy and placebo arm.
The study also showed significant improvements in secondary efficacy endpoints, including pathologic complete response (pCR) and major pathologic response (MPR).
The regimen was effective in all efficacy endpoints and participants, with a safety profile that was consistent with previous NSCLC studies, and no new safety signals were reported.
Initial results from the CheckMate -77T trial were presented at the European Society of Medical Oncology (ESMO) 2023 and published in The New England Journal of Medicine.
Updated findings were shared at the ESMO Congress 2024. The trial is ongoing to evaluate overall survival (OS) as a key secondary endpoint.
The EC’s approval is applicable across all 27 member states of the European Union (EU), along with Iceland, Liechtenstein, and Norway.
Opdivo-based treatments are also approved for various tumour types in the EU.
In October 2024, the US Food and Drug Administration (FDA) approved Opdivo for treating adults with NSCLC without known EGFR mutations or ALK rearrangements, based on the CheckMate -77T trial.
Bristol Myers Squibb vice president and Opdivo global program lead Dana Walker 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.”
