Results from the phase 3 CheckMate-816 trial have shown that Bristol Myers Squibb’s (BMS) PD-1 checkpoint inhibitor Opdivo (nivolumab) plus chemotherapy improved event-free survival in patients with resectable non-small cell lung cancer (NSCLC).
CheckMate-816 compared Opdivo plus chemotherapy to chemotherapy alone in 358 patients prior to surgery, measuring both pathologic complete response (pCR) and event-free survival (EFS). BMS has previously announced that the combination showed a significant improvement of pCR.
“While the intent of surgery is curative in resectable non-small cell lung cancer, between 30% to 55% of patients experience recurrence after surgery and ultimately succumb to the disease, presenting a strong need for additional options that can disrupt this cycle,” said professor of respiratory medicine at Paris Saclay University, Dr Nicolas Girard.
“The positive event-free survival data seen with neoadjuvant nivolumab plus chemotherapy is groundbreaking and can have important implications for how we treat resectable non-small cell lung cancer,” he added.
This data on neoadjuvant (pre-surgical) use of Opdivo in NSCLC adds to efficacy data in three other early-stage cancers: bladder and oesophageal/gastroesophageal junction cancers and melanoma.
“The event-free survival data from CheckMate-816 strengthen the evidence for the potential of Opdivo-based therapies to improve long-term clinical outcomes when used in the earlier stages of non-metastatic cancers,” said Dr Abderrahim Oukessou, thoracic cancers development lead at BMS.
Opdivo is already a major blockbuster for BMS, with sales of more than $5.5bn in the first nine months of 2021 from more than 20 oncology indications.
The scientific rationale for using immunotherapy in the neoadjuvant setting is twofold, said BMS; the presence of a tumour during immunotherapy treatment may enable a stronger immune response, potentially making the treatment more effective against a primary tumour, and offer an opportunity to target ‘covert micro-metastasis’.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that harnesses the body’s immune system to fight tumours. It was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world – in the US in July 2014 – and is currently approved in more than 65 countries.