Bristol-Myers Squibb has announced updated results from the CheckMate -012 study, a multi-arm, Phase Ib trial evaluating nivolumab alone or in combination with other therapies, in patients with previously-untreated advanced non-small cell lung cancer (NSCLC). Results from a pooled analysis of two nivolumab and ipilimumab combination regimen cohorts showed that patients demonstrated a greater response to treatment with the combination regimen when expressing high levels of the protein PD-L1.* In the study (n=77), the objective response rate (ORR) in patients with ≥1% PD-L1 expression was 57%. For those patients that expressed ≥50% PD-L1, the confirmed ORR was 92% (n=12/13). ORR indicates significant reduction in a patient’s tumours. The ORR in the overall population was 47% (95% CI, 31-64) and 39% (95% CI, 23-55) for the Q12W and Q6W, respectively, regardless of PD-L1 expression level.
In the -012 study, the rate of treatment related Grade 3/4 adverse events (AEs) for the combination regimen of nivolumab and ipilimumab was 33% and 37%, when given every six or 12 weeks respectively. The rate of treatment-related Grade 3/4 AEs which led to discontinuation was 8% and 5% (six and 12 weeks respectively). When nivolumab was administered as monotherapy, 19% of patients experienced Grade 3/4 AEs with 10% of patients discontinuing treatment. There were no treatment-related deaths. These data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting during an oral presentation (Abstract #3001). Commenting on the data, Professor Jeff Evans, Director of Institute of Cancer Sciences and Professor of Translational Cancer Research at the University of Glasgow, said, “Harnessing the immune system to tackle cancers is one of the most exciting areas in cancer research right now. Studies of this combination of nivolumab and ipilimumab report very encouraging results in lung cancer. This combination has been shown to be effective in shrinking tumours with manageable side-effects. Further trials will determine how we can best use these medicines in patients with lung cancer in the future.”
Lung cancer continues to be a growing health burden in the UK. In 2012, almost 44,500 people in the UK were diagnosed (all forms of lung cancer)1 With UK survival rates lagging behind those of some other European countries and around 80% of those diagnosed with advanced disease dying within one year,2, 3 the outlook for these patients is poor. Over 35,000 deaths were attributable to the disease in 2012,i more than those from breast and bowel cancer deaths combined.4, 5
“While early stage, these data are very encouraging and demonstrate real potential for combining nivolumab and ipilimumab in lung cancer patients,” said Dr Sue Bailey, Disease Area Head, Oncology, Bristol-Myers Squibb UK and Ireland. “Bristol-Myers Squibb is pioneering the area of immunotherapy and we are wholeheartedly committed to progressing this research with the aim of improving survival for more cancer patients in the future.” In lung cancer, the combination of nivolumab and ipilimumab remains investigational and is not licensed for use. As a single therapy, nivolumab is currently licensed to treat patients with locally advanced or metastatic NSCLC whose disease has progressed after prior chemotherapy. However, access for NHS patients in the UK remains uncertain while regulatory authorities continue their assessments.
“These data further support the real potential for immunotherapy to increase survival in patients with advanced lung cancer. However, in the UK, NHS access to nivolumab in both types of pre-treated non-small cell lung cancers remain uncertain, despite months of negotiations with NICE and the Department of Health. We are continuing to work with all parties to make nivolumab available to lung cancer patients as quickly as possible,” comments Johanna Mercier, General Manager, Bristol-Myers Squibb UK & Ireland.