Nivolumab plus ipilimumab with chemotherapy shows improved overall survival vs. chemotherapy alone in first-line metastatic nonsmall cell lung cancer in a phase 3 trial

• Nivolumab plus ipilimumab, combined with two cycles of chemotherapy, reduced the risk of death by 34% compared to chemotherapy alone, at a minimum of 12.7 month follow up1 • The investigational combination of the dual immunotherapy and chemotherapy combination demonstrated a median progression-free survival (PFS) of 6.74 months vs. 4.96 months for chemotherapy alone1 • Lung cancer is the most common cause of cancer death in the UK and accounts for 21% of all cancer deaths.2 

(Uxbridge, Middlesex, 14 May 2020) Bristol Myers Squibb has announced results from the Phase 3 CheckMate -9LA trial, which demonstrated a statistically significant overall survival benefit with nivolumab plus ipilimumab, given simultaneously with two cycles of chemotherapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK mutations. The study met both its primary and key secondary endpoints, demonstrating superior overall survival (OS), progression-free survival (PFS) and objective response rate (ORR).1 These results (Abstract #9501) will be featured in an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting 2020, held virtually, from May 29-31.  

At a minimal follow up of 12.7 months, nivolumab plus ipilimumab combined with two cycles of chemotherapy (n=361) reduced the risk of death by 34%, and show sustained OS improvement versus chemotherapy alone (n=358) (median OS of 15.6 months versus 10.9 months, respectively [HR 0.66, 95% CI: 0.55–0.80]). This benefit was observed across sub-populations including PD-L1 expression and tumour histology (squamous and non-squamous). Finally, the dual immunotherapy and chemotherapy combination demonstrated a median PFS of 6.74 months vs. 4.96 months for chemotherapy alone (HR 0.68, 95% CI: 0.57 to 0.82) and an ORR of 38% compared to 25% with chemotherapy alone.1 

The CheckMate -9LA trial showed seven (2%) drug toxicity-related deaths for the dual immunotherapy plus chemotherapy vs six (1.6%) with chemotherapy alone. Grade 3-4 drug related AEs for all treated patients, at a minimal follow up of 12.7 months, were seen in 168 people (46.9%) on dual immunotherapy plus chemotherapy and 132 people (37.8%) on chemotherapy alone.1 The most commonly occurring grade 3-4 immune-related AEs for the dual immunotherapy combination plus chemotherapy versus chemotherapy alone, included endocrine (2.8% vs. N/A), gastrointestinal (5.6% vs. 0.6%), hepatic (4.5% vs. 0.9%) and skin reaction (4.5% vs. 0.3%), adverse events respectively.1 

Lung cancer is the most common cause of cancer death in the UK and accounts for 21% of all cancer deaths.2 NSCLC accounts for nearly 90% of all lung cancer cases.3 There are around 47,200 new lung cancer cases diagnosed in the UK every year and around three-quarters of lung cancer cases are diagnosed at a late stage (where the cancer has spread to other parts of the body) in England.2  

“Our findings show that nivolumab and ipilimumab – the first dual immunotherapy combination tested in combination with chemotherapy in this setting –makes a significant difference in slowing the progression of this lung cancer compared to chemotherapy alone.’ said Faisal Mehmud, UK Country Medical Director, Bristol Myers Squibb. “Striving for improved survival in this patient group is a key priority for Bristol Myers Squibb, as there remains a high unmet need for patients in UK and Ireland”