Largest Real World Dataset of Immune Checkpoint Inhibitors in Melanoma Treatment Demonstrates Similar Outcomes to Randomised Clinical Trials

Rapid treatment uptake and similar outcomes in patients with metastatic melanoma.
25 Feb 2020
Cancer Immunology and Immunotherapy;  Melanoma and other skin tumours

Findings from a largest real world dataset in metastatic melanoma setting demonstrate rapid uptake of immune checkpoint inhibitors and patient outcomes similar to those achieved in randomised clinical trials. Use of emergency services varied by regimen, with colitis dominating hospitalisation after treatment with ipilimumab or ipilimumab plus nivolumab treatment. The results were presented by Dr Philippa Corrie of the Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK at 2020 ASCO-SITC Clinical Immuno-Oncology Symposium held from 6 to 8 February in Orlando, FL, US.  

Population-based research provides real world information about prescribing trends, as well as benefits and harms associated with new interventions first evaluated in randomised clinical trials. The national health service in England has comprehensive databases that the study team used to track prescribing of immune checkpoint inhibitors approved for use in first-line treatment for metastatic melanoma and determine patient outcomes associated with survival and treatment toxicity. 

The National Cancer Registration and Analysis Services datasets were used to identify metastatic melanoma patients prescribed first-line immune checkpoint inhibitors and to calculate survival outcomes. The Hospital Episode Statistics database was used to identify emergency attendances and emergency hospital admissions. 

From April 2014 to March 2018, in total 5465 patients with melanoma were registered and 2322 patients received first-line treatment with immune checkpoint inhibitors, of those 1174 pembrolizumab, 724 ipilimumab, 52 nivolumab, and 372 combination of ipilimumab and nivolumab.  

Prescribing reflected national access, with ipilimumab starting in July 2014 and dropping rapidly on approval of pemrolizumab in November 2015. Ipilimumab plus nivolumab prescriptions increased annually since July 2016.  

There was good 3-year overall survival concordance with outcomes from randomised clinical trials for ipilimumab plus nivolumab (56%), nivolumab (51%), pembrolizumab (40%) and ipilimumab (32%).  

Patients treated with ipilimumab plus nivolumab were significantly younger (88% vs. 49% <70 years, p < 0.001) and fitter (60% vs. 38% ECOG performance score 0, p < 0.0001) than patients treated with anti-PD1 therapy.  

A 30-day mortality from last systemic anticancer therapy was 3.8% for ipilimumab plus nivolumab, 9.1% for anti-PD1 treatment and 9.4% for ipilimumab.  

The 30-day rates of emergency hospital admissions/adverse events emergency attendances from the earliest systemic anticancer therapy and last systemic anticancer treatment dates were significantly higher for ipilimumab plus nivolumab (37%/16% and 55%/19%) compared with anti-PD1 treatment (17%/8% and 29%/14%) and ipilimumab (24%/9% and 40%/15%), p < 0.01. In total, 25% of ipilimumab plus nivolumab-treated, 4% of anti-PD1-treated and 15% of ipilimumab-treated patients had a hospital admission for colitis. 

The authors concluded that real world data demonstrate similar patient outcomes to those from randomised clinical trials. Hospitalisation due to colitis after ipilimumab or ipilimumab plus nivolumab treatment was dominating among adverse events emergency. Patient selection differ for different regimens and the consequences warrant further research. 

 

Reference  

Corrie PG, Chao D, Board R, et al. Metastatic melanoma patient outcomes since introduction of immune checkpoint inhibitors in England between 2014 and 2018. J Clin Oncol 2020; 38:(suppl 5; abstr 55).   

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