Melanoma real world outcomes with checkpoint inhibitors are similar to RCTs

Skin cancers

By Michael Woodhead

27 Feb 2020

Dr Philippa Corrie

Real world patient outcomes with immune checkpoint inhibitors in metastatic melanoma match the survival outcomes and toxicities seen in randomised controlled trials, UK experience shows.

The findings come from a review of NHS cancer databases for more than 2300  patients with melanoma treated with pembrolizumab, ipilimumab, nivolumab, and combinations of ipilimumab and nivolumab between 2014 and 2018, following their approval for first line treatment of melanoma in the UK.

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

Patients selection varied between agents, with those treated with ipilimumab plus nivolumab being significantly younger (88% vs. 49% <70 years) and fitter (60% vs. 38% ECOG performance score 0) than patients treated with anti-PD1 therapy.

Serious adverse events were dominated by colitis, as measured by emergency hospitalisation rates due to colitis with ipilimumab or ipilimumab + nivolumab treatment.

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 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%). I

The study authors noted that uptake of checkpoint inhibitor therapy had been rapid following their approval for melanoma treatment. According to the National Cancer Registration and Analysis Services datasets for 5465 patients registered with melanoma, 2322 patients received first-line treatment with the immune checkpoint inhibitors pembrolizumab (1174), ipilimumab, (724 ) nivolumab (52), and combination of ipilimumab and nivolumab (372) .

“This largest real world dataset demonstrated rapid uptake of checkpoint inhibitors and survival outcomes similar to RCTs,” concluded the study authors led by Dr Philippa Corrie of the Cambridge University Hospitals NHS Foundation Trust, UK.

“Patient selection appeared to differ for different regimens, the consequences of which warrant further research,” they added.

The results were presented by  at the  ASCO-SITC 2020 Clinical Immuno-Oncology Symposium held from 6 to 8 February in Orlando.

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