Nivolumab/Ipilimumab Associated With High Rates of Long-Term Survival in Melanoma

In the past decade, the 5-year survival rate for patients with metastatic melanoma has increased dramatically, from less than 5% with chemotherapy to 20% with ipilimumab monotherapy. More recently, the introduction of PD-1 and PD-L1 inhibitors into the care of patients with metastatic melanoma has further improved survival outcomes, particularly when used in combination with CTLA-4 inhibitors like ipilimumab. During the Presidential Session at the ESMO Congress 2019, James Larkin, FRCP, PhD (Royal Marsden NHS Foundation Trust, London, United Kingdom), presented long-term follow-up data from the phase III CheckMate-067 trial, which evaluated combination nivolumab and ipilimumab, nivolumab monotherapy, and ipilimumab monotherapy as first-line treatment for metastatic melanoma.  These results were simultaneously published in The New England Journal of Medicine.

The estimated 5-year overall survival (OS) was 52% for patients receiving the combination of nivolumab and ipilimumab and 44% for patients receiving nivolumab alone. This was compared to 26% in patients receiving ipilimumab monotherapy. Similarly, 5-year rates of progression-free survival (PFS) were improved in patients receiving nivolumab plus ipilimumab or nivolumab monotherapy compared to ipilimumab monotherapy (36% and 29% vs 8%). The objective response rate (ORR) was 58% for patients receiving the combination, 45% for patients receiving nivolumab monotherapy, and 19% for ipilimumab monotherapy. Importantly, patients treated with nivolumab and ipilimumab in combination who later discontinued treatment had much longer treatment-free intervals than patients receiving either agent alone (18.1 months vs 1.9 months and 1.8 months). The adverse event (AE) profile was consistent with previous reports from this study and no new safety signals were observed.

Dr Larkin concluded that the long-term survival benefit of combination nivolumab and ipilimumab, combined with the prolonged treatment-free interval for patients discontinuing therapy, provide strong evidence supporting the efficacy of this combination as a first-line treatment for patients with metastatic melanoma, in addition to providing additional evidence in support of this combination for other malignancies, including renal cell carcinoma.

Read more about this study on Medscape Medical News.

N Engl J Med. 2019 Sept 28. [Epub ahead of print.]

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