The combination of ipilimumab and nivolumab is as effective in the real-world setting as it was in clinical trials for patients with metastatic melanoma, according to a recent study (Cancers. 2020;12[8]:E2329. doi:10.3390/cancers12082329).
“Immunotherapy has drastically changed the outlook for melanoma patients over the past decade. Specifically, the dual blockade of immune checkpoints using ipilimumab and nivolumab has shown unprecedented response rates and survival outcomes,” explained Nethanel Asher, MD, Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Israel, and colleagues.
"This immense achievement, though, is at the cost of toxicity, with 60% of the patients experiencing high-grade adverse events,” they continued.
In this study, Dr Asher and colleagues aimed to report the efficacy and toxicity outcomes of ipilimumab and nivolumab in the real-world setting.
Data on metastatic melanoma patients treated with ipilimumab and nivolumab was retrieved using a single-center prospectively updated, medical-records based oncologic registry. This data included demographics, clinical and pathological information, tumor responses, and survival.
A total of 172 patients treated for metastatic melanoma were identified. Of these patients, 64% were treatment naïve. The median follow-up was 12 months.
The response rates were 61% for treatment-naïve patients and 25% for those previously treated. Median progression-free survival (PFS) were 12.2 months and 2.6 months, respectively, and median overall survival (OS) were not-reached and 6.1 months, respectively. The estimated 3-year OS for treatment-naïve patients was 58% (95% CI 42–65).
At data cutoff, 22% were still on-treatment. Grade 3–4 adverse events (AEs) were reported in 60% of the patients, the majority of whom received steroid treatments (59%). Fatal AEs occurred in 4 patients and led to permanent treatment discontinuation in 31%.
Factors significantly associated with outcomes were cutaneous histology, low lactate dehydrogenase (LDH), low number of metastatic sites, performance status, first line of treatment and number of combinations administered during the induction phase.
“Despite the profoundly different baseline patient characteristics, the combination of ipilimumab and nivolumab is as effective in the real-world population as it was in clinical trials, including long-term outcomes,” Dr Asher and colleagues concluded.
“In addition to confirming the significance of baseline prognostic factors, our study reveals that the number of combinations effectively administered may also be correlated with good outcome,” they added.—Janelle Bradley
