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Ipilimumab demonstrates long-term survival benefit in advanced melanoma
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Some patients with advanced melanoma treated with ipilimumab continued to derive a survival benefit at least 5 years after treatment, according to study results.
The results showed that, for certain patients, retreatment with ipilimumab (Yervoy, Bristol-Myers Squibb) can re-establish disease control while demonstrating a safety profile comparable to that observed during ipilimumab induction, researchers wrote.
The analysis included patients treated with ipilimumab in one of six phase 2 clinical trials. In those trials, ipilimumab was administered in doses of 0.3 mg/kg, 3 mg/kg or 10 mg/kg.
In the current companion study — conducted by Celeste Lebbé, MD, PhD, professor of dermatology at Hôpital Saint-Louis in Paris, and colleagues — patients underwent ipilimumab retreatment, extended maintenance therapy or follow-up for survival only.
Follow-up was 5.5 to 6 years.
Researchers reported 5-year OS rates of 12.3% for patients who received ipilimumab induction at 0.3 mg/kg; 12.3% to 16.5% for those who received induction at 3 mg/kg; and 15.5% to 28.4% for those who received induction at 10 mg/kg.
Among treatment-naive patients, 5-year OS rates were 26.8% for those who received ipilimumab induction at 3 mg/kg, and 21.4% to 49.5% among those who received induction at 10 mg/kg.
Results showed “little to no change in OS” between year five and year six, researchers wrote.
Lebbé and colleagues reported a 23% objective response rate among retreated patients.
In the retreated group, incidence of grade 3 or grade 4 immune-related adverse events was 25% among those who initially received a 0.3-mg/kg dose; 5.9% among those who initially received a 3-mg/kg dose; and 13.2% among those who initially received a 10-mg/kg dose.
The most common adverse events were observed in the skin (4.2% for 0.3 mg/kg; 2.9% for 3 mg/kg; and 3.8% for 10 mg/kg) and gastrointestinal tract (12.5% for 0.3 mg/kg; 2.9% for 3 mg/kg; and 3.8% for 10 mg/kg).
“Further studies are needed to determine the contribution of ipilimumab retreatment to OS,” Lebbé and colleagues wrote.
Disclosure: See the full study for a list of the researchers’ relevant financial disclosures.
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