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Combo treatment has potential antitumor efficacy against stage IV melanoma
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Treating patients with stage IV melanoma with a combination of intravenous tremelimumab and subcutanous interferon alfa had acceptable levels of toxicity and holds promise against the promotion of tumor elimination, according to results of phase 2 study.
The possibility of improved clinical outcomes warrant further study in a randomized clinical trial, the researchers said.
In the study, 37 patients with stage IV melanoma were assigned treatment with tremelimumab (Pfizer) and interferon alfa using two delivery methods. Patients first were given 15 mg/kg/course of tremelimumab every 12 weeks. High-dose interferferon alfa was given currently as an IV injection for 4 weeks, then as subcutaneous maintenance for 8 weeks per course.
Researchers hypothesized that, together, these two drugs may have a more powerful clinical effect.
“High-dose interferon-alfa has been shown to play a critical role in the interruption of tumor immune tolerance by both improving tumor immunogenicity and increasing dendritic-cell activation and survival,” the researchers wrote. “Tremelimumab has been demonstrated to have a significant immune modulating role in which it unlocks the immune response by disrupting CTLA-4, enhances proinflammatory T-cell cytokine production, and increases T-cell infiltration in responding tumors.”
After treatment, four patients had a complete response and five had partial responses. Thirty-eight percent of patients had stable disease lasting 1.5 to 21 months.
Median PFS was 6.4 months (95% CI, 3.3-12.1) and median OS was 21 months (95% CI, 9.5 to not reached).
The most common grade-3 and grade-4 adverse events were neutropenia (17%); diarrhea/colitis (11%); fatigue (40%); liver enzyme increase (11%); rash (11%); and anxiety/depression (14%). This frequency of adverse events was similar to that of high-dose interferon, tremelimumab or ipilimumab (Yervoy, Bristol-Myers Squibb) monotherapy, according to the researchers.
For more information:
- Tarhini AA. J Clin Oncol. 2011;30:322-328.