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news.US-based Incyte has reported preliminary results from an ongoing Phase I/II trial of INCB24360, its oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, combined with ipilimumab in patients with unresectable or metastatic melanoma.
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The results showed that the combination was generally well tolerated and produced evidence of clinical response.
In the trial, 42% of immunotherapy-naïve patients who received ipilimumab with INCB24360 at 25mg or 50mg twice-daily showed an objective response and 75% (9/12) achieved disease control as evaluated using immune-related response criteria (irRC).
The company said that one patient with pulmonary metastases treated with ipilimumab and INCB24360 50mg twice-daily experienced a complete response.
Immune-related adverse events observed in these groups were generally mild-to-moderate (Grade 1 or Grade 2), and grade 3 or 4 immune related adverse events were qualitatively similar to ipilimumab monotherapy and were generally manageable and reversible.
Incyte president and chief executive officer Hervé Hoppenot said immune-targeted combination therapy represents one of the most promising approaches in oncology and the company’s preclinical data suggested that combination of an IDO1 inhibitor with checkpoint inhibitors could have significant anti-tumor synergy.
"The synergistic activity observed between INCB24360 and ipilimumab increases our confidence in the value of investigating other immunotherapy combinations with INCB24360 in multiple tumor types," Hoppenot said.