![]() In the dose-escalation portion of the trial, 15 patients with advanced solid tumors were treated with IK-175 monotherapy, and 5 patients received the combination of IK-175 and nivolumab. Initial clinical data from the trial presented at the 2022 SITC Annual Meeting showed that IK-175 was well tolerated and demonstrated encouraging, durable antitumor activity in stage 1 of the trial’s monotherapy and combination arms in patients with urothelial carcinoma. ![]() IK-175 is currently under evaluation as monotherapy and in combination with nivolumab in the phase 1 IK-175-001 trial (NCT04200963) in patients with locally advanced or metastatic solid tumors including urothelial carcinoma. The fast track designation for IK-175 reflects the FDA’s interest in the potential role of our AHR antagonist to overcome the development of resistance to checkpoint inhibitors and supports our strategy of combining IK-175 with nivolumab to expand the number of cancer that can benefit from immunotherapy,” Sergio Santillana, MD, chief medical officer of Ikena Oncology, stated in a news release. “There is an urgent need for new treatment options for urothelial carcinoma, many of whom find themselves out of options after progressing on checkpoint inhibitors. IK-175 is designed to targeted AHR, which is a cancer-driving transcription factor that prevents immune recognition in a multitude of cancers by modulation of innate and adaptive immunity. The FDA has granted a fast track designation to the novel aryl hydrocarbon receptor (AHR) antagonist IK-175 in combination with nivolumab (Opdivo) for the treatment of patients with advanced urothelial carcinoma who have progressed on or within 3 months of receiving the last dose of checkpoint inhibitors.
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