Arcus Biosciences disclosed updated data from its ARC-20 study showing that casdatifan combined with cabozantinib produced a median progression-free survival of 14.5 months in patients with second-line clear cell renal cell carcinoma (ccRCC). The figures were reported in an 8-K filing with the U.S. Securities and Exchange Commission using a September 4, 2026 data cutoff. […]
Summit Therapeutics has announced the initiation and opening of clinical trial sites for SMT112-216 (NCT07877194), a randomized, open-label, multiregional Phase II trial evaluating ivonescimab-based regimens in previously untreated advanced clear cell renal cell carcinoma (ccRCC) with sites active in the United States (US) and China. The study is being conducted in collaboration with Akeso Inc., […]
The U.S. Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with lenvatinib (Lenvima, Eisai Inc.) on September 24, 2026, for adults with advanced renal cell carcinoma with a clear cell component (ccRCC) whose disease has progressed following treatment with a PD-1 or PD-L1 inhibitor. The approval was supported by data […]
The FDA has approved belzutifan (Welireg) in combination with pembrolizumab for the adjuvant treatment of adults with intermediate-high or high-risk clear cell renal cell carcinoma following nephrectomy. The approval is based on the phase 3 LITESPARK-022 trial, which demonstrated a 28% reduction in the risk of recurrence, metastasis, or death compared with pembrolizumab alone.
Indeterminate renal masses (IRMs) are a common diagnostic challenge, often leading to invasive biopsies, unnecessary surgery, or prolonged surveillance due to imaging uncertainty. The ZIRCON-X analysis evaluated whether adding TLX250-CDx PET/CT, a carbonic anhydrase IX (CAIX)-targeted molecular imaging agent, could improve real-world clinical decision making. By providing non-invasive, biologically specific characterization of suspected clear cell […]
The FDA has issued a Complete Response Letter for TLX250-CDx (Zircaix), rejecting the biologics license application for this breakthrough therapy-designated PET imaging agent due to chemistry, manufacturing, and controls deficiencies rather than clinical efficacy concerns. Telix believes these manufacturing comparability issues are readily addressable, maintaining the drug’s potential as the first commercial imaging agent for […]
GLP-1 agonists in mRCC patients showed 51% lower mortality and reduced immune toxicity with checkpoint inhibitors in 994-patient analysis.
68Ga-NY104 PET/CT shows better diagnostic efficacy than 18F-FDG PET/CT in patients with metastatic clear cell renal cell carcinoma.