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News
The FDA has approved belzutifan (Welireg) plus lenvatinib (Lenvima) for adults with advanced clear cell renal cell carcinoma (ccRCC) whose disease progressed after PD-1/PD-L1 inhibitor therapy. The decision was backed by the phase 3 LITESPARK-011 trial, which showed the combo reduced the risk of disease progression by 26% compared to cabozantinib alone, extending median PFS from 10.6 to 14.6 months.
The FDA has approved the combination of belzutifan (Welireg, Merck) and lenvatinib (Lenvima, Eisai) for adults with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) that progressed during or after PD-1/PD-L1 inhibitor therapy — or within 6 months of completing adjuvant PD-1 therapy. This adds a new post-immunotherapy option for a patient population with limited treatment choices.
The approval was based on data from the randomized, phase 3 LITESPARK-011 trial involving 747 patients. The belzutifan + lenvatinib combo outperformed cabozantinib monotherapy on progression-free survival, one of the co-primary endpoints. Overall survival trended in favor of the combination but did not reach statistical significance at final analysis.
By the Numbers:
Why it matters: For patients with advanced kidney cancer who've already been through immunotherapy, treatment options are limited. This newly approved regimen offers a meaningful PFS benefit over the current standard, giving oncologists a strong new option — though the OS benefit will require continued monitoring.
