Dr. Emmanuel Seront, medical oncologist at Clinique Universitaire Saint-Luc, discussed the findings presented in the proffered paper session on renal cancer.
The randomized open-label Phase 3 LITESPARK-005 study compared the utilization of belzutifan with everolimus in extensively treated patients afflicted with metastatic clear cell renal cell carcinoma (ccRCC).
Patients were randomly assigned to either the belzutifan or everolimus group. The primary endpoints of this study included Progression-Free Survival (PFS) and Overall Survival (OS).
Among the secondary outcomes, the overall response rate notably increased in patients treated with belzutifan. Not only was there an augmentation in PFS, but the duration of response also exhibited a substantial extension. Belzutifan has emerged as a new standard of care following the failure of multiple treatments, despite the premature nature of OS results at this stage of the trial.
In the Phase 2 LITESPARK-013 study, two different doses of belzutifan were evaluated in patients with advanced RCC. The results indicated that the higher dose of 200mg did not enhance the treatment’s efficacy compared to the current dose of 120mg. This finding validates the decision to proceed with further trials employing the 120mg dosage.
Additionally, the combination of belzutifan with cabozantinib in ccRCC, as presented in the Phase 2 LITESPARK-003 study, demonstrated promising results in both previously treated and untreated patients. However, due to the absence of comparisons with either agent administered alone, further investigation is necessary to ascertain the full potential of this combination therapy.