KEY TAKEAWAYS
- Phase III LITESPARK-022 trial aimed to assess the efficacy and safety of the adjuvant therapy pembro plus belzutifan for RCC patients with a high risk of recurrence after surgery.
- LITESPARK-022 analyzed the results of pembro, including KEYNOTE-564, where pembro plus belzutifan compared with placebo plus pembro.
- The primary outcome measure of this study was DFS, with OS, AEs, HRQoL, DRSS1, and DRSS2 among the second outcome measures.
- Assessing disease-free survival, while the secondary endpoints consist of evaluating overall survival, safety, disease recurrence-specific survival, and patient-reported outcomes.
For patients with clear cell renal cell carcinoma (ccRCC), the phase 3 LITESPARK-022 trial will assess the efficacy and safety of pembro plus belzutifan as adjuvant therapy after nephrectomy and compare the results to placebo plus pembro.
In an earlier study, the treatment with the PD-1 inhibitor Pembrolizumab (pembro) significantly increased patients’ (pts’) disease-free survival following surgery for patients at risk of recurrence after surgery despite advancements in the therapy landscape for RCC. As a result, Pembro was authorized by the US Food and Drug Administration and the European Medicines Agency for adjuvant treatment of patients with RCC at higher risk of recurrence.
Adults with intermediate-high risk, high risk, or M1 RCCs with a clear cell component that has been histologically or cytologically confirmed as having one or more of these risk factors as well as patients who have undergone no nephrectomy, metastasectomy, or prior systemic therapy within the previous 12 weeks of randomization are also essential eligibility criteria.
Belzutifan 120 mg once daily plus pembro 400 mg intravenously (IV) every 6 weeks (Q6W) or an oral placebo plus pembro 400 mg IV Q6W was administered to randomly assigned 1,600 pts, until verified disease recurrence by blinded independent central review, the beginning of a new anticancer treatment, unacceptable toxicity, or the decision to discontinue.
Tumor grade (grade 1 or 2 vs. grade 3 or 4) and risk type are stratification variables (intermediate-high risk versus high risk versus M1 NED) with regular radiological evaluations every 12 weeks (Q12W), every 16 weeks (Q16W), and every 24 weeks (Q24W), starting in year 3.
The study will track adverse events for the duration of the investigation and for 30 days after the study’s treatment has ended (90 days for serious adverse events). Survival without illness is the main goal. Overall mortality, safety, disease-specific survival, and patient-reported outcomes are examples of secondary endpoints. Asia, Oceania, Europe, North America, and South America actively recruit.
Source: https://meetings.asco.org/abstracts-presentations/216707
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT05239728
Choueiri T. K., Bedke J., Karam J. A., McKay R. R., Motzer R. J., Pal S. M., Suárez C., Uzzo R., Liu H., Burgents J. E., Sharma M. & Powles T. (2023). Phase 3 LITESPARK-022: Pembrolizumab (pembro) plus hypoxia-inducible factor 2α (HIF-2α) inhibitor belzutifan as adjuvant treatment for clear cell renal cell carcinoma (ccRCC). J Clin Oncol 41, 2023 (suppl 6; abstr TPS748) DOI: 10.1200/JCO.2023.41.6_suppl.TPS748
