LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy

Figures & data

Figure 1. Study design.

^aIncluding 1 anti-PD-1/PD-L1-containing adjuvant or neoadjuvant/adjuvant regimens with progression on or within 6months from the last dose of that regimen OR 1 or 2 regimens for locoregional/advanced disease.

DOR: Duration-of-response; IMDC: International Metastatic Renal Cell Carcinoma Database Consortium; KPS: Karnofsky Performance Status Scale; ORR: Objective response rate; OS: Overall survival; PD-1: Programmed death 1; PD-L1: Programmed death ligand 1; PFS: Progression-free survival; Q8W: Every 8 weeks; Q12W: Every 12 weeks; QD: Once daily; R: Randomization; RCC: Renal cell carcinoma; RECIST 1.1: Response Evaluation Criteria in Solid Tumors, version 1.1; ROW: Rest of world.

Table 1. Patient eligibility criteria.

Key inclusion criteria	Key exclusion criteria
• Age ≥18 years	• CNS metastases and/or carcinomatous meningitis
• Locally advanced or metastatic clear cell RCC (with or without sarcomatoid features)	• Moderate to severe hepatic impairment (Child–Pugh B or C)
• Measurable disease per RECIST v1.1 as assessed by the local site investigator/radiology	• Prior treatment with belzutifan or another HIF-2α inhibitor, lenvatinib, or cabozantinib
• Disease progression on or after an anti-PD-1/PD-L1 therapy as either first- or second-line treatment for locally advanced/metastatic RCC or as neoadjuvant/adjuvant treatment with progression on or within 6months of the last dose	• Having received any type of small molecule kinase inhibitor ≤2 weeks before randomization
• Has not received >2 prior systemic regimens, including 1 anti-PD-1/PD-L1-containing adjuvant or neoadjuvant/adjuvant regimenwith progression on or within 6months from the last dose of that regimen OR 1 or 2 regimens for locoregional/advanced disease ○ No more than 1 anti-PD-1/PD-L1 therapy for adjuvant, neoadjuvant/adjuvant, or locally advanced/metastatic clear cell RCC permitted	• Having received any systemic cancer antibody ≤4 weeks before randomization
• KPS score ≥70% assessed within 10 days before randomization	• Active infection necessitating systemic therapy • History of HIV infection • History of hepatitis B virus or active hepatitis C virus infection

KPS: Karnofsky Performance Status Scale; PD-1: Programmed death 1; PD-L1: Programmed death ligand 1; RCC: Renal cell carcinoma. RECIST 1.1: Response Evaluation Criteria in Solid Tumor, version 1.1.