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DISCOVER WELIREG (belzutifan), THE FIRST AND ONLY HIF-2α INHIBITOR FOR YOUR APPROPRIATE PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC)

WELIREG is indicated for the treatment of adult patients with advanced RCC following immune checkpoint and anti-angiogenic therapies.

LITESPARK-005: WELIREG^TM (belzutifan) demonstrated superior PFS vs everolimus at first interim analysis

Kaplan-Meier Estimates of PFS in LITESPARK-005

• 25% reduced risk of disease progression or death demonstrated with WELIREG vs everolimus (HR=0.75^a; 95% CI, 0.63–0.90; P=0.00077).^b
• Events observed: 257/374 (69%) with WELIREG vs 262/372 (70%) with everolimus.
• Median PFS^c: 5.6 months (95% CI, 3.9–7.0) with WELIREG vs 5.6 months (95% CI, 4.8–5.8) with everolimus.

WELIREG demonstrated superior ORR vs everolimus at first interim analysis

Patients who received WELIREG achieved an ORR of 22% vs 3.5% of patients who received everolimus (P<0.00001)

• Median DOR^c was not reached with WELIREG (range: 1.7+–23.2+ months) vs 17.2 months with everolimus (range: 3.8–18.0+ months).

• 74% of patients who responded with WELIREG maintained a response that lasted ≥12 month vs 68% of patients who responded with everolimus.

LITESPARK-005 study design: The only Phase 3 trial in advanced RCC to specifically evaluate patients who progressed following treatment with both anti–PD-1/L1 and VEGF-TKI therapies

WELIREG was studied in an open-label, randomized, Phase 3 trial vs everolimus

Stratification Factors

• IMDC risk categories (favorable vs intermediate vs poor)
• Number of prior VEGF receptor–targeted therapies (1 vs 2–3)

Primary Efficacy Outcomes

• PFS^d
• OS

Secondary Efficacy Outcomes

• ORR^d
• DOR^d

Patients were evaluated radiologically at Week 9 from the date of randomization, then every 8 weeks through Week 49, and every 12 weeks thereafter.

Study Population Characteristics

• Median age: 63 years (range: 22 years to 90 years)
• 42% age 65 years or older
• 78% male
• 79% White, 12% Asian, 1.1% Black or African-American
• ECOG PS of 0, 43%; ECOG PS of 1, 55%
• Prior therapies: 13% of patients had 1 prior line of therapy, 43% had 2 prior lines of therapy, and 43% had 3 prior lines of therapy

• 49% received 2 to 3 prior VEGF receptor–targeted therapies

• Patient distribution by IMDC risk categories was 22% favorable, 66% intermediate, and 12% poor

Subsequent prespecified analysis with median follow-up time of 17.8 months (range: 0.2–39.1 months)

LIMITATION: No statistical testing was performed for the updated PFS, ORR, and DOR analyses. No conclusions can be drawn.

Updated PFS

• HR=0.74 (95% CI, 0.63–0.88) with WELIREG vs everolimus.
• Events observed: 289 with WELIREG vs 276 with everolimus.
• Median PFS: 5.6 months (95% CI, 3.8–6.5) with WELIREG vs 5.6 months (95% CI, 4.8–5.8) with everolimus.

OS

• OS favored WELIREG over everolimus but did not reach statistical significance (HR=0.88; 95% CI, 0.73–1.07).
• Median OS: 21.4 months (95% CI, 18.2–24.3) with WELIREG vs 18.1 months (95% CI, 15.8–21.8) with everolimus.

Updated ORR

• 22.7% with WELIREG vs 3.5% with everolimus.
• Median DOR: 19.5 months (range: 1.9–31.6+) with WELIREG vs 13.7 months (range: 3.8–21.2+) with everolimus.

• Based on Kaplan-Meier estimates, patients with a DOR ≥12 months was 73% for WELIREG versus 62% for everolimus.

• Median TTR: 3.8 months (range: 1.7–22.0) with WELIREG and 3.7 months (range: 1.8–5.4) with everolimus.

Following treatment with both anti–PD-1/L1 and VEGF-TKI therapies, consider WELIREG as early as the second line for your appropriate patients with advanced RCC

^aBased on the stratified Cox regression model.

^bBased on first prespecified interim analysis.

^cFrom product-limit (Kaplan-Meier) method for censored data.

^dMeasured by blinded independent central review using RECIST v1.1.

Anti–PD-1/L1 = anti–PD-1 or anti–PD-L1; AR = adverse reaction; CI = confidence interval; CR = complete response; DOR = duration of response; ECOG PS = Eastern Cooperative Oncology Group performance status; HIF-2α = hypoxia-inducible factor 2 alpha; HR = hazard ratio; IMDC = International Metastatic Database Consortium; ORR = objective response rate; OS = overall survival; PD-1 = programmed death receptor-1; PD-L1 = programmed death ligand 1; PFS = progression-free survival; PR = partial response; RCC = renal cell carcinoma; RECIST v1.1 = Response Evaluation Criteria In Solid Tumors v1.1; TTR = time to response; VEGF-TKI = vascular endothelial growth factor tyrosine kinase inhibitor.

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