https://doi.org/10.55788/181f901e
Belzutifan is a treatment option in advanced clear cell RCC after PD-(L)1 inhibitor and VEGFR TKI
Previous results from the phase 3 LITESPARK-005 study showed an improved PFS and objective response rate (ORR) with belzutifan over everolimus in patients with advanced clear cell RCC after PD-(L)1 inhibitor and VEGFR TKI therapy [1]. Prof. Brian Rini (Vanderbilt-Ingram Cancer Center, Nashville, TN, USA) now presented results from the final analysis after a median follow-up of 35.8 months [2].
The 12-month PFS rate was 33.7% versus 17.6% in participants treated with belzutifan (n=374) and everolimus (n=372), respectively; the 24-month PFS rate was 17.5% versus 4.1% (HR 0.75; 95% CI 0.63–0.88). However, no OS benefit of belzutifan was observed. Median OS was 21.4 months versus 18.2 months, respectively (HR 0.92; 95% CI 0.77–1.10; P=0.18). Objective response rate favoured belzutifan over everolimus: 22.7% (3.5% complete response; 19.3% partial response) versus 3.5% (0% complete response; 3.5% partial response). In addition, the median duration of response was improved with belzutifan: 19.3 versus 13.7 months. No new safety signals for belzutifan were observed.
Dual checkpoint inhibitor improves survival in advanced/metastatic non-clear cell RCC
Non-clear cell RCC is a rare and heterogeneous disease comprising more than 20 histological and molecular defined entities. The phase 2, investigator-driven SUNNIFORECAST trial (NCT03075423) enrolled 309 therapy-naïve patients with metastatic or locally advanced non-clear cell RCC (nearly 60% papillary RCC, 20% chromophobe RCC). They were randomised 1:1 to first-line double immunotherapy (nivolumab/ipilimumab, 4 cycles) plus nivolumab maintenance therapy versus standard-of-care (predominantly TKI monotherapy). Prof. Lothar Bergmann (University Hospital Frankfurt, Germany) presented the results [3].
OS rate at 12 months, the primary endpoint of SUNNIFORECAST, favoured double immunotherapy: 86.9% versus 76.8% (P=0.0141). However, the median OS was not significantly different between both treatment arms: 42.4 versus 33.9 months, respectively (P=0.292). Participants with PD-L1 ≥1% had a significant OS benefit of double immunotherapy over standard-of-care (HR 0.56; P=0.031) whereas those with PD-L1 <1% had not (HR 1.40; P=0.244). No PFS benefit was observed.
- Choueiri TK, et al. N Eng J Med 2024;391:710-721.
- Rini B, et al. Final analysis of the phase 3 LITESPARK-005 study of belzutifan versus everolimus in participants with previously treated advanced clear cell renal cell carcinoma. Abstract LBA74, ESMO Congress 2024, 13–17 September, Barcelona, Spain.
- Bergmann L, et al. Prospective randomised phase-II trial of ipilimumab/nivolumab versus standard of care in non-clear cell renal cell cancer: Results of the SUNNIFORECAST trial. Abstract LBA75, ESMO Congress 2024, 13–17 September, Barcelona, Spain.
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Table of Contents: ESMO 2024
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