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PEER-TO-PEER CLINICAL CONVERSATIONS |
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TiNivo-2 Trial Results: Tivozanib in Advanced Renal Cell Carcinoma Treatment
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Toni Choueiri, MD
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| Toni Choueiri discusses the TiNivo-2 trial results, comparing tivozanib-nivolumab combination to tivozanib monotherapy in advanced clear cell renal cell carcinoma. The study, involving 343 patients, shows no benefit in rechallenging with nivolumab after prior immunotherapy.
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Highlights from the 2024 European Society of Medical Oncology Annual Meeting |
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| Proffered Paper Session 1: GU Tumors, Non-Prostate |
| Tivozanib–Nivolumab vs Tivozanib Monotherapy in Patients with RCC Following 1 or 2 Prior Therapies including an Immune Checkpoint Inhibitor – Results of the Phase III TiNivo-2 Study
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| Toni K. Choueiri, MD
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| The phase III TiNivo-2 trial, presented at ESMO 2024, evaluated tivozanib combined with nivolumab versus tivozanib monotherapy in advanced RCC patients who had progressed after prior immune checkpoint inhibitor therapy. The trial did not meet its primary endpoint, with no improvement in progression-free survival or overall survival in the combination arm compared to monotherapy. These results suggest that rechallenging with a PD-1 inhibitor, such as nivolumab, does not enhance outcomes in this setting, and tivozanib monotherapy remains a viable second-line treatment option.
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| Final Analysis of the Phase 3 LITESPARK-005 Study of Belzutifan Versus Everolimus in Participants with Previously Treated Advanced Clear Cell RCC |
| Brian Rini, MD, FASCO |
| The final analysis of the phase 3 LITESPARK-005 trial, presented at ESMO 2024, demonstrated that belzutifan significantly improved progression-free survival and objective response rate compared to everolimus in advanced clear cell RCC patients who had previously received PD-(L)1 inhibitors and VEGFR-TKIs. Although belzutifan showed durable responses lasting over two years, no significant improvement in overall survival was observed. |
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| Prospective Randomized Phase II Trial of Ipilimumab + Nivolumab Versus Standard of Care in Non-Clear Cell RCC: Results of the SUNNIFORECAST Trial
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| Lothar Bergmann, MD
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| The phase II SUNNIFORECAST trial compared ipilimumab + nivolumab to standard of care in patients with advanced non-clear cell RCC, showing that the combination significantly improved the 12-month overall survival rate and objective response rate. However, progression-free survival was not significantly different between the two arms. These findings suggest that dual checkpoint inhibitor therapy offers a meaningful survival benefit and could become a new standard for non-clear cell RCC, though further research is needed for these rare subtypes.
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| Invited Discussant: Optimizing Post-IO Therapy in Clear Cell RCC and Expanding Options for Non-Clear Cell RCC |
| Manuela Schmidinger, MD |
| Manuela Schmidinger discussed post-immunotherapy options in RCC, highlighting that TiNivo-2 showed no superiority of tivozanib-nivolumab over tivozanib alone in RCC patients post-IO failure. She also reviewed the LITESPARK-005 trial, which demonstrated belzutifan's progression-free survival benefit but no overall survival advantage. In the SUNNIFORECAST trial for non-clear cell RCC, nivolumab-ipilimumab improved overall survival and response rates compared to standard care, though results were less robust compared to clear cell RCC outcomes. |
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| BL-B01D1-201: BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma |
| Dingwei Ye, MD |
| Dingwei Ye presented promising results from the phase Ib/II trial of BL-B01D1, an EGFR x HER3 bispecific antibody-drug conjugate, in patients with locally advanced or metastatic urothelial carcinoma. The study showed an objective response rate of 40.7% and a disease control rate of 96.3%, with particularly strong efficacy in patients who had one prior chemotherapy line. |
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| NKT2152, a Novel Oral HIF-2α Inhibitor, in Participants with Previously Treated Advanced Clear Cell RCC: Preliminary Results of a Phase 1/2 Study
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| Eric Jonasch, MD
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| Eric Jonasch presented preliminary results from a phase 1/2 study of NKT2152, a novel oral HIF-2α inhibitor, in patients with advanced clear cell RCC who had previously undergone multiple therapies. The study showed an objective response rate of 20%, with a median progression-free survival of 7.4 months. In patients without prior mTOR inhibitor therapy, the ORR was 35.6%, and PFS was 12.7 months.
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| Invited Discussant: Moving the Needle: Novel Targets and Refined Approaches in Genitourinary Cancers |
| Jonathan Rosenberg, MD |
| Jonathan Rosenberg highlights the promising antitumor activity of BL-B01D1, an EGFR x HER3 bispecific antibody-drug conjugate, in advanced urothelial carcinoma, showing a 40.7% response rate with manageable toxicity. He also discussed NKT2152, a novel HIF-2α inhibitor, which demonstrated a 20% response rate and 9.2-month progression-free survival in heavily pre-treated clear cell RCC patients, with tolerable anemia and hypoxia as the main side effects. |
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