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Highlights from the 2022 European Society of Medical Oncology Annual Meeting |
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| Presidential Symposium III |
| Duration of Androgen Deprivation Therapy with Post-Operative Radiotherapy for Prostate Cancer First Results of the RADICALS-HD Trial ISRCTN40814031 |
| Chris C. Parker, MD, FRCR, MRCP |
| At the Presidential Symposium III of the European Society for Medical Oncology (ESMO) Annual Congress, Chris Parker presented the results of the RADICALS-HD trial examining the effect of differing durations of androgen deprivation therapy (ADT) among men receiving post-operative radiotherapy following radical prostatectomy for prostate cancer. |
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| Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Previously Untreated Advanced Renal Cell Carcinoma of Imdc Intermediate or Poor Risk (COSMIC-313) |
| Toni K. Choueiri, MD
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| Chouieri presented highly awaited results from the COSMIC-313 trial, examining the role of triplet therapy with cabozantinib, nivolumab, and ipilimumab as first-line treatment in patients with advanced renal cell carcinoma (aRCC). Dr. Choueiri concluded that the triplet combination of cabozantinib, nivolumab and ipilimumab significantly improved progression-free survival compared to placebo, nivolumab and ipilimumab (a current standard of care) as first-line treatment of patients with IMDC intermediate or poor risk advanced RCC. |
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| Proffered Paper Session 2: GU Tumors, Non-Prostate |
| Bempegaldesleukin plus Nivolumab Compared to the Investigator’s Choice of Sunitinib or Cabozantinib in Previously Untreated Advanced Renal Cell Carcinoma Results from a Phase 3 Randomized Study |
| Nizar Tannir, MD |
| Nizar Tannir presented the results from the phase 3 PIVOT-09 trial assessing the combination of bempegaldesleukin plus nivolumab as first-line therapy for advanced renal cell carcinoma (RCC), compared to sunitinib or cabozantinib. Based on these data, in first line treatment of advanced/metastatic clear-cell RCC, bempegaldesleukin plus nivolumab did not improve outcomes vs investigator’s choice of TKI. |
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| Study EV-103 Cohort K: Antitumor Activity of Enfortumab Vedotin Monotherapy or in Combination with Pembrolizumab in Previously Untreated Cisplatin-Ineligible Patients with Locally Advanced or Metastatic Urothelial Cancer (la/mUC) |
| Jonathan E. Rosenberg, MD |
| Jonathan Rosenberg presented the results of Cohort K of the EV-103 trial assessing the efficacy of enfortumab vedotin (EV) monotherapy or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer (la/mUC). |
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| Invited Discussant: The Results of the PIVOT-09 Trial & the Role of Enfortumab Vedotin |
| Laurence Albiges, MD, Ph.D. |
| Following presentations from Nizar Tannir discussing results of the PIVOT-09 trial examining bempegaldesleukin plus nivolumab compared to the investigator’s choice of Sunitinib or Cabozantinib in first-line treatment of advanced RCC and from Jonathan Rosenberg discussing the role of enfortumab vedotin either as monotherapy or in combination with pembrolizumab in cisplatin-ineligible patients with advanced urothelial cancer, Laurence Albiges provided a discussion to contextualize these results. |
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| Phase 2 Study of Belzutifan plus Cabozantinib as First-Line Treatment of Advanced Renal Cell Carcinoma Cohort 1 of LITESPARK-003
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| Jaime Merchan, MD |
| During the second Proffered Paper session of the European Society for Medical Oncology (ESMO) Annual Congress focusing on non-prostate genitourinary cancers, Dr. Jaime Merchan presented the first data from Cohort 1 of LITESPARK-003, a phase 2 study assessing Belzutifan Plus Cabozantinib as First-line Treatment of Advanced Renal Cell Carcinoma (RCC). |
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| Invited Discussant: Results of the Phase 2 LITESPARK-003 Trial |
| Andre Fay, MD, Ph.D. |
| Following a presentation from Jaime Merchan discussing the results of the phase 2 LITESPARK-003 trial examining the HIF inhibitor belzutifan plus cabozanitinib as first-line therapy in advanced renal cell carcinoma (RCC), Andre Fay provided an invited discussion to contextualize these results. |
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| Mini Oral Session 2: GU Tumors, Non-Prostate |
| In-Situ Immune Markers Predict Nivolumab +/- Ipilimumab Efficacy in Frontline Metastatic Clear Cell Renal Cell Carcinoma (mccRCC): Key Ancillary Analyses from the BIONIKK Randomized Trial
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| Maxime Meylan, Ph.D.
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| Meylan presented key ancillary analyses of the phase II BIONIKK trial (NCT02960906) aimed at understanding immune markers predictive of the efficacy of immune checkpoint inhibition as first-line therapy in metastatic clear cell renal cell carcinoma (mccRCC).
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| Longitudinal Analysis Reveals Gut Microbiota Shift During Standard Therapies in Metastatic Renal Cell Carcinoma (mRCC) |
| Carolina Alves Costa Silva, MD |
| During the second Mini Oral session of the European Society for Medical Oncology (ESMO) Annual Congress focusing on non-prostate genitourinary cancers, Dr. Alves Costa Silva presented a longitudinal assessment of gut microbiota during treatment for metastatic renal cell carcinoma (mRCC). |
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| Belzutifan, a HIF-2α Inhibitor, for von Hippel-Lindau (VHL) Disease–Associated Neoplasms: 36 Months of Follow-Up of the Phase 2 LITESPARK-004 Study |
| Ramaprasad Srinivasan, MD, Ph.D. |
| Ramaprasad Srinivasan presented the results of the LITESPARK-004 trial of Belzutifan for von Hippel-Lindau (VHL) Disease–Associated Neoplasms, after additional follow-up. Dr. Srinivasan highlighted that this longer follow-up of the LITESPARK-004 trial (37.8 months) demonstrates that belzutifan continues to have clinically meaningful antitumor activity and durable responses in VHL disease–associated RCC, pNET, and CNS and retinal hemangioblastomas, with a manageable safety profile. |
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| Invited Discussant: BIONIKK trial, Changes in Gut Microbiota, & LITESPARK-004 trial |
| Guillermo A. De Velasco Oria, MD, Ph.D.
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| Following presentations from Maxime Meylan discussing predictive biomarkers in advanced RCC based on ancillary analyses of the BIONIKK trial, Carolina Alves Costa Silva examining changes in gut microbiota during standard systemic therapy for metastatic RCC, and Ramaprasad Srinivasan providing updated longer-term follow-up of the LITESPARK-004 trial assessing the HIF-2alpha inhibitor belzutifan in von-Hippel-Lindau disease associated neoplasms, Guillermo De Velasco Oria provided an invited discussion to contextualize these results. |
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| Urothelial Cancer Posters |
| Disease-Free Survival and Distant Metastasis-Free Survival as Surrogates for Overall Survival in Adjuvant Treatment of Muscle-Invasive Bladder Cancer |
| Cora Sternberg, MD |
| Cora Sternberg discussed disease-free survival (DFS) and distant metastasis-free survival (DMFS) as surrogates for overall survival (OS) in adjuvant treatment of muscle-invasive bladder cancer. Despite prolonged times to observe mature OS, there is a lack of well-established surrogates that can enable earlier evaluation of efficacy. Using DFS as a primary endpoint as a surrogate of OS may expedite the development of new treatments, increase statistical power, and enable an earlier assessment of randomized trials conducted in earlier treatment of muscle-invasive bladder cancer. |
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| Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results from Patients with ≥12 Months of Treatment in JAVELIN Bladder 100
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| Jeanny Aragon-Ching, MD
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| Jeanny Aragon-Ching discussed the extended results of JAVELIN Bladder 100 for patients receiving ≥12 months of Avelumab first-line maintenance for advanced urothelial carcinoma. These results further support the use of Avelumab first-line maintenance until progression or unacceptable toxicity for all patients with advanced urothelial carcinoma that has not progressed with first-line platinum-based chemotherapy.
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