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Key Studies in Genitourinary Cancers: CCO Independent Conference Highlights of the 2021 ASCO Annual Meeting
  • CME

Daniel P. Petrylak, MD
Elizabeth R. Plimack, MD, MS
Released: September 7, 2021
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References

  1. ClinicalTrials.gov. Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564). clinicaltrials.gov/ct2/show/NCT03142334. Accessed August 26, 2021.
  2. Choueiri TK, Tomczak P, Park, SH, et al. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for patients with renal cell carcinoma: Randomized, double-blind, phase III KEYNOTE-564 study. Presented at: 57th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2021. Abstract LBA5.
  3. Rini BI, Plimack ER, Stus, V, et al. Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Results from 42-month follow-up of KEYNOTE-426. Presented at: 57th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2021. Abstract 4500.
  4. ClinicalTrials.gov. Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426). clinicaltrials.gov/ct2/show/NCT02853331. Accessed August 26, 2021.
  5. Rini BI, Plimack ER, Stus V, et al. Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019;380:1116-1127.
  6. Powles T, Plimack ET, Soulieres D, et al. Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial. Lancet Oncol. 2020;21:1563-1573.
  7. Motzer RJ, Escudier B, McDermott DF, et al. Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial. J Immunother Cancer. 2020;8:e000891.
  8. Motzer RJ, Choueiri TK, Powles T, et al. Nivolumab + cabozantinib (NIVO+CABO) versus sunitinib (SUN) for advanced renal cell carcinoma (aRCC): Outcomes by sarcomatoid histology and updated trial results with extended follow-up of CheckMate 9ER. Presented at: 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium; February 11-13, 2021. Abstract 308.
  9. Motzer R, Alekseev B, Rha SY, et al. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Engl J Med. 2021;384:1289-300.
  10. Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018;378:1277-1290.
  11. Apolo AB, Powles T, Burotto M, et al. Nivolumab plus cabozantinib (N+C) versus sunitinib (S) for advanced renal cell carcinoma (aRCC): Outcomes by baseline disease characteristics in the phase 3 CheckMate 9ER trial. Presented at: 57th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2021. Abstract 4553.
  12. ClinicalTrials.gov. A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER). clinicaltrials.gov/ct2/show/NCT03141177. Accessed August 26, 2021.
  13. O’Donnell PH, Balar AV, Vuky J, et al. First-line pembrolizumab (pembro) in cisplatin-ineligible patients with advanced urothelial cancer (UC): Response and survival results up to five years from the KEYNOTE-052 phase 2 study. Presented at: 57th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2021. Abstract 4508.
  14. Vuky J, Balar AV, Castellano D, et al. Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer. J Clin Oncol. 2020;38:2568-2666.
  15. Balar AV, Catellano D, O’Donnel PH, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase II study. Lancet Oncol. 2017;18:1483-1492.
  16. ClinicalTrials.gov. Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052). clinicaltrials.gov/ct2/show/NCT02335424. Accessed August 26, 2021.
  17. Bellmunt J, Necchi A, De Wit R, et al. Pembrolizumab (pembro) versus investigator’s choice of paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC): 5-year follow-up from the phase 3 KEYNOTE-045 trial. Presented at: 57th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2021. Abstract 4532.
  18. ClinicalTrials.gov. A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045). clinicaltrials.gov/ct2/show/NCT02256436. Accessed August 26, 2021.
  19. Bellmunt J, De Wit R, Vaughn DJ, et al. Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma. N Engl J Med. 2017;376:1015-1026.
  20. Fradet Y, Bellmunt J, Vaughn DJ, et al. Randomized phase III KEYNOTE-045 trial of pembrolizumab versus paclitaxel, docetaxel, or vinflunine in recurrent advanced urothelial cancer: results of >2 years of follow-up. Ann Oncol. 2019;30:970-976.
  21. Fizazi K, Malodonado X, Foulon S, et al. A phase 3 trial with a 2x2 factorial design of abiraterone acetate plus prednisone and/or local radiotherapy in men with de novo metastatic castration-sensitive prostate cancer (mCSPC): First results of PEACE-1. Presented at: 57th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2021. Abstract 5000.
  22. ClinicalTrials.gov. A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer (PEACE1). clinicaltrials.gov/ct2/show/NCT01957436. Accessed August 26, 2021.
  23. Feyeraben S, Saad F, Perualila, et al. Adjusting Overall Survival Estimates for Treatment Switching in Metastatic, Castration‑Sensitive Prostate Cancer: Results from the LATITUDE Study. Target Oncol. 2019;14:681-388.
  24. Morris MJ, De Bono JS, Chi KN, et al. Phase II study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION). Presented at: 57th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2021. Abstract LBA4.
  25. ClinicalTrials.gov. Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION). clinicaltrials.gov/ct2/show/NCT03511664. Accessed August 26, 2021.
  26. Hofman MS, Emmett L, Snadu S, et al. [177Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial. Lancet. 2021;397:797-804.
  27. Smith M, Parker C, Saad F, et al. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20:408-419.
  28. Gillessen S, Choudry A, Rodriguez-Vida A, et al. Decreased fracture rate by mandating bone protecting agents in the EORTC 1333/PEACEIII trial combining Ra223 with enzalutamide versus enzalutamide alone: An updated safety analysis. Presented at: 57th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2021. Abstract 5002.
  29. ClinicalTrials.gov. Phase III Radium 223 mCRPC-PEACE III (PEACE III). clinicaltrials.gov/ct2/show/NCT02194842. Accessed August 26, 2021.
  30. De Bono JS, Fong L, Beer TM, et al. Results of an ongoing phase 1/2a dose escalation study of HPN424, a tri-specific half-life extended PSMA-targeting T-cell engager, in patients with metastatic castration-resistant prostate cancer (mCRPC). Presented at: 57th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2021. Abstract 5013.
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