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Session Highlights from the 2021 Annual Meeting |
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STAR: A Randomized Multi-Stage Phase II/III Trial of Standard First-Line Therapy (Sunitinib or Pazopanib) Comparing Temporary Cessation with Allowing Continuation, in the Treatment of Locally Advanced And/or Metastatic RCC
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Janet Brown, MD
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Janet Brown presented results of the phase II/III STAR trial assessing standard first-line therapy comparing cessation of treatment versus allowing continuation in the treatment of metastatic RCC. 42.7% of patients in the drug-free interval strategy arm who continued post-week-24 had multiple treatment breaks. Further exploratory analysis will consider the characteristics of patients who benefited from a treatment break. |
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Nivolumab in Combination With Alternatively Scheduled Ipilimumab in First-Line Treatment of Patients With Advanced RCC: A Randomized Phase II Trial (PRISM)
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Naveen Vasudev, Ph.D., MRCP, MBChB, BMSc (Hons)
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The ESMO 2021 annual meeting’s non-prostate cancer proffered paper session included a presentation by Dr. Naveen Vasudev discussing results of the phase II PRISM trial assessing nivolumab combination with alternatively scheduled ipilimumab in first-line treatment of advanced renal cell carcinoma.
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High- Versus Low-Dose Pre-Operative Ipilimumab and Nivolumab in Locoregionally Advanced Urothelial Cancer: NABUCCO Cohort 2
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Jeroen Van Dorp, MD
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Jeroen Van Dorp presented the results of NABUCCO Cohort 2 assessing high- versus low-dose pre-operative ipilimumab and nivolumab in locoregional advanced urothelial cancer. This data suggests that ipilimumab 3 mg/kg + nivolumab 1 mg/kg (arm A) is more efficacious than ipilimumab 1 mg/kg + nivolumab 3 mg/kg (Arm B) as preoperative treatment for stage III urothelial carcinoma.
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Avelumab as the Basis of Neoadjuvant Chemotherapy Regimen in Platinum Eligible and Ineligible Patients with Non-Metastatic Muscle Invasive Bladder Cancer: AURA Trial
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Nieves Martinez Chanza, MD
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Nieves Martinez Chanza discusses results of avelumab as neoadjuvant therapy in platinum eligible and ineligible patients with muscle-invasive bladder cancer (MIBC). Dr. Chanza reported preliminary data from the AURA trial assessing preoperative avelumab with two cisplatin-based regimens in the cisplatin eligible cohort.
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Cisplatin-Related Immunomodulation and Efficacy with Atezolizumab + Cisplatin Versus Carboplatin-Based Chemotherapy in Metastatic Urothelial Cancer
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Matthew D. Galsky, MD
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Matthew Galsky discussed the results of cisplatin-related immunomodulation and efficacy with atezolizumab + cisplatin versus carboplatin-based chemotherapy in metastatic urothelial cancer. In this exploratory analysis from IMvigor130, PD-L1 IC2/3 status was associated with longer OS in cisplatin- but not carboplatin-treated patients with metastatic urothelial cancer.
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Antibiotic Therapy and Outcome from Nivolumab in Metastatic RCC Patients: Results of the GETUG-AFU 26 NIVOREN Multicentric Phase II Study
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Lisa Derosa, MD
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The ESMO 2021 annual meeting’s non-prostate cancer mini-oral session included a presentation by Dr. Lisa Derosa discussing results of the phase 2 GETUG-AFU 26 NIVOREN trial and the impact of antibiotic therapy on outcomes. This work provides strong justification for prospective analyses to determine whether microbial infections and antibiotics represent a surrogate for a frail or immunodeficient patient or whether antibiotics directly impair the immune response causing immune checkpoint inhibitor failure.
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Pembrolizumab vs Placebo As Adjuvant Therapy for Patients With Renal Cell Carcinoma: Patient-Reported Outcomes in KEYNOTE-564 |
Toni Choueiri, MD |
In this presentation, Toni Choueiri discussed patient reported outcomes (PROs) from KEYNOTE-564, a randomized phase 3 study of adjuvant Pembrolizumab versus placebo in patients with renal cell carcinoma (RCC). Dr. Choueiri concluded by emphasizing that in KEYNOTE-564, the first positive phase 3 study of adjuvant immunotherapy in RCC, there was no clinically meaningful difference in HRQoL or symptom scores for patients treated with Pembrolizumab compared to placebo. |
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A Phase 2 Prospective Trial of Frontline Cabozantinib in Metastatic Collecting Duct Renal Cell Carcinoma: The BONSAI Trial (Meeturo 2)
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Giuseppe Procopio, MD
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The ESMO 2021 annual meeting’s non-prostate cancer mini-oral session included a presentation by Dr. Giuseppe Procopio discussing results from the phase 2 BONSAI trial. Metastatic collecting duct carcinoma is biologically poorly characterized and under-represented in prospective randomized trials. At the ESMO congress, Dr. Procopio presented results of BONSAI, a prospective, phase 2 trial of frontline cabozantinib in metastatic collecting duct renal cell carcinoma.
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Phase 2 Study of Belzutifan (MK-6482), an Oral Hypoxia-Inducible Factor 2α (HIF-2α) Inhibitor, Plus Cabozantinib for Treatment of Advanced Clear Cell RCC
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David F. McDermott, MD
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David McDermott discussed the results of a phase 2 study of belzutifan + cabozantinib for the treatment of advanced clear cell renal cell carcinoma. With a median follow-up of 15.4 months, belzutifan + cabozantinib showed promising activity in all patients with previously treated metastatic clear cell RCC who were enrolled in cohort 2.
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Single-Dose Carboplatin Followed by Involved-Node Radiotherapy As Curative Treatment for Seminoma Stage IIA/B: Efficacy Results From the International Multicenter Phase II Trial SAKK 01/10
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Alexandros Papachristofilou, MD
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Alexandros Papachristofilou discussed results from the SAKK 01/10 phase II trial testing a single dose of carboplatin followed by involved-node radiotherapy as curative treatment for seminoma stage IIA/B. SAKK 01/10 is the largest completed prospective trial in seminoma stage IIA/B to date. A favorable 3-year PFS using the combination of single dose carboplatin AUC7 and 30-36 Gy involved node radiotherapy was achieved. Toxicity is so far very low and certainly considerably less than with standard chemotherapy or radiotherapy.
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A Prospective Phase II Trial of Cabazitaxel in Male Patients with Chemotherapy Pre-Treated Metastatic Germ-Cell Tumors: The CABA-GCT Study
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Giulia Baciarello, MD
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Giulia Baciarello presented results from the phase 2 CABA-GCT trial. In this multicenter phase II study, men with cancer progression after at least 2 chemotherapy regimens for advanced germ cell tumor received cabazitaxel 25 mg/m2 every 3 weeks, for a maximum of 6 cycles. |
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Subsequent Therapy Following Pembrolizumab + Axitinib or Sunitinib Treatment for Advanced RCC in the Phase 3 KEYNOTE-426 Study |
Rustem Gafanov, MD |
Rustem Gafanov discussed the results of subsequent therapy in KEYNOTE-426 for patients treated with pembrolizumab + axitinib or sunitinib for advanced RCC. Of the patients that received subsequent therapy, baseline characteristics were similar to those in the overall population, subsequent PD-1/PD-L1 inhibitor therapy was less frequent after pembrolizumab + axitinib, and subsequent VEGF/VEGFR therapy was more frequent after pembrolizumab + axitinib therapy. |
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