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Highlights From The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting |
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| A Phase 2 Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients with RCC with Bone Metastases: RADICAL (Alliance A031801)
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| Rana McKay, MD
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| Rana McKay presented on the RADICAL phase 2 trial which tested cabozantinib with or without radium-223 in RCC with bone metastases, but the combination did not improve symptomatic skeletal event-free survival and the DSMB recommended stopping the study early for futility. Toxicity was manageable, and while overall survival curves separated after about a year, the trial did not show a clear clinical benefit for adding radium-223.
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| ctDNA Analysis in Participants with RCC Treated with Adjuvant Pembrolizumab in the KEYNOTE-564 Trial
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| Toni Choueiri, MD
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| Toni Choueiri presented a ctDNA analysis from KEYNOTE-564 showing that ctDNA positivity after nephrectomy was uncommon but strongly associated with worse disease-free survival in both the pembrolizumab and placebo arms. These data highlight the limitations of low ctDNA positivity rate in high-risk resected clear cell RCC and do not support the routine use of current ctDNA technology (exome-based) to select patients at increased risk of recurrence post nephrectomy for adjuvant pembrolizumab therapy.
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| Intravesical Recombinant BCG Combined with Chemo-IO as Perioperative Therapy for Patients with MIBC: Primary Analysis of SAKK 06/19
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| Richard Cathomas, MD
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| Richard Cathomas presented primary results from SAKK 06/19, showing that intravesical recombinant BCG combined with cisplatin/gemcitabine and atezolizumab was feasible, tolerable, and produced a high pathologic complete response rate in operable MIBC. The addition of intravesical recombinant BCG (rBCG) to chemo-immunotherapy in MIBC is feasible, tolerable, and has promising efficacy with a high pathological complete response rate. Further investigation of intravesical rBCG in combination with next-generation systemic regimens in randomized trials is warranted.
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| A Prospective, Multi-Center, Phase 1b/II Trial of First-Line Cadonilimab + Axitinib in Advanced Non-Clear Cell RCC
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| Junru Chen, MD, PhD
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| Junru Chen presented initial results from a phase Ib/II trial of cadonilimab plus axitinib as first-line therapy in advanced non-clear cell RCC, showing manageable safety and encouraging activity. The combination of cadonilimab + axitinib showed a manageable safety profile, with no dose-limiting toxicities observed in phase Ib, supporting 10 mg/kg every 3 weeks as the recommended phase 2 dose. First-line cadonilimab + axitinib demonstrated promising antitumor activity in patients with advanced non-clear cell RCC.
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| HRQoL with Pembrolizumab or Observation for High-Risk Muscle-Invasive Urothelial Carcinoma after Surgery: Results from the AMBASSADOR Randomized Trial (Alliance A031501)
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| Ronald Chen, MD, MPH
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| Ronald Chen presented HRQoL results from the AMBASSADOR trial comparing adjuvant pembrolizumab with observation after surgery for high-risk muscle-invasive urothelial carcinoma, alongside the previously reported disease-free survival benefit. Pembrolizumab was associated with more fatigue and dyspnea, which modestly affected physical and role functioning, but it did not worsen overall global health or quality of life.
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| Perioperative SHR-A2102, a Novel Nectin-4-Targeted ADC, in Combination with Adebrelimab for Patients with MIBC: Results from a Phase 2/3 Study
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| Yijun Shen, MD
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| Yijun Shen presented preliminary phase 2/3 results of perioperative SHR-A2102 plus adebrelimab in MIBC, showing promising antitumor activity with a pCR rate of 48.1% and pathologic downstaging in 59.3% of evaluable patients. The regimen was feasible and generally well tolerated, with no treatment-related toxicities preventing surgery, including in patients with reduced renal function. Furthermore, no treatment-related adverse events prevented surgery, supporting continued development of this nectin-4–targeted ADC plus PD-L1 inhibition strategy in the perioperative setting. Longer follow-up and completion of the ongoing phase 2/3 program will further define the durability of these responses and the impact on long-term oncologic outcomes.
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