|
|
|
|
|
|
|
Highlights from the 2025 American Society of Clinical Oncology Annual Meeting |
|
|
|
| Five-Year Follow-Up Results from the Phase 3 KEYNOTE-564 Study of Adjuvant Pembrolizumab for the Treatment of Clear Cell RCC
|
| Naomi B. Haas, MD
|
| The five-year follow-up results from the Phase 3 KEYNOTE-564 trial evaluate adjuvant pembrolizumab in patients with clear cell renal cell carcinoma at high risk of recurrence following nephrectomy. Pembrolizumab was associated with a statistically significant improvement in overall survival, showing a 38% reduction in the risk of death compared to placebo.
|
|
|
|
|
|
| Zanzalintinib, Nivolumab, Relatlimab in Patients with Previously Untreated Clear Cell RCC—Results from an Expansion Cohort of the Phase 1b STELLAR-002 Study
|
| Jad Chahoud, MD
|
| An expansion cohort of the phase 1b STELLAR-002 trial evaluates zanzalintinib + nivolumab ± relatlimab in previously untreated clear cell RCC. The zanzalintinib + nivolumab arm showed a 63% objective response rate and 83.2% 6-month PFS, with both arms demonstrating manageable safety and low rates of severe palmar-plantar erythrodysesthesia. These results support further investigation of zanzalintinib-based combinations in the first-line setting.
|
|
|
|
|
|
| Ipilimumab and Nivolumab in Patients with Metastatic Clear Cell RCC Treated on the Phase 3 PDIGREE (Alliance A031704) Trial: Results from Step 1 Analysis
|
| Tian Zhang, MD
|
| Step 1 results from the Phase 3 PDIGREE trial evaluate first-line ipilimumab + nivolumab in patients with metastatic clear cell RCC. Among 1,111 enrolled patients, 67% proceeded to Step 2, while 33% discontinued due to adverse events, disease progression, or other factors. The trial highlights real-world tolerability and treatment response of ipilimumab + nivolumab, with 29% experiencing grade 3/4 treatment-related adverse events. These findings offer early insight into immunotherapy sequencing in a representative U.S. population.
|
|
|
|
|
|
|
|
|
|
|
| AREN1721, a Randomized Phase 2 Trial of Axitinib + Nivolumab Combination Therapy Versus Single Agent Nivolumab for the Treatment of TFE/translocation RCC Across All Age Groups: An NCI NCTN Phase 2 Study
|
| James I. Geller, MD
|
| Results from the randomized phase 2 AREN1721 trial evaluate axitinib + nivolumab versus nivolumab alone in patients with translocation RCC across all age groups. Although the trial closed early due to poor accrual, the combination arm showed a 33% partial response rate and significantly improved progression-free survival (10.5 vs. 1.8 months; p = 0.0004). Overall survival was also significantly improved with the combination. These findings suggest potential benefit of VEGF + PD-1 inhibition in this rare, aggressive RCC subtype.
|
|
|
|
|
|
| Sasanlimab in Combination with BCG in BCG-Naive High-Risk NMIBC: Event-Free Survival Subgroup Analyses Based on Disease Stage from the CREST Study
|
| Thomas Powles, MD
|
| Subgroup analyses from the Phase 3 CREST study show that sasanlimab + BCG (induction and maintenance) improves 3-year event-free survival vs BCG alone in BCG-naive, high-risk NMIBC. Patients with CIS had an event-free survival rate of 83.0% vs 71.8%, and those with T1 tumors showed 81.3% vs 72.2%, respectively. These findings support the potential of sasanlimab + BCG as a practice-changing option for aggressive NMIBC.
|
|
|
|
|
|
| CLONEVO: Preoperative Abemaciclib for Cisplatin Ineligible MIBC with Molecular Response Assessment
|
| Bishoy Faltas, MD
|
| The CLONEVO trial evaluated short-term preoperative abemaciclib in cisplatin-ineligible muscle invasive bladder cancer. Among 16 evaluable patients, pathologic complete response was observed in 18.8%, with downstaging in 31.3%. Molecular analyses confirmed on-target activity and significant reductions in tumor burden and proliferation markers. These findings support abemaciclib’s potential role in modulating cell cycle pathways and enhancing response to future combination strategies.
|
|
|
|
|
|
| First Results of SURE-02: A Phase 2 Study of Neoadjuvant Sacituzumab Govitecan + Pembrolizumab, Followed by Response-Adapted Bladder Sparing and Adjuvant Pembrolizumab, in Patients with MIBC
|
| Andrea Necchi, MD
|
| Interim findings from the phase 2 SURE-02 study evaluating neoadjuvant sacituzumab govitecan + pembrolizumab followed by response-adapted bladder preservation in cisplatin-ineligible or -refusing MIBC patients showed a 38.7% clinical complete response rate and a ypT≤1N0-x rate of 51.6%. The combination was well tolerated, and early molecular analyses suggest luminal and genomically unstable tumors may be more responsive. These results support continued accrual and further investigation of this bladder-sparing approach.
|
|
|
|
|
|
| 9MW2821, a Novel Nectin-4 Antibody Drug Conjugate, Combined with Toripalimab in Treatment-Naïve Patients with Locally Advanced or Metastatic Urothelial Carcinoma: Results from a Phase 1b/2 Study
|
| Xinan Sheng, MD
|
| Early findings from a phase 1b/2 study of 9MW2821, a novel Nectin-4 antibody-drug conjugate, plus toripalimab in treatment-naïve advanced urothelial carcinoma show an 80% confirmed response rate and 92.5% disease control rate. Responses were consistent across key subgroups, and the combination demonstrated a manageable safety profile. A phase 3 trial is ongoing.
|
|
|
|
|
|
| Nivolumab + Ipilimumab versus Gemcitabine + Carboplatin Chemotherapy for Previously Untreated Unresectable or Metastatic Urothelial Carcinoma: Final Results for Cisplatin-Ineligible Patients from the CheckMate 901 Trial
|
| Michiel van der Heijden, MD, PhD
|
| Final results from CheckMate 901 show that in cisplatin-ineligible patients with previously untreated unresectable or metastatic urothelial carcinoma, nivolumab + ipilimumab did not meet the predefined statistical threshold for overall survival benefit over gemcitabine + carboplatin (19.1 vs 13.2 months; HR 0.79; p=0.0245). However, the combination demonstrated durable responses and a favorable long-term survival trend, with a manageable safety profile. These findings support the potential of chemotherapy-free, immune-based regimens in select patients.
|
|
|
|
|
|
| Avelumab + Sacituzumab Govitecan versus Avelumab Monotherapy as First-Line Maintenance Treatment in Patients with Advanced Urothelial Carcinoma: Interim Analysis from the JAVELIN Bladder Medley Phase 2 Trial
|
| Jeannie Hoffman-Censits, MD
|
| An interim analysis from the JAVELIN Bladder Medley phase 2 trial shows that avelumab + sacituzumab govitecan significantly improved progression-free survival (11.2 vs 3.8 months; HR 0.49) versus avelumab monotherapy as maintenance therapy in advanced urothelial carcinoma post-platinum chemotherapy. Higher rates of grade ≥3 adverse events were reported with the combination, consistent with known safety profiles. These findings support continued evaluation of Trop-2–targeted combinations in this setting.
|
|
|
|
|
|
|
|
|
|
|
