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Highlights from the 2021 American Society of Clinical Oncology Annual Meeting
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| Breaking Barriers: Ensuring Equity in Cancer Diagnosis, Treatment, and Trial Enrollment for Patients with Kidney and Bladder Cancers |
| Regulating Change: The FDA and Diversity in the Modern Era of Genitourinary Oncology Trials |
| Chana Weinstock, MD
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| Chana Weinstock presented the role of the FDA to create a regulatory environment to encourage diversity in the modern era of genitourinary oncology trials. Dr. Weinstock emphasized that COVID-19 has introduced some novel approaches to facilitate flexibility in trial conduct including remote monitoring and visits. While these may help many, the effects may not be consistent and may disproportionately disenfranchise those who are already marginalized and don’t have access to or a facility with technology. |
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| Women and Bladder Cancer: Ensuring the Best Care for All of Our Patients
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| Jean Hoffman-Censits, MD
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| As part of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, a session entitled “Breaking Barriers: Ensuring Equity in Cancer Diagnosis, Treatment, and Trial Enrollment for Patients with Kidney and Bladder Cancers” was held on Friday June 4th, 2021. Within this session, Jean Hoffman-Censits presented on bladder cancer in women. |
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| Older, Wiser, and Better: Clinical Trial Enrollment and Optimal Care for Older Adults With Kidney and Bladder Cancer
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| Ravindran Kanesvaran, MD
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| Ravindran Kanesvaran presented on how we may optimize care, including clinical trial enrollments for older patients with kidney and bladder cancer. He emphasized that older adults are under-represented in clinical trials generally though this appears to be less so in trials of systemic therapy in advanced kidney and bladder cancer. After a geriatric assessment, older adults can derive similar benefits from systemic therapies as their younger counterparts. |
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| Poster Session - Kidney and Bladder |
| Avelumab First-Line Maintenance plus Best Supportive Care Versus Best Supportive Care Alone for Advanced Urothelial Carcinoma: Analysis of Time to End of Next-Line Therapy in JAVELIN Bladder 100
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| Petros Grivas, MD, Ph.D.
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| Petros Grivas reported results of a post hoc analysis of time to end of next-line therapy (for any reason) in the randomized trial population from JAVELIN Bladder 100. Patients who received avelumab first-line maintenance + best supportive care had prolonged time to end of next-line treatment compared with those who received best supportive care alone, irrespective of PD-L1 status.
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| Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Analysis of Clinical and Genomic Subgroups from the JAVELIN Bladder 100 Trial
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| Thomas Powles, MBBS, MRCP, MD
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| Thomas Powles presented results of post hoc analyses in previously unreported clinical and genomic subgroups in the phase 3 JAVELIN Bladder 100 trial. An OS and PFS benefit was seen for avelumab first-line maintenance + best supportive care versus best supportive care alone across subgroups of interest, including patients with upper or lower tract disease, metastatic disease, unresectable locally advance disease, or lymph node-only disease, PD-L1 positive tumors who received first-line gemcitabine + carboplatin, and tumor genomic subtypes defined by the TCGA (except luminal).
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| Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma in the JAVELIN Bladder 100 Trial: Subgroup Analysis by Duration of Treatment-Free Interval from End of Chemotherapy to Start of Maintenance
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| Srikala Sridhar MD, MSc, FRCPC
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| Srikala Sridhar presented results of a post hoc analysis assessing efficacy by duration of the treatment-free interval from completion of first-line chemotherapy in the JAVELIN Bladder 100 Trial. In patients with advanced urothelial carcinoma that had not progressed with first-line platinum-containing chemotherapy, avelumab first-line maintenance prolonged OS irrespective of the treatment-free interval assessed in this study (4-10 weeks), supporting this new treatment strategy as a standard of care.
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| Enfortumab Vedotin in Cisplatin-Ineligible Patients with Locally Advanced or Metastatic Urothelial Cancer Who Received Prior PD-1/PD-L1 Inhibitors: An Updated Analysis of EV-201 Cohort 2 |
| Bradley McGregor, MD |
| Bradley McGregor presented updated results of Cohort 2 of the EV-201 trial with three additional months of follow-up in which all responders were followed for ≥ 6 months after the onset of response. These data show the potential for enfortumab vedotin as a non-platinum option for cisplatin-ineligible patients following anti-PD-1/L1 treatment. |
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| Study EV-103: Update on Durability Results and Long Term Outcome of Enfortumab Vedotin + Pembrolizumab in First Line Locally Advanced or Metastatic Urothelial Carcinoma |
| Terence W. Friedlander, MD
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| Terence Friedlander reported updated data from the EV-103 clinical trial at this year's 2021 American Society of Clinical Oncology Annual Meeting. Enfortumab vedotin + pembrolizumab, a platinum-free option, continues to demonstrate promising activity with a durable response profile in first-line cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. |
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| Quality of Life, Functioning, and Symptoms in Patients with Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma from EV-301: A Randomized Phase 3 Trial of Enfortumab Vedotin vs Chemotherapy |
| Ronac Mamtani, MD, MSCE
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| Ronac Mamtani reports results of key prespecified quality-of-life endpoints, a secondary objective of EV-301. Quality of life was maintained cross the course of study treatment with patients receiving enfortumab vedotin. Enfortumab vedotin treated patients had statistically significant reductions in pain symptoms compared with chemotherapy-treated patients, however enfortumab vedotin treated patients had significantly more appetite loss. |
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| Novel Immunotherapy Approaches Across the Spectrum of Urothelial Cancer Stages |
| Bishoy Faltas, MD
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| The bladder cancer poster discussion session at American Society of Clinical Oncology (ASCO) 2021 featured a discussant presentation by Dr. Bishoy Faltas examining novel immunotherapy approaches across the spectrum of urothelial cancer stages. |
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| KEYNOTE-B15/EV-304: Randomized Phase 3 Study of Perioperative Enfortumab Vedotin Plus Pembrolizumab vs Chemotherapy in Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer |
| Christopher Hoimes, DO, Ph.D.
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| Christopher Hoimes presented the design of the KEYNOTE-B15/EV-304 (NCT04700124), a randomized, open-label, phase 3 study to evaluate the efficacy and safety of perioperative EV + pembrolizumab versus neoadjuvant chemotherapy using gemcitabine/cisplatin in cisplatin-eligible patients with MIBC. |
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| Impact of Recurrence On Health-Related Quality of Life In Patients at High Risk of Recurrence After Radical Surgery For Muscle-Invasive Urothelial Carcinoma: Results From the Phase 3 CheckMate 274 Trial |
| Matt D. Galsky, MD
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| Matt Galsky presented results of a post hoc analysis assessing the impact of recurrence on HRQoL using data from the phase 3 CheckMate 274 trial. This data suggests that treatment delaying recurrence after radical surgery for high-risk muscle-invasive urothelial carcinoma may prevent or delay HRQoL deterioration in these patients. |
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| Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: SWOG S1605 |
| Peter Black, MD
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| Peter Black presented the results of a trial evaluating the activity of atezolizumab in BCG-unresponsive high-risk NMIBC. The observed complete response to atezolizumab at 6 months and the 12-month durability of complete response in patients with BCG-unresponsive CIS were similar to that of recently reported trials. Atezolizumab demonstrates clinically meaningful activity in patients with BCG-unresponsive CIS, Ta, and T1 tumors who are ineligible for or decline cystectomy. |
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| To view our full coverage of the 2021 ASCO Annual Meeting, visit the Conference Coverage section on UroToday.com
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