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ASCO GU 2019

ASCO GU 2019: JAVELIN Renal 101: Outcomes for Avelumab + Axitinib vs Sunitinib in Advanced Renal Cell Carcinoma (RCC)

San Francisco, CA (UroToday.com) While immunotherapy has entered both the first- and second-line treatment options for patients with metastatic renal cell carcinoma, the majority of patients do not have an objective response to single agent immunotherapy. Even with dual checkpoint inhibition as demonstrated in CheckMate 214, 58% of patients did not have an objective response1. Thus, several combination therapies are now being evaluated in this space, combining checkpoint inhibition with VEGF/VEGFR inhibition. JAVELIN Renal 101 is a global phase III study of avelumab plus axitinib versus sunitinib alone. During ASCO 2017, results from the avelumab + axitinib phase 1b study demonstrated that 58% of patients had an objective response (5% complete response, 53% partial response), and 45 out of 53 patients experienced tumor shrinkage2. This abstract provides the subgroup analysis of JAVELIN 101.

ASCO GU 2019: Multidisciplinary Tumor Board: Case-Based Discussion on Kidney Cancer

San Francisco, CA (UroToday.com) Dr. Toni Choueiri chaired the advanced/metastatic kidney cancer panel, presenting a case from his practice for discussion. This patient was a 63-year-old female with a 3-month history of bloating, malaise, weight loss, inability to concentrate, and intermittent gross hematuria. Her medical history was significant for hypertension, arthritis, and CAD. Pertinent medications included 325 mg aspirin and methotrexate and her images are as follows demonstrating an infiltrative right renal mass with peri-aortic lymphadenopathy.

ASCO GU 2019: Efficacy and safety of Nivolumab on Patients with Non-Clear Cell Renal Cell Carcinoma: Results from the Phase IIIb/IV CheckMate 374 Study

San Francisco, CA (UroToday.com) Nivolumab monotherapy is approved for the treatment of patients with advanced renal cell carcinoma (aRCC) who received prior antiangiogenic therapy. In the phase 3 Checkmate 025 trial in patients with previously treated aRCC, Nivolumab monotherapy demonstrated higher objective response rate and superior overall survival compared to everolimus (HR 0.79, p=0.002), with a lower incidence of treatment-relatedgrade 3-4 adverse events (19% vs. 37%).

ASCO GU 2019: Results from KEYNOTE-427 Cohort Bb - First-line Pembrolizumab Monotherapy for Advanced Non-Clear Cell RCC

San Francisco, CA (UroToday.com) Most renal cell carcinoma (RCC) histology is clear cell (80%), however clinical trial data for non-ccRCC are limited as many of these patients are often excluded from clinical trials. Therapies specifically approved by the FDA for advanced non-ccRCC are lacking, resulting in a substantial unmet need for safe and effective treatment options. PD-1/L1 pathway inhibitors are effective in clear cell RCC, but efficacy of PD-1 inhibitors (or any therapy) in non-ccRCC has not been established. KEYNOTE-427 is a single-arm, open-label, phase 2 study of pembrolizumab monotherapy in patients with advanced ccRCC (cohort A) and non-ccRCC (cohort B).

ASCO GU 2019: Final Analysis from the NIVOREN GETUG AFU 26 Study

San Francisco, CA (UroToday.com) The final presentation of GU ASCO 2019 featured Dr. Laurence Albiges presenting results from the final analysis of the NIVOREN GETUG AFU 26 study. This was a French multicenter prospective study to evaluate the safety and efficacy of nivolumab in a broad “real world setting” in mRCC after failure of 1 or 2 tyrosine kinase inhibitors.

ASCO GU 2019: PIVOT-02 Study of NKTR-214 with Nivolumab in Metastatic Urothelial Carcinoma

San Francisco, CA (UroToday.com) Immune checkpoint inhibitors are approved both in the first line and second line for patients with metastatic urothelial carcinoma. In the first line, KEYNOTE 052 showed that pembrolizumab has significant anti-tumor activity for cisplatin ineligible patients with UC1, for a 38% objective response rate for patients with a combined positive score of 10% or more (PD-L1 positive). Further analysis last year found that the benefit to checkpoint inhibition in the first line was restricted to patients with a high PD-L1 expression, as defined by CPS≥10 or PD-L1 IC ≥5%. In the second line, KEYNOTE 045 improved median overall survival compared with chemo (10.3 v 7.4 months; HR, 0.70; P < 0.001)2.

ASCO GU 2019: Health-Related Quality of Life Reporting in Phase III Randomized Controlled Trials of Metastatic Prostate Adenocarcinoma and Urothelial Carcinoma

San Francisco, CA (UroToday.com) Health-related quality of life (HRQOL) reflects the patient’s subjective perception of several functional domains: physical, psychological, cognitive, social, and general well-being. HRQOL is central to assessment of efficacy and guides decision at a regulatory level, especially when drug impacts on overall survival is limited.
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