Startseite Kongressberichte & Archiv 2021 ASCO Annual Meeting Urogenital Cancer Genitourinary Cancer—Kidney and Bladder
Genitourinary Cancer—Kidney and Bladder
Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Results from 42-month follow-up of KEYNOTE-426
Brian I. Rini, Elizabeth R. Plimack, Viktor Stus, et al.
The study authors present the longest follow-up of an anti-PD–1/L1 immunotherapy combined with a VEGF/VEGFR inhibitor for first-line RCC (median follow-up of 42.8 mo). Pembrolizumab + axiitinib continues to demonstrate superior efficacy over sunitinib with respect to OS, PFS, and ORR. No new safety signals were observed. Clinical trial information: NCT02853331
CANTATA: Primary analysis of a global, randomized, placebo (Pbo)-controlled, double-blind trial of telaglenastat (CB-839) + cabozantinib versus Pbo + cabozantinib in advanced/metastatic renal cell carcinoma (mRCC) patients (pts) who progressed on immune checkpoint inhibitor (ICI) or anti-angiogenic therapies.
Nizar M. Tannir, Neeraj Agarwal, Camillo Porta, et al.
The study authors demonstrated, that the addition of telaglenastat - an investigational, first-in-class, selective, oral GLS inhibitor that blocks glutamine utilization and critical downstream pathways - did not improve the efficacy of cabozantinb in mRCC. The combination was well tolerated and the adverse events were consistent with known risks of both agents. Clinical trial information: NCT03428217
Health-related quality-of-life (HRQoL) analysis from the phase 3 CLEAR trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) or everolimus (EVE) versus sunitinib (SUN) for patients (pts) with advanced renal cell carcinoma (aRCC).
Robert J. Motzer, Camillo Porta, Boris Alekseev, et al.
The study authors conclude, that compared with sunitinib, patients in lenvatinib + pembrolizumab group had similar or better symptoms and health-related quality-of-life. Clinical trial information: NCT02811861
Phase 2 trial of gemcitabine, cisplatin, plus nivolumab with selective bladder sparing in patients with muscle- invasive bladder cancer (MIBC): HCRN GU 16-257.
Matt D. Galsky, Siamak Daneshmand, Kevin G. Chan, et al.
The study authors conclude, that the transurethral resection of bladder tumor + gemcitabine, cisplatin, plus nivolumab achieves stringently defined cCR in a large subset of patients with MIBC. 1-year bladder intact survival is possible through the durability of responses. The role of genomic biomarkers in management algorithms requires longer follow-up. Clinical trial information: NCT03558087
Pembrolizumab (pembro) in combination with gemcitabine (Gem) and concurrent hypofractionated radiation therapy (RT) as bladder sparing treatment for muscle-invasive urothelial cancer of the bladder (MIBC): A multicenter phase 2 trial.
Arjun Vasant Balar, Matthew I. Milowsky, Peter H. O'Donnell, et al.
The study authors conclude, that pembrolizumab added to hypofractionated RT and twice-weekly gem was well-tolerated. A promising efficacy was observed in this early analysis. Pembrolizumab-related toxicity did not differ from prior monotherapy trials. Clinical trial information: NCT02621151
Phase II trial of durvalumab plus tremelimumab with concurrent radiotherapy (RT) in patients (pts) with localized muscle invasive bladder cancer (MIBC) treated with a selective bladder preservation approach: IMMUNOPRESERVE-SOGUG trial.
Xavier Garcia del Muro, Begoña P. Valderrama, Ana Medina, et al.
The study authors conclude, that a combined-modality approach including durvalumab + tremelimumab with concurrent radiotherapy is feasible and safe. The treatment is showing high efficacy in terms of response and eliciting bladder preservation in a large number of patients. Clinical trial information: NCT03702179
A randomized phase II study comparing cisplatin and gemcitabine with or without berzosertib in patients with advanced urothelial carcinoma.
Sumanta K. Pal, Amir Mortazavi, Matthew I. Milowsky, et al.
The study authors oberved no improvement in progression-free survival with the addition of berzosertib to cisplatin with gemcitabine. Also a trend towards inferior survival was observed. Caution is suggested in reducing the starting dose of cytotoxic therapy to accommodate the addition of a myelosuppressive agent, as in the experimental arm of this study. Clinical trial information: NCT02567409
First-line pembrolizumab (pembro) in cisplatin-ineligible patients with advanced urothelial cancer (UC): Response and survival results up to five years from the KEYNOTE-052 phase 2 study.
Peter H. O'Donnell, Arjun Vasant Balar, Jacqueline Vuky, et al.
The study authors conclude, that after up to 5 y of follow-up, pembrolizumab continued to elicit clinically meaningful, durable antitumor activity in cisplatin-ineligible patients with advanced UC - and more pronounced in patients with combined positive score ≥10 (CPS, number of PD-L1–staining cells [tumor cells, lymphocytes, macrophages] divided by the total number of viable tumor cells, multiplied by 100). Clinical trial information: NCT02335424
Inducible T-cell co-stimulatory (ICOS) receptor agonist, feladilimab (fela), alone and in combination (combo) with pembrolizumab (P): Results from INDUCE-1 urothelial carcinoma (UC) expansion cohorts (ECs).
Arjun Vasant Balar, Victor Moreno, Eric Angevin, et al.
The study authors present results with feladilimab, the first Inducible T-cell co-stimulatory (ICOS) receptor agonist with reported single-agent activity in anti-PD-1/L1–exp relapsed/refractory UC. The combination with feladilimab and pembrolizumab shows promising clinical activity and manageable safety in PD-1/L1–naïve R/M UC.Clinical trial information: NCT02723955