It is this time of the year again: TOP 20 GU Oncology clinical trials published in 2021:

Some negative, some positive, some led to @FDAOncology approval; we learned from all!

Feel free to add & retweet & tag anyone involved

This is not an exhaustive list

1/ (177Lu)–PSMA-617 showing improved PFS and OS in pre-treated mCRPC patients vs. SOC, in addition to a favorable safety profile @sartor_oliver @morr316 @NEJM…
2/ MRI with targeted & standard biopsy in men with MRI suggestive of prostate cancer (PC) was noninferior to standard biopsy for detecting clinically significant PC &resulted in less detection of clinically insignificant cancer @NEJM @TobiasNordstrom…
3/ ACIS Phase 3 trial: Combo apalutamide + abiraterone (vs. abiraterone/placebo) in patients with mCRPC => improved rPFS & an acceptable safety profile @DRathkopf @EfstathiouEleni @AttardLab @PCFnews #FredSaad @chumontreal @TheLancetOncol…
4/ TRANSFORMER phase 2 trial showing a meaningful clinical activity of bipolar androgen therapy (BAT) in the management of mCRPC, along with acceptable safety profile @EAntonarakis @neerajaiims @sonpavde @MarkowskiGUOnc #JorgeGarcia…
5/ IPATential 150 phase 3 trial @TheLancet with combination of ipatasertib and abiraterone (vs. abiraterone + placebo) showing improved rPFS in mCRPC and functional PTEN-loss (not in ITT pop) @ChrisSweens1 @DanaFarber_GU #deBono @drcmassard…
6/ The POP-RT phase 3 trial showing improved 5-year biochemical failure free survival (BFFS) and DFS with whole-pelvic radiotherapy (WPRT) vs. prostate-only radiotherapy in patients with high risk #PCa @VedangMurthy @docpriyamvada…
7/ The CheckMate 274 phase 3 trial showing improved DFS with adjuvant nivolumab (vs. placebo) in patients with MIBC who had undergone surgery @MattGalsky @IcahnMountSinai #DeanBajorin @sloan_kettering @DrShariat…
8/ Phase 3 EV-301 trial showing improved PFS and OS with EV (vs. chemo) in patients with previously treated mUC @tompowles1 @Bartscancer @DrRosenbergMSK @sloan_kettering @DanielPetrylak @YaleCancer @cdanicas @y_loriot @sonpavde @DanaFarber_GU…
9/ Pembrolizumab monotherapy showing promising activity in patients with BCG-unresponsive NMIBC with CR rate of 41% at 3 months and an acceptable safety profile @ArjunBalarMD @UroDocAsh @PGrivasMDPhD @bkonety @eric_facs…
10/ The phase 3 KEYNOTE-361 trial showing that the addition of pembrolizumab to first-line platinum-based chemotherapy does not improve PFS/OS of patients with mUC @tompowles1 @AlvaAjjai @UMRogelCancer @y_loriot @GustaveRoussy…
11/ Phase 3 IMvigor010 trial of adjuvant atezolizumab in muscle-invasive urothelial carcinoma showing no major improvement in outcomes/DFS as compared to observation @OncoBellmunt @df_hcc @BIDMChealth @siadaneshmand #MahaHussain @NorthwesternU…
12/ The phase 2 study of neoadjuvant gemcitabine + cisplatin + pembrolizumab pre- cystectomy in MIBC: met its primary endpoint for improved pathologic downstaging @TracyLRoseMD @MRHarrisonMD @MattMilowsky @WilliamKimMD @TiansterZhang @angiesmith_uro…
13/ The phase 2 trial TALAPRO-1 showing durable anti-tumor activity of talazoparib monotherapy in heavily pretreated patients with mCRPC @NivenMehra #DeBono #Fizazi @jodebon @ICR_London @JCO_ASCO…
14/ TROPHY-U-01, evaluating the efficacy and safety of SG in patients with mUC who progressed on platinum or checkpoint inhibitors with ORR=27.4%, and manageable AEs @DrScottTagawa @PGrivasMDPhD @ArjunBalarMD…
15/ Phase 3 CALGB 90601 trial of gemcitabine + cisplatin + bevacizumab showing no improved OS compared to gem/cis only in 1L patients with mUC @DrRosenbergMSK @morr316 @ERPlimackMD @ChrisSweens1 @ALLIANCE_org @WalterStadler5 @DrScottTagawa…
16/ Phase II trial of HIF-2α inhibitor Belzutifan showing promising results in patients with VHL disease with renal (RR=49%) and non-renal (RR=77% in pancreas, 30% in CNS) neoplasms @EJonasch @theNCI @FDonskov #Srinivasan #Linehan @KimrynRathmell @NEJM…
17/ Phase 3 KEYNOTE-564 trial comparing adjuvant pembrolizumab to placebo in patients with ccRCC at int/high risk for recurrence after nephrectomy is + for DFS @tompowles1 @HHammersMD #NaomiHaas @ASCO @myESMO @AmerUrological, COI: 1st author…
18/ The three-arm phase 3 CLEAR trial of pembro + lenv vs. lenv. + everolimus vs. sunitinib in patients with mRCC showing longer PFS/OS/ORR with pem/len group vs. sunitinib @motzermd @NEJM @schmidingerRCC @ViktorGruenwald; COI: senior author…
19/ Phase 3 CheckMate-9ER trial of nivolumab+cabozantinib vs. sunitinib in 1L metastatic ccRCC showing improved PFS/OS/ORR for nivo + cabo across subgroups @motzermd @tompowles1 @apolo_andrea @BourlonMaite #JensBedke @uni_tue; COI: 1st author…
20/ Randomized trial @SWOG 1500 trial in advanced papillary RCC of cabozantinib, sunitinib, crizotinib and savolitinib. Cabo showed benefit in PFS (9mo)/ RR (23%) vs. sunitinib (5.6mo, 4%) @montypal @PrimoLaraMD @DrDanielHeng @Daniel_J_George @TheLancet…
I am sure many more studies are out there; but this is a collection from top @ASCO @myESMO @JCO_ASCO @TheLancetOncol @NEJM @TheLancet @Twitter #plenaries @OncoAlert @Uromigos @OncLive + many more. Stay safe and to a healthy 😷and successful 2022.


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More from @DrChoueiri

18 Aug
1/ On the heels of @ASCO #ASCO21 plenary, we are happy to share the results of KEYNOTE-564 trial of adjuvant pembrolizumab in mRCC just published in @NEJM ! A step towards better outcomes for all our patients with kidney cancer!…
@OncoAlert @tompowles1
2/ Following nephrectomy for kidney cancer, a significant percentage of patients will experience disease recurrence, most of them with distant metastases, highlighting the need for effective adjuvant therapies.
3/ Despite many decades of research and clinical investigations, there are currently no globally approved adjuvant regimens for the management of #kidneycancer
Read 16 tweets
22 Apr
Just out @NatureMedicine: Inhibition of HIF-2 alpha in RCC with belzutfian (MK-6482) - phase 1 trial and biomarker analysis- 1st study to report on the 2nd gen. HIF-2 inhibitors in pts with metastatic ccRCC!! @OncoAlert

1/The HIF2 axis biology is fascinating culminating in a 2019 @nobel prize, including our own @DanaFarber @kaelin_lab
2/In this study: 95 patients were enrolled (dose-escalation cohort: n=43 and dose-expansion cohort: n=52). Among these, 55 had advanced ccRCC, with a median age of 62 years, a median of 3 previous systemic therapies, and 76% (n=42) with intermediate/poor @IMDConline risk groups.
Read 16 tweets
22 Jun 20
Proud of this @NatureMedicine collaboration with #FeedmanLab on a novel method detecting early stage RCC in plasma&urine w/cell-free DNA methylomes. Work led by super stars @PierVitaleNuzzo @Jberchuck @keegankorthauer #SandorSpisak
1/ RCC kills 175,000 patients worldwide with no screening test available….
A screening test that detects RCC while still localized (2/3 RCCs) will possibly reduce mortality. RCC and CNS tumors do not shed much cfDNA in the blood!
2/ Developed initially by @decarvalho_lab (co-senior author), we validated this ultra-sensitive cfMeDIP-seq using plasma cfDNA and, for the 1st time, cfDNA from urine samples collected in our #GelbCenter (Chair M. Pomerantz)
Read 13 tweets
29 May 20
1/ Our latest work was just published in @NatureMedicine!
Congratulations to first author Super-Star @BraunMDPhD and to all authors. #CathyWu #SachetShukla @LabSignoretti @VanAllenLab #FreemanLab #SharpeLab
@DanaFarberNews @DanaFarber
#kcsm #KidneyCancer…
2/ Our study analyzes patient samples from 3 prospective clinical trials of PD-1 blockade.
The study includes 592 tumors that were profiled by WES, RNA-seq, and/or IF for CD8+ T cells on samples collected before treatment with Nivolumab (anti-PD1) or Everolimus (mTOR inhibitor)
3/ We evaluated genomic correlates of response to PD-1 inhibitors in ccRCC.
Molecular features that had been previously suggested to correlate with outcomes (e.g. TMB, NeoAg load) were not found to be predictive of benefit from PD-1 blockade.
Read 19 tweets

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