Toni Choueiri, MD Profile picture
Dec 28, 2021 22 tweets 42 min read Read on X
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

@OncoAlert
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
nejm.org/doi/full/10.10…
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
nejm.org/doi/full/10.10…
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
thelancet.com/article/S1470-…
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 ascopubs.org/doi/full/10.12…
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
thelancet.com/journals/lance…
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
ascopubs.org/doi/abs/10.120…
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 nejm.org/doi/full/10.10…
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 nejm.org/doi/full/10.10…
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 thelancet.com/journals/lanon…
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
thelancet.com/journals/lanon…
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
thelancet.com/article/S1470-…
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 ascopubs.org/doi/abs/10.120…
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 ascopubs.org/doi/abs/10.120…
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
ascopubs.org/doi/full/10.12…
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 ascopubs.org/doi/abs/10.120…
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 nejm.org/doi/full/10.10…
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
nejm.org/doi/full/10.10…
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
nejm.org/doi/10.1056/NE…
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
nejm.org/doi/full/10.10…
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
thelancet.com/journals/lance…
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.

Fin...

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More from @DrChoueiri

Dec 26, 2023
And now, onto the Top 10 Translational GU Papers of 20-23. Again, not an exhaustive list, with some our @DanaFarber @DanaFarber_GU being involved in.

Let us start! Image
1/#RCC histological subtypes display diverse epigenetic configurations. Allelic imbalances play a role in modifying TF binding sites, especially through candidate SNPs.

Potential targets for future investigations and therapeutic strategies?

@AminNassarMD @sarahaboualaiwi @SylvanBacaLab #FreedmanLab

nature.com/articles/s4146…Image
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2/ Unlocking metastatic secrets: 🧬A novel #RCC model created with CRISPR-Cas9 editing reveals 9p21 disruption’s role, recurrent patterns driving progression, and #INF signaling’s

@perelli_luigi @LabGenovese @NatureCancer
nature.com/articles/s4301…

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Read 11 tweets
Dec 24, 2023
It is this time of the year again: TOP 10 GU Oncology clinical papers/trials in 2023: Some negative, some positive, but we learned from all!

Feel free to add more & retweet & tag

This is not an exhaustive list!

@OncoAlert @danafarber @DanaFarber_GU

#OnwardFor2024 Image
1/#COSMIC-313 phase 3 trial shows ⬆️PFS with Cabozantinib plus Nivolumab and Ipilimumab in patients with previously untreated advanced or metastatic #RCC presented @myESMO #ESMO22

@motzermd @NEJM @tompowles1 @AlbigesL @DrDanielHeng @FabioSchutz78 @BurottoMauricio



COI: trial PInejm.org/doi/full/10.10…Image
2/In HRR-def #mCRPC: adding talazoparib to enza as 1L improved rPFS(HR=0.45), #PSA-progression, time to chemo, RR, could ⬆️OS (HR=0.69, immature) from Ph 3 #TALAPRO-2 trial. Presented #GU23 @ASCO

@neerajaiims @NatureMedicine #Fizazi @AzadOncology

nature.com/articles/s4159…


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Read 11 tweets
Dec 29, 2022
It is this time of the year again: TOP 10 GU Oncology clinical papers/trials in 2022:

Some negative, some positive, but we learned from all!

Feel free to add more & retweet & tag anyone involved

This is not an exhaustive list!

@OncoAlert @DanaFarber

#OnwardFor2023 Image
1/ #ARASENS phase 3 trial shows ⬆️OS with darolutamide in combination with docetaxel and ADT in #mHSPC (vs docetaxel + ADT alone) with similar AE profile, leading to @US_FDA approval.
#MatthewSmith @BertrandTOMBAL @MGHMedicine @NEJM
nejm.org/doi/full/10.10… ImageImageImage
2/ In #PCa patients with detectable PSA after prostatectomy, lymph node RT + ADT+ PBRT⬆️freedom from progression compared to ADT+ PBRT and PBRT alone according to #SPPORT trial.
@_APollack @DrHowardSandler @TheLancet
thelancet.com/journals/lance… ImageImage
Read 11 tweets
May 27, 2022
Now that #ASCO22 abstracts are released, more insights into Top 10 #GUOnc abstracts (still many LBAs):

@DanaFarber_GU @OncoAlert @ASCO @ASCOPost

1/LBA| Chris Ryan @OHSUKnight=>The long awaited EVEREST study with adjuvant everolimus in RCC: stay tuned!
2/Interesting relationship between DepOR and clinical outcomes in CM-9ER! Greater proportions of pts receiving Nivo+Cabo had deeper responses vs SUN. This translated into better PFS/OS

Dr. Cristina Súarez @vallhebron Image
3/Better HEQOL baseline scores were associated with significantly reduced death on Checkmate-214. Pts with improved/stable 6mo-HRQoL had a 52% reduction in risk of death compared to pts who had worsened.
@CellaDavid @MSSatNU Image
Read 10 tweets
Aug 18, 2021
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!
nejm.org/doi/full/10.10…
@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
Apr 22, 2021
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

A THREAD!

nature.com/articles/s4159…
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

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