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
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
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
3/ Addition of Nivolumab to Gem/Cis #chemotherapy as a 1L unresectable or #mUC significantly improves OS (HR=0.78) and PFS (HR=0.72). Presented #ESMO23 @myESMO
4/Encouraging data from phase3 #THOR trial: in patients with refractory post-PD1 #mUC with #FGFR3/2 alt resulted in ⬆️OS and PFS with ⬇️ TRAEs compared to chemotherapy.
5/More therapeutic option for #nccRCC! Results from phase 2 trial #KEYNOTEB61 support the use of Pembro+Lenvatinib as 1L therapy for patents with previously untreated advanced #nccRCC
6/For patients with high-risk biochemical recurrent #PC: phase 3 #EMBARK shows that enzalutamide plus leuprolide and enzalutamide monotherapy were superior to leuprolide alone in term of metastasis-free survival!
7/ Encouraging prelim findings from #AMG-509(xaluritamig): T cell engager targeting #STEAP1 immunotherapy in patients with #mCRPC improves clinical outcomes. Phase I safe and tolerable.
8/This phase 2 trial demonstrated that #NAC in high-grade #UTUC was tolerated, and lead to ⬆️PFS and OS of responders compared to non responders. Kudos to the exceptional team @MSKCancerCenter GU Center @DrRosenbergMSK
9/More on #RCC from#CONTACT-03 led by @montypal : 1st trial assessing #rechallenging with #ICI in #RCC with #anti-PDL1 didn’t show improvement of PFS and OS , w/ ⬆️toxicity.
10/Promising data from this phase1 trial evaluating☢️ radioligand therapy with #ICI in patients with #mCRPC:a single priming dose of #LuPSMA followed by pembro maintenance was safe with confirmed OR.
TOP 10 #cancerclinicaltrials in 2025 w/MOST Impact
1/ #DeLLphi304 @NEJM led by #Zeusofoncology @g_mountzios @HenryDunantGR : In relapsed SCLC post-platinum, BiTE DLL-3 Tarlatamab improved mOS vs. Chemo (13.6 vs 8.3 m, HR 0.60). PFS and in cancer-related dyspnea also improved.
3/ #SERENA6 is the first Phase III trial to use a ctDNA-guided approach to tackle endocrine resistance: In ER+/HER2– metastatic breast cancer, early switch to Camizestrant upon ctDNA-detected ESR1 mutation markedly delayed progression. PFS 16.0 vs 9.2 m (HR 0.44). QoL decline was delayed and toxicity remained low. Glad to see our own investigator-extraordinaire @elmayerm @DanaFarber 2nd author. Also #ASCO2025 Plenary
2/ Updated EV-302 (2.5-yr f/u). EV+pembro as 1L SOC in la/mUC. PFS 12.5 vs 6.3 mo (HR 0.48); OS 33.8 vs 15.9 mo (HR 0.51) vs chemo. Durable benefit with no new safety signals.
@tompowles1 @shilpaonc
3/ POTOMAC (Phase III): adding 1 year of durvalumab to BCG induction + maintenance In BCG-naive high-risk NMIBC significantly improved DFS vs BCG alone. 32% risk reduction for recurrence or death (HR 0.68) at ~5-yr f/u. Manageable safety profile. Supports IO + BCG as a potential new standard in high-risk NMIBC.
The #TRANSMET study shows liver transplantation + chemo improves 5-year survival (56.6%) vs chemo alone (12.6%) for unresectable colorectal liver metastases. A potential game-changer in colorectal liver metastases! @TheLancetOncol
The #TOPGEAR trial in @NEJM reveals: Adding preoperative chemoradiotherapy to perioperative chemo in resectable gastric cancer doubled pathological complete responses (17% vs 8%) but did not boost overall survival.
A step forward in understanding optimal strategies for gastric cancer treatment!
1/ Enfortumab Vedotin (EV) + Pembrolizumab new SOC for patients with metastatic #UC. Trial #EV302 displaced 30y Platinum-based combos
⏩ PFS benefit: 12.5 vs 6.3 mo (HR= 0.45)
⏩ OS benefit: 31.5 vs 16.1 mo (HR= 0.47)
2/NIAGARA trial: Perioperative durvalumab with NAC in operable bladder cancer à EFS and OS benefit.
⏩32% reduction in risk of recurrence/death
⏩ 25% reduction in the risk of death
⏩No new safety signals.
🎯Potential new SOC for cisplatin-eligible MIBC!
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!
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?