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NIAGARA Trial : FDA Approval Launch Pack for Clinicians

Brian Shields : Mar 29, 2025 6:40:06 AM

NIAGARA mibc durvalumab

NIAGARA Trial : FDA Approval Launch Pack for Clinicians

NIAGARA TRIAL: Key Resources from the Digital KOL Community

This is a collection of resources from the GU Oncology KOL Community with commentary and direct sources to key clinical trial presentation of the NIAGARA Trial Leading to FDA Approval for durvalumab for resectable MIBC.

FDA Approval Announcement:

JUST IN (again): @US_FDA approved Durvalumab for the Neoadjuvant treatment of muscle-invasive bladder cancer based on the #Niagara study https://t.co/GRXKnr4HuA

Study presented #ESMO24 /published in @NEJM https://t.co/J1Q7tbaFWt

HR EFS 0.68 (0.5-0.8)
HR OS 0.75 (0.59-0.93)
— Toni Choueiri, MD (@DrChoueiri) March 28, 2025

Durvalumab now @US_FDA approved in resectable MIBC based off #NIAGARA: Ph III, Gem/Cis +/- Durvalumab —> ✂️ —> post-op Durva

- New SoC
- 2 yr OS: 82.2% vs. 75.2% (HR: 0.75)
- 2yr EFS: 67.8% vs. 59.8% (HR: 0.68)
- Do we need adj Durva if pCR? #OncTwitter #MedTwitter #gusm pic.twitter.com/4Uia7MP3YE
— Oncology Brothers (@OncBrothers) March 28, 2025

NIAGARA NEJM Publication and Editorial

NEJM Publication:

NEJM Editorial Podcast

Clinical Implications by Dr. Plimmack

NIAGRA presented #ESMO24 and published today @NEJM – huge accomplishment 1000+ patients enrolled. Exciting results!
Some thoughts on applying them to practice... pic.twitter.com/6vXd50lC83
— Elizabeth Plimack MD (@ERPlimackMD) September 15, 2024

Discussant Questions by Dr. Grivas

Brilliant discussion by @PGrivasMDPhD about NIAGARA trials focused on different roles of neoadj vs. adjuvant part of the study and future perspectives opened by this study. @BladderCancerUS @OncoAlert @GUOncologyNow pic.twitter.com/xOfYTnGRYf
— Roberto Iacovelli (@DrIacovelli) September 15, 2024

Exploratory Analysis Presented by Dr. Galsky

⚡️UC Oral Abstract Session⚡️
Additional outcomes and an exploratory analysis of the impact of pCR on long-term outcomes from NIAGARA @MattGalsky @urotoday #GU25

Durva vs Comparison Arm:
📌⬆️EFS (HR 0.68, 95% CI 0.56-0.82) ⬆️ OS (HR 0.75, 95% CI 0.59-0.93), 10% ⬆️ in pCR rate… pic.twitter.com/7GMS53H1Us
— Zach Klaassen (@zklaassen_md) February 14, 2025

NIAGARA Results presented by Dr. Tom Powles at #ESMO24

💫🌟🚨🔝🔝🔝💥 NIAGARA Trial Phase 3 Results! 💥@OncoAlert @myESMO
Presented by @tompowles1, at #ESMO24 on Durvalumab + Chemotherapy in Muscle-invasive Bladder Cancer (MIBC).

Key results:
🔹 Event-Free Survival (EFS) at 24 months:
Durvalumab Arm: 67.8%
Comparator Arm: 59.8%… pic.twitter.com/ML97Y03Ale
— Dra. María Natalia Gandur Quiroga (@nataliagandur) September 15, 2024

NIAGARA Clinical Trial Criticisms

Valid points to show pitfalls in Niagara trial . The question of benifit of neoadjuvant IO over adjuvant IO alone is unanswered. As in tnbc or nsclc. @ASCO #GU25 pic.twitter.com/PY4OqV26Oh
— Dr Amol Akhade (@SuyogCancer) February 15, 2025

Where are post-recurrence data? Not available.
NIAGARA enrolled in LMIC countries with limited access to best post-recurrence care, which likely led to positive OS. Despite high expectations, NIAGARA did not have a standing ovation, and this is a good sign for oncology! https://t.co/8fXUNKohQ2 pic.twitter.com/ISWhYi4MWw
— Timothée Olivier, MD (@Timothee_MD) September 15, 2024

Digital KOL Sentiment Analysis

Doctor Name	Sentiment	Comment
Neeraj Agarwal, MD, FASCO	POSITIVE	Fantastic discussion of the Niagara trial results by master @PGrivasMDPhD in the @myESMO #ESMO24 presidential session👉Comparison with other adjuvant trials👇perioperative durvalumab with cisplatin chemo is new standard of care due to OS benefit @urotoday @OncoAlert https://t.co/0Vu6oHkZst https://t.co/jvZNdaoF4w
Petros Grivas	POSITIVE	Fantastic atmosphere in Barcelona Presidential symposium with practice changing data including NIAGARA trial #bladdercancer @myESMO #ESMO24 #ESMOAmbassadors @OncoAlert @Uromigos @tompowles1 @DrChoueiri @MyriamChalabi @lab_kok @curijoey @KKronig @AndresC27622123 @peters_solange https://t.co/0KfdqnuyiJ https://t.co/8Hsc3ufYqS
Neeraj Agarwal, MD, FASCO	POSITIVE	Breaking news (practice changing) from @myESMO #ESMO24 👉@tompowles1 presents the 1st results of the ph3 Niagara trial of cisplatin + gemcitabine +\|- durvalumab in MIBC #bladdercancer 👉Significant improvement in DFS (HR 0.68) & OS (HR 0.75) with durvalumab @OncoAlert @urotoday https://t.co/CsipAvOLe8
Toni Choueiri, MD	POSITIVE	NIAGARA. Chemo +Durva is a NEW SOC in HIGH RISK PERIOP Muscle-Invasive Bladder Cancer #ESMO24. @tompowles1 does it again! Concomitant @NEJM paper! https://t.co/6H7JzrZnsm
Javier Puente	POSITIVE	#ESMO24 @tompowles1 has presented another practice changing bladder trial!! periop GC+Durva, meets EFS+OS NIAGARA trial Congrats!!!!! https://t.co/EXn2fXAEDf
Tian Zhang, MD, MHS	POSITIVE	Masterful discussion from @PGrivasMDPhD -- placing #NIAGARA in context of our #bladdercancer practice -- neoadjuvant and adjuvant OS benefits. Patients are living longer from earlier use of IO agents. Proposes future trial designs. @myESMO #ESMO24 #ESMOAmbassadors @OncoAlert https://t.co/UDtmsD84Ni
Shilpa Gupta	POSITIVE	#ESMO24 The indomitable & humble @tompowles1 does it again w/ the large practice changing NIAGARA! neoadjuavnt GC durvalumab & adjuvant durva improves EFS & OS compared to GC in MIBC! @montypal @neerajaiims @PGrivasMDPhD @DrRosenbergMSK @apolo_andrea @UroDocAsh @DrChoueiri https://t.co/m4K1q0U9L0
Sabine D. Brookman-May	NEUTRAL	The right questions addressed by @PGrivasMDPhD after NIAGARA trial presentation: ❓should we proceed with adjuvant treatment in ypT0? ❓Is there a role of ctDNA for adjuvant treatment decisions ❓can pts be cured with systemic therapy #BladderSparing approach? @oncodaily #MIBC https://t.co/h9wAhkPSbt
Sergio Vázquez	NEUTRAL	NIAGARA: Probably a new SoC, but we don’t know if it’s better than adjuvant immunotherapy in operable bladder cancer. The pCR is not statistically significant. Fantastic discussion by @PGrivasMDPhD #ESMO24 #bladdecancer https://t.co/SatsnffhvP
Dr Amol Akhade	NEUTRAL	Good discussion @PGrivasMDPhD 👌 👍 many unanswered questions. Important one is Post progression therapy for control arm ? Not there in published paper also ? This is important Data as was asked during discussion. We will need that to see that @VPrasadMDMPH @Timothee_MD @myESMO… https://t.co/DxWMYriziv https://t.co/YmemcNSaMr
Jason Brown	NEUTRAL	The awaited Niagara results are here @tompowles1. Perioperative Durvalumab shows clear PFS and OS benefit in MIBC. 💉pCR rate 33% ‼️PFS HR 0.68 👍🏻OS HR 0.75 ❓ Is adjuvant IO needed for all patients? https://t.co/ZIf5IH68EU
Vinay Prasad MD MPH	NEGATIVE	@SuyogCancer @PGrivasMDPhD @Timothee_MD @myESMO The authors have not even looked at post recurrence data. I think this is a new low @NEJM should have made them report this as condition to publish. Sad day for doctors who want to read science and be able to analyze it properly
Vinay Prasad MD MPH	NEGATIVE	@SuyogCancer @tompowles1 The authors have not even explored post-recurrence data. Pretty bad
Timothée Olivier, MD	NEGATIVE	Where are post-recurrence data? Not available. NIAGARA enrolled in LMIC countries with limited access to best post-recurrence care, which likely led to positive OS. Despite high expectations, NIAGARA did not have a standing ovation, and this is a good sign for oncology! https://t.co/IRvgi78f9H https://t.co/ISWhYi4MWw https://t.co/8fXUNKohQ2