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Niklas Klümper· @niklas_kluemper · X·· 3 days agoScore70

KEYNOTE-B15

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Honoured to have had the opportunity to present "Optimal induction treatment in non-metastatic bladder cancer" at #ESMO26 in Madrid!

🚨 Does a deeper pathological response translate into greater survival benefit in perioperative MIBC?

An intriguing pattern across four phase III trials:
🔹 NIAGARA: ΔpCR +10 pp | EFS HR 0.68
🔹 KEYNOTE-B15: +23 pp | HR 0.53
🔹 VOLGA: +32 pp | HR 0.51
🔹 KEYNOTE-905: +49 pp | HR 0.40

Larger absolute pCR gains appear to track with greater EFS benefit.

But the comparator matters!

KEYNOTE-905 and VOLGA used surgery-based controls without neoadjuvant systemic therapy (control "pCR" ~8–9%), whereas NIAGARA and KEYNOTE-B15 used active neoadjuvant cisplatin-based chemotherapy.

Thus, the magnitude of ΔpCR is not directly comparable across trials.

The key question: Can pCR, combined with utDNA + ctDNA clearance, become a reliable tool for response-adapted treatment intensity?

⚠️ This is an exploratory, trial-level observation—not proof that pCR improvements cause EFS benefits or that pCR is a validated surrogate endpoint!

Better biomarkers could help us maximize cure while minimizing overtreatment. 🔬

#ESMO26 #BladderCancer

@weoncologists @urotoday @Uromigos

@OncoAlert Faculty: @DrChoueiri @tompowles1 @apolo_andrea @neerajaiims @montypal @Silke_Gillessen @AOmlin @brian_rini @PGrivasMDPhD @TiansterZhang @amerseburger @DrDanielHeng @HHammersMD @scocmem @AndreaNecchi @AmandaNizamMD @drenriquegrande @nataliagandur @AlbigesL @cdanicas @declangmurphy @seanmmcbride @shilpaonc @DrRanaMcKay @scserendipity1 @DrYukselUrun @ravikanesvaran @BraunMDPhD @EfstathiouEleni @mzugman @crisbergerot @Markuseckstein3

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Conference abstracts
4734Omatched by Proffered paper 1: Genitourinary tumour, renal and urothelial

ctDNA analysis of the Phase 3 KEYNOTE-B15 trial: neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) + pembrolizumab (pembro) for participants (pts) with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin

https://esmocongress.esmo.org
NCT04700124NCT04700124matched by - **标题 / Title:** Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

- **标题 / Title:** Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

https://esmocongress.esmo.org

Source: Niklas Klümper · x.com

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