🚨 A negative phase III trial can still sharpen the field.
@OncoAlert
At #ESMO26, KEYNOTE-866 tested whether adding perioperative pembrolizumab to neoadjuvant gemcitabine/cisplatin and radical cystectomy could improve outcomes in cisplatin-eligible MIBC.
📊 n=907
➡️ EFS: 74.1 mo vs NR
HR 0.88 (0.71–1.10), p=.1366
➡️ pCR: 44.4% vs 35.8%
➡️ OS: HR 1.00 (0.79–1.27)
⚠️ Grade 3–5 TEAEs: 80.2% vs 75.1%
The key point: perioperative pembrolizumab did not significantly improve EFS.
🎯 Why this matters: not every perioperative IO strategy adds meaningful benefit to cisplatin-based chemotherapy.
For me, this is a reminder that the perioperative MIBC space cannot be treated as one interchangeable class effect.
We need to understand:
🔹 which combinations truly improve long-term outcomes
🔹 whether pCR gains translate into survival benefit
🔹 which patients need intensification
🔹 and how biomarkers may help us avoid adding toxicity without enough efficacy
More therapy is not automatically better perioperative therapy. Better selection matters.
Important data from @garysteinbergmd @DrChrisHoimes and the KEYNOTE-866 investigators.
Pinging @DrChoueiri @tompowles1 @apolo_andrea @PGrivasMDPhD @AndreaNecchi @DrYukselUrun @drenriquegrande @crisbergerot @niklas_kluemper @nataliagandur
#OncoAlert #ESMO26 #BladderCancer #MIBC #Immunotherapy #PerioperativeTherapy #GUOncology
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Perioperative pembrolizumab (pembro) or placebo (pbo) + neoadjuvant cisplatin (cis) and gemcitabine (gem) in participants (pts) with muscle-invasive bladder cancer (MIBC): the double-blind, phase 3 KEYNOTE-866 study
https://esmocongress.esmo.orgOncoAlert 4Sight Abstracts to be Presented at #ESMO26 Perioperative Pembrolizumab or Placebo + Neoadjuvant Cisplatin and Gemcitabine in Muscle-Invasive Bladder Cancer: The Double-Blind, Phase 3 KEYNOTE-866 Study @garysteinbergmd @DrChrisHoimes 🔬 Phase 3, double-blind (n=907): perioperative pembrolizumab or placebo + neoadjuvant gemcitabine-cisplatin and RC + PLND in cisplatin-eligible MIBC. Primary endpoint: EFS. ➡️ Median EFS 74.1 mo vs NR; HR 0.88 (0.71–1.10); P=.1366 ➡️ pCR 44.4% vs 35.8%; OS HR 1.00 (0.79–1.27); neither formally tested ➡️ Grade 3–5 TEAEs 80.2% vs 75.1% ✅ Perioperative pembrolizumab did not confer a statistically significant EFS benefit; safety profile manageable and consistent with prior reports. #BladderCancer 🎙️ Jens Bedke 👥 Arlene Siefker-Radtke · Gary Steinberg · Hiroyuki Nishiyama · Xiao Fang · Ritesh Kataria · Blanca Homet Moreno · Christopher Hoimes (4Sight Made from Abstracts publicly available at the ESMO website) Pinging Our 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, @niklas_kluemper在 X 查看被引用的帖子
Source: Dra. María Natalia Gandur Quiroga · x.com