BNT324-03: A phase 3, randomized, open-label trial comparing elfetabart drozuntecan, a B7H3 antibody-drug conjugate, with investigator's choice of docetaxel or cabazitaxel in patients with metastatic castration-resistant prostate cancer
https://esmocongress.esmo.org
ESMO Congress 2026
October 23–27, 2026 · Madrid · 2669 items
docetaxel
★★★Late-breaking15 people · 18 posts · 3 abstracts
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Heat now 3·Peak in the comparable set 5 (Oct 24 17:00)·Change over 24h in the comparable set –·Participants now 7
Docetaxel's foundational role in prostate cancer comes from the TAX 327 phase III trial, which demonstrated in hormone-refractory metastatic prostate cancer that docetaxel 75 mg/m² every three weeks plus prednisone significantly reduced death risk versus mitoxantrone plus prednisone (HR 0.76, 95% CI 0.62–0.94, P=0.009) [5]. This established docetaxel as the standard chemotherapy backbone for advanced prostate cancer, with subsequent intensification strategies using it as control or component.
This ESMO meeting presented multiple new datasets involving docetaxel. PEACE-1 phase III long-term follow-up (median 7.7 years, n=1173) showed that in de novo metastatic hormone-sensitive prostate cancer, adding abiraterone plus prednisone to standard of care (ADT ± docetaxel) significantly improved overall survival (OS HR 0.75, 95% CI 0.65–0.87, P=0.0001); in the ADT+docetaxel subgroup median OS was 6.2 vs 4.4 years, 8-year OS 40.3% vs 27.1%, high-volume subgroup 8-year OS 38% vs 20%, interaction P=0.56. The TRIDA real-world study assessed darolutamide+ADT+docetaxel in mHSPC, median follow-up 11 months, 18-month survival 86.5%, 16.2% progressed to CRPC, safety similar to ARASENS. PR21 phase III compared ¹⁷⁷Lu-PSMA-617 versus docetaxel in mCRPC; patient-reported quality of life (FACT-P) was stable with Lu-PSMA but declined with docetaxel, side-effect bother "quite a bit/very much" 15% vs 41%, rPFS no significant difference. Himalayas-1 phase III (n=600) in abiraterone-failed mCRPC compares rinzimetostat+darolutamide versus physician's choice (ARPI or docetaxel), primary endpoint rPFS. BNT324-03 phase III (N≈736) pits B7-H3 ADC Elfe-D against docetaxel head-to-head in taxane-naïve mCRPC after 1–2 ARPIs, dual primary endpoints rPFS and OS.
These data advance understanding in two directions: first, PEACE-1 with nearly 8-year follow-up confirms the long-term survival benefit of triplet intensification (abiraterone+ADT+docetaxel) in de novo mCSPC regardless of metastatic volume, reinforcing the principle of early, full-intensity intensification; second, PR21 with patient-reported outcomes as core narrative demonstrates Lu-PSMA's quality-of-life advantage over docetaxel in the mCRPC first-line chemotherapy setting, providing non-survival endpoint support for treatment sequencing. Meanwhile, Himalayas-1 and BNT324-03 are still recruiting, respectively exploring PRC2 inhibitor combined with ARPI and B7-H3 ADC against docetaxel control, reflecting docetaxel remains the standard comparator for novel agent development.
Limitations include: PEACE-1 despite long follow-up lacks detailed triplet toxicity accumulation and subsequent therapy heterogeneity in the abstract; TRIDA is a single-arm real-world cohort with only 11-month follow-up, OS immature; PR21 centers on quality-of-life narrative, rPFS no difference and OS data pending; Himalayas-1 and BNT324-03 remain in recruitment, efficacy and safety both await confirmation. Optimal triplet selection, biomarker-guided sequencing, and balancing accessibility with toxicity still require further evidence.
- 1.Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer · N Engl J Med 2015
- 2.Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer · N Engl J Med 2015
- 3.Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial · Lancet 2016
- 4.Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial · Lancet Oncol 2012
- 5.Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer · N Engl J Med 2004
- 6.Sipuleucel-T immunotherapy for castration-resistant prostate cancer · N Engl J Med 2010
Anbenitamab plus albumin-bound docetaxel in patients (pts) with HER2-positive advanced breast cancer (BC): A randomized phase III study
https://esmocongress.esmo.org- **标题 / Title:** Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED)
https://esmocongress.esmo.orgTom Powles@tompowles1 ABBV-969 dual-targeting ADC #ESMO26
OncoAlert@OncoAlert OncoAlert 4Sight Abstracts to be Presented at #ESMO26
Zach Klaassen@zklaassen_md Dra. María Natalia Gandur Quiroga@nataliagandur 🚨 This is what durable treatment intensification looks like.
引用@OncoAlert 4Sight Abstracts to be Presented at #ESMO26 Long-Term Overall Survival With Abiraterone Acetate Plus Prednisone in the PEACE-1 Phase 3 Trial for De Novo Metastatic Castration-Sensitive Prostate Cancer (mCSPC) @RayMcDermott1 @BertrandTOMBAL 🔬 Phase 3, 2×2 factorial (n=1173): abiraterone and/or prostate RT added to SOC (ADT ± docetaxel) in de novo mCSPC. Median follow-up 7.7 y. ➡️ Abiraterone: OS HR 0.75 (0.65–0.87); p=0.0001 ➡️ ADT + docetaxel ± abiraterone: median OS 4.4 vs 6.2 y; 8-year OS 27.1% vs 40.3% ➡️ High-volume: 8-year OS 20% vs 38%; interaction by metastatic extent p=0.56 ✅ Major OS benefit of adding abiraterone to SOC, irrespective of metastatic extent; triplet associated with almost twice as many long-term survivors in some subgroups. #ProstateCancer 🎙️ Karim Fizazi 👥 Stéphanie Foulon · Joan Carles · Guilhem Roubaud · Ray McDermott · Aude Fléchon · Bertrand Tombal · Stéphane Supiot · Dominik Berthold · Philippe Ronchin · Gabriel Kacso · Gwenaëlle Gravis · Fabio Calabro · Jean-François Berdah · Ali Hasbini · Marlon Silva · Antoine Thiery-Vuillemin · Igor Latorzeff · Loïc Mourey · Brigitte Laguerre · Sophie Abadie-Lacourtoisie · Etienne Martin · Claude El Kouri · Anne Escande · Alvar Rosello · Nicolas Magne · Friederike Schlurmann · Frank Priou · Marie-Eve Chand-Fouche · Salvador Villà Freixa · Muhammad Jamaluddin · Isabelle Rieger · Alberto Bossi (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
★★★Same topic docetaxel · 15 people#PROSTATECANCER#MCSPC#MHSPC#TRIPLETTHERAPY#GUONCOLOGY313 views9 likes6 reposts0 repliesTian Zhang, MD, MHS, FASCO (@tiansterzhangmd.bsky)@TiansterZhang Deborah Mukherji@dmukherji Quality of life matters in mCRPC
Toni Choueiri, MD@DrChoueiri Gil Morgan, MD@weoncologists Nearly 8 years of follow-up & the triplet still delivers 💪
Zach Klaassen@zklaassen_md Deborah Mukherji@dmukherji Kenrick Ng@Kenrickng1 Favourite study of #ESMO25: CCTG PR21, ¹⁷⁷Lu-PSMA-617 vs docetaxel in mCRPC
UroToday.com@urotoday UroToday.com@urotoday Julian Chavarriaga@chavarriagaj #ESMO26 🧬 Could B7-H3-targeted ADCs challenge docetaxel in mCRPC?
Ricardo Sánchez-E@tioriri OncoDaily RT@OncoDailyRT ScienceLink@sciencelinkonco #ScienceLink #Madrid2026 #ESMO26 #PEACE1 #Abiraterona
Same topic docetaxel · 15 people#SCIENCELINK#MADRID2026#PEACE1#ABIRATERONA10 views0 likes1 repost0 repliesMartin ZapataLaguado@zapatalaguadomd