Top KOLs Discussing OptiTROP-Breast01
OptiTROP-Breast01 Key Slides & Visuals
ESMO 2026 slides
| Sac-TMT (n=130) | Chemotherapy (n=133) | |
|---|---|---|
| OS events, n (%) | 88 (67.7) | 109 (82.0) |
| Median OS, months (95% CI) | 14.7 (12.1–20.1) | 9.9 (8.6–11.8) |
| 24-month OS rate (abstract) | 33.8% | 21.4% |
| 30-month OS rate (95% CI) | 26.8% (19.0–35.2) | 13.2% (7.8–20.0) |
| HR (95% CI) | 0.60 (0.45–0.80), nominal P = 0.0004 |
| Sac-TMT (n=130) | Chemotherapy (n=133) | |
|---|---|---|
| Any subsequent anticancer therapy, n (%) | 88 (67.7) | 98 (73.7) |
| Subsequent ADC, n (%) | 24 (18.5) | 37 (27.8) |
| TROP2-directed ADC | 6 (4.6) | 29 (21.8) |
| HER2-directed ADC | 16 (12.3) | 11 (8.3) |
| RPSFT-adjusted median OS, months (95% CI) | 14.7 (12.1–20.1) | 9.4 (8.4–11.2) |
| RPSFT-adjusted HR (95% CI) | 0.55 (0.39–0.73) |
| Subgroup | Sac-TMT median OS (n) | Chemo median OS (n) | HR (95% CI) |
|---|---|---|---|
| Prior PD-1/PD-L1 inhibitor | 17.4 mo (32) | 11.2 mo (36) | 0.54 (0.32–0.93) |
| No prior PD-1/PD-L1 inhibitor | 14.6 mo (98) | 9.8 mo (97) | 0.64 (0.46–0.90) |
| HER2 0 | 17.4 mo (74) | 10.9 mo (77) | 0.64 (0.43–0.93) |
| HER2-low | 14.0 mo (56) | 8.6 mo (56) | 0.60 (0.39–0.91) |
Same slides also posted by @Dr_ElvinaA, @ElisaAgostinett.
| Subgroup | Sac-TMT | Chemo | HR (95% CI) |
|---|---|---|---|
| All patients | 88/130 | 109/133 | 0.60 (0.45–0.80) |
| Prior lines 2–3 | 75/114 | 93/113 | 0.58 (0.43–0.79) |
| Prior lines >3 | 13/16 | 16/20 | 0.84 (0.40–1.75) |
| Liver metastases: yes | 33/45 | 38/45 | 0.67 (0.42–1.07) |
| Liver metastases: no | 55/85 | 71/88 | 0.58 (0.41–0.83) |
| TNBC at initial diagnosis: yes | 62/92 | 69/88 | 0.62 (0.44–0.88) |
| TNBC at initial diagnosis: no | 26/38 | 40/45 | 0.61 (0.37–1.00) |
| Visceral metastases: yes | 82/115 | 92/113 | 0.65 (0.48–0.88) |
| Visceral metastases: no | 6/15 | 17/20 | 0.34 (0.13–0.86) |
| Treatment-related AEs, n (%) | Sac-TMT (n=130) | Chemotherapy (n=132) |
|---|---|---|
| Any TRAE | 130 (100) | 127 (96.2) |
| Grade ≥3 TRAEs | 84 (64.6) | 76 (57.6) |
| Serious TRAEs | 28 (21.5) | 18 (13.6) |
| TRAEs leading to discontinuation | 2 (1.5) | 2 (1.5) |
| TRAEs leading to death | 1 (0.8) | 0 |
| Grade ≥3 neutrophil count decreased | 47 (36.2) | 62 (47.0) |
| Grade ≥3 anemia | 38 (29.2) | 8 (6.1) |
| Stomatitis, any grade / grade 3 | 65 (50.0) / 13 (10.0) | 6 (4.5) / 1 (0.8) |
Same slides also posted by @Dr_Oncologista.
Same slides also posted by @to_be_elizabeth, @MamMa_mimumemo.
| Analysis | Sac-TMT events / median OS | Chemo events / median OS | HR (95% CI) |
|---|---|---|---|
| A. Final OS (ITT) | 88 / 14.7 mo (12.1–20.1) | 109 / 9.9 mo (8.6–11.8) | 0.60 (0.45–0.80); P = 0.0004 |
| B. RPSFT-adjusted OS | 88 / 14.7 mo (12.1–20.1) | 96 / 9.4 mo (8.4–11.2) | 0.55 (0.39–0.73) |
| C. Censoring-adjusted OS (sensitivity) | 75 / 14.7 mo (12.1–20.4) | 81 / 9.4 mo (8.4–11.8) | not legible in the posted figure |
Physician reactions to OptiTROP-Breast01
OptiTROP-Breast01: Sac-TMT improved median OS in pretreated mTNBC (14.7 vs 9.9 months; HR 0.60), reinforcing the role of ADCs in later-line treatment. @OncoAlert #ESMO26 #ESMOAmbassadors #ESMOcommunity @myESMO #BreastCancer #bcsm https://t.co/KExulTOhAR
Sacituzumab tirumotecan versus chemotherapy in previously treated locally recurrent or metastatic triple-negative breast cancer: final overall survival analysis of the Phase III OptiTROP-Breast01 - Annals of Oncology https://t.co/0w3KTCce3E
#ESMO26 | OptiTROP-Breast01: sustained OS benefit with sac-TMT in pretreated advanced TNBC. Median OS: 14.7 vs 9.9 months; HR 0.60. Encouraging durability despite subsequent ADC use in 27.8% of controls. How best to sequence TROP2 ADCs remains a key question. @OncoAlert @Larvol #breastcancer
Oral abstract #BreastCancer session at #ESMO26: updated data on #OptiTROPbreast01 showing improved overall survival with #SacTMT in pretreated patients with triple negative disease @OncoAlert @myESMO https://t.co/YfZkV5G9tw
📌 Phase III OptiTROP-Breast01 Final OS analysis of sacituzumab tiru- motecan versus chemotherapy in previ-ously treated locally recurrent or metastatic triple-negative breast can-cer ✨Man Li #ESMO26 🇪🇸 @OncoAlert #OncoAlertAF https://t.co/UgkvGjy9gP
#ESMO26 | OptiTROP-Breast01 Sacituzumab tirumotecan maintained its OS benefit over chemotherapy in previously treated metastatic TNBC at the final analysis: 14.7 vs 9 months; HR 0.60. A clinically meaningful gain. But as ADCs sharing the same target and payload class accumulate, the key question remains: Does it work after other ADCs? More options, but optimal sequencing remains unclear.
Context: on the presentation slide, median OS with chemotherapy was 9.9 months.
Rapid Oral 2始まりました。 TNBCへのSac-TMTのOptiTROP-Breast01試験のfinal OS。 mOSを14.7m vs 9.9mで有意にOSを延長。 HER2 status、前治療でのPD-1/PD-L1阻害薬の有無によらず。 #ESMO26 https://t.co/6aGaEHrBDR
OptiTROP-Breast01 Sac-TMT vs chemo in mTNBC (≥2chemo/≥1 in MBC) OS: 14.7 vs 9.9 mo, HR 0.60, p=0.0004 @OncoAlert #ESMO26 https://t.co/PLdWIbtkyF
At #ESMO26 Rapid oral abstracts session on advanced #breastcancer Final OS of OptiTROP-Breast01 Saci-TMT ⬆️ OS vs. CT in pretreated advanced TNBC @OncoAlert https://t.co/swS1kqnsjr
#ESMO2026. The ADC question I am watching this week is not which target. It is which payload, and in what order. Monday, one breast session: SWITCH (4RO), ADC after ADC. OptiTROP-Breast01 (4639RO), final OS for sac-TMT in pretreated TNBC. Bulumtatug fuvedotin (4640RO), MMAE after a TopoI ADC. Same day, Presidential Symposium: TroFuse-005 (LBA11), sac-TMT in previously treated endometrial cancer. TROP2 is expressed in most endometrial tumors. If sac-TMT works, the target was never the hard part. The hard part is what comes after. I give the best treatment first. The tumor that progresses is then already resistant to that payload, and the next line needs a different mechanism. That is where we need more small molecule targeted drugs, not another antibody carrying the same payload. #gyncsm #bcsm
Posted on October 22, before the presentation.
#ESMO26 | OptiTROP-Breast01 – Final OS In metastatic TNBC, sacituzumab tirumotecan improved median OS from 9.9 to 14.7 months vs chemotherapy (HR 0.60). 30-month OS: 26.8% vs 13.2%. The survival benefit was maintained with longer follow-up. However, the lack of direct comparisons with existing ADCs leaves its place in treatment sequencing uncertain.
Posted on October 19 from the 4639RO abstract, before the presentation.
#lcsm may have the plenaries, but #bcsm has 🔥 hot new ADCs! For abstract no.5️⃣, I OPT for #OptiTROP-Breast01. SKB264 is a new Trop2 ADC with promising ph1 data and multiple ongoing ph3 trials. OptiTROP-B01 is the first ph 3 trial for TNBC. Excited to see the results at #ASCO24! https://t.co/V3mWxjmulx
Posted on May 21, 2024, before the final PFS and interim OS results were presented at ASCO 2024.
What physicians are weighing
Where does sac-TMT fit in ADC sequencing?
Three physicians raised ADC sequencing. Yakup Ergün, MD, asked whether sac-TMT works after other ADCs and wrote that optimal sequencing remains unclear; Elvina Almuradova, MD, called the durability encouraging despite subsequent ADC use in 27.8% of controls and named TROP2 ADC sequencing as a key question; Mali Barbi, MD, framed the question as which payload to give, and in what order. The trial cannot answer this directly: patients previously treated with a TROP2-targeted therapy were excluded (ClinicalTrials.gov), and post-study TROP2 ADC use was 21.8% in the chemotherapy arm vs 4.6% in the sac-TMT arm (4639RO slides).
Comparator: chemotherapy, not another TROP2 ADC
The control arm was single-agent chemotherapy (eribulin in 66.2%, vinorelbine 15.8%, gemcitabine 15.0%, capecitabine 3.0%) (Nature Medicine). There is no head-to-head comparison with sacituzumab govitecan, whose approval in the same pretreated setting rests on the ASCENT trial. Yakup Ergün, MD, noted in his abstract-day post that the lack of direct comparisons with existing ADCs leaves sac-TMT’s place in sequencing uncertain.
Generalizability of a China-only trial
All 263 patients were enrolled at 49 sites in China, and the Nature Medicine authors list the China-only population as a limitation, noting that global studies of sac-TMT are ongoing. Enrollment was limited to ages 18–75 and excluded patients with CNS metastases (ClinicalTrials.gov). Merck is running global phase 3 trials of sac-TMT (MK-2870), including TroFuse-011 (NCT06841354) in previously untreated advanced TNBC with PD-L1 CPS <10, a different setting from OptiTROP-Breast01.
US status: sac-TMT vs sacituzumab govitecan
Sac-TMT is approved in China but not in the US, where it remains investigational. For US patients with TNBC after two or more prior systemic therapies, the FDA-approved TROP2 ADC is sacituzumab govitecan (TRODELVY). OptiTROP-Breast01 does not change US labeling.
OptiTROP-Breast01 Trial Design
OptiTROP-Breast01 asked whether sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870), a TROP2-directed antibody-drug conjugate with a belotecan-derivative topoisomerase I inhibitor payload, improves outcomes over standard single-agent chemotherapy for patients with triple-negative breast cancer that has progressed after at least two prior systemic therapies. Sponsored by Sichuan Kelun-Biotech Biopharmaceutical, the trial enrolled 263 patients at 49 sites in China between August 2022 and April 2023. The primary PFS results and interim OS were published in Nature Medicine in 2025; the final OS analysis was presented by Man Li, MD, at ESMO 2026 (4639RO, Rapid Oral session, October 26, 2026) and published simultaneously in Annals of Oncology.
Study Design
Randomized 1:1, open-label, multicenter phase 3 (NCT05347134); 263 randomized (130 vs 133). Stratified by number of prior lines (2–3 vs >3) and liver metastases.
Population
Unresectable locally advanced, recurrent or metastatic TNBC, ECOG 0–1, ≥2 prior systemic therapies with ≥1 for metastatic disease, prior taxane; no prior TROP2-targeted therapy; no CNS metastases. 24.6% vs 27.1% had prior PD-1/PD-L1 inhibitors.
Interventions
Sac-TMT 5 mg/kg IV every 2 weeks vs physician’s choice of eribulin, capecitabine, gemcitabine or vinorelbine, until progression, unacceptable toxicity or other discontinuation.
Endpoints
Primary: PFS by BICR (RECIST v1.1). Key secondary: OS. Other secondary: investigator-assessed PFS, ORR, DCR, DOR, safety. Hierarchical testing PFS → OS → ORR at one-sided α 0.025.
Presenter
Man Li, MD (The Second Hospital of Dalian Medical University). Corresponding author Binghe Xu (Cancer Hospital, Chinese Academy of Medical Sciences).
Data Cuts
Interim PFS: Jun 21, 2023. Final PFS and interim OS: Nov 30, 2023. Final OS: Sep 17, 2025 (median follow-up 29.4 months).
OptiTROP-Breast01 in the News
OptiTROP-Breast01 Questions
What is the OptiTROP-Breast01 trial?
OptiTROP-Breast01 (NCT05347134) is a randomized, open-label phase 3 trial sponsored by Sichuan Kelun-Biotech that compared sacituzumab tirumotecan (sac-TMT), a TROP2-directed antibody-drug conjugate, with physician’s choice of chemotherapy in 263 patients in China with locally recurrent or metastatic triple-negative breast cancer after at least two prior systemic therapies, at least one for metastatic disease. Design: Trial Design.
What did the final overall survival analysis show at ESMO 2026?
At a median follow-up of 29.4 months (data cutoff September 17, 2025), median OS was 14.7 months with sac-TMT vs 9.9 months with chemotherapy (HR 0.60; 95% CI 0.45–0.80). The final analysis was descriptive; OS had already met its prespecified significance criterion at the interim analysis (HR 0.53). Figures: At a Glance.
Did later ADC treatment in the chemotherapy arm affect the survival result?
27.8% of patients in the chemotherapy arm received an ADC as subsequent therapy after study treatment (21.8% a TROP2-directed ADC). A prespecified RPSFT adjustment for this gave an OS hazard ratio of 0.55 (95% CI 0.39–0.73), and a sensitivity analysis censoring at subsequent ADC start was described as consistent.
Is sacituzumab tirumotecan approved?
Sac-TMT is approved in China: the NMPA approved it in November 2024 for adults with unresectable locally advanced or metastatic TNBC after at least two prior systemic therapies, at least one for advanced or metastatic disease, based on OptiTROP-Breast01. It is not FDA approved and is investigational in the US, where Merck (MSD) holds rights outside Greater China. In the US, the TROP2 ADC approved for this setting is sacituzumab govitecan (TRODELVY).
How does sac-TMT compare with sacituzumab govitecan?
They have not been compared head to head. OptiTROP-Breast01 compared sac-TMT with chemotherapy, enrolled only in China, and excluded patients previously treated with a TROP2-targeted therapy. Sacituzumab govitecan’s US approval in this setting rests on the separate ASCENT trial versus chemotherapy.
What were the main side effects?
At the final analysis, grade ≥3 treatment-related adverse events occurred in 64.6% with sac-TMT and 57.6% with chemotherapy; treatment-related discontinuation was 1.5% in each arm. Hematologic toxicity was most common; stomatitis occurred in 50.0% with sac-TMT (grade 3, 10.0%). Details: At a Glance.