Top KOLs Discussing TroFuse-005
TroFuse-005 Key Slides & Visuals
ESMO 2026 slides
| Sac-TMT (n=386) | TPC (n=390) | HR (95% CI); P | |
|---|---|---|---|
| Participants with event (deaths) | 40.7% | 52.3% | — |
| Median OS, months (95% CI) | 19.0 (16.1–NR) | 12.1 (11.0–15.2) | 0.68 (0.55–0.84); one-sided P = 0.0001 |
| 6-month OS | 85.7% | 74.8% | — |
| 12-month OS | 63.4% | 50.8% | — |
| Patients at risk at 12 / 24 months | 166 / 1 | 132 / 1 | — |
| Subsequent anticancer therapy (of whom received an ADC) | 35.0% (4.9%) | 49.0% (12.1%) | — |
| Sac-TMT | TPC | Difference | |
|---|---|---|---|
| Confirmed ORR (95% CI) | 35.1% (30.3–40.2) | 17.3% (13.6–21.6) | 17.8 pp (11.6–23.9); P < 0.00001 |
| Complete / partial response | 6.1% / 29.0% | 4.5% / 12.8% | — |
| Disease control rate | 74.5% | 57.3% | 17.2 pp (10.5–23.7) |
| ORR, non-endometrioid histology | 57/138 (41.3%) | 23/145 (15.9%) | — |
| ORR, endometrioid histology | 71/208 (34.1%) | 40/209 (19.1%) | — |
| ORR, carcinosarcoma | 4/27 (14.8%) | 2/21 (9.5%) | — |
| Median duration of response, months (95% CI) | 11.1 (9.2–13.0) | 6.9 (5.4–9.1) | — |
| Sac-TMT (n=386) | TPC (n=390) | HR (95% CI); P | |
|---|---|---|---|
| Participants with event | 70.2% | 73.1% | — |
| Median PFS, months (95% CI) | 7.2 (5.6–7.6) | 3.9 (3.7–5.3) | 0.59 (0.50–0.70); one-sided P < 0.0001 |
| 6-month PFS | 51.2% | 31.9% | — |
| 12-month PFS | 29.4% | 12.4% | — |
| Patients at risk at 6 / 12 months | 186 / 63 | 95 / 18 | — |
| Sac-TMT | TPC | |
|---|---|---|
| Anemia | 71.4% | 46.6% |
| Oral mucositis/stomatitis | 57.0% | 17.4% |
| Neutropenia (grouped terms) | 41.1% | 36.2% |
| Ocular surface toxicity | 30.5% | 6.8% |
| Leukopenia | 18.2% | 19.9% |
| Thrombocytopenia | 12.8% | 10.1% |
| Hypersensitivity/IRR within 2 days | 4.2% | 2.5% |
| ILD/pneumonitis | 1.8% | 0.5% |
| Sac-TMT any grade | Sac-TMT grade 3 / 4 | TPC any grade | TPC grade 3 / 4 | |
|---|---|---|---|---|
| Anemia | 62.5% | 20.3% / 0.5% | 39.8% | 13.4% / 0 |
| Neutropenia | 20.8% | 5.7% / 3.9% | 15.3% | 6.3% / 3.0% |
| Neutrophil count decreased | 18.5% | 6.5% / 2.3% | 17.2% | 5.2% / 5.7% |
| WBC count decreased | 12.5% | 1.6% / 0.8% | 15.8% | 6.0% / 3.3% |
| Febrile neutropenia (footnote) | 2.3% | — | 5.2% | — |
| Sac-TMT any grade | Sac-TMT grade 3 | TPC any grade | TPC grade 3 | |
|---|---|---|---|---|
| Stomatitis | 54.9% | 9.9% | 14.4% | 1.6% |
| Alopecia | 43.8% | 0 | 32.4% | 0 |
| Nausea | 35.9% | 0.8% | 28.9% | 0.5% |
| Fatigue | 25.9% | 3.1% | 22.6% | 2.2% |
| Dry eye | 18.5% | 0.3% | 3.0% | 0 |
| Vomiting | 17.7% | 1.0% | 10.4% | 1.1% |
| Asthenia | 17.2% | 2.6% | 12.8% | 1.9% |
| Diarrhea | 17.2% | 1.8% | 7.9% | 0.3% |
KOL-Made Infographics
Summary graphics designed by physicians (not conference slides), made from the abstract before the presentation. Values are as the authors drew them. Click to enlarge.
@ChandrakanthMv
@DrRishabhOncoSurvival benefit, toxicity and what comes next
A survival benefit in a setting with few options
Dr. Katy Moore (@DrKatyMoore), a gynecologic oncologist at the Buffett Cancer Center, wrote that options after carboplatin, paclitaxel and immunotherapy in recurrent endometrial cancer “are limited and poor,” and that the PFS, response and OS results are “clinically meaningful and warrants use.” @PerezFidal called it a “new changing practice trial,” and the presenter’s conclusion slide states that the findings support sac-TMT as a new standard of care for patients who have received platinum-based chemotherapy and immunotherapy. Antonio González-Martín, MD (Clínica Universidad de Navarra), noted to ESMO that almost 85% of patients had pMMR disease and almost 80% had medium or high TROP2 expression.
LBA11 presentation slides (Domenica Lorusso, ESMO 2026) · ESMO Insights, Oct 26, 2026Stomatitis, eyes and anemia need active management
Moore called the toxicity “a concern”: stomatitis that “needs prophylactic steroid mouthwash,” ocular events and anemia, requiring “aggressive counseling and mitigation.” On the slides, oral mucositis/stomatitis occurred in 57.0% vs 17.4%, ocular surface toxicity in 30.5% vs 6.8% and anemia in 71.4% vs 46.6% (adverse events of special interest); grade 3 treatment-related stomatitis was 9.9% vs 1.6%. After exposure adjustment, event rates were generally similar between arms except higher oral mucositis/stomatitis and ocular surface toxicity with sac-TMT (LBA11 slide). Jordyn Silverstein, MD (UCLA), described the results as practice changing “with proactive stomatitis management.” The current ClinicalTrials.gov record lists steroid mouthwash (dexamethasone or equivalent) among rescue medications given before sac-TMT infusion.
LBA11 presentation slides (Domenica Lorusso, ESMO 2026) · ClinicalTrials.gov NCT06132958Is TROP2 a biomarker, and what comes after an ADC?
Randomization was stratified by TROP2 expression (low vs medium-high, by a Roche immunohistochemistry assay), but patients were not selected on it. González-Martín told ESMO that “While not currently validated, there is a signal that TROP2 could become a biomarker,” and that, as ADCs become standard of care, a biomarker to select patients will be necessary. Before the readout, Mali Barbi, MD (Northwell Health), framed the question as payload and sequence: a tumor that progresses on one payload may need “a different mechanism” next. Moore noted that several other ADCs are in phase 3. Sac-TMT is also being tested earlier: TroFuse-033 (NCT06952504) studies sac-TMT plus pembrolizumab as first-line maintenance in pMMR endometrial cancer.
ESMO Insights, Oct 26, 2026 · LBA11 presentation slides (Domenica Lorusso, ESMO 2026)Physician reactions to TroFuse-005
Sacituzumab tirumotecan in previously treated advanced or recurrent endometrial cancer: Results from the phase 3 TroFuse-005/ENGOT-en23/GOG-3095 study by Domenica Lorusso (Italy) #ESMO2026 https://t.co/ekWkDKGlAK
🩷 #ESMO26 TroFuse-005 (ph III): sacituzumab tirumotecan vs chemo after platinum + IO in advanced endometrial cancer. PFS 7.2 vs 3.9 mo (HR 0.59) OS 19.0 vs 12.1 mo (HR 0.68) ORR 35% vs 17% Potential new option; monitor stomatitis and cytopenias. #gynonc https://t.co/q21z0FcOGy
Sacituzumab tirumotecan versus treatment of physician's choice in previously treated endometrial cancer (TroFuse-005/ENGOT-en23/GOG-3095): a randomised, open-label, phase 3 trial - The Lancet https://t.co/bf16VAZOYo
Been waiting for these positive results which will be practice changing for patients with endometrial cancer with proactive stomatitis management! #ESMO26 https://t.co/LPkNTOp2da
TroFuse-005/GOG-3095 (Lorusso, #ESMO26): Options after carbo/paclitaxel/ICI in recurrent endometrial cancer are limited and poor. Sac-TMT is the first TOP1 ADC to read out positive in phase 3: PFS HR 0.59 (7.2 vs 3.9 mo), ORR 35% vs 17%, plus an OS benefit. That is clinically meaningful and warrants use. The tox is a concern. Stomatitis 57% (mostly low grade, needs prophylactic steroid mouthwash), ocular 31%, anemia 71%. Requires aggressive counseling and mitigation. Several other ADCs are in phase 3, and I hope they match this efficacy with better tolerability. Time will tell. @myESMO
Context: the presented summary slide describes sac-TMT as the first ADC to show statistically significant PFS and OS improvements vs chemotherapy in previously treated advanced endometrial cancer; other topoisomerase I ADCs, including sac-TMT in breast and lung cancer, have positive phase 3 trials in other cancers.
We have new changing practice trial in endometrial cancer in #ESMO2026 !!!! Again the presentation of Dr Lorusso has been absolutely perfect!! Sac-tmt was superior to CT in heavily pretreated endometrial cancer https://t.co/kwqVIBzSgP
TroFuse-005 | ESMO 2026 | LBA11 A TROP2 ADC delivers a survival advantage after platinum + immunotherapy in advanced/recurrent endometrial cancer! Part 1 — Rationale & Design: Sacituzumab tirumotecan (Sac-TMT), a TROP2-directed ADC (DAR ~7.4), versus chemotherapy. Phase III, n=776. Part 2 — Efficacy: PFS: 7.2 vs 3.9 mo | HR 0.59 OS: 19.0 vs 12.1 mo | HR 0.68 ORR: 35.1% vs 17.3% DoR: 11.1 vs 6.9 mo Part 3 — Safety & Verdict: Grade ≥3 TRAEs: 54.4% vs 41.4%. TAKE-HOME: Meaningful OS benefit (+6.9 months in median OS), with greater toxicity. A promising post-IO treatment advance! Ref: Lorusso D et al. TroFuse-005 (ENGOT-en23/GOG-3095). ESMO 2026, LBA11. #ESMO26 #TroFuse005 #EndometrialCancer #ADC #MVOnco @myESMO @OncoAlert
Posted on October 26 before the presentation, from the abstract.
🚨 Nearly 7 MONTHS longer median survival in endometrial cancer! #ESMO26 LBA11 | Phase III TroFuse-005 Sacituzumab tirumotecan vs chemotherapy: 🔹 OS: 19.0 vs 12.1 months (HR 0.68) 🔹 PFS: 7.2 vs 3.9 months (HR 0.59) 🔹 ORR: 35.1% vs 17.3% A potential new standard after platinum + immunotherapy! @myesmo @ESMO_open @oncoalert
Posted on October 26 before the presentation, from the abstract.
ESMO 2026 | TroFuse-005 (LBA11): Sacituzumab tirumotecan (Sac-TMT), a TROP2-directed ADC, delivers BOTH PFS and OS benefit! Phase 3 | N=776 | Previously treated advanced/recurrent endometrial cancer after platinum + immunotherapy. 📊 Sac-TMT vs Physician's Choice: ✅ Median PFS: 7.2 vs 3.9 months (HR 0.59; p<0.0001) ✅ Median OS: 19.0 vs 12.1 months (HR 0.68; p=0.0001) ✅ ORR: 35.1% vs 17.3% ✅ Median DoR: 11.1 vs 6.9 months ⚠️ Grade ≥3 treatment-related AEs: 54.4% vs 41.4% 💡 Take-home: A significant 6.9-month median OS improvement in a difficult-to-treat, post-immunotherapy population! @myESMO @OncoAlert #ESMO26 #TroFuse005 #EndometrialCancer #ADC
Posted on October 26 before the presentation, from the abstract.
#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 abstract was released.
TroFuse-005 Trial Design
TroFuse-005 asked whether a TROP2-directed antibody-drug conjugate could improve survival over single-agent chemotherapy for patients with endometrial cancer whose disease progressed after platinum-based chemotherapy and immunotherapy. It is sponsored by Merck (MSD) with the ENGOT and GOG Foundation trial groups. Results were presented by Domenica Lorusso, MD, at ESMO 2026 (LBA11, Presidential Symposium III, October 26, 2026), with Joyce Liu, MD, MPH, as discussant, and published simultaneously in The Lancet.
Study Design
Randomized 1:1, open-label, active-controlled, global phase 3 trial (NCT06132958; EU CT 2023-504816-14-00). 776 patients randomized: 386 to sac-TMT, 390 to TPC. Stratified by MMR status, TROP2 expression, prior lines of therapy (2 or fewer vs 3) and measurable vs non-measurable disease.
Population
Advanced or recurrent endometrial carcinoma, including carcinosarcoma (capped at 4%), with prior platinum and anti-PD-1/PD-L1 therapy in any setting, separately or together, and up to 3 prior lines. Prior TROP2 or topoisomerase I ADCs excluded. About 85% pMMR (ESMO Insights).
Interventions
Sac-TMT 4 mg/kg IV every 2 weeks vs TPC: doxorubicin 60 mg/m² every 3 weeks (lifetime cap 450 mg/m²) or paclitaxel 80 mg/m² on days 1, 8 and 15 every 4 weeks, until progression or unacceptable toxicity.
Endpoints
Dual primary: PFS by BICR (RECIST 1.1) and OS. Key secondary: ORR by BICR. Other secondary: duration of response, quality of life, safety and tolerability.
Analysis and Data Cut
Pre-specified interim analysis (described on the slide as the final formal analysis); data cutoff March 23, 2026; median follow-up 14.0 months. One-sided boundaries at this analysis: PFS P = 0.0025, OS P = 0.00636 (information fraction 67.5%).
Drug
Sac-TMT (MK-2870, SKB264): TROP2-directed ADC with a belotecan-derived topoisomerase I inhibitor payload (drug-to-antibody ratio 7.4), developed by Kelun-Biotech; Merck holds rights outside Greater China.
TroFuse-005 in the News
TroFuse-005 Questions
What is the TroFuse-005 trial?
TroFuse-005 (MK-2870-005/ENGOT-en23/GOG-3095; NCT06132958) is a global, randomized, open-label phase 3 trial sponsored by Merck (MSD), run with the ENGOT and GOG Foundation trial groups. It enrolled 776 patients with advanced or recurrent endometrial carcinoma, including carcinosarcoma, who had received prior platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy (separately or together), with up to 3 prior lines. Patients were randomized 1:1 to sacituzumab tirumotecan (sac-TMT) 4 mg/kg every 2 weeks or treatment of physician’s choice (TPC): doxorubicin 60 mg/m² every 3 weeks or paclitaxel 80 mg/m² on days 1, 8 and 15 of 28-day cycles.
What did TroFuse-005 show at ESMO 2026?
At the pre-specified interim analysis (data cutoff March 23, 2026; median follow-up 14.0 months), both dual primary endpoints were met. Median PFS by blinded independent central review was 7.2 vs 3.9 months (HR 0.59, 95% CI 0.50–0.70; one-sided P < 0.0001), and median OS was 19.0 vs 12.1 months (HR 0.68, 95% CI 0.55–0.84; one-sided P = 0.0001). The key secondary endpoint, ORR, was 35.1% vs 17.3% (P < 0.00001). Results were presented by Domenica Lorusso, MD, as LBA11 in Presidential Symposium III on October 26, 2026, with a simultaneous publication in The Lancet.
Was this the final analysis?
The presented slide describes it as the pre-specified interim analysis and the final formal analysis. At this interim analysis, the PFS result met the pre-specified one-sided significance boundary of P = 0.0025, OS crossed its boundary of P = 0.00636 (information fraction 67.5%), and ORR crossed its boundary of P = 0.025 (LBA11 slides).
What were the main side effects of sac-TMT?
Grade 3 or higher treatment-related adverse events occurred in 54.4% with sac-TMT vs 41.4% with chemotherapy; discontinuation for treatment-related adverse events was 3.1% vs 4.9%, and 0.8% of patients in each arm died of a treatment-related adverse event (abstract). The most frequent adverse events of special interest with sac-TMT were anemia (71.4% vs 46.6%), oral mucositis/stomatitis (57.0% vs 17.4%) and ocular surface toxicity (30.5% vs 6.8%), mostly dry eye; ILD/pneumonitis occurred in 1.8% vs 0.5% (LBA11 slide). The presenter reported that stomatitis incidence and severity decreased after mitigations including mouthwash prophylaxis.
Is sac-TMT approved for endometrial cancer?
No. Sac-TMT is investigational for endometrial cancer and is not approved by the FDA or EMA for any use. Merck reports that the FDA has accepted a Biologics License Application for priority review, for adults with endometrial cancer previously treated with platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor, with a target action date (PDUFA) of June 15, 2027. In China, sac-TMT is approved by the NMPA in other cancers (breast and lung), not endometrial cancer. Sac-TMT is a different drug from sacituzumab govitecan (TRODELVY).
Who developed sac-TMT?
Sac-TMT (also called MK-2870 and SKB264) is a TROP2-directed antibody-drug conjugate with a belotecan-derived topoisomerase I inhibitor payload, developed by Kelun-Biotech. Merck holds exclusive rights to develop and commercialize it outside Greater China.