Phase II — Sacituzumab govitecan + trastuzumab in HER2+ metastatic breast cancer post-T-DXd. Reported negative primary endpoint at ESMO Breast 2026.
Discover KOL Sentiment on SATEEN →Design - Single-arm investigator-initiated Phase 2 trial of sacituzumab govitecan (Trodelvy, Trop-2 ADC) + trastuzumab (Herceptin) in HER2+ metastatic breast cancer after trastuzumab deruxtecan (T-DXd) (NCT06100874; Dana-Farber, PI A.G. Waks; Gilead drug supply).
Efficacy (primary, NOT MET) - Objective response rate 3.7%; median progression-free survival ~2.3 months; median overall survival 9.2 months - the trial did not meet its primary endpoint in this heavily pretreated population.
Safety - Manageable safety profile consistent with the known toxicities of each agent; no new safety signals with the sacituzumab govitecan plus trastuzumab combination.
Regulatory / sponsor - Investigational and negative; the SG + trastuzumab combination is not FDA approved in HER2+ disease. Sponsor Dana-Farber (Gilead drug supply). ESMO Breast 2026.
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated July 21, 2026.
Trial slides shared by KOLs at ESMO Breast 2026 (#ESMOBreast26). Click any image to expand. OCR text extracted via AWS Textract.
[Slide 1] ESMO BREAST CANCER BERLIN GERMANY Annual Congress 6-8 MAY 2026 ESMO 2026 ESMO BREAST CANCER Annual Congress Sacituzumab govitecan plus trastuzumab in patients with HER2+ metastatic breast cancer after trastuzumab deruxtecan: Results from the phase II SATEEN trial Paolo Tarantino, Luowen Yu. Meredith Faggen, Reshma Mahtani, Denise Yardley, Erin Wallace, Eliza Kallfelz, Esther Pasternak, Alexander Schubert, Ashka Patel, Tasnim Rahman, Chloe Falls, Sarah Bucher, Joanna Baginska, Tianyu Li, Harold J. Burstein, Erica L. Mayer, Nabihah Tayob, Sara M. Tolaney and Adrienne G. Waks Paolo Tarantino, MD, PhD Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA Dana-Farber HARVARD Cancer Institute MEDICAL SCHOOL ESMO 09:09 ENG $0 - e 8 May 2026 ESMO BREAST CANCER --- [Slide 2] ESMO BREAST CANCER BERLIN GERMANY Annual Congress 6-8 MAY 2026 ESMO SATEEN: DESIGN Phase 2, single arm, investigator-initiated, multicenter trial Advanced HER2+ cancer Prior taxane, trastuzumab and ENDPOINTS T-DXd in any setting Sacituzumab govitecan Primary: Progression on T-DXd not required 10 mg/kg IV D1,8 Q21D ORR T-DXd not required to be the + Secondary endpoints: immediate prior line Trastuzumab Q3W (IV or SC) - CBR Patients ineligible for T-DXd allowed - PFS to enroll OS No prior anti-Trop2 ADC ≤5 prior lines of chemo/ADC * Brain metastases allowed# Paolo Tarantino, MD. PhD Content of this presentation is copyright and responsibility of the author Permission is required for no use MO "amended from original protocol which allowed any number of prior lines of treatment # patients with active brain metastases capped at 20% of the study population ESMO BREAST CANCER --- [Slide 3] ESMO BREAST CANCER BERLIN GERMANY Annual Congress 6-8 MAY 2026 ESMO PRIMARY ENDPOINT: OBJECTIVE RESPONSE RATE One confirmed partial response was observed (ORR 3.7%). The trial did not meet its primary endpoint and was stopped after the 1st stage. 100 PATIENTS (N=27) 80 ORR 3.7% (95% CI: 0.1%-19%) Best Response 60 PR CBR > > 18 weeks 14.8% (95% CI: 4%-33%) SD % Change of target lesion 40 PD Symbol Key 20 X Progression on Prior T-DXd : : X No Progression on Prior T-DXd 0 HR+ at enrollment : : : A : . A HR- at enrollment Brain Metastasis at enrollment -20 -40 Prior lines of HER2-directed therapy 574310322671538653422354143 in metastatic setting Content of this presentation is copynght and responsibility of the author Permission is required for no use Paolo Tarantino, MD, PhD ESMO "percent change target lesion capped a 100% for visualization the maximum observed % change was 330% CBR cirical benefit rate CR Confirmed complete response (PR Confirmed cartial response ORR overall response rate SD: stable disease ESMO BREAST CANCER --- [Slide 4] Rapid Oral session 2 CER BERLIN GERMANY Annual Congress 6-8 MAY 2026 ESMO SATEEN TRIAL: CONCLUSIONS SG plus trastuzumab demonstrated an ORR of 3.7% in heavily pre-treated HER2+ metastatic breast cancer after T-DXd The trial did not meet its primary endpoint and stopped at the interim analysis for futility This constitutes the first prospective data for SG + trastuzumab post-T-DXd in HER2+ MBC Safety was consistent with prior SG trials, although these data emphasize the importance of growth factor support during SG therapy, particularly among heavily pretreated patients Biomarker analyses are ongoing to unveil mechanisms of resistance to sequential TOPO1 ADCs and to inform effective post-ADC treatment strategies Paolo Tarantino, MD. PhD Content of this presentation is copynght and responsibility of the author Permission is required for to use ESMO ESMO BREAST CANCER
[Slide 1] ESMO BREAST CANCER BERLIN GERMANY Annual Congress 6-8 MAY 2026 ESMO SATEEN: DESIGN Phase 2, single arm, investigator-initiated, multicenter trial Advanced HER2+ cancer Stage 1 Stage 2 Prior taxane, trastuzumab and n=27 n=40 T-DXd in any setting 3/27 patients 7/40 patients Progression on T-DXd not required Minimum responders Minimum responders T-DXd not required to be the needed to proceed to needed to declare immediate prior line stage 2 promising antitumor Patients ineligible for T-DXd allowed activity to enroll No prior anti-Trop2 ADC STATISTICS: Simon's two-stage design: 27 patients in stage 1, with up to ≤5 prior lines of chemo/ADC * 40 planned overall; 90% power to distinguish an ORR of 25% from a null Brain metastases allowed# ORR of 10% using a one-sided 10% type I error. Paolo Tarantino, MD. PhD Content of this presentation is copyright and responsibility of the author Permission is required for to use ESMO "amended from original protocol which allowed any number of prior lines of treatment # patients with active brain metastases capped at 20% of the study population ESMO BREAST CANCER --- [Slide 2] ESMO BREAST CANCER BERLIN GERMANY Annual Congress 6-8 MAY 2026 ESMO PRIMARY ENDPOINT: OBJECTIVE RESPONSE RATE One confirmed partial response was observed (ORR 3.7%). The trial did not meet its primary endpoint and was stopped after the 1st stage. 100 PATIENTS (N = 27) 80 ORR 3.7% (95% CI: 0.1%-19%) Best Response 60 PR CBR > 18 weeks 14.8% (95% CI: 4%-33%) SD % Change of target lesion 40 PD Symbol Key 20 Progression on Prior T-DXd : : : No Progression on Prior T-DXd 0 HR+ at enrollment . : : : X : : A : ** : *** HR- at enrollment Brain Metastasis at enrollment -20 -40 Prior lines of HER2-directed therapy 51743032267153865342235414 3 in metastatic setting Content of this presentation is copyright and responsibility of the author Permission is required for to use Paolo Tarantino, MD, PhD ESMO "percent change capped if 100% for visialization the maxment observed % change was 330% CBR circal benefit rate CR Confirmed complete response (PR Confirmed partial response ORR (veral response rate so stable disease ESMO BREAST CANCER --- [Slide 3] ESMO BREAST CANCER BERLIN GERMANY Annual Congress 6-8 MAY 2026 ESMO SATEEN: TOXICITY Grade 2+ TRAEs occurring in >10% of pts: The most common grade ≥2 treatment-related adverse events (TRAEs) were anemia, neutropenia, diarrhea Grade ≥2 Grade 3 Grade 4 and fatigue. Any TRAE 23 (85%) 13 (48%) 7 (26%) Anemia 9 patients (33%) required dose modifications due to 16 (59%) 7 (26%) - adverse events Neutropenia 16 (59%) 8 (30%) 8 (30%) Diarrhea 8 (30%) 5 (19%) - There was one grade 5 TRAE (neutropenic sepsis with - multi-organ failure) after which mandatory growth Fatigue 7 (26%) 1 (4%) factor support after day 8 (+/- after day 1) was Thrombocytopenia 5 (19%) - 1 (4%) implemented in the study. Alopecia 4 (15%) - - Nausea 3 (11%) 1 (4%) - Paolo Tarantino, MD. PhD Content of this presentation is copyright and responsibility of the author Permission is required for to use ESMO Grade 1 AEs were not recorded per protocol ESMO BREAST CANCER --- [Slide 4] ESMO BREAST CANCER BERLIN GERMANY Annual Congress 6-8 MAY 2026 ESMO SATEEN TRIAL: CONCLUSIONS SG plus trastuzumab demonstrated an ORR of 3.7% in heavily pre-treated HER2+ metastatic breast cancer after T-DXd The trial did not meet its primary endpoint and stopped at the interim analysis for futility This constitutes the first prospective data for SG + trastuzumab post-T-DXd in HER2+ MBC Safety was consistent with prior SG trials, although these data emphasize the importance of growth factor support during SG therapy, particularly among heavily pretreated patients Biomarker analyses are ongoing to unveil mechanisms of resistance to sequential TOPO1 ADCs and to inform effective post-ADC treatment strategies Paolo Tarantino, MD. PhD Content of this presentation IN copyright and responsibility of the author Permission is required for re use ESMO ESMO 1 BREAST CANCER
[Slide 1] ESMO BREAST CANCER BERLIN GERMANY Annual Congress 6-8 MAY 2026 ESMO SATEEN: DESIGN Phase 2, single arm, investigator-initiated, multicenter trial Advanced HER2+ cancer Stage 1 Stage 2 Prior taxane, trastuzumab and n=27 n=40 T-DXd in any setting 3/27 patients 7/40 patients Progression on T-DXd not required Minimum responders Minimum responders T-DXd not required to be the needed to proceed to needed to declare immediate prior line stage 2 promising antitumor Patients ineligible for T-DXd allowed activity to enroll No prior anti-Trop2 ADC STATISTICS: Simon's two-stage design: 27 patients in stage 1, with up to ≤5 prior lines of chemo/ADC * 40 planned overall; 90% power to distinguish an ORR of 25% from a null Brain metastases allowed* ORR of 10% using a one-sided 10% type I error. Paolo Tarantino, MD, PhD Content of this presentation is copynght and responsibility of the author Permission 8 required for re use ESMO "amended from original protocol which allowed any number of prior lines of treatment; # patients with active brain metastases capped at 20% of the study population ESMO BREAST CANCER --- [Slide 2] BERLIN GERMANY 6-8 MAY 2026 ESMO PRIMARY ENDPOINT: OBJECTIVE RESPONSE RATE One confirmed partial response was observed (ORR 3.7%). The trial did not meet its primary endpoint and was stopped after the 1st stage. 100 PATIENTS (N = 27) 80 ORR 3.7% (95% CI: 0.1%-19%) Best Response 60 PR CBR > 18 weeks 14.8% (95% Cl: 4%-33%) SD % Change of target lesion 40 PD Symbol Key 20 X Progression on Prior T-DXd X No Progression on Prior T-DXd X X X X 0 HR+ at enrollment A HR- at enrollment Brain Metastasis at enrollment -20 -40 Prior lines of HER2-directed therapy 51743032267153865342235443 in metastatic setting Content of this presentation is copyright and responsibility of the author Permission is required for re use Paolo Tarantino, MD, PhD ESMO "percent change in target lesion IS capped at 100% for visualization the maximum observed % change was 330% CBR clinical benefit rate: CCR Confirmed complete response cPR Confirmed cartial response ORR overall response rate SD stable disease ESMO BREAST CANCER --- [Slide 3] BERLIN GERMANY 6-8 MAY 2026 ESMO SATEEN: SURVIVAL OUTCOMES Progression-free Survival Overall Survival Median PFS: 2.3 months Median OS: 9.2 months 1.0 1.0 95% CI (2.0-3.5) 95% CI (7.6-NR) Probability of Progression-Free Survival 0.8 0.8 0.6 0.4 Probability of Overall Survival 0.6 0.4 0.2 0.2 0.0 0.0 0 1 2 3 4 5 6 7 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Months from Registration Months from Registration Number at risk Number at risk All 27 25 17 9 6 3 2 1 All 27 25 24 20 15 13 12 12 11 9 7 6 5 5 4 3 1 1 0 Paolo Tarantino, MD, PhD Content of this presentation is copyright and responsibility of the author Permission is required for re use ESMO ESMO BREAST CANCER
[Slide 1] SATEEN: DESIGN Phase 2, single arm, investigator-initiated, multicenter trial Advanced HER2+ cancer Prior taxane, trastuzumab and ENDPOINTS T-DXd in any setting Sacituzumab govitecan Primary: Progression on T-DXd not required 10 mg/kg IV D1,8 Q21D ORR T-DXd not required to be the + Secondary endpoints: immediate prior line Trastuzumab Q3W (IV or SC) - CBR Patients ineligible for T-DXd allowed - PFS to enroll - OS No prior anti-Trop2 ADC ≤5 prior lines of chemo/ADC* Brain metastases allowed# Paolo Tarantino, MD. PhD Content of this presentation is copyright and responsibility of the author Permission is required for re use ESMO "amended from original protocol which allowed any number of prior lines of treatment; # patients with active brain metastases capped at 20% of the study population ESMO BREAST CANCER --- [Slide 2] PRIMARY ENDPOINT: OBJECTIVE RESPONSE RATE One confirmed partial response was observed (ORR 3.7%). The trial did not meet its primary endpoint and was stopped after the 1st stage. 100 PATIENTS (N=27) 80 ORR 3.7% (95% CI: 0.1%-19%) Best Response 60 PR CBR > 18 weeks 14.8% (95% CI: 4%-33%) SD % Change of target lesion 40 PD Symbol Key 20 Progression on Prior T-DXd X No Progression on Prior T-DXd 0 HR+ at enrollment : : *** : *** : : ** A : : *** *** HR- at enrollment Brain Metastasis at enrollment -20 - -40 Prior lines of HER2-directed therapy 51743032267153865342235443 in metastatic setting Content of this presentation is copyright and responsibility of the author Permission 15 required for re use Paolo Tarantino, MD, PhD ESMO "percent change n target term capped at 100% for visualization: the maximum observed % change was 330% CBR circal benefit rate: CR Confirmed complete response (PR Confirmed certify response: ORR overan response rate so stable disease ESMO BREAST CANCER --- [Slide 3] SATEEN: TOXICITY Grade 2+ TRAEs occurring in >10% of pts: The most common grade ≥2 treatment-related adverse events (TRAEs) were anemia, neutropenia, diarrhea Grade ≥2 Grade 3 Grade 4 and fatigue. Any TRAE 23 (85%) 13 (48%) 7 (26%) Anemia 9 patients (33%) required dose modifications due to 16 (59%) 7 (26%) - adverse events Neutropenia 16 (59%) 8 (30%) 8 (30%) Diarrhea 8 (30%) 5 (19%) - Fatigue 7 (26%) 1 (4%) - Thrombocytopenia 5 (19%) - 1 (4%) Alopecia 4 (15%) - - Nausea 3 (11%) 1 (4%) - Paolo Tarantino, MD, PhD Content of this presentation is copyright and responsibility of the author Permission is required for re use ESMO Grade 1 AEs were not recorded per protocol --- [Slide 4] SATEEN TRIAL: CONCLUSIONS SG plus trastuzumab demonstrated an ORR of 3.7% in heavily pre-treated HER2+ metastatic breast cancer after T-DXd The trial did not meet its primary endpoint and stopped at the interim analysis for futility This constitutes the first prospective data for SG + trastuzumab post-T-DXd in HER2+ MBC Safety was consistent with prior SG trials, although these data emphasize the importance of growth factor support during SG therapy, particularly among heavily pretreated patients Biomarker analyses are ongoing to unveil mechanisms of resistance to sequential TOPO1 ADCs and to inform effective post-ADC treatment strategies Paolo Tarantino, MD. PhD Content of this presentation is copyright and responsibility of the author Permission IS required for re use ESMO ESMO BREAST CANCER
[Slide 1] 2026 ESMO BREAST CANCER Annual Congress Sacituzumab govitecan plus trastuzumab in patients with HER2+ metastatic breast cancer after trastuzumab deruxtecan: Results from the phase II SATEEN trial Paolo Tarantino, Luowen Yu, Meredith Faggen, Reshma Mahtani, Denise Yardley, Erin Wallace, Eliza Kallfelz, Esther Pasternak, Alexander Schubert, Ashka Patel, Tasnim Rahman, Chloe Falls, Sarah Bucher, Joanna Baginska, Tianyu Li, Harold J. Burstein, Erica L. Mayer, Nabihah Tayob, Sara M. Tolaney and Adrienne G. Waks Paolo Tarantino, MD, PhD Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA Dana-Farber HARVARD Cancer Institute MEDICAL SCHOOL ESMO --- [Slide 2] SATEEN: DESIGN Phase 2, single arm, investigator-initiated, multicenter trial Advanced HER2+ cancer Prior taxane, trastuzumab and ENDPOINTS T-DXd in any setting Sacituzumab govitecan Primary: Progression on T-DXd not required 10 mg/kg IV D1,8 Q21D - ORR T-DXd not required to be the + Secondary endpoints: immediate prior line Trastuzumab Q3W (IV or SC) - CBR Patients ineligible for T-DXd allowed - PFS to enroll - OS No prior anti-Trop2 ADC ≤5 prior lines of chemo/ADC* Brain metastases allowed# Paolo Tarantino, MD, PhD Content of this presentation is copyright and responsibility of the author Permission is required for re use ESMO "amended from original protocol which allowed any number of prior lines of treatment # patients with active brain metastases capped at 20% of the study population --- [Slide 3] PRIMARY ENDPOINT: OBJECTIVE RESPONSE RATE One confirmed partial response was observed (ORR 3.7%). The trial did not meet its primary endpoint and was stopped after the 1st stage. 100 PATIENTS (N = 27) 80 ORR 3.7% (95% CI: 0.1%-19%) Best Response 60 PR CBR > 18 weeks 14.8% (95% CI: 4%-33%) SD % Change of target lesion 40 PD Symbol Key 20 X Progression on Prior T-DXd X No Progression on Prior T-DXd X X 0 HR+ at enrollment X X X A A A A HR- at enrollment Brain Metastasis at enrollment -20 -40 Prior lines of HER2-directed therapy 51743032267153865342235443 in metastatic setting Content of this presentation is copyright and responsibility of the author Permission is required for re use Paolo Tarantino, MD, PhD ESMO "percent change in target lesion is capped at 100% for visualization the maximum observed % change was 330% CBR clinical benefit rate CCR Confirmed complete response CPR Confirmed partial response ORR overall response rate SD stable disease --- [Slide 4] SATEEN: TOXICITY Grade 2+ TRAEs occurring in >10% of pts: The most common grade ≥2 treatment-related adverse events (TRAEs) were anemia, neutropenia, diarrhea Grade ≥2 Grade 3 Grade 4 and fatigue. Any TRAE 23 (85%) 13 (48%) 7 (26%) Anemia 9 patients (33%) required dose modifications due to 16 (59%) 7 (26%) - adverse events Neutropenia 16 (59%) 8 (30%) 8 (30%) Diarrhea 8 (30%) 5 (19%) - Fatigue 7 (26%) 1 (4%) - Thrombocytopenia 5 (19%) - 1 (4%) Alopecia 4 (15%) - - Nausea 3 (11%) 1 (4%) - Paolo Tarantino, MD, PhD Content of this presentation is copyright and responsibility of the author Permission is required for re use ESMO Grade 1 AEs were not recorded per protocol
[Slide 1] SATEEN: DESIGN Phase 2, single arm, investigator-initiated, multicenter trial Advanced HER2+ cancer Prior taxane, trastuzumab and ENDPOINTS T-DXd in any setting Sacituzumab govitecan Primary: Progression on T-DXd not required 10 mg/kg IV D1,8 Q21D - ORR T-DXd not required to be the + immediate prior line Secondary endpoints: Patients ineligible for T-DXd allowed Trastuzumab Q3W (IV or SC) CBR to enroll PFS - OS No prior anti-Trop2 ADC ≤5 prior lines of chemo/ADC* Brain metastases allowed# Paolo Tarantino, MD, PhD Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESMO amended from original protocol which allowed any number of prior lines of treatment # patients with active brain metastases capped at 20% of the study population
Highest-engagement tweets about this trial, ranked by KOL discussant count (replies + quote-tweets). Replies in green, quote-tweets in blue. Wall Street, stock-promo, and non-substantive replies excluded.
#ESMOBreast26 SATEEN is negative, but highly informative. Mechanistically, SG + trastuzumab was a reasonable idea after T-DXd, especially for tumors with HER2 loss or reduced HER2 dependency. But the efficacy was very limited. ADC resistance is layered: target expression, https
@myESMO #ESMOBC26 @PTarantinoMD SATEEN trial SG +T in 27 TDXd rx’d HER2+ pts w/ MBC. ORR 3.7% in very heavily preRx (5+ lines). Chemo resistant dse w/ topo1 inh ADC post #’s of effective HER2 targeted Rx - nothing works here - impossible task! Nice presentation! @OncoAlert https:
📌 Results from the phase II SATEEN trial Efficacy and safety of sacituzumab govitecan plus trastuzumab in patients with HER2+ metastatic breast cancer after prior trastuzumab deruxtecan (T-DXd) @PTarantinoMD #ESMOBreast26 @OncoAlert #OncoAlertAF https://t.co/cIZv8ZU0t1
SATEEN beautifully presented by @PTarantinoMD SG+ Trastuzumab in pts with HER2+ MBC post TDXd 2-stage single-arm ph 2 trial, didn't get to 2nd stage Median 5 prior lines ORR 3.7% (1 PR in 27 pts) CBR 14.8% #ESMOBreast26 @OncoAlert @DFCI_BreastOnc
SATEEN was a Phase II investigator-initiated trial evaluating sacituzumab govitecan (SG, anti-Trop-2 antibody-drug conjugate) combined with trastuzumab in patients with HER2-positive metastatic breast cancer who had progressed after prior taxane, trastuzumab, and trastuzumab deruxtecan (T-DXd). Presented at ESMO Breast 2026, the trial was designed to test whether re-targeting Trop-2 with SG plus continued HER2 blockade could rescue activity in heavily pretreated patients with limited remaining options. The primary endpoint of objective response rate was not met, with the trial reporting an ORR of 3.7% and short progression-free survival of approximately 2.3 months. Despite the negative result, KOLs noted the trial provides important prospective data on Trop-2 ADCs after T-DXd progression and may inform future biomarker-driven sequencing strategies.
Population: Patients with HER2-positive metastatic breast cancer who had received prior taxane chemotherapy, trastuzumab, and T-DXd, with measurable disease and progression on most recent therapy.
Interventions: Sacituzumab govitecan (SG, anti-Trop-2 ADC with SN-38 payload) administered intravenously in combination with trastuzumab as continued HER2-directed therapy.
Endpoints: Primary endpoint: objective response rate (ORR) by RECIST 1.1. Secondary endpoints included progression-free survival, overall survival, duration of response, and safety/tolerability.
The trial did not meet its primary endpoint. SG plus trastuzumab demonstrated limited efficacy in this heavily pretreated HER2+ population: ORR of 3.7%, median PFS of approximately 2.3 months, and median OS of 9.2 months. KOL commentary highlighted that mechanistic overlap between T-DXd and SG (both targeting topoisomerase I via different antibody-payload combinations) likely contributed to the lack of activity post-T-DXd progression.
The combination demonstrated a manageable safety profile consistent with the known toxicities of each individual agent. No new safety signals emerged with the SG + trastuzumab combination. Adverse events were primarily attributable to SG, with neutropenia and gastrointestinal toxicity being the most common. Discontinuations due to toxicity were limited.
⚠️ SATEEN is an investigational trial that did not meet its primary endpoint and does not support a new clinical indication for SG plus trastuzumab in HER2+ MBC after T-DXd. The negative result highlights the challenge of sequencing topoisomerase-I-targeting ADCs and reinforces the need for biomarker-driven patient selection — particularly Trop-2 expression and tumor heterogeneity assessment — when designing post-T-DXd salvage strategies. KOLs (notably Dr. Yakup Ergün, Dr. Sara Tolaney, Dr. Hope Rugo, Dr. Paolo Tarantino) emphasized this trial's value in providing prospective data that informs the broader question of ADC sequencing in HER2+ disease.
SATEEN (NCT06100874) is a single-arm, investigator-initiated Phase 2 trial from the Dana-Farber Cancer Institute (principal investigator Adrienne G. Waks, with drug supplied by Gilead) that tested the Trop-2 antibody-drug conjugate sacituzumab govitecan (Trodelvy) combined with trastuzumab (Herceptin) in patients with HER2-positive metastatic breast cancer whose disease progressed after trastuzumab deruxtecan (T-DXd).
SATEEN did not meet its primary endpoint. In this heavily pretreated HER2-positive population, sacituzumab govitecan plus trastuzumab produced an objective response rate of only 3.7%, with a median progression-free survival of about 2.3 months and a median overall survival of 9.2 months, indicating limited efficacy of the combination after T-DXd.
No. The combination tested in SATEEN is not FDA approved for HER2-positive metastatic breast cancer and did not meet its primary endpoint. Sacituzumab govitecan (Trodelvy) and trastuzumab (Herceptin) are each separately FDA-approved in other breast-cancer settings, but their combination in this post-T-DXd HER2-positive population is investigational.
The combination showed a manageable safety profile consistent with the known toxicities of sacituzumab govitecan and trastuzumab individually, and no new safety signals emerged with the combination. The limiting factor in SATEEN was efficacy rather than tolerability.
SATEEN addresses a pressing clinical question - what to give after trastuzumab deruxtecan in HER2-positive metastatic breast cancer, an increasingly common and difficult scenario. The negative result helps clinicians avoid an ineffective combination and refocuses attention on other post-T-DXd strategies, making it a useful, hypothesis-clarifying study even though the primary endpoint was not met.
| Handle | Name | Sentiment | Tweet (excerpt) | Imp. |
|---|---|---|---|---|
| @PTarantinoMD | Paolo Tarantino | Positive | It will be the first prospective data of SG after T-DXd and the first data of SG in HER2+ disease. We’re very glad to ha… | 1,405 |
| @dr_yakupergun | Yakup Ergün | Neutral | #ESMOBreast26 SATEEN is negative, but highly informative. Mechanistically, SG + trastuzumab was a reasonable idea after… | 10,528 |
| @DrBarbiOnc | Mali Barbi, MD MSc | Breast & Gyn Oncolo | Neutral | Two prospective phase II trials at #ESMOBC26 just settled something the field has been debating retrospectively. #SATEE… | 3,602 |
| @TejasPatilMD | Tejas Patil | Neutral | ⭐️Everything in this post is directly relevant to #lungcancer as well. #SATEEN answers the value of using sequential ADC… | 1,788 |
| @to_be_elizabeth | Elisabetta Bonzano MD, PhD | Neutral | 📌 Results from the phase II SATEEN trial Efficacy and safety of sacituzumab govitecan plus trastuzumab in patients with … | 1,482 |
