Abstract
Background
Sacituzumab tirumotecan (sac-TMT) is a novel anti-trophoblast cell-surface antigen 2 antibody-drug conjugate and has been approved for second-line and subsequent treatment of metastatic triple-negative breast cancer (TNBC) in China. This post-hoc exploratory study aims to further characterize the safety profile of sac-TMT to inform clinical practice.
Methods
This analysis was based on the safety set from the OptiTROP-Breast01 study, including all subjects who have received at least one dose of sac-TMT or treatment of physician’s choice (TPC). Frequencies and patterns of the adverse events (AEs) were reported. Particular emphasis was placed on hematologic toxicities (including anemia, neutropenia, thrombocytopenia) and stomatitis, which were defined as key AEs in this study.
Results
262 patients (130 for sac-TMT, 132 for TPC) were included. Median time to the onset of grade 3 or higher key AEs primarily occurred within the first two cycles. Most patients with key AEs in the sac-TMT arm ultimately recovered to grade 2 or lower, typically within 14 days. Efficacy was generally comparable among subgroups with early/late dose reduction (reduction within/after 2 months from treatment initiation), or without dose reduction of sac-TMT. Among patients with treatment duration more than 7 months, the incidence of treatment related AEs (TRAEs), including both any grade and grade 3 or higher TRAEs, decreased over time.
Conclusion
Sac-TMT demonstrated a manageable safety profile, with adverse events effectively managed through dose modification and appropriate supportive care without compromising its efficacy. Long-term use of sac-TMT further supports its manageable toxicity profile.
ClinicalTrials.gov identifier
Study registration dates
2022-04-26.
Supplementary Information
The online version contains supplementary material available at https://doi.org/10.1186/s13058-026-02339-z.
Keywords: Triple-negative breast cancer, Antibody-drug conjugates, Sacituzumab tirumotecan, Anemia, Neutropenia, Thrombocytopenia, Stomatitis
Translational relevance
TNBC represents the most intractable subtype of breast cancer with unsatisfactory outcomes. Based on the positive results from the OptiTROP-Breast01 study, sac-TMT has been approved for second-line and subsequent treatment of metastatic TNBC in China. Comprehensive evidence specifically detailing its safety profile remains unavailable. This safety analysis based on the randomized OptiTROP-Breast01 study specifically focused on the onset time of adverse events (AEs), their clinical management and outcomes, long-term safety of sac-TMT, and the impact of AE-induced dose reductions on treatment efficacy, thereby providing guidance for clinical practice.
Introduction
Triple-negative breast cancer (TNBC) is characterized by the negative expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor 2 (HER2). Chemotherapy remained the standard of care for patients with metastatic TNBC for a long time with unsatisfactory outcomes [1–3]. Currently, antibody drug conjugates (ADCs) have become important modality of treatment in advanced TNBC [4, 5], such as the anti-trophoblast cell-surface antigen 2 (anti-TROP2) ADC sacituzumab govitecan (SG) for previously treated TNBC and the anti-HER2 ADC trastuzumab deruxtecan (also known as DS-8201/T-DXd) which is indicated for HER2-low metastatic breast cancer [6, 7]. Another anti-TROP2 ADC, datopotamab deruxtecan (Dato-DXd), with the same payload of T-DXd has also demonstrated antitumor activity in TNBC across multiple clinical studies [8, 9]. Sacituzumab tirumotecan (sac-TMT; also known as MK-2870/SKB264) is a novel TROP2 ADC but with a different structure and mechanism of action compared to SG and Dato-DXd. It is developed with a proprietary Kthiol (pyrimidine-thiol) linker to conjugate its payload a belotecan-derivative topoisomerase I inhibitor, to achieve an average drug-to-antibody ratio of 7.4. The unique, bifunctional linker maximizes payload delivery to tumor cells both through its irreversible connection with the antibody and its pH-sensitive cleavage from the payload in the lysosome. The membrane-permeability of the payload enables a bystander effect in nearby tumor cells. Based on the positive results from the OptiTROP-Breast01 study, sac-TMT has been approved for second-line and subsequent treatment of metastatic TNBC in China [3].
With gradually increasing wide application of ADCs in TNBC, a focus on safety and tolerability is critical for optimizing their efficacy. The complexity of ADCs, involving antibodies, cytotoxic payloads, linkers, and conjugation methods, results in unique adverse event profiles and significant heterogeneity in safety across different agents [10, 11]. SN-38, the cytotoxic payload of SG, is a topoisomerase-1 inhibitor and the active metabolite of irinotecan. As previously reported in the safety analysis of the ASCENT study, it is associated with severe or life-threatening neutropenia and diarrhea, resulting in warnings and/or precautions in the relevant prescribing information for SG [12]. Deruxtecan (DXd)-based ADCs have demonstrated efficacy in multiple cancer types, the payload of which (DXd) is a topoisomerase I inhibitor of 10-fold potency compared to SN-38 in vitro [13]. However, interstitial lung disease (ILD) is a significant adverse event associated with DXd-based ADCs, including T-DXd and Dato-DXd, limiting their tolerance [14–17]. Previous studies have proposed that although specific mechanism of ILD induced by DXd-based ADCs is yet to be elucidated, the carried payload partly play a role [18]. Meanwhile, as a novel anti-TROP2 ADC, sac-TMT demonstrated a different safety profile compared to T-DXd and SG, characterized by a low incidence of ILD and manageable hematologic toxicities through dose modifications and appropriate supportive care [3].
While the safety profiles of SG and DXd-based ADCs have been extensively documented in pivotal trials (e.g., ASCENT, DESTINY/TROPION-Breast series) and post-marketing real-world studies [19–22], the safety profile of sac-TMT requires detailed analysis to inform clinical practice. Therefore, this post-hoc exploratory study aims to further characterize the safety profile of sac-TMT based on data from the OptiTROP-Breast 01 study. Particular emphasis is placed on the adverse events of hematologic toxicities (including anemia, neutropenia, thrombocytopenia) and stomatitis. Common adverse events associated with other ADCs approved for advanced TNBC were also reported, including diarrhea, interstitial lung disease, ocular toxicity, hepatotoxicity and infusion-related reaction/hypersensitivity.
Methods
Study design, patients, and procedures
OptiTROP-Breast01 is a phase 3, multicenter, open-label, randomized, controlled trial (ClinicalTrials.gov Identifier: NCT05347134). The methods used in the trial have been previously reported [3]. The primary endpoint was progression-free survival (PFS) as assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary endpoints included overall survival (OS) and safety of sac-TMT.
Treatment
Patients with previously treated metastatic TNBC were enrolled and randomly assigned in a 1:1 ratio to receive sac-TMT or treatment of physician’s choice (TPC), stratified at randomization according to lines of prior therapy (2 or 3 vs. > 3) and presence of liver metastases (yes vs. no). The full eligibility criteria of the patients have been previously reported [3].
In the sac-TMT arm, patients received 5 mg/kg sac-TMT intravenously once every two weeks over a 28-day cycle. Patients in the TPC arm received one of the following four options at the physician’s discretion: eribulin, given intravenously at 1.4 mg/m2 on days 1 and 8 of a 21-day cycle; capecitabine, given as oral tablets at 1000–1250 mg/m2 twice daily on days 1 through 14 of a 21-day cycle; gemcitabine, given intravenously at 1000 mg/m2 on days 1 and 8 of a 21-day cycle; or vinorelbine, given intravenously at 25 mg/m2 on days 1 and 8 of a 21-day cycle.
All treatments were administered to patients until disease progression, unacceptable toxicity, or any other reason for discontinuation. Dose interruptions and dose reduction were allowed for adverse events (AEs) according to the OptiTROP-Breast01 Protocol.
Assessments
Adverse events were observed and recorded from signing the informed consent form until 30 days after the last dose, and only adverse events related to study intervention were recorded from signing the informed consent form until the first dose. The AEs occurred were required to be followed up until resolution or becoming stable as judged by the investigator, subjects lost to follow-up, or the event can be otherwise explained.
AEs were graded per Common Terminology Criteria for Adverse Events version 5.0 and were summarized using Medical Dictionary for Regulatory Activities preferred terms version 25.0.
Statistical analysis
Full statistical analysis plan has been reported elsewhere [3]. Safety analyses were conducted based on the safety set (SS) which consists of all subjects who have received at least one dose of the study drugs. Frequencies and patterns of the AEs were reported through descriptive statistics according to the treatment arm.
To detect the impact of dose reduction on efficacy of sac-TMT, a landmark analysis was conducted to avoid immortal bias [23, 24]. The landmark time point of 2 months was selected to allow for assessment while providing sufficient time for potential dose reductions. Patients with a PFS shorter than the landmark time were excluded from the landmark analysis. The remaining patients were categorized into three groups according to the timing of the first dose reduction. An early dose reduction was defined as the first reduction occurring before the landmark time point of 2 months. A first dose reduction occurring after the landmark time point was defined as a late dose reduction, whereas patients who did not undergo any dose reduction were categorized as the without dose reduction group. The PFS and OS were then recalculated starting from the landmark point (rather than from randomization), using the Kaplan-Meier method, with medians and corresponding 95% confidence intervals (CIs) determined according to the Brookmeyer and Crowley method with log-log transformation. All calculations and analyses were performed using SAS (version 9.4).
Results
Patient disposition and baseline characteristics
Initially, a total of 263 patients were enrolled and assigned to receive study treatment. One patient assigned to the TPC arm did not receive any study treatment and was consequently excluded from the safety analysis. Therefore, a total of 262 patients were included in the safety set, with 130 patients in the sac-TMT arm and 132 in the TPC arm. Among patients in the TPC arm, 88 (66.67%) received eribulin, 4 (3.03%) capecitabine, 20 (15.15%) gemcitabine, and 20 (15.15%) vinorelbine.
As previously reported in the OptiTROP-Breast 01 study, at the data cutoff date of November 30, 2023, 28 patients (21.5%) continued treatment with sac-TMT and 2 patients (1.5%) continued chemotherapy. The most common reason for treatment discontinuation was disease progression, occurring in 73 patients receiving sac-TMT and 106 patients receiving TPC (Supplementary Fig. 1).
Baseline patient characteristics were well balanced between the two arms. The median age was 51 years, with the majority of patients under 65 years old (91.5% [119/130] in the sac-TMT arm and 89.4% [118/132] in the TPC arm). All patients were female (100%) in both groups. Baseline Eastern Cooperative Oncology Group (ECOG) performance status showed that the majority of patients had a score of 1, with 69.2% (90/130) in the sac-TMT arm and 71.2% (94/132) in the TPC arm. The median number of previous chemotherapy lines in advanced setting was 3 (range, 2–6) in the sac-TMT arm and 2 (range, 2–6) in the TPC arm (Table 1).
Table 1.
Baseline Patient Characteristics (Safety Population)
| Sac-TMT (N = 130) |
TPC (N = 132) |
|
|---|---|---|
| Female, n (%) | 130 (100) | 132 (100) |
| Median age (range), years | 51.0 (19, 70) | 51 (25, 72) |
| Age < 65 years, n (%) | 119 (91.5) | 118 (89.4) |
| TNBC at initial diagnosis, n (%) | 92 (70.8) | 87 (65.9) |
| ECOG performance status, n (%) | ||
| 0 | 40 (30.8) | 38 (28.8) |
| 1 | 90 (69.2) | 94 (71.2) |
| Location of metastases, n (%) | ||
| Lymph node | 81 (62.3) | 75 (56.8) |
| Lung | 62 (47.7) | 63 (47.7) |
| Liver | 45 (34.6) | 45 (34.1) |
| Visceral sites | 115 (88.5) | 112 (84.8) |
| Prior therapy | ||
| Taxane | 130 (100) | 132 (100) |
| Anthracycline(s) | 122 (93.8) | 121 (91.7) |
| PD-1 or PD-L1 inhibitor(s) | 32 (24.6) | 36 (27.3) |
| (Neo)adjuvant | 116 (89.2) | 117 (88.6) |
| Previous chemotherapy lines in advanced setting, n (%) | ||
| Median (range) | 3.0 (2, 6) | 2.0 (2, 6) |
| 2 lines, n (%) | 62 (47.7) | 75 (56.8) |
| 3 lines, n (%) | 52 (40.0) | 37 (28.0) |
| > 3 lines, n (%) | 16 (12.3) | 20 (15.2) |
Data cutoff: November 30, 2023
ECOG Eastern Cooperative Oncology Group, sac-TMT sacituzumab tirumotecan, TNBC triple-negative breast cancer
Safety by treatment arm
The median duration of exposure was 24.9 weeks (range, 2.0 to 66.1 weeks) for sac-TMT and 8.6 weeks (range, 1.0 to 65.0 weeks) for TPC. The median relative dose intensity (RDI) was 89.5% with sac-TMT and 95.5% with TPC (Supplementary Table 1).
Comparable treatment-related adverse event (TRAE) profiles were observed between the sac-TMT and TPC arms. All patients treated with sac-TMT experienced TRAEs of any grade, with grade 3 or 4 events occurring in 82 patients (63.1%). In the TPC arm, 127 patients (96.2%) reported TRAEs of any grade, including 75 cases (56.8%) of grade 3 or higher. The sac-TMT arm demonstrated a higher frequency of dose modifications, with dose reductions in 40 patients (30.8%), compared to 21 patients (15.9%) in the TPC arm. Treatment interruptions were more frequent with sac-TMT (73 patients, 56.2%) than with chemotherapy (54 patients, 40.9%). TRAEs led to discontinuation in 1.5% of patients in both the sac-TMT and TPC arms (2 patients each). One fatal TRAE (multiple organ dysfunction syndrome) occurred in the sac-TMT arm, while no fatal TRAEs were documented in the TPC arm. As previously reported, this patient received only one dose of sac-TMT, and death occurred 24 days after administration. The investigator assessed that the possible causes of death included confounding factors such as pre-existing coronavirus disease 2019 (COVID-19) infection, rapid tumor progression, and liver failure due to acute cholecystitis [3] (Supplementary Table 2).
TRAEs with an incidence of ≥ 10% in either treatment group were summarized for events of any grade and grade 3 or higher (Supplementary Tables 3 & 4). Among grade 3 or higher TRAEs, the most common adverse events were hematologic toxicities and stomatitis. Therefore, particular emphasis is placed on anemia, neutropenia, thrombocytopenia and stomatitis, which were defined as key adverse events in this study. In addition to the key adverse events, common adverse events associated with other ADCs approved for advanced TNBC were also reported, including diarrhea, interstitial lung disease, ocular toxicity, hepatotoxicity and infusion-related reaction/hypersensitivity.
Anemia
Treatment related anemia was more frequent in sac-TMT arm compared to TPC arm (any grade: 82.3% vs. 54.5%; grade 3 or higher: 29.2% vs. 6.1%) (Table 2).
Table 2.
Summary of Key Adverse Events in the Safety Population
| Sac-TMT (N = 130) n (%) |
TPC (N = 132) n (%) |
|
|---|---|---|
| Anemia | ||
| TRAE of any grade | 107 (82.3) | 72 (54.5) |
| TRAE of grade 3 or higher | 38 (29.2) | 8 (6.1) |
| TRAE leading to dose reduction | 20 (15.4) | 1 (0.8) |
| TRAE leading to treatment interruption | 20 (15.4) | 4 (3.0) |
| TRAE leading to treatment discontinuation | 0 | 0 |
| TRAE leading to death | 0 | 0 |
| Neutropenia | ||
| TRAE of any grade | 102 (78.5) | 98 (74.2) |
| TRAE of grade 3 or higher | 45 (34.6) | 62 (47.0) |
| TRAE leading to dose reduction | 5 (3.8) | 15 (11.4) |
| TRAE leading to treatment interruption | 31 (23.8) | 38 (28.8) |
| TRAE leading to treatment discontinuation | 0 | 0 |
| TRAE leading to death | 0 | 0 |
| Thrombocytopenia | ||
| TRAE of any grade | 53 (40.8) | 34 (25.8) |
| TRAE of grade 3 or higher | 17 (13.1) | 5 (3.8) |
| TRAE leading to dose reduction | 3 (2.3) | 5 (3.8) |
| TRAE leading to treatment interruption | 12 (9.2) | 9 (6.8) |
| TRAE leading to treatment discontinuation | 0 | 0 |
| TRAE leading to death | 0 | 0 |
| Stomatitis | ||
| TRAE of any grade | 64 (49.2) | 6 (4.5) |
| TRAE of grade 3 or higher | 13 (10.0) | 1 (0.8) |
| TRAE leading to dose reduction | 10 (7.7) | 0 |
| TRAE leading to treatment interruption | 13 (10.0) | 2 (1.5) |
| TRAE leading to treatment discontinuation | 0 | 0 |
| TRAE leading to death | 0 | 0 |
Data cutoff: November 30, 2023
Median time to onset of grade 3 or higher anemia was comparable between sac-TMT and TPC (36.5 vs. 45 days) (Fig. 1).
Fig. 1.
Median Time to Onset of Key Adverse Events. First onset of an AE was defined as the time from the start of the sac-TMT until the initial occurrence of a specified AE (any grade or grade 3 or higher) for each subject
Medical anemia management was required in 24.6% of sac-TMT arm and 3.8% in the TPC arm respectively, including erythropoietin (23.8% vs. 3.8%) and blood product transfusions (2.3% vs. 1.5%).
Among patients who experienced grade 3 or higher anemia, the majority in both arms recovered to grade 2 or lower, with 36 out of 38 patients in the sac-TMT arm and 7 out of 8 patients in the TPC arm. The median time to recovery was 7 days for sac-TMT and 9 days for TPC. Dose interruptions due to anemia occurred in 15.4% and 3% of patients in the sac-TMT and TPC arms, respectively, whereas dose reductions due to anemia occurred in 15.4% and 0.8% of patients in the sac-TMT and TPC arm. No anemia events led to treatment discontinuation or death in either arm (Table 2).
Neutropenia
Treatment related neutropenia of any grade was similar between both arms while neutropenia of grade 3 or higher was lower for sac-TMT compared to TPC (any grade: 78.5% vs. 74.2%; grade 3 or higher: 34.6% vs. 47%). Febrile neutropenia occurred in 2 patients (1.5%) in the sac-TMT arm (both Grade 3) and in 4 patients (3.0%) in the TPC arm (3 patients with grade 3 and 1 patient with grade 4) (Table 2).
Median time to onset of grade 3 or higher neutropenia was later for sac-TMT with 22 days compared to TPC with 12.5 days. (Fig. 1).
Granulocyte colony-stimulating factor (G-CSF) was administered as secondary prophylaxis in 25.4% and 39.4% of patients and as treatment for neutropenia in 47.7% and 62.1% of patients in the sac-TMT and TPC arms, respectively (Fig. 2a). During the initial cycles, G-CSF use was consistently lower in the sac-TMT arm than in the TPC arm, and decreased in both arms as the number of treatment cycles increased (Fig. 2a and b).
Fig. 2.
Patterns and trends of G-CSF use (a) Percentage of G-CSF as secondary prophylaxis or treatment (b) Trend of G-CSF use by cycles
Among patients who experienced grade 3 or higher neutropenia, the majority in both arms recovered to grade 2 or lower, with 44 out of 45 patients in the sac-TMT arm and all 62 patients in the TPC arm. The median time to recovery was 5 days for sac-TMT and 3 days for TPC.
Dose interruptions due to neutropenia occurred in 23.8% and 28.8% of patients in the sac-TMT and TPC arms, respectively, with dose reductions in 3.8% and 11.4% of patients. There were no treatment discontinuations or deaths in either arm due to neutropenia (Table 2).
Thrombocytopenia
Treatment-related thrombocytopenia of any grade, as well as grade 3 or higher, was more frequent with sac-TMT compared to TPC (any grade: 40.8% vs. 25.8%; grade 3 or higher: 13.1% vs. 3.8%) (Table 2).
Median time to onset of grade 3 or higher thrombocytopenia was 12 days for sac-TMT and 15 days for TPC (Fig. 1).
Treatment for thrombocytopenia was administered to 20.8% of patients in the sac-TMT arm compared to 10.6% in the TPC arm. Among them, 10.8% and 6.1% of patients received recombinant human thrombopoietin (rhTPO) in the sac-TMT and TPC arm, respectively.
Among patients experiencing grade 3 or higher thrombocytopenia, the majority in both arms recovered to grade 2 or lower, with 15 out of 17 patients in the sac-TMT arm and all 5 patients in the TPC arm. The median time to recovery was 7 days for sac-TMT and 8 days for TPC. Dose interruptions due to thrombocytopenia occurred in 9.2% of patients in the sac-TMT arm and 6.8% in the TPC arm, while dose reductions for this reason were reported in 2.3% and 3.8% of patients, respectively. No treatment discontinuations or deaths in either arm due to thrombocytopenia (Table 2).
Stomatitis
Stomatitis of any grade as well as grade 3 or higher, was higher for sac-TMT compared to TPC (any grade: 49.2% vs. 4.5%; grade 3 or higher: 10.0% vs. 0.8%), only one patient in the TPC arm experienced grade 3 or higher stomatitis (Table 2).
The median time to onset of any grade stomatitis was 16.5 and 4.5 days for sac-TMT and TPC, respectively. The median time to onset of grade 3 or higher stomatitis for sac-TMT was 24 days (Fig. 1). In the sac-TMT arm, 4.6% (6/130) of patients received prophylaxis, and 30.8% (40/130) received symptomatic treatment for stomatitis, including medications for oral lesions and ulcers.
Among patients experiencing grade 3 or higher stomatitis in the sac-TMT arm, 12 out of 13 patients recovered to grade 2 or lower, with a median time to recovery of 11 days. Dose interruptions and dose reductions due to stomatitis occurred in 10.0% and 7.7% of patients in the sac-TMT arm, respectively. No treatment discontinuations or deaths related to stomatitis were observed in either treatment group (Table 2).
Other adverse events
In the sac-TMT arm, 17 patients (13.1%) reported diarrhea, all were grade 1 or 2, except for one grade 3 event. One patient (0.8%) reported grade 2 interstitial lung disease. Three patients (2.3%) reported xerophthalmia, with one at grade 1 and two at grade 2, and blurred vision (both grade 1) occurred in two patients (1.5%). In addition, the incidence of grade 3 or higher increased alanine aminotransferase and increased aspartate aminotransferase with sac-TMT was low (0.8% and 2.3%, respectively). Grade 3 or higher infusion-related reaction/hypersensitivity were reported in 1.5% of patients.
Hematologic toxicity of key adverse events by previous lines of therapy
In the safety population of the sac-TMT group, when grouped by prior lines of therapy, the hematologic toxicity profile of sac-TMT was generally consistent with that observed in the overall population. Overall TRAEs occurred in 88.7% of patients who had previously received 2 lines of therapy and in 95.6% of those who had received ≥ 3 lines of therapy. Grade 3 or higher TRAEs were reported in 48.4% and 45.6% of patients, respectively.
For hematologic TRAEs of any grade, the incidences of neutropenia and thrombocytopenia were numerically slightly higher among patients previously treated with ≥ 3 versus 2 lines of therapy, whereas the incidence of anemia was comparable between the two subgroups. Specifically, among patients previously treated with ≥ 3 versus 2 lines of therapy, neutropenia occurred in 80.9% versus 75.8% of patients, thrombocytopenia in 42.6% versus 38.7%, and anemia in 82.4% versus 82.3%, respectively. For grade 3 or higher hematologic TRAEs, neutropenia occurred in 30.9% versus 38.7% of patients, thrombocytopenia in 13.2% versus 12.9%, and anemia in 30.9% versus 27.4%, respectively. Overall, the hematologic toxicity profile remained generally consistent across these subgroups (Supplementary Table 5).
Efficacy by dose reductions
After excluding patients with a PFS shorter than the landmark time, 97 patients were included in this landmark analysis. These patients were categorized into three groups: the early dose reduction group (18 patients, 18.56%), the late dose reduction group (20 patients, 20.62%), and the without dose reduction group (59 patients, 60.82%). Among the three groups, the early dose reduction group had the lowest median RDI of 67.15% followed by the late dose reduction group of 79.83%, while the without dose reduction group had the highest median RDI of 94.20%. The median PFS was 5.2 months in the early dose reduction group, 6.5 months in the late dose reduction group, and 6.0 months in the without dose reduction group (Fig. 3a). The median OS was not reached in the without dose reduction group, while it was 7.5 months in the early dose reduction group and 12.3 months in the late dose reduction group (Fig. 3b).
Fig. 3.
Comparison of Efficacy Outcomes in the Sac-TMT arm by Timing of Dose Reduction (a) PFS of sac-TMT by timing of dose reduction (b) OS of sac-TMT by timing of dose reduction. In this part of landmark analysis, a landmark time of 2 months was selected, patients with a PFS shorter than the landmark time were excluded. The PFS and OS were recalculated starting at the landmark time rather than at time of randomization
A sensitivity analysis was also conducted by categorizing patients included in the landmark analysis according to their RDI during the first 2 months. The overall median RDI during the first two months was 88.89%. Patients were categorized based on whether their RDI was at/above or below the median RDI. Median PFS was numerically slightly longer in patients with RDI ≥ median than in those with RDI < median (6.3 months [95% CI, 3.6–10.6] vs. 5.2 months [95% CI, 3.8–7.6]). Median OS was not reached in the RDI ≥ median group (95% CI, 9.2 months to not estimable) and was 12.3 months (95% CI, 8.3 months to not estimable) in the RDI < median group.
Safety profile of sac-TMT with long-term use
This study evaluated the safety profile of sac-TMT with long-term use. A total of 50 patients with a treatment duration of ≥ 7 months were included. Both the incidences of any grade and grade 3 or higher TRAEs showed a decreasing trend over time. The incidence of grade 3 or higher TRAEs declined notable beginning from cycle 2 and remained consistently low from cycle 4 onward (Fig. 4). No additional late onset TRAEs were identified.
Fig. 4.
Frequency of any grade or grade 3 or higher TRAEs among patients with ≥ 7 months of treatment duration
Discussion
This post-hoc exploratory study aims to further characterize the safety profile of sac-TMT based on data from the OptiTROP-Breast01 study; in this study, the most common TRAEs with sac-TMT were hematologic toxicities and stomatitis, generally consistent with those reported previously [25, 26]. This study enrolled heavily pretreated Chinese female patients. With regard to gender, women are known to have a greater susceptibility to hematological adverse events [27]. Extensive prior treatment may also impair bone marrow function and consequently lead to poorer baseline hematological condition [28]. Therefore, in addition to drug-related factors, these patient characteristics may also have contributed to the occurrence of hematological toxicities. Importantly, febrile neutropenia was rare with sac-TMT in this study [3].
In this detailed safety analysis, the median time to the onset of grade 3 or higher key adverse events indicated that these events primarily occurred within the first two cycles. Therefore, closer monitoring of hematologic toxicities is essential during the first two months of administration. Consistent with this, the prescribing information for sac-TMT recommends weekly monitoring of blood cell counts during the first two months of treatment, followed by monitoring before each subsequent cycle of sac-TMT administration. Most patients who experienced grade 3 or higher key adverse events in the sac-TMT arm ultimately recovered to grade 2 or lower, with most achieving recovery within 14 days. Meanwhile, the proportion of key adverse events leading to dose reduction was low, and no key adverse events led to treatment discontinuation or death, demonstrating a manageable safety profile of sac-TMT.
This study also explored the impact of dose reduction on the efficacy of sac-TMT. Patients in the early dose reduction group had numerically shorter PFS than those in the without dose reduction and late dose reduction groups. One possible explanation is that early dose reduction may reduce dose intensity, leading to insufficient drug exposure and potentially less effective tumor control [29, 30]. However, the numerical differences in PFS were modest, both across the early dose reduction, late dose reduction, and without dose reduction groups (5.2, 6.5, and 6.0 months, respectively) and in the sensitivity analysis comparing patients with an RDI at or above the median versus those with an RDI below the median (6.3 vs. 5.2 months). The apparent numerical differences in OS may be attributable to the limited sample size after subgrouping in the landmark analysis and the potential influence of subsequent anticancer therapies. Overall, the available data suggest that dose modification for the management of adverse events did not appear to compromise the efficacy of sac-TMT; however, the timing of dose reduction may still be clinically relevant. Given the limited sample size in the landmark analysis, these findings require further validation.
This study further demonstrated that safety profile of sac-TMT differs from those reported in clinical trials of other ADCs. In the safety analysis of the ASCENT study, grade 3 or higher neutropenia and diarrhea occurred in 51% and 10% of patients treated with SG, respectively [31]. Previous studies indicated that SN-38, the cytotoxic payload of SG, is associated with severe or life-threatening neutropenia and diarrhea. In contrast, hematologic toxicities with sac-TMT were manageable, and the incidence of severe diarrhea was low in both the current study and previously reported studies [3, 25, 32–34]. ILD has been reported across various clinical trials of DXd-based ADCs. T-DXd was associated with an incidence of ILD/pneumonitis ranging from 10.4 to 15.8% [14–17]. Dato-DXd, another TROP2-targeting ADC with a DXd payload, has also been associated with ILD [35]. In a pooled analysis of drug-related ILD associated with Dato-DXd, the incidence of ILD of any grade was 5%, including 2% for grades 3–5 and 1% for grade 5 [36]. By comparison, ILD was rarely reported in patients receiving sac-TMT across various clinical trials and was generally low grade [3, 25, 32–34]. Ocular toxicity is also a common adverse event associated with TROP2 ADCs. In patients with TNBC treated with Dato-DXd, the incidence of ocular surface events is 36.4% [35]. As previously reported, sac-TMT showed a low incidence of ocular toxicity [3, 25, 32–34]. The distinct and manageable safety profile of sac-TMT may be attributed to its different structure and mechanism of action compared to other ADCs. Sac-TMT is developed with a novel DNA topoisomerase I inhibitor (KL610023) and a linker that confers an optimized conjugation method to minimize the off-target toxicity. Although sac-TMT shares the same monoclonal antibody as SG, it differs in conjugation chemistry (pyrimidine versus maleimide, respectively) and cytotoxic payload (belotecan-derived topoisomerase I inhibitor versus SN-38). For sac-TMT, the pyrimidine conjugation chemistry was designed to enhance linker stability and reduce payload release in circulation, resulting in fewer off-target effects [37].
Stomatitis is recognized as an on-target toxicity of anti-TROP2 ADCs, likely due to the TROP2 expression in normal mucosal tissues [38]. In the TROPION-PanTumor01 study, stomatitis occurred in 72.7% TNBC patients treated with Dato-DXd, with grade 3 or higher events reported in 11.4% [8]. For SG, the incidence of stomatitis was 10%, including 1% of grade 3 or higher [6]. In this study, stomatitis of any grade occurred in 49.2% of patients treated with sac-TMT, and grade 3 or higher stomatitis occurred in 10%. Most patients who developed grade 3 or higher stomatitis in the sac-TMT arm ultimately recovered to grade 2 or lower, and dose reductions due to stomatitis were required in only a small proportion of patients. These findings suggest that stomatitis associated with sac-TMT can be effectively managed with supportive care and dose modification.
This study has several limitations. First, it was a post hoc analysis based on the OptiTROP-Breast01 study. Given its exploratory nature and the small sample size after subgrouping by adverse events, the findings require further validation in prospective trials with larger sample sizes. Second, this analysis reflects only the safety profiles of sac-TMT observed in clinical trial population of heavily pretreated patients and may not fully represent its safety profile in routine clinical practice. Therefore, further validation in broader real-world populations is warranted. Nevertheless, this detailed safety analysis of the OptiTROP-Breast 01 study showed that sac-TMT had a manageable safety profile, offering valuable insights for its safety management in previously treated triple-negative breast cancer.
Conclusion
Sac-TMT demonstrated a manageable safety profile, with adverse events effectively managed through dose modification and appropriate supportive care without compromising its efficacy. Long-term use of sac-TMT further supports its manageable toxicity profile.
Supplementary Information
Acknowledgements
The authors thank the patients who volunteered to participate in the OptiTROP-Breast01 study and their families for their valuable contribution and commitment as well as the dedicated clinical trial investigators and their devoted team members for participating in the OptiTROP-Breast01 study.
Authors’ contributions
Conception and design: B.X., X.J. and Y.D. Provision of study materials or patients: B.X., Y.F., Q.O., Y.Y., L.S., X.W., W.L., M.L., X.Y., S.W., T.S., Y.T., X.T., Z.T. and Z.S. Collection and assembly of data: B.X., Y.F., Q.O., Y.Y., L.S., X.W., W.L., M.L., X.Y., S.W., T.S., Y.T., X.T., Z.T. and Z.S. Data analysis and interpretation: B.X., Y.F., Q.O., J.G., X.J., Y.D. and G.L. Writing, review and editing of the paper: all authors. Final approval of the paper: all authors. Accountable for all aspects of the work: all authors.
Funding
This study was funded by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and was partly supported by the CAMS Innovation Fund for Medical Sciences (CIFMS; 2021-I2M-1-014 received by B.X. and 2023-I2M-C & T-B-077 received by Y.F.) and by Major Project of Medical Oncology Key Foundation of Cancer Hospital Chinese Academy of Medical Sciences CICAMS-MOMP202203 (received by Y.F.), by National High Level Hospital Clinical Research Funding (2025-LYZX-D-A02 received by B.X.) and by Noncommunicable Chronic Diseases-National Science and Technology Major Project (2025ZD0552504 received by B.X.). Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. participated in study conception and design, data analysis, data interpretation, drafting or revising the paper and approval of the final version of the paper.
Data availability
To protect the privacy of study participants and proprietary information, the sponsor shares anonymized individual patient data upon reasonable request or as required by law or regulation with qualified external researchers based on submitted curriculum vitae and reflecting non-conflict of interest. The data provided include demographic, efficacy and safety information. Approval of such requests is at the sponsor’s discretion and depends on the nature of the request, the merit of the research proposed, the availability of the data and the intended use of the data. Data requests should be sent to mict@kelun.com. In response to the inquiry, the timeframe for responding to requests is approximately 2 weeks.
Declarations
Ethics approval and consent to participate
This study has been approved by the ethical committee of Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College (ethics approval number: 21/536–3207) and the First Affiliated Hospital of Nanjing Medical University (ethics approval number: 2022-MD-008). Approval from all other participating centers for the study was also obtained as previously reported [3]. All participating patients read and signed an informed consent form. This trial was performed in accordance with Good Clinical Practice standards, the Declaration of Helsinki, and relevant laws and regulations.
Consent for publication
Not applicable.
Competing interests
B.X. has served as advisor or consultant for Novartis and AstraZeneca. J.G., X.J., Y.D. and G.L. are employees of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. The other authors declare no competing interests.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Ying Fan and Quchang Ouyang contributed equally to this work.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
To protect the privacy of study participants and proprietary information, the sponsor shares anonymized individual patient data upon reasonable request or as required by law or regulation with qualified external researchers based on submitted curriculum vitae and reflecting non-conflict of interest. The data provided include demographic, efficacy and safety information. Approval of such requests is at the sponsor’s discretion and depends on the nature of the request, the merit of the research proposed, the availability of the data and the intended use of the data. Data requests should be sent to mict@kelun.com. In response to the inquiry, the timeframe for responding to requests is approximately 2 weeks.