Sponsor: Merck Sharp & Dohme LLC (industry)
Phase: 3
Start date: Dec. 15, 2023
Planned enrollment: 614
Last updated in HealthScout: Sep 2024
Sacituzumab tirumotecan (sac-TMT), also known as SKB264 or MK-2870, is an investigational antibody-drug conjugate (ADC) targeting TROP2, a cell surface glycoprotein overexpressed in various cancers. (prnewswire.com)
Sac-TMT comprises a monoclonal antibody directed against TROP2 linked to a topoisomerase I inhibitor payload. This design facilitates targeted delivery of the cytotoxic agent to TROP2-expressing tumor cells, aiming to enhance antitumor efficacy while minimizing systemic toxicity. (prnewswire.com)
Endometrial and Ovarian Cancers
In the phase 2 KL264-01 trial (NCT04152499), sac-TMT monotherapy was evaluated in patients with previously treated advanced endometrial and ovarian cancers. Preliminary results presented at the 2024 ESMO Congress showed:
Median Duration of Response (DOR): 5.7 months (range, 3.8 to 7.4+)
Ovarian Cancer Cohort (n = 40):
Triple-Negative Breast Cancer (TNBC)
The phase 3 OptiTROP-Breast01 study (NCT05347134) compared sac-TMT to physician's choice of chemotherapy in patients with previously treated locally recurrent or metastatic TNBC. Results indicated:
Median Overall Survival (OS): Not reached (95% CI, 11.2 to NE)
Chemotherapy Arm (n = 133):
Sac-TMT demonstrated a statistically significant improvement in PFS and OS compared to chemotherapy. (ascopubs.org)
In the KL264-01 trial, treatment-related adverse events (TRAEs) occurred in all patients:
Common TRAEs: Anemia (88.6%), decreased white blood cell count (81.8%), decreased neutrophil count (65.9%)
Ovarian Cancer Cohort:
No TRAEs led to death, and there were no reports of drug-related interstitial lung disease or pneumonitis. (onclive.com)
In the OptiTROP-Breast01 study, common grade ≥3 TRAEs in the sac-TMT arm included:
Last updated: Apr 2025
Last updated: Apr 2025
Goal: The primary goal of this trial is to evaluate whether the combination of the investigational drug sacituzumab tirumotecan with pembrolizumab improves overall survival compared to pembrolizumab monotherapy in patients with metastatic non-small cell lung cancer expressing high levels of PD-L1.
Patients: The trial specifically targets participants with metastatic non-small cell lung cancer (NSCLC) whose tumors demonstrate PD-L1 expression in at least 50% of tumor cells. Participants must have a confirmed diagnosis of either squamous or non-squamous NSCLC and no prior indication for EGFR, ALK, or ROS1-targeted therapy.
Design: This is a Phase 3, open-label, randomized study comparing the combination therapy to pembrolizumab monotherapy. It has a planned enrollment of 614 patients.
Treatments: The study is examining the effect of sacituzumab tirumotecan, an antibody-drug conjugate targeting the TROP2 protein, in combination with pembrolizumab. Sacituzumab tirumotecan has demonstrated significant efficacy in increasing progression-free survival and overall survival in previous trials, particularly in breast cancer, and works by delivering a cytotoxic topoisomerase I inhibitor specifically to tumor cells. Pembrolizumab, a PD-1 inhibitor, is an established immune checkpoint inhibitor used as a monotherapy for various cancers, including NSCLC.
Outcomes: Primary outcomes include overall survival and progression-free survival. Secondary outcomes involve assessments of objective response rate, duration of response, and changes in global health status and quality of life using EORTC questionnaires. Time to deterioration in symptoms such as dyspnea, cough, and chest pain, as well as the percentage of participants experiencing adverse events or discontinuing treatment due to adverse events, are also evaluated.
Burden on patient: The burden on patients in this trial is expected to be moderate. While the regimen involves intravenous administration every 6 weeks, which aligns with existing treatment intervals, participants are required to undergo regular medical assessments, including imaging studies and clinical evaluations, to monitor treatment efficacy and progression. Frequent health-related quality of life evaluations through questionnaires may additionally contribute to patient burden. The need for upfront tumor profiling to confirm PD-L1 expression, however, aligns with current standard diagnostic practices, lessening the overall increase in procedural burden.
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC
* Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
* Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
* A life expectancy of at least 3 months.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria:
* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Has Grade ≥2 peripheral neuropathy.
* History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
* Received prior systemic anticancer therapy for their metastatic NSCLC.
* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received radiation therapy to the lung that is \>30 Gy within 6 months of start of study intervention.
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
* Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
* Active infection requiring systemic therapy
* Concurrent active Hepatitis B and Hepatitis C virus infection.
* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* History of allogeneic tissue/solid organ transplant.
* Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.
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