Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sacituzumab tirumotecan · 19 trials · 27 indications
OS is defined as time from randomization to death due to any cause.
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
EFS is defined as the time from randomization to disease progression that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
OS is defined as the time from randomization to death due to any cause.
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
OS is defined as the time from randomization to death due to any cause.
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
OS is defined as the time from randomization to death due to any cause.
To determine the intracranial efficacy of sacituzumab tirumotecan in patients with metastatic triple-negative breast cancer and brain metastases. RANO-BM evaluates treatment response by categorizing results into Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
The percentage of patients with confirmed partial response (PR) or complete response (CR) based on RECIST 1.1 criteria where Complete Response (CR) - disappearance of all target lesions and measurable lymph nodes. Partial Response (PR) - ≥30% decrease in the sum of target lesion diameters (SLD) compared to baseline, with no new lesions or progression of non-target lesions. Stable Disease (SD) - change in SLD between -30% and +20% compared to baseline, with no new or unequivocally progressing non-target lesions. Progressive Disease (PD) - ≥20% increase in SLD compared to the smallest recorded SLD (nadir) or appearance of new lesion
DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (7 weeks). All toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0.
An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who experience an AE will be reported.
An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who discontinue study treatment due to an AE will be reported.
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0). The number of participants who experience a DLT in Part 1 will be reported.
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants experiencing an AE in Part 1 will be reported.
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinue study treatment due to an AE in Part 1 will be reported.
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the NCI CTCAE 5.0. The number of participants who experience a DLT in Part 2 will be reported.
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants experiencing an AE in Part 2 will be reported.
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinue study treatment due to an AE in Part 2 will be reported.
ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) (disappearance of all target lesions) or partial response (PR) (at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator. ORR will be reported for participants in Part 2.
A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. The number of participants who experience a DLT will be reported.
An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.
An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.
ORR is defined as the percentage of participants with confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
A DLT is defined as any of the following: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia or lymphopenia; any nonhematologic AE ≥Grade 3 in severity (with some exceptions); any Grade 3 or Grade 4 nonhematologic laboratory value (if certain criteria are met); febrile neutropenia Grade 3 or Grade 4; a prolonged delay (\>2 weeks) in initiating sacituzumab tirumotecan second dose due to intervention-related toxicity; any intervention-related toxicity that causes the participant to discontinue intervention during DLT evaluation period; or any Grade 5 toxicity. All toxicities will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
| Arm | Type | Description |
|---|---|---|
| Sacituzumab tirumotecan | EXPERIMENTAL | Participants receive 4 mg/kg of sacituzumab tirumotecan every 2 weeks (Q2W) via intravenous (IV) infusion until disease progression or unacceptable toxicity. |
| Chemotherapy | ACTIVE_COMPARATOR | Participants receive paclitaxel 175 mg/m\^2, docetaxel 75 mg/m\^2, or vinflunine 320 mg/m\^2 IV every 3 weeks (Q3W), at the investigator's discretion, until disease progression or unacceptable toxicity. |
| Sac-TMT +/- Bevacizumab | EXPERIMENTAL | Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses. |
| Standard of Care | ACTIVE_COMPARATOR | Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab. |
| sac-TMT | EXPERIMENTAL | Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) + IV pembrolizumab 200 mg every 3 weeks (Q3W), for 12 weeks; then receive IV pembrolizumab 200 mg Q3W and IV carboplatin area under the curve (AUC) 1.5 + IV paclitaxel 80 mg/m\^2 once weekly, for 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant treatment of physician's choice (TPC) may be administered to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); capecitabine 1000-1250 mg/m\^2 oral twice daily on days 1-14 and 22-35 each cycle for 4 six-week cycles; or doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV infusion Q3W/Q2W + cyclophosphamide 600 mg/m\^2 IV infusion Q3W/Q2W for 4 doses. |
| Part 1: Sacituzumab tirumotecan + Bevacizumab | EXPERIMENTAL | Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks |
| Part 2: Sacituzumab tirumotecan | EXPERIMENTAL | Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation. |
| Part 2: Standard of care (SOC) | ACTIVE_COMPARATOR | Participants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation. |
| Arm A: Sacituzumab Tirumotecan | EXPERIMENTAL | Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) until disease progression, toxicity or discontinuation. |
| Arm B: Sacituzumab Tirumotecan + Pembrolizumab | EXPERIMENTAL | Participants receive sacituzumab tirumotecan IV 4 mg/kg Q2W until disease progression, toxicity or discontinuation PLUS pembrolizumab IV 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to \~2 years). |
| Arm C: Treatment of Physician's Choice (TPC) | ACTIVE_COMPARATOR | Participants receive physician's choice of chemotherapy agent(s): paclitaxel IV 80 mg/m\^2 once every week (Q1W) OR paclitaxel IV 90 mg/m\^2 on Days 1, 8, and 15, every 4 weeks (Q4W) OR nab-paclitaxel IV 100 mg/m\^2 on Days 1, 8, and 15, Q4W OR gemcitabine IV 1000 mg/m\^2 on Days 1 and 8, every 3 weeks (Q3W) PLUS carboplatin IV area under the curve (AUC) 2 mg/mL/min on Days 1 and 8, Q3W, until disease progression, toxicity or discontinuation. |
| Treatment of Physician's Choice (TPC) | ACTIVE_COMPARATOR | At the physician's discretion, participants will receive 500 mg/m\^2 of pemetrexed on day 1 of every 3-week cycle via IV infusion OR 2 mg/kg of tisotumab vedotin on day 1 of every 3-week cycle via IV infusion OR 1 mg/m\^2 (or 1.25 mg/m\^2 if tolerating well) topotecan on days 1, 2, 3, 4, and 5 of every 3-week cycle via IV infusion OR 30 mg/m\^2 of vinorelbine on days 1 and 8 of every 3-week cycle via IV infusion OR 1000 mg/m\^2 of gemcitabine on day 1 and 8 of every 3-week cycle via IV infusion OR 100 mg/m\^2 (or 125 mg/m\^2 if tolerating well) of irinotecan on days 1, 8, 15, and 22 of every 6 week cycle via IV infusion, until progressive disease or discontinuation. |
| Pemetrexed Plus Carboplatin | ACTIVE_COMPARATOR | Participants receive, via IV infusion, 500 mg/m2 pemetrexed every 3 weeks (Days 1 and 22 of every 6-week cycle) plus area under the curve (AUC) 5 mg/mL\*min carboplatin every 3 weeks (Days 1 and 22 of every 6-week cycle for 4 doses), then 500 mg/m2 pemetrexed every 3 weeks until discontinuation criteria is met. |
| Arm B:Pembrolizumab + Sacituzumab tirumotecan | EXPERIMENTAL | Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to \~2 years). |
| Pembrolizumab + Sacituzumab tirumotecan | EXPERIMENTAL | Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 12 doses (\~24 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (\~42 weeks). |
| Pembrolizumab | ACTIVE_COMPARATOR | Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (\~42 weeks). |
| Sacituzumab tirumotecan plus EV | EXPERIMENTAL | Participants will receive sacituzumab tirumotecan as an intravenous (IV) infusion and EV as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision. |
| Sacituzumab tirumotecan plus EV and pembrolizumab | EXPERIMENTAL | Participants will receive sacituzumab tirumotecan as an IV infusion and EV as an IV infusion on Days 1 and 8 of every 3-week cycle until disease progression, intolerable toxicity, or investigator decision. Participants will also receive pembrolizumab 200 mg as an IV infusion on Day 1 of every 3-week cycle for up to \~2 years (35 cycles). |
| Sacituzumab tirumotecan + Chemotherapy | EXPERIMENTAL | Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment. |
| Sacituzumab tirumotecan + Cisplatin + Pembrolizumab | EXPERIMENTAL | Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years. |
| Arm 1: Sacituzumab tirumotecan Monotherapy | EXPERIMENTAL | Participants receive single doses of sacituzumab tirumotecan monotherapy once every 2 weeks (Q2W). |
| Arm 2: Pembrolizumab + Sacituzumab tirumotecan Combination Therapy | EXPERIMENTAL | Participants receive sacituzumab tirumotecan Q2W in combination with pembrolizumab once every 6 weeks (Q6W). |
| Name | Type | Description |
|---|---|---|
| Sacituzumab tirumotecan | BIOLOGICAL | IV infusion |
| Vinflunine | DRUG | IV infusion |
| Docetaxel | DRUG | IV infusion |
| Paclitaxel | DRUG | IV infusion |
| Rescue medications for sacituzumab tirumotecan | DRUG | Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are pegfilgrastim or equivalent, histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent). |
| Rescue medications for chemotherapy | DRUG | Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are dexamethasone or equivalent, H1 receptor antagonist, H2 receptor antagonist, and laxative. |
| Bevacizumab | DRUG | Administered via IV infusion at a dose of 15mg/kg |
| Rescue Medications | DRUG | Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent. |
| Pembrolizumab | BIOLOGICAL | IV infusion |
| Rescue Medication | DRUG | Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent). |
| Carboplatin | DRUG | IV infusion |
| Doxorubicin | DRUG | IV infusion |
| Epirubicin | DRUG | IV infusion |
| Cyclophosphamide | DRUG | IV infusion |
| Capecitabine | DRUG | Oral tablet |
| Olaparib | DRUG | Oral tablet |
| H1 receptor antagonist | DRUG | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| H2 receptor antagonist | DRUG | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| Acetaminophen (or equivalent) | DRUG | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| Dexamethasone (or equivalent) | DRUG | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| Steroid mouthwash (dexamethasone or equivalent) | DRUG | Rescue medication taken orally 2-4 times daily |
| Nab-paclitaxel | DRUG | IV Infusion |
| Gemcitabine | DRUG | IV Infusion |
| Pemetrexed | DRUG | IV infusion |
| Tisotumab Vedotin | BIOLOGICAL | IV infusion |
| Topotecan | DRUG | IV infusion |
| Vinorelbine | DRUG | IV infusion |
| Irinotecan | DRUG | IV infusion |
| Trifluridine-Tipiracil | DRUG | Trifluridine-tipiracil will be administered at 35 mg/m\^2 as tablet orally twice a day on days 1-5 and 8-12 of every 28-day cycle. |
| Supportive care measures | DRUG | Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors. |
| Liposomal doxorubicin | DRUG | IV infusion |
| Cisplatin | DRUG | Cisplatin is administered as 75 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase |
| Enfortumab Vedotin | BIOLOGICAL | IV infusion at different dose levels |
| Fluorouracil (5-FU) | DRUG | 5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks. |
| Leucovorin (LV) or levoleucovorin | DRUG | LV or levoleucovorin is administered by IV infusion every 2 weeks. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment * Ha...
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