Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Datopotamab Deruxtecan (Dato-DXd), Datopotamab deruxtecan (Dato-DXd)
Datopotamab deruxtecan · 10 trials · 21 indications
PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR), or death due to any cause.
OS is defined as the time from randomization until the date of death due to any cause.
The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. The measure of interest is the HR of DFS. Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components.
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population: • TROP2 biomarker positive population The measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis.
OS is defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population: • TROP2 biomarker positive population The measure of interest is the HR of OS.
PFS is defined as time from randomisation until progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by BICR, or death due to any cause.
OS is defined as the time from randomisation until the date of death due to any cause.
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
OS is defined as the time from randomisation until the date of death due to any cause.
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
The intracranial objective response rate (iORR) is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to the RANO-BM (Response Assessment in Neuro-Oncology Brain Metastases) criteria, as assessed by central review. The best overall CNS (central nervous system) response is determined based on a composite assessment of radiographical CNS target and non-target lesion responses, corticosteroid use, and clinical status.
The number of participants with triple negative breast cancer (TNBC) with molecular residual disease (MRD) only recurrence, which is defined as ctDNA positivity without radiographically measurable recurrence, during post-surgery surveillance.
Proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1.
Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.
Proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later.
PFS is defined as time from start of treatment until progression per RECIST 1.1 as assessed by the investigator or death due to any cause.
Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as assessed by ICR per RECIST 1.1.
DLTs, TEAEs, SAEs, AESIs, ECOG PS, vital sign measurements, standard clinical laboratory parameters (hematology, clinical chemistry, and urinalysis), ECG parameters, ECHO/MUGA scan findings, and ophthalmologic findings
| Arm | Type | Description |
|---|---|---|
| Arm A: Datopotamab deruxtecan (Dato-DXd) monotherapy | EXPERIMENTAL | Participants in the Dato-DXd monotherapy group will receive Dato-DXd as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
| Arm B: Docetaxel monotherapy | ACTIVE_COMPARATOR | Participants in the docetaxel monotherapy group will receive docetaxel as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
| Dato-DXd + rilvegostomig | EXPERIMENTAL | Participants in the Dato-DXd in combination with rilvegostomig group will receive Dato-DXd and rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W). |
| Rilvegostomig | EXPERIMENTAL | Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W). |
| Standard of Care (SoC) | ACTIVE_COMPARATOR | Patients in SoC group will undergo observation or will receive Investigator's Choice of Chemotherapy (ICC). |
| Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig | EXPERIMENTAL | Participants in the Datopotamab Deruxtecan (Dato-DXd) in combination with Rilvegostomig group will receive Dato-DXd plus rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
| Arm 2: Rilvegostomig Monotherapy | EXPERIMENTAL | Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
| Arm 3: Pembrolizumab Monotherapy | ACTIVE_COMPARATOR | Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
| Dato-DXd + Durvalumab + Carboplatin | EXPERIMENTAL | Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 1120 mg durvalumab plus carboplatin area under the curve \[AUC\] 5 mg/mL/minute. |
| Histologic-specific therapy | ACTIVE_COMPARATOR | Non-squamous NSCLC participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m2 pemetrexed plus either AUC 5 mg/mL/minute carboplatin or 75 mg/m2 cisplatin. Squamous NSCLC participants will be randomized to receive 200 mg of pembrolizumab plus 200 mg/m2 paclitaxel plus AUC 5 or 6 mg/mL/minute carboplatin. |
| Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd) | EXPERIMENTAL | Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd. |
| Pembrolizumb | ACTIVE_COMPARATOR | Participants will be randomized to receive 200 mg pembrolizumab. |
| Single arm: pembrolizumab, datopotamab-deruxtecan, and carboplatin | EXPERIMENTAL | Study treatment: * INDUCTION: Pembrolizumab 200 mg IV Q3W; Datopotamab-Deruxtecan 6mg/kg IV Q3W; Carboplatin AUC 5 IV Q3W. * For four (4) cycles. * MAINTENANCE: Pembrolizumab 200 mg IV Q3W for 35 cycles; Datopotamab-Deruxtecan 6mg/ kg IV Q3W.\* * until disease progression or unacceptable toxicity. |
| Patients with higher residual cancer burden | EXPERIMENTAL | Participants with stage II/III triple negative breast cancer (TNBC) and residual disease post-neoadjuvant therapy, particularly patients with higher residual cancer burden (RCB II/III), remain at high risk for developing recurrence. |
| Substudy-1A | EXPERIMENTAL | Dato-DXd will be evaluated as monotherapy |
| Substudy-2A | EXPERIMENTAL | Dato-DXd in combination with capecitabine will be evaluated |
| Substudy-2B | EXPERIMENTAL | Dato-DXd in combination with 5-FU will be evaluated |
| Substudy-3A | EXPERIMENTAL | Dato-DXd will be evaluated as monotherapy |
| Substudy-3C | EXPERIMENTAL | Dato-DXd will be evaluated in combination with prednisone/prednisolone |
| Substudy-4A | EXPERIMENTAL | Dato-DXd will be evaluated as monotherapy |
| Substudy-4C | EXPERIMENTAL | Dato-DXd in combination with carboplatin + bevacizumab followed by Dato-DXd + bevacizumab will be evaluated |
| Substudy-5A | EXPERIMENTAL | Dato-DXd will be evaluated as monotherapy |
| Substudy-6A | EXPERIMENTAL | Dato-DXd in combination with volrustomig (MEDI5752) will be evaluated |
| Substudy-6B | EXPERIMENTAL | Data-DXd in combination with rilvegostomig (AZD2936) will be evaluated |
| Substudy-6C | EXPERIMENTAL | Dato-DXd will be evaluated as monotherapy |
| Substudy-6D | EXPERIMENTAL | Dato-DXd in combination with carboplatin or cisplatin will be evaluated |
| Substudy-6E | EXPERIMENTAL | Dato-DXd in combination with rilvegostomig (AZD2936) will be evaluated |
| Substudy-7A | EXPERIMENTAL | Dato-DXd will be evaluated as monotherapy |
| Dato-DXd Arm | EXPERIMENTAL | This single-arm study consists of multiple cohorts, divided by indication. |
| Cohort 1 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + Durvalumab in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy |
| Cohort 2 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + Durvalumab in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy |
| Cohort 3 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + Durvalumab + Carboplatin in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy |
| Cohort 4 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + Durvalumab + Carboplatin in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy |
| Cohort 5 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + AZD2936 in participants with treatment-naïve NSCLC |
| Cohort 6 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + AZD2936 in participants with treatment-naïve NSCLC |
| Cohort 7 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin in participants with treatment-naïve NSCLC |
| Cohort 8 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin in participants with treatment-naïve NSCLC |
| Cohort 9 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin in participants with treatment-naïve NSCLC |
| Cohort 10 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin in participants with treatment-naïve NSCLC |
| Cohort 11 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + MEDI5752 in participants with treatment-naïve NSCLC |
| Cohort 12 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with CPI acquired resistant NSCLC |
| Cohort 13 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with CPI acquired resistant NSCLC |
| Cohort 14 | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with treatment-naïve NSCLC |
| Cohort 4A | EXPERIMENTAL | Datopotamab deruxtecan (Dato-DXd) + Durvalumab + carboplatin in participants with treatment-naïve NSCLC |
| Name | Type | Description |
|---|---|---|
| Datopotamab deruxtecan (Dato-DXd) | DRUG | Dato-DXd administered intravenously (IV) |
| Docetaxel | DRUG | Docetaxel administered intravenously (IV) |
| Datopotamab Deruxtecan | DRUG | Datopotamab Deruxtecan IV (intravenous) |
| Rilvegostomig | DRUG | Rilvegostomig IV (intravenous) |
| Carboplatin | DRUG | Carboplatin IV (intravenous), Active Comparator |
| Cisplatin | DRUG | Cisplatin IV (intravenous), Active Comparator |
| Etoposide | DRUG | Etoposide IV (intravenous), Active Comparator |
| Pemetrexed | DRUG | Pemetrexed IV (intravenous), Active Comparator |
| Vinorelbine | DRUG | Vinorelbine IV (intravenous), Active Comparator |
| UFT | DRUG | UFT Oral route of administration, Active Comparator |
| Pembrolizumab | DRUG | Pembrolizumab IV (intravenous) |
| Durvalumab | DRUG | Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
| Paclitaxel | DRUG | Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. |
| Circulating tumor DNA (ctDNA) testing | DIAGNOSTIC_TEST | Circulating tumor DNA (ctDNA) testing is a type of biopsy that analyzes fragments of DNA shed by cancer cells into the bloodstream. These fragments, known as ctDNA, can provide valuable information about the genetic makeup of a tumor without needing a traditional tissue biopsy. |
| Capecitabine | DRUG | Administered orally |
| 5-Fluorouracil | DRUG | Administered as an IV |
| Volrustomig | DRUG | Administered as an IV |
| Bevacizumab | DRUG | Administered as an IV |
| Prednisone/ prednisolone | DRUG | Administered orally |
| AZD2936 | DRUG | Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle |
| MEDI5752 | DRUG | Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle |
| AZD7789 | DRUG | Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle |
Inclusion Criteria: \- Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) at the time of randomisation and meets the criteria for NSCLC: * Participants must have documented negative test results for E...
Top 20 of 79 competitors
Datopotamab deruxtecan is an investigational antibody-drug conjugate being developed by AstraZeneca PLC (ticker AZN) for oncology indications. It is being studied in advanced or metastatic non-small cell lung cancer, breast cancer including triple negative breast cancer, and endometrial cancer. It is an antibody-drug conjugate, or ADC, and remains in clinical development.
Datopotamab deruxtecan is being studied for advanced or metastatic non-small cell lung cancer, breast cancer including triple negative breast cancer, and endometrial cancer. It is an investigational therapy and is not yet established as a treatment outside of clinical trials. Studies include previously treated non-squamous NSCLC and treatment-naive brain metastases from NSCLC.
Datopotamab deruxtecan targets TROP2, a protein expressed on tumor cells. It is an antibody-drug conjugate built on an antibody component, meaning the antibody portion binds TROP2 and delivers a cytotoxic payload to those cells. This targeted delivery approach is the basis for its study across multiple solid tumor types.
Datopotamab deruxtecan is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is running the clinical development program, which includes Phase 2 and Phase 3 studies in non-small cell lung cancer and breast cancer. The drug is also referred to as Dato-DXd.
Datopotamab deruxtecan is in clinical development, with studies spanning Phase 2 and Phase 3. It is investigational and has not been established as an approved therapy. The program includes three recruiting studies and one active, not recruiting study, with a combined planned enrollment of roughly 1,350 participants across the listed trials.
Datopotamab deruxtecan is being studied in several trials, including NCT07291037, a Phase 3 study versus docetaxel in previously treated TROP2-positive advanced or metastatic non-squamous NSCLC; NCT07069595, a Phase 2 ctDNA surveillance study in triple negative breast cancer with residual disease; and NCT06822543, a Phase 2 study with carboplatin and pembrolizumab in treatment-naive NSCLC brain metastases. NCT06564844 is a Phase 3 adjuvant study in Stage I adenocarcinoma NSCLC.
Yes, Datopotamab deruxtecan is also known as Dato-DXd. Dato-DXd is a shortened name used for the same antibody-drug conjugate developed by AstraZeneca PLC. Searches for either name refer to the same investigational TROP2-targeting agent being studied in non-small cell lung cancer, breast cancer, and endometrial cancer.