Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembrolizumab · 2 trials · 4 indications
Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or 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.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Trastuzumab Deruxtecan (T-DXd) |
| Arm 2 | ACTIVE_COMPARATOR | Standard of Care Treatment (platinum, pemetrexed and 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. |
| Name | Type | Description |
|---|---|---|
| Trastuzumab Deruxtecan | DRUG | Trastuzumab Deruxtecan administered by intravenous infusion |
| Cisplatin | DRUG | Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion |
| Carboplatin | DRUG | Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion |
| Pembrolizumab | DRUG | Pembrolizumab administered by intravenous infusion |
| Pemetrexed | DRUG | Pemetrexed administered by intravenous infusion |
| Datopotamab deruxtecan | DRUG | Datopotamab deruxtecan (Dato-DXd) is a novel antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 IgG1 monoclonal antibody linked to a topoisomerase I inhibitor payload and a cleavable linker. |
Inclusion Criteria: * Participants at least 18 years of age * Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease * Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA * Treatment-naïve for palliative ...