Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SEA-CD40
SEA-CD70 · 2 trials · 4 indications
cORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions.
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
To be summarized using descriptive statistics.
To be summarized using descriptive statistics.
| Arm | Type | Description |
|---|---|---|
| Melanoma Arm | EXPERIMENTAL | SEA-CD40 + pembrolizumab |
| NSCLC Arm | EXPERIMENTAL | SEA-CD40 + pembrolizumab + pemetrexed + carboplatin |
| Part A | EXPERIMENTAL | SEA-CD70 dose escalation cohort in relapsed/refractory (HMA-failure) MDS |
| Part B | EXPERIMENTAL | SEA-CD70 expansion cohort in relapsed/refractory (HMA-failure) MDS |
| Part C | EXPERIMENTAL | SEA-CD70 expansion cohort in relapsed/refractory AML |
| Part D | EXPERIMENTAL | SEA-CD70 + azacitidine dose-finding/dose optimization cohorts in relapsed/refractory MDS or MDS/AML, and previously untreated higher-risk MDS or MDS/AML |
| Part E | EXPERIMENTAL | SEA-CD70 + azacitidine vs azacitidine expansion cohort in previously untreated higher-risk MDS or MDS/AML |
| Part F | EXPERIMENTAL | SEA-CD70 + azacitidine expansion cohort in relapsed/refractory MDS or MDS/AML |
| Part G | EXPERIMENTAL | SEA-CD70 + azacitidine +venetoclax dose-finding/dose optimization in previously untreated and unfit for induction therapy AML |
| Name | Type | Description |
|---|---|---|
| SEA-CD40 | DRUG | Given into the vein (IV; intravenously); schedule is cohort-specific |
| pembrolizumab (KEYTRUDA®) | DRUG | Given by IV; schedule is cohort-specific. |
| pemetrexed | DRUG | Given by IV on Day 1 of each 21-day cycle. |
| carboplatin | DRUG | Given by IV on Day 1 of Cycles 1-4. Each cycle will be 21 days long. |
| SEA-CD70 | DRUG | Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle |
| azacitidine | DRUG | 75mg/m\^2 injected under the skin (SC; subcutaneous) or given into the vein (IV; intravenously) on Days 1 through 7 of each treatment cycle. |
| Venetoclax | DRUG | 400 mg /day PO, continuously; administered with ramping |
Inclusion Criteria: * Histologically or cytologically confirmed unresectable malignancy defined as one of the following: * Cohort 1: Relapsed and/or refractory metastatic melanoma * Uveal/ocular melanoma is excluded * Must have progressed on treatment with an anti-PD-(L)1 mAb. PD-(L)1 t...
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SEA-CD70 is an investigational oncology therapy being studied in myeloid malignancies, including myelodysplastic syndrome and acute myeloid leukemia. It is also being evaluated in melanoma. The drug is in Phase 2 development and has not been approved for any indication.
SEA-CD70 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating SEA-CD70 in myeloid malignancies and other cancers.
SEA-CD70 is in Phase 2 clinical development. One Phase 1 trial and one Phase 2 trial have been conducted. The Phase 1 trial is active but not recruiting, and the Phase 2 trial has been completed. SEA-CD70 remains investigational and is not FDA approved.
SEA-CD70 has been studied in two registered clinical trials. NCT04227847 is a Phase 1 safety study in patients with myeloid malignancies, including myelodysplastic syndrome and acute myeloid leukemia, and is active but not recruiting. NCT04993677 is a completed Phase 2 study in melanoma and non-small cell lung cancer.
Yes, SEA-CD70 is also known as SEA-CD40. Both names refer to the same investigational agent developed by Pfizer. The alternative name SEA-CD40 appears in trial records and publications, so readers searching for either name are looking at the same drug asset.