Therapy Detail
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| Therapy Name | ALKS 4230 + Pembrolizumab |
| Synonyms | |
| Therapy Description |
ALKS 4230 is a fusion protein of IL2 and IL2RA, which activates effector lymphocytes upon binding to intermediate affinity IL2 receptors to enhance cell death of tumor cells (AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 4088). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| ALKS 4230 | RDB 1450|Nemvaleukin alfa|ALKS-4230|ALKS4230|RBD1450|RBD-1450 | ALKS 4230 is a fusion protein of IL2 and IL2RA, which activates effector lymphocytes upon binding to intermediate affinity IL2 receptors to enhance cell death of tumor cells (AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 4088, PMID: 32317293). | ||
| Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 147 PD-L1/PD-1 antibody 117 | Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-expressing NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemotherapy in NSCLC, with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, with axitinib or lenvatinib in RCC, with Lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemotherapy for patients with esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemotherapy for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, and in combination with chemoradiation for cervical cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04144517 | Phase II | ALKS 4230 + Pembrolizumab | A Study of ALKS 4230 With Pembrolizumab in Head and Neck Cancer | Completed | USA | 0 |
| NCT03861793 | Phase I | ALKS 4230 + Pembrolizumab ALKS 4230 | A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine (ALKS 4230) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Patients With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2) | Completed | USA | NLD | ESP | CAN | 2 |
| NCT05092360 | Phase III | Pembrolizumab ALKS 4230 Topotecan Paclitaxel Pegylated liposomal doxorubicin Gemcitabine ALKS 4230 + Pembrolizumab | Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab (ARTISTRY-7) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 5 |
| NCT04592653 | Phase Ib/II | ALKS 4230 ALKS 4230 + Pembrolizumab | Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3) (ARTISTRY-3) | Recruiting | USA | ESP | 0 |
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