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 150 PD-L1/PD-1 antibody 136 | 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, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, HNSCC, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive cervical cancer, with gemcitabine and cisplatin for biliary tract cancer, with chemoradiation for cervical cancer, with carboplatin and paclitaxel for endometrial carcinoma, with paclitaxel with or without bevacizumab for epithelial ovarian, Fallopian tube, and peritonium 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 |
|---|---|---|---|---|---|---|
| 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 |
| NCT04144517 | Phase II | ALKS 4230 + Pembrolizumab | A Study of ALKS 4230 With Pembrolizumab in Head and Neck Cancer | Completed | USA | 0 |
| 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) | Active, not recruiting | USA | ESP | 0 |
| 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) | Terminated | USA | ITA | GBR | FRA | ESP | DEU | CZE | CAN | BEL | AUT | AUS | 3 |
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