Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALKS 4230 · 2 trials · 1 indication
Includes AEs that are both serious and drug-related
Includes AEs that are both serious and drug-related
Overall Response rate (ORR) will be based on investigator review of radiographic and photographic images
DLT was defined by any of following events possibly, probably, or definitely related to ALKS 4230: Grade 4 neutrophil count decreased (neutropenia); Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; Thrombocytopenia; Any Grade 3 cardiac or central nervous system toxicity; Liver transaminase elevation higher than 8\*upper limit of normal (ULN) or total bilirubin higher than 6\*ULN; Grade 4 hypoalbuminemia; Fever more than (\>) 40 degree Celsius (°C) sustained for \>24 hours; Hypotension required the use of pressors or prolonged hospitalization (\>48 hours) for hypotension requiring medical intervention; Grade 3 or higher electrolyte abnormalities; Increase in amylase or lipase; Grade 3 or higher nausea, vomiting, or diarrhea; Any other Grade 4 nonhematologic toxicity or any other Grade 3 non-hematologic toxicity; Any other toxicity or adverse event (AE) not defined above that resulted in participant removal from the study or discontinuation of dosing by the Investigator.
TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product.
TEAEs were defined as AEs that were newly occurring or worsening from the time of the first dose of study drug. Severity was graded according to the National Cancer Institute (NCI) CTCAE (version 4.03) where, Grade 1: Mild- asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate- minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. As planned, Grades 1 and 2 were combined for reporting.
ORR rate was defined as the percentage of participants with objective evidence of CR or PR based on RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| ALKS 4230 | EXPERIMENTAL | Administered via SC injection once every 7 days or once every 21 days at escalating doses |
| ALKS 4230 + pembrolizumab | EXPERIMENTAL | ALKS 4230 will be administered via SC injection once every 7 or 21 days at escalating doses or at the recommended phase 2 dose and schedule; pembrolizumab will be administered as an intravenous infusion given over 30 minutes; the dose level for pembrolizumab will be 200 mg per the approved label. In December 2020, an RP2D of 3 mg with an administration schedule of q7d was determined for SC ALKS 4230. |
| Name | Type | Description |
|---|---|---|
| ALKS 4230 | BIOLOGICAL | SC injection administered in the back of the arm or the abdomen |
| Pembrolizumab | BIOLOGICAL | Administered as an intravenous (IV) infusion over 30 minutes |
| ALKS 4230 + pembrolizumab | DRUG | IV infusion of ALKS 4230 over 30 minutes given daily for 5 consecutive days followed by an off-treatment period; pembrolizumab administered IV once with ALKS 4230 on the first day of each cycle |
Inclusion Criteria: * For Phase I the subject has histological or cytological evidence of a solid tumor. For Phase II the subject must have 1 of the specified adult solid tumor types: gastric, ovarian, lung, head and neck. * Subject must have at least one target lesion based on RECIST * Subject has...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ALKS 4230, also known as nemvaleukin alfa, is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors. It is in Phase 1 clinical development and has been evaluated in two completed trials enrolling a total of 359 patients with advanced solid tumors.
ALKS 4230 is a monoclonal antibody designed to target the IL-2 receptor pathway. It is being developed as a cytokine-based therapy for advanced solid tumors, with the goal of modulating immune responses against cancer cells.
ALKS 4230 is being developed by Mural Oncology plc, a biopharmaceutical company listed on the stock exchange under the ticker MURA. The company is conducting clinical research on this investigational drug for advanced solid tumors.
ALKS 4230 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with no active trials currently ongoing.
ALKS 4230 has been studied in two completed Phase 1 clinical trials: NCT02799095, which enrolled 243 patients with advanced solid tumors, and NCT03861793 (ARTISTRY-2), which enrolled 116 patients and evaluated subcutaneous administration alone and in combination with pembrolizumab.
Yes, ALKS 4230 is also known as nemvaleukin alfa. Both names refer to the same investigational drug being developed by Mural Oncology for the treatment of advanced solid tumors.