Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IMA901
IMA901 and Leukine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sunitinib | ACTIVE_COMPARATOR | Sunitib as Standard therapy per Label. |
| IMA901 plus GM-CSF added to sunitinib after single dose of cy | EXPERIMENTAL | After 1 cycle of sunitinib, intradermal vaccinations with IMA901 plus GM-CSF as adjuvant after a single dose of cyclophosphamide will be applied for a period of 4 months while continuing treatment with sunitinib |
| Name | Type | Description |
|---|---|---|
| Sunitinib | DRUG | As per label. |
| GM-CSF | BIOLOGICAL | Intradermal injection of GM-CSF as adjuvant. |
| Cyclophosphamide | DRUG | One single low-dose i.v. infusion prior to the first vaccination |
| IMA901 | DRUG | Intradermal vaccinations with IMA901 vaccine. |
Inclusion Criteria: 1. Aged at least 18 years. 2. HLA type: HLA-A\*02-positive 3. Metastatic and/or locally advanced RCC with clear cell histology (histological confirmation by local pathologist required). NOTE: prior nephrectomy is NOT required. 4. Measurable and/or non-measurable tumor lesions as...
IMA901 and Leukine refers to a combination treatment studied in metastatic renal cell carcinoma. IMA901 is a therapeutic cancer vaccine developed by Immatics N.V., and Leukine is a granulocyte-macrophage colony-stimulating factor used as an immune adjuvant. The combination was evaluated in a Phase 3 trial in patients receiving sunitinib.
IMA901 and Leukine was studied as a treatment for metastatic renal cell carcinoma, also called advanced kidney cancer. The combination was given to patients who were also receiving sunitinib, a standard targeted therapy. The goal was to evaluate whether adding the vaccine and immune adjuvant improved outcomes in this patient population.
IMA901 is developed by Immatics N.V., a biopharmaceutical company traded on the Nasdaq under the ticker IMTX. Leukine is a commercially available product from another manufacturer. Immatics sponsored the Phase 3 trial that evaluated IMA901 in combination with Leukine and sunitinib in metastatic renal cell carcinoma.
IMA901 and Leukine has been evaluated in a Phase 3 clinical trial. The trial, NCT01265901, is completed. As of the available information, the combination is not approved by the FDA and remains an investigational treatment for metastatic renal cell carcinoma.
IMA901 and Leukine was studied in one Phase 3 clinical trial, NCT01265901, titled IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma. The trial enrolled 339 patients across multiple countries including the United States, France, Germany, Italy, and the United Kingdom. It was active-controlled, randomized, and completed.