Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ALIMTA ® is a folate analog metabolic inhibitor indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. FDA label
Also known as LY231514, Alimta
pemetrexed disodium · 9 trials · 11 indications
Grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion or lasting \>7 days; febrile neutropenia; grade 3 neutropenia associated with infection; any other grade \>/=3 non-hematologic toxicity considered by the investigator to be related to study drug.
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 (Phase I).
Grade 3/4 toxicity occurring in a patient within 1 cycle.
To determine the response rate of bortezomib in combination with pemetrexed in patients with advanced NSCLC. Response rate was assessed by CT scan. CT scans was performed at baseline and every two cycles (prior to 3rd and 5th cycle). The evaluation of response was based on standard RECIST criteria.
| Name | Type | Description |
|---|---|---|
| pemetrexed disodium | DRUG | - |
| ALIMTA | DRUG | - |
| Carboplatin | DRUG | - |
| gemcitabine | DRUG | - |
| Oxaliplatin | DRUG | - |
| cisplatin | DRUG | - |
| bortezomib | DRUG | - |
| gene expression analysis | GENETIC | - |
| mutation analysis | GENETIC | - |
| protein expression analysis | GENETIC | - |
| reverse transcriptase-polymerase chain reaction | GENETIC | - |
| flow cytometry | OTHER | - |
| immunoenzyme technique | OTHER | - |
| immunohistochemistry staining method | OTHER | - |
| folic acid | DRUG | - |
| multi-vitamins | DRUG | - |
| irinotecan | DRUG | - |
| ALIMTA plus Epirubicin | DRUG | - |
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal cancer * Recurrent or persistent disease * Measurable disease * At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) ...
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Pemetrexed disodium is an investigational small molecule being studied in oncology for lung cancer and ovarian cancer. It has been evaluated in clinical trials for advanced non-small cell lung cancer, other solid tumors, ovarian epithelial cancer, and primary peritoneal cancer. It is not described as approved for these uses.
Pemetrexed disodium targets DHFR, GART, and TYMS. It acts as an inhibitor of these enzymes, which are involved in folate metabolism and nucleotide synthesis. By inhibiting these targets, the drug interferes with processes that cancer cells rely on for growth and division.
Pemetrexed disodium is developed by Eli Lilly and Company, which trades under the ticker LLY. The company is the sponsor associated with the clinical development of this small molecule oncology candidate.
Pemetrexed disodium is in Phase 1 clinical development. It is an investigational agent and has not been described as FDA approved. The development program includes a completed Phase 1 trial and a completed Phase 2 trial in different cancer types.
Pemetrexed disodium has been studied in two completed trials. NCT00389805 was a Phase 1 trial combining bortezomib and pemetrexed disodium in advanced non-small cell lung cancer or other solid tumors, enrolling 27 patients. NCT00087087 was a Phase 2 trial in ovarian epithelial or primary peritoneal cancer, enrolling 51 patients.