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Also known as Pirtobrutinib
Pirtobrutinib and rituximab · 1 trial · 1 indication
To assess the activity of Pirtobrutinib in combination with rituximab (P-R) as a therapeutic alternative to immunochemotherapy (R-Bendamustine or R-CHOP regimen) in patients with an indolent clinical presentation of MCL. The primary objective will be assessed by the complete remission rate (CRR), defined as the percentage of patients who achieve a complete response (CR) at the end of Cycle 6 of the P-R combination according to the Lugano Classification.
| Arm | Type | Description |
|---|---|---|
| Pirtobrutinib with rituximab | EXPERIMENTAL | Patients will receive a P-R combination for at least 24 cycles (C24). The first cycle of P-R will be administered at day 1 (baseline) . Pirtobrutinib discontinuation will be decided after C24, according to the MRD response and the TP53 mutational status. Rituximab treatment will end up at C23. |
| Name | Type | Description |
|---|---|---|
| Pirtobrutinib and rituximab | DRUG | Patients will receive the study treatment (P-R combination) at day 1 (baseline) and during the treatment period (C24). Pirtobrutinib discontinuation per protocol will be decided after C24, according to the MRD response and the TP53 mutational status. Rituximab treatment will end up at C23. |
Inclusion Criteria: 1. Adult patients (≥18 years of age). 2. Written informed consent must be obtained before any study-specific assessment is performed. 3. Subjects with confirmed diagnosis of Mantle Cell Lymphoma according to the International Consensus Classification, (ICC) 2022\] or World Healt...
Pirtobrutinib is an investigational small molecule being studied for Waldenstrom Macroglobulinemia, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Non-Hodgkin Lymphoma, and other B-cell malignancies. It is also being evaluated in healthy volunteers. The drug is in Phase 3 clinical development for these oncology indications.
Pirtobrutinib is a kinase inhibitor, as indicated by its -tinib suffix. It is being developed to treat B-cell malignancies including Waldenstrom Macroglobulinemia and Mantle Cell Lymphoma. The drug is administered orally and is currently in Phase 3 clinical trials.
Pirtobrutinib is being developed by Eli Lilly and Company, which trades on the NYSE under the ticker LLY. The company is conducting Phase 3 trials of the drug in multiple oncology indications, including chronic lymphocytic leukemia and small lymphocytic lymphoma.
Pirtobrutinib is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in multiple Phase 3 trials for B-cell malignancies, including chronic lymphocytic leukemia and small lymphocytic lymphoma.
Pirtobrutinib is being studied in several Phase 3 trials, including NCT04666038 comparing it to idelalisib plus rituximab or bendamustine plus rituximab in previously treated CLL/SLL, and NCT04965493 testing it with venetoclax and rituximab versus venetoclax and rituximab alone. A Phase 1 trial, NCT03740529, has been completed.
Pirtobrutinib and rituximab is a combination regimen being studied in clinical trials, not an alternative name for the single drug Pirtobrutinib. The combination is being evaluated in Phase 3 trials for chronic lymphocytic leukemia and small lymphocytic lymphoma.