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Therapy Name | LOXO-305 |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
LOXO-305 | LOXO 305|LOXO305|pirtobrutinib | BTK inhibitor 32 | LOXO-305 selectively inhibits activation of BTK, which results in decreased tumor growth (PMID: 32170458, PMID: 33676628). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
BTK V416L | diffuse large B-cell lymphoma | resistant | LOXO-305 | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK V416L demonstrated resistance to LOXO-305 in culture (PMID: 35196427). | 35196427 |
BTK T474I | diffuse large B-cell lymphoma | resistant | LOXO-305 | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK T474I demonstrated resistance to LOXO-305 in culture (PMID: 35196427). | 35196427 |
BTK M437R | chronic lymphocytic leukemia | predicted - resistant | LOXO-305 | Case Reports/Case Series | Actionable | In a clinical case study, a patient with chronic lymphocytic leukemia harboring BTK C481S who previously responded to LOXO-305 treatment was found to have acquired BTK M437R upon disease progression (PMID: 35196427). | 35196427 |
BTK L528W | diffuse large B-cell lymphoma | resistant | LOXO-305 | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK L528W demonstrated resistance to LOXO-305 in culture (PMID: 35196427). | 35196427 |
BTK C481S | diffuse large B-cell lymphoma | sensitive | LOXO-305 | Preclinical - Cell culture | Actionable | In a preclinical study, LOXO-305 treatment inhibited viability of a diffuse large B-cell lymphoma cell line harboring BTK C481S in culture (PMID: 35196427). | 35196427 |
BTK V416L | chronic lymphocytic leukemia | predicted - resistant | LOXO-305 | Case Reports/Case Series | Actionable | In a clinical case study, a patient with chronic lymphocytic leukemia who previously responded to LOXO-305 treatment was found to have acquired a BTK V416L upon disease progression (PMID: 35196427). | 35196427 |
BTK L528W | chronic lymphocytic leukemia | predicted - resistant | LOXO-305 | Case Reports/Case Series | Actionable | In a clinical case study, two patients with chronic lymphocytic leukemia who previously responded to LOXO-305 treatment were found to have acquired BTK L528W upon disease progression (PMID: 35196427). | 35196427 |
BTK A428D | diffuse large B-cell lymphoma | resistant | LOXO-305 | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK A428D demonstrated resistance to LOXO-305 in culture (PMID: 35196427). | 35196427 |
BTK M437R | diffuse large B-cell lymphoma | resistant | LOXO-305 | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK M437R demonstrated resistance to LOXO-305 in culture (PMID: 35196427). | 35196427 |
BTK T474I BTK L528W | chronic lymphocytic leukemia | predicted - resistant | LOXO-305 | Case Reports/Case Series | Actionable | In a clinical case study, a patient with chronic lymphocytic leukemia harboring BTK C481S who previously responded to LOXO-305 treatment was found to have acquired BTK T474I and BTK L528W upon disease progression (PMID: 35196427). | 35196427 |
BTK T474I | chronic lymphocytic leukemia | predicted - resistant | LOXO-305 | Case Reports/Case Series | Actionable | In a clinical case study, two patients with chronic lymphocytic leukemia who previously responded to LOXO-305 treatment were found to have acquired BTK T474I upon disease progression (PMID: 35196427). | 35196427 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04662255 | Phase III | Ibrutinib Zanubrutinib LOXO-305 Acalabrutinib | Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 16 |
NCT05023980 | Phase III | LOXO-305 Bendamustine + Rituximab | A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313) | Recruiting | USA | ITA | FRA | ESP | AUT | 10 |
NCT05172700 | Expanded access | LOXO-305 | Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer | Available | USA | DEU | BEL | 5 |
NCT05254743 | Phase III | Ibrutinib LOXO-305 | A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN-CLL-314) | Recruiting | USA | 0 |
NCT04666038 | Phase III | Idelalisib + Rituximab LOXO-305 Bendamustine + Rituximab | Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With CLL or SLL | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 14 |
NCT03740529 | Phase Ib/II | Cyclophosphamide + Doxorubicin + LOXO-305 + Prednisone + Rituximab + Vincristine Sulfate LOXO-305 + Rituximab + Venetoclax LOXO-305 + Venetoclax LOXO-305 | A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL | Recruiting | USA | ITA | FRA | 7 |