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Therapy Name | Pirtobrutinib |
Synonyms | |
Therapy Description |
Jaypirca (pirtobrutinib) selectively inhibits the activation of BTK, which may result in decreased tumor growth (PMID: 32170458, PMID: 33676628). Jaypirca (pirtobrutinib) is FDA approved for use in patients with relapsed or refractory mantle cell lymphoma who had received at least two lines of systemic therapy, and in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Pirtobrutinib | Jaypirca | LOXO-305|LOXO 305|LOXO305|RXC005|REDX08608 | BTK inhibitor 36 | Jaypirca (pirtobrutinib) selectively inhibits the activation of BTK, which may result in decreased tumor growth (PMID: 32170458, PMID: 33676628). Jaypirca (pirtobrutinib) is FDA approved for use in patients with relapsed or refractory mantle cell lymphoma who had received at least two lines of systemic therapy, and in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
BTK T474I | diffuse large B-cell lymphoma | resistant | Pirtobrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK T474I demonstrated resistance to Jaypirca (pirtobrutinib) in culture (PMID: 35196427). | 35196427 |
BTK T474I | diffuse large B-cell lymphoma | resistant | Pirtobrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK T474I demonstrated resistance to Jaypirca (pirtobrutinib) in culture (PMID: 38301010). | 38301010 |
TP53 loss | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Pirtobrutinib | Guideline | Actionable | Jaypirca (pirtobrutinib) is included in guidelines as second-line or third-line therapy for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma with TP53 loss and for patients with relapsed or refractory disease after prior BTK inhibitor and Venclexta (venetoclax)-based therapy (NCCN.org). | detail... |
TP53 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Pirtobrutinib | Guideline | Actionable | Jaypirca (pirtobrutinib) is included in guidelines as second-line or third-line therapy for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma with a TP53 mutation and for patients with relapsed or refractory disease after prior BTK inhibitor and Venclexta (venetoclax)-based therapy (NCCN.org). | detail... |
BTK L528W | chronic lymphocytic leukemia | predicted - resistant | Pirtobrutinib | Case Reports/Case Series | Actionable | In a clinical case study, 2 patients with chronic lymphocytic leukemia who previously responded to Jaypirca (pirtobrutinib) treatment were found to have acquired BTK L528W upon disease progression (PMID: 35196427). | 35196427 |
BTK C481S | chronic lymphocytic leukemia | sensitive | Pirtobrutinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, Jaypirca (pirtobrutinib) inhibited proliferation of patient-derived chronic lymphocytic leukemia cells harboring BTK C481S in culture (PMID: 36287227). | 36287227 |
BTK M437R | chronic lymphocytic leukemia | predicted - resistant | Pirtobrutinib | Case Reports/Case Series | Actionable | In a clinical case study, a patient with chronic lymphocytic leukemia harboring BTK C481S who previously responded to Jaypirca (pirtobrutinib) treatment was found to have acquired BTK M437R upon disease progression (PMID: 35196427). | 35196427 |
BTK A428D | diffuse large B-cell lymphoma | resistant | Pirtobrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK A428D demonstrated resistance to Jaypirca (pirtobrutinib) in culture (PMID: 35196427). | 35196427 |
BTK T474I | chronic lymphocytic leukemia | predicted - resistant | Pirtobrutinib | Case Reports/Case Series | Actionable | In a clinical case study, two patients with chronic lymphocytic leukemia who previously responded to Jaypirca (pirtobrutinib) treatment were found to have acquired BTK T474I upon disease progression (PMID: 35196427). | 35196427 |
BTK T474I BTK C481S | chronic lymphocytic leukemia | predicted - resistant | Pirtobrutinib | Case Reports/Case Series | Actionable | In a clinical case study, Jaypirca (pirtobrutinib) treatment resulted in a continued decrease of cancer cell fraction (CCF) of a clone of cells harboring BTK C481S but persistent increase of a clone harboring BTK T474I in a patient with chronic lymphocytic leukemia, as well as low-level CCF increase of BTK T474L, and BTK M477I (PMID: 36287227). | 36287227 |
BTK T474I BTK L528W | chronic lymphocytic leukemia | predicted - resistant | Pirtobrutinib | Case Reports/Case Series | Actionable | In a clinical case study, a patient with chronic lymphocytic leukemia harboring BTK C481S who previously responded to Jaypirca (pirtobrutinib) treatment was found to have acquired BTK T474I and BTK L528W upon disease progression (PMID: 35196427). | 35196427 |
ERBB4 over exp | marginal zone lymphoma | resistant | Pirtobrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a marginal zone lymphoma cell line with ERBB4 overexpression demonstrated resistance to Jaypirca (pirtobrutinib) in culture (PMID: 38052765). | 38052765 |
BTK V416L | diffuse large B-cell lymphoma | resistant | Pirtobrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK V416L demonstrated resistance to Jaypirca (pirtobrutinib) in culture (PMID: 35196427). | 35196427 |
BTK V416L | diffuse large B-cell lymphoma | resistant | Pirtobrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK V416L demonstrated resistance to Jaypirca (pirtobrutinib) in culture (PMID: 38301010). | 38301010 |
BTK C481S | diffuse large B-cell lymphoma | sensitive | Pirtobrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, Jaypirca (pirtobrutinib) treatment inhibited viability of a diffuse large B-cell lymphoma cell line harboring BTK C481S in culture (PMID: 35196427). | 35196427 |
BTK L528W | diffuse large B-cell lymphoma | resistant | Pirtobrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK L528W demonstrated resistance to Jaypirca (pirtobrutinib) in culture (PMID: 35196427). | 35196427 |
BTK L528W | diffuse large B-cell lymphoma | resistant | Pirtobrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK L528W demonstrated resistance to Jaypirca (pirtobrutinib) in culture (PMID: 38301010). | 38301010 |
BTK A428D | mantle cell lymphoma | resistant | Pirtobrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a mantle cell lymphoma cell line developed resistance to Jaypirca (pirtobrutinib) after prolonged exposure in culture, and was subsequently found to have acquired BTK A428D (PMID: 36661329). | 36661329 |
BTK V416L | chronic lymphocytic leukemia | predicted - resistant | Pirtobrutinib | Case Reports/Case Series | Actionable | In a clinical case study, a patient with chronic lymphocytic leukemia who previously responded to Jaypirca (pirtobrutinib) treatment was found to have acquired a BTK V416L upon disease progression (PMID: 35196427). | 35196427 |
BTK M437R | diffuse large B-cell lymphoma | resistant | Pirtobrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, a diffuse large B-cell lymphoma cell line expressing BTK M437R demonstrated resistance to Jaypirca (pirtobrutinib) in culture (PMID: 35196427). | 35196427 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT05172700 | Expanded access | Pirtobrutinib | Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer | Available | 0 | |
NCT04666038 | Phase III | Idelalisib + Rituximab Pirtobrutinib Bendamustine + Rituximab | Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With CLL or SLL | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 14 |
NCT04662255 | Phase III | Ibrutinib Zanubrutinib Pirtobrutinib Acalabrutinib | Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321) | Active, not recruiting | USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 14 |
NCT06333262 | Phase II | Obinutuzumab + Pirtobrutinib Pirtobrutinib | Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia | Recruiting | USA | 0 |
NCT05254743 | Phase III | Ibrutinib Pirtobrutinib | A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN-CLL-314) | Recruiting | USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 12 |
NCT03740529 | Phase Ib/II | Cyclophosphamide + Doxorubicin + Pirtobrutinib + Prednisone + Rituximab + Vincristine Sulfate Pirtobrutinib + Rituximab + Venetoclax Pirtobrutinib + Venetoclax Pirtobrutinib | A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL | Active, not recruiting | USA | ITA | GBR | FRA | AUS | 5 |
NCT05023980 | Phase III | Pirtobrutinib 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) | Active, not recruiting | USA | NZL | ITA | GBR | FRA | ESP | AUT | AUS | 12 |