Therapy Detail

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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).

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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).

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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

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  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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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


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