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 39 | 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 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 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 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 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 T474I | 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 experienced progressive disease after an initial response on treatment with Jaypirca (pirtobrutinib) and was found to have acquired BTK T474I and lost BTK C481S (PMID: 39048721). | 39048721 |
| 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 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 |
| 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 |
| TP53 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Pirtobrutinib | Guideline | Actionable | Jaypirca (pirtobrutinib) is included in guidelines (category 1) as second-line or subsequent therapy for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma with a TP53 mutation and for patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma with a TP53 mutation after prior BTK inhibitor-based and BCL2 inhibitor-containing regimens (NCCN.org). | detail... |
| 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 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 |
| 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 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 C481S | chronic lymphocytic leukemia | sensitive | Pirtobrutinib | Case Reports/Case Series | Actionable | In a clinical case study, Jaypirca (pirtobrutinib) resulted in disease control lasting 7 months in a patient with chronic lymphocytic leukemia harboring BTK C481S (PMID: 39048721). | 39048721 |
| 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 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 |
| TP53 loss | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Pirtobrutinib | Guideline | Actionable | Jaypirca (pirtobrutinib) is included in guidelines (category 1) as second-line or subsequent 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 BCL2 inhibitor-containing therapy (NCCN.org). | detail... |
| 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 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 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 |
| 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | TUR | POL | ITA | ISR | IRL | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 6 |
| NCT06839872 | Phase II | Pirtobrutinib Acalabrutinib | A Study to Investigate the Sequencing Strategy of Pirtobrutinib After Disease Progression on First-line Acalabrutinib Treatment for Adult Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (BOSS) | Withdrawn | 0 | |
| 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 | POL | NZL | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | 6 |
| NCT06553872 | Phase II | Brexucabtagene autoleucel Brexucabtagene autoleucel + Pirtobrutinib Pirtobrutinib | Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL | Recruiting | USA | 0 |
| NCT06973187 | Phase III | Pirtobrutinib BGB-16673 | A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | Recruiting | USA | SWE | ROU | POL | NZL | NLD | ITA | ISR | GBR | FRA | ESP | DEU | CHE | BRA | BEL | AUT | AUS | ARG | 6 |
| 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 | ROU | POL | NZL | ITA | HUN | GBR | FRA | ESP | CZE | BRA | BGR | AUT | AUS | 6 |
| NCT07428707 | Phase I | Pirtobrutinib | Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib | Recruiting | USA | 0 |
| NCT06588478 | Phase II | Pirtobrutinib | A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Recruiting | USA | TUR | SVK | ROU | POL | ITA | HUN | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BEL | AUS | 1 |
| NCT07218341 | Expanded access | Pirtobrutinib Idelalisib | A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Recruiting | USA | POL | ITA | IRL | HUN | HRV | GBR | FRA | ESP | CZE | CAN | BEL | AUT | AUS | 2 |
| NCT07207785 | Phase II | Pirtobrutinib | PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma (FIL_PUMA) | Not yet recruiting | ITA | 0 |
| NCT06812715 | Phase II | Pirtobrutinib | Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated with Pirtobrutinib After Previous Treatment with Zanubrutinib (PIPOZA) | Recruiting | AUS | 0 |
| NCT06333262 | Phase II | Obinutuzumab + Pirtobrutinib Pirtobrutinib | Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia | Recruiting | USA | 0 |
| 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 | Completed | USA | SWE | POL | ITA | GBR | FRA | CHE | AUS | 2 |
| NCT07685717 | Phase II | Pirtobrutinib | Pirtobrutinib for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia | Recruiting | USA | 0 |
| NCT07342478 | Phase III | LP-168 Pirtobrutinib | ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL | Recruiting | USA | 0 |
| NCT06390956 | Phase II | Pirtobrutinib Pirtobrutinib + Rituximab | Pirtobrutinib in Combination With Rituximab in Adults With Untreated Marginal Zone Lymphoma (PIONEER-MZL) | Recruiting | USA | 0 |
| NCT05172700 | Expanded access | Pirtobrutinib | Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer | Approved for marketing | 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 | TUR | POL | NZL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 5 |
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