If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Jaypirca ® (pirtobrutinib) tablets
50 mg,100 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What clinical trials are planned or ongoing for Jaypirca™ (pirtobrutinib)?
Jaypirca (pirtobrutinib) is currently being studied in patients with chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) and non-Hodgkin's lymphomas.
Pirtobrutinib (LOXO-305) Clinical Development
Lilly-Sponsored Clinical Studies
Pirtobrutinib (LOXO-305) is being studied as a single agent and in combination for the treatment of patients with various B-cell malignancies. Phase 3 studies are currently recruiting patients to evaluate the use of pirtobrutinib for first-line treatment of chronic lymphocytic leukemia (CLL) and relapsed or refractory mantle cell lymphoma (MCL) and CLL. presents details of ongoing Eli Lilly and Company (Lilly)-sponsored pirtobrutinib (LOXO-305) clinical trials.
Trial |
Sponsor |
Phase/Study Design |
Tumor Type |
Regimen |
Primary Outcomes |
NCT Number/ |
Phase 3 |
||||||
LOXO@Lilly |
Randomized, open-label |
MCL |
Arm A |
PFS assessed by IRC per Lugano criteria |
NCT04662255/ |
|
LOXO@Lilly |
Randomized, open-label |
CLL |
Arm A |
PFS assessed by IRC per iwCLL 2018 response criteria |
NCT04666038/ |
|
LOXO@Lilly |
Randomized, open-label |
CLL |
Arm A |
PFS by blinded IRC per iwCLL 2018 response criteria |
NCT04965493/ |
|
LOXO@Lilly |
Randomized, open-label |
CLL |
Arm A |
PFS by blinded IRC per iwCLL 2018 response criteria |
NCT05023980/ |
|
BRUIN-CLL-314 (LOXO-BTK-20030)9 |
LOXO@Lilly |
Randomized, open-label |
CLL |
Arm A |
ORR assessed by IRC per iwCLL 2018 response criteria |
NCT05254743/ |
Phase 1/2 |
||||||
BRUIN (LOXO-BTK-18001)10 |
LOXO@Lilly |
Nonrandomized, open label |
CLL |
Phase 1 |
MTD/RP2D (phase 1) |
NCT03740529/ |
Phase 1 |
||||||
LOXO-BCL-2000111 |
LOXO@Lilly |
Randomized, open label |
CLL |
Part 1 |
MTD/RP2D of LOXO-338 (part 1) |
NCT05024045/Active, not recruiting |
Abbreviations: BCL = B-cell lymphoma; BTK = Bruton's tyrosine kinase; CLL = chronic lymphocytic leukemia; IRC = independent review committee; iwCLL = International Workshop on Chronic Lymphocytic Leukemia; LOXO-305 = pirtobrutinib; MCL = mantle cell lymphoma; MM = multiple myeloma; MTD = maximum tolerated dose; MZL = marginal zone lymphoma; NHL = non-Hodgkin's lymphoma; ORR = overall response rate; PFS = progression-free survival; RP2D = recommended phase 2 dose; SLL = small lymphocytic lymphoma; WM = Waldenström's macroglobulinemia.
aInvestigator's choice.
Non-Lilly Sponsored Clinical Studies
Trial |
Sponsor |
Study Design |
Tumor Type |
Regimen |
Primary Outcome |
NCT Number/Status |
Phase 2 |
||||||
Pirtobrutinib consolidation for MRD eradication12 |
MD Anderson |
Nonrandomized, open label |
CLL |
Pirtobrutinib plus venetoclax |
U-MRD in the peripheral blood assessed by NGS |
NCT05317936/Recruiting |
Pirtobrutinib plus venetoclax in relapsed/refractory MCL13 |
MD Anderson |
Nonrandomized, open label |
MCL |
Pirtobrutinib plus venetoclax |
ORR |
NCT05529069/Recruiting |
Time-limited pirtobrutinib, venetoclax, and obinutuzumab for treatment-naïve CLL and RT14 |
MD Anderson |
Nonrandomized, open label |
CLL |
Pirtobrutinib plus venetoclax and obinutuzumab |
AE severity assessed by CTCAE, v5.0 |
NCT05536349/Recruiting |
Pirtobrutinib and venetoclax combined with minimal residual disease detection for previously untreated chronic lymphocytic leukemia, MIRACLE study15 |
Mayo Clinic |
Nonrandomized, open label |
CLL |
Pirtobrutinib plus venetoclax |
uMRD |
NCT05677919/Recruiting |
Pirtobrutinib and venetoclax in Waldenström macroglobulinemia16 |
Dana-Farber Cancer Institute |
Nonrandomized, open label |
WM |
Pirtobrutinib plus venetoclax |
VGPR or better response rate |
NCT05734495/Recruiting |
Glofitamab and pirtobrutinib in mantle cell lymphoma patients with prior BTK inhibitor exposure (GOlDiLOX)17 |
Australasian Leukaemia and Lymphoma Group |
Nonrandomized, open label |
MCL |
Pirtobrutinib plus glofitimab |
CR rate according to Lugano criteria |
NCT05833763/Not yet recruiting |
Phase 1 |
||||||
LV20.19 CAR T-cells in combination with pirtobrutinib for relapsed, refractory B-cell malignancies18 |
Medical College of Wisconsin |
Nonrandomized, open label |
NHL |
Pirtobrutinib plus LV20.19 CAR T-cells |
AE incidence after administration |
NCT05990465/Not yet recruiting |
Abbreviations: AE = adverse event; BL = Burkitt lymphoma; BTK = Bruton's tyrosine kinase; CAR = chimeric antigen receptor; CLL = chronic lymphocytic leukemia; CR = complete response; CTCAE = Common Terminology Criteria for Adverse Events; DLBCL = diffuse large B-cell lymphoma; FL = follicular lymphoma; MCL = mantle cell lymphoma; MZL = marginal zone lymphoma; MRD = minimal residual disease; NGS = next generation sequencing; NHL = non‑Hodgkin lymphoma; ORR = overall response rate; RT = Richter transformation; SLL = small lymphocytic lymphoma; U-MRD = undetectable minimal residual disease; uMRD = undetected minimal residual disease; v = version; VGPR = very good partial response; WM = Waldenström macroglobulinemia.
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Study of BTK inhibitor LOXO-305 versus approved BTK inhibitor drugs in patients with mantle cell lymphoma (MCL) (BRUIN-MCL-321). ClinicalTrials.gov identifier: NCT04662255. Updated August 30, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT04662255
2Eyre TA, Shah NN, LeGouill S, et al. BRUIN MCL-321: a phase 3, open-label, randomized study of pirtobrutinib versus investigator choice of BTK inhibitor in patients with previously treated, BTK inhibitor naïve mantle cell lymphoma (trial in progress). Poster presented at: 63rd Annual Meeting of the American Society of Hematology (ASH Virtual); December 11-14, 2021. https://www.lillymedical.com/assets/vaultpdf/us/en/b63d548b2cdf79f2e937c331e58f9f6459d586bdf7d122cf2b157fb851efc1af/bruin-mcl-321-a-phase-3-trial-in-progress
3Study of LOXO-305 versus investigator's choice (IdelaR or BR) in patients with previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (BRUIN CLL-321). Clinicaltrials.gov identifier: NCT04666038. Updated July 3, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT04666038
4Sharman JP, Jurczak W, Coombs CC, et al. BRUIN CLL-321: a phase 3 open-label, randomized study of pirtobrutinib versus investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab in BTK inhibitor pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (trial in progress). Poster presented at: 63rd Annual Meeting of the American Society of Hematology (ASH Virtual); December 11-14, 2021. https://www.lillymedical.com/assets/vaultpdf/us/en/f163aa34041e43f5d95e0e4669c7dc663ba5fee74c6d6b88175ef7b9dc39ac83/bruin-cll-321-a-phase-3-trial-in-progress
5A trial of pirtobrutinib (LOXO-305) plus venetoclax and rituximab (PVR) versus venetoclax and rituximab (VR) in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) (BRUIN CLL-322). Clinicaltrials.gov identifier: NCT04965493. Updated September 14, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT04965493
6Mato AR, Wierda WG, Pagel JM, et al. BRUIN CLL-322: a phase 3 open-label, randomized study of fixed duration pirtobrutinib plus venetoclax and rituximab versus venetoclax and rituximab in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (trial in progress) Poster presented at: 63rd Annual Meeting of the American Society of Hematology (ASH Virtual); December 11-14, 2021. https://www.lillymedical.com/assets/vaultpdf/us/en/2f7d484ac6421004d1588feb6e42feb92b614861fe5366d35f09802570316221/bruin-cll-322-a-phase-3-trial-in-progress
7A 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). Clinicaltrials.gov identifier: NCT05023980. Updated July 11, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT05023980
8Jurczack W, Dartigeas C, Coscia M, et al. BRUIN CLL-313: a phase 3 open-label, randomized study of pirtobrutinib versus bendamustine plus rituximab in untreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (trial in progress). Poster presented at: 63rd Annual Meeting of the American Society of Hematology (ASH Virtual); December 11-14, 2021. https://www.lillymedical.com/assets/vaultpdf/us/en/9925e8a232bf221824be44b7a8c65397456fe57ec350ba23e2919c5952650083/bruin-cll-313-a-phase-3-trial-in-progress
9A study of pirtobrutinib (LOXO-305) versus ibrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (BRUIN-CLL-314). Clinicaltrials.gov identifier: NCT05254743. Updated July 11, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT05254743
10A study of oral LOXO-305 in patients with previously treated CLL/SLL or NHL. ClinicalTrials.gov identifier: NCT03740529. Updated March 8, 2023. Accessed September 15, 2023. https://www.clinicaltrials.gov/ct2/show/NCT03740529
11Study of oral LOXO-338 in patients with advanced blood cancers. ClinicalTrials.gov identifier: NCT05024045. Updated June 1, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT05024045
12Pirtobrutinib (LOXO-305) consolidation for MRD eradication in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL) treated with venetoclax. ClinicalTrials.gov identifier: NCT05317936. Updated February 23, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT05317936
13Phase II study of pirtobrutinib with venetoclax in relapsed-refractory MCL (mantle cell lymphoma) patients. ClinicalTrials.gov identifier: NCT05529069. Updated September 13, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT05529069?term=NCT05529069
14Time-limited triplet combination of pirtobrutinib, venetoclax, and obinutuzumab for patients with treatment-naïve chronic lymphocytic leukemia (CLL) or Richter transformation (RT). ClinicalTrials.gov identifier: NCT05536349. Updated June 18, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT05536349
15Pirtobrutinib and venetoclax combined with minimal residual disease detection for previously untreated chronic lymphocytic leukemia, MIRACLE study. ClinicalTrials.gov identifier: NCT05677919. Updated February 2, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT05677919
16Pirtobrutinib and venetoclax in Waldenström macroglobulinemia. ClinicalTrials.gov identifier: NCT05734495. Updated May 10, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT05734495
17A phase 2 trial of glofitamab and pirtobrutinib in mantle cell lymphoma patients with prior BTK inhibitor exposure (GOlDiLOX). ClinicalTrials.gov identifier: NCT05833763. Updated April 27, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT05833763
18LV20.19 CAR T-cells in combination with pirtobrutinib for relapsed, refractory B-cell malignancies. ClinicalTrials.gov identifier: NCT05990465. Updated August 14, 2023. Accessed September 15, 2023. https://clinicaltrials.gov/ct2/show/NCT05990465
Date of Last Review: September 15, 2023