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Jaypirca ® (pirtobrutinib) tablets
50 mg,100 mg
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What are the efficacy and safety results for the Jaypirca™ (pirtobrutinib) in the phase 1/2 BRUIN trial?
In a phase 1/2 BRUIN study, Jaypirca (pirtobrutinib) has shown efficacy in heavily pretreated patients with various B-cell malignancies and the most common TEAEs included fatigue, diarrhea, and neutropenia.
Efficacy Results in Phase 1/2 BRUIN Study
BRUIN is a global, multicenter phase 1/2 trial evaluating pirtobrutinib (LOXO-305) in patients with previously treated chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin's lymphoma (NHL) who have failed or are intolerant to standard of care (NCT03740529).1,2 BRUIN Phase 1/2 Study Schema provides additional details on the BRUIN study design.
Mantle Cell Lymphoma
As of the data cut-off date on May 5, 2023, 778 patients had been enrolled in the BRUIN trial for treatment with pirtobrutinib monotherapy, of which 166 were patients with mantle cell lymphoma (MCL). Efficacy analysis was performed in 152 patients with MCL who had
- enrolled from either phase 1 or phase 2
- received ≥1 dose of pirtobrutinib monotherapy at any dose level
- received a prior Bruton's tyrosine kinase (BTK) inhibitor-containing regimen,
- measurable disease, and
- no central nervous system involvement.3
Efficacy Results Among Patients With MCL in the Phase 1/2 BRUIN Study presents efficacy for patients with MCL in the by prior treatment with a BTK inhibitor as of the data cutoff of May 5, 2023.3
Response, n (%) |
MCL (cBTKi-naïve)a |
MCL (Previous cBTKi)b |
85.7 (57.2-98.2) |
49.3 (41.1-57.6) |
|
CR |
6 (42.9) |
24 (15.8) |
PR |
6 (42.9) |
51 (33.6) |
Median DOR, months (95% CI) |
NE (13.0-NE) |
21.6 (9.2-27.2) |
Median PFS, months (95% CI) |
NE (16.7-NE) |
5.6 (5.3-9.2) |
Median OS, months (95% CI) |
NE (NE-NE) |
23.5 (17.1-NE) |
Abbreviations: cBTKi = covalent Bruton's tyrosine kinase inhibitor; CR = complete response; DOR = duration of response; IRC = independent review committee; MCL = mantle cell lymphoma; NE = not estimable; NR = not reported; OS = overall survival; PFS = progression-free survival; PR = partial response.
aOne cBTKi naïve patient was not evaluable.
bThirteen cBTKi pre-treated MCL patients were not evaluable.
cORR includes patients with a best response of CR and PR.
dResponse status per Lugano 2014 criteria based on IRC assessment.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
As of the data cut-off date on May 5, 2023, 778 patients had been enrolled in the BRUIN trial for treatment with pirtobrutinib monotherapy, of which 317 were patients with CLL/SLL. Efficacy analysis was performed in 282 patients with CLL/SLL who had
- enrolled from either phase 1 or phase 2
- received ≥1 dose of pirtobrutinib monotherapy at any dose level, and
- received a prior BTK inhibitor-containing regimen.4
Efficacy Results Among Patients With CLL/SLL Who Received Prior BTK Inhibitor Treatment in the Phase 1/2 BRUIN Study presents efficacy for patients with CLL/SLL who received prior BTK inhibitor treatment in the efficacy analysis set.4
Response, n (%) |
CLL/SLL |
ORRb, % (95% CI) |
81.6 (76.5-85.9) |
CR |
5 (1.8) |
Nodular PR |
2 (0.7) |
PR |
196 (69.5) |
PR-L |
27 (9.6) |
Median PFS, months (95% CI)c |
19.4 (16.6-22.1) |
Median OS, months (95% CI)d |
NE (NE-NE) |
Abbreviations: BTK = Bruton's tyrosine kinase; CLL = chronic lymphocytic leukemia; CR = complete response; IRC = independent review committee; iwCLL = International Workshop on Chronic Lymphocytic Leukemia; PFS = progression-free survival; PR = partial response; PR-L = partial response with lymphocytosis; SLL = small lymphocytic lymphoma.
aPost-cBTKi patients included a subgroup of 19 patients with one prior line of cBTKi-containing therapy and second line therapy of pirtobrutinib, who had an ORR including PR-L of 89.5% (95% CI: 66.9-98.7).
bORR including PR-L is the number of patients with best response of PR-L or better divided by the total number of patients; 14 patients with a best response of not evaluable (NE) are included in the denominator. Response status per iwCLL 2018 according to IRC assessment.
cMedian follow-up of 27.5 months.
dMedian follow-up of 29.3 months.
Other Non-Hodgkin's Lymphomas
In the BRUIN study, patients with other B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL), Waldenström's macroglobulinemia (WM), follicular lymphoma (FL), marginal zone lymphoma (MZL), Richter's transformation (RT), B-cell prolymphocytic leukemia (B-PLL), Hairy Cell Leukemia, primary central nervous system lymphoma (PCNSL), and other transformations, were permitted to enroll.5 Additional efficacy details on these subgroups are included below.
Richter's Transformation
As of the data cut-off date on May 5, 2023, 778 patients had been enrolled in the BRUIN trial for treatment with pirtobrutinib monotherapy, of which 82 were patients with RT. Of these 82 patients, 74 patients had received prior RT-directed treatment.6
Efficacy Results Among Patients With RT in the Phase 1/2 BRUIN Study presents efficacy for patients with RT as of the data cutoff of May 5, 2023.6
Responsea, n (%) |
All RT Patients |
Prior RT Therapy |
50.0d (38.7-61.3) |
48.6 (36.9-60.6) |
|
CR |
11 (13.4) |
9 (12.2) |
PR |
30 (36.6) |
27 (36.5) |
Median DOR, months (95% CI) |
7.4 (3.1-19.1) |
5.4 (2.5-15.9) |
Median PFS, months (95% CI) |
3.7 (2.7-4.9) |
3.6 (2.4-4.6) |
Median OS, months (95% CI) |
12.5 (6.9-20.5) |
11.8 (6.9-19.5) |
Abbreviations: CR = complete response; CT = computed tomography; DOR = duration of response; NE = not estimable; OS = overall survival; PET = positron emission tomography; PFS = progression-free survival; PR = partial response; RT = Richter's transformation.
aTen patients with a best response of not evaluable (NE) are included in the denominator.
bResponse as assessed by investigator based on Lugano criteria.
cORR is the number of patients with best response of CR or PR divided by the total number of patients.
dFor patients with adequate post-baseline assessment, the ORR was similar between Lugano assessments done by PET vs. CT. ORR for PET (n=49) was 57.1% (95%CI: 42.2-71.2), and for CT only (n=62), the ORR was 54.8% (95% CI: 41.7-67.5).
Waldenström's Macroglobulinemia
As of the data cut-off date on July 29, 2022, 773 patients had been enrolled in the BRUIN trial, of which 80 were patients with WM. Of these 80 patients, 63 patients had received prior BTK inhibitor treatment.7
Efficacy Results Among Patients With WM in the Phase 1/2 BRUIN Study presents efficacy for patients with WM.7
WM (cBTKi-naïve) |
WM (Previous cBTKi) |
|
Major response ratec, % (95% CI) |
88.2 (63.6-98.5) |
66.7 (53.7-78.0) |
CR + VGPR, % (95% CI) |
29.4 (10.3-56.0) |
23.8 (14.0-36.2) |
Best response, n (%) |
||
VGPRd |
5 (29.4) |
15 (23.8) |
PR |
10 (58.8) |
27 (42.9) |
MR |
0 |
9 (14.3) |
SD |
2 (11.8) |
9 (14.3) |
Median PFS, months (95% CI) |
NR |
19.4 (15.1-22.1) |
Median OS, months (95% CI) |
NR |
NE |
Abbreviations: cBTKi = covalent Bruton's tyrosine kinase inhibitor; CR = complete response; MR = minor response; NE = not estimable; NR= not reported; OS = overall survival; PFS = progression-free survival; PR = partial response; SD = stable disease; VGPR = very good partial response; WM = Waldenström's macroglobulinemia.
aResponse as assessed by investigator based on Modified IWWM6 (Owen’s) criteria.
bTotal % may be different than the sum of the individual components due to rounding.
cMajor response includes subjects with a best response of CR, VGPR, or PR.
dUnder modified IWWM6 criteria, a PR is upgraded to VGPR if corresponding IgM is in normal range or has at least 90% reduction from baseline.
Follicular Lymphoma
As of the data cutoff of May 05, 2023, there were 48 patients with follicular lymphoma (FL) enrolled in the BRUIN trial. Patients were eligible for participation in the FL subgroup if they had active disease in need of treatment and were previously treated for FL.8
Efficacy Results Among Patients With Follicular Lymphoma in the Phase 1/2 BRUIN Study summarizes the efficacy results among patients with FL in the BRUIN study as assessed according to Lugano criteria. At 18 months, the
- progression-free survival rate was 32.3%
- overall survival rate was 78.3%, and
- duration of response rate was 41%.8
Efficacy Endpointa |
All FL Patients |
ORR, % (95% CI) |
50.0 (35.2-64.8)b |
Best response, n (%) |
|
CR |
7 (14.6) |
PR |
17 (35.4) |
Median PFS, months (95% CI) |
5.8 (3.8-8.1)c |
Median OS, months (95% CI) |
NEd |
Median DOR, months (95% CI) |
5.5 (3.7-NE)e |
Abbreviations: CR = complete response; DOR = duration of response; FL = follicular lymphoma; NE = not estimable; ORR = overall response rate; OS = overall survival; PFS = progression-free survival; PR = partial response.
aEfficacy assessment based on Lugano criteria.
bMedian time-to-response was 1.9 months (range, 1.6-7.5) among 44 response-evaluable patients.
cMedian follow-up was 16.8 months among 48 response-evaluable patients.
dMedian follow-up was 20.4 months among 48 response-evaluable patients.
eMedian follow-up was 18.4 months among 24 response-evaluable patients.
Marginal Zone Lymphoma
As of the data cutoff of May 05, 2023, there were 36 patients with marginal zone lymphoma (MZL) enrolled in the BRUIN trial. Patients were eligible for participation in the MZL subgroup if they had active MZL in need of treatment and had previously been treated for the disease.9
Efficacy Results Among Patients With Marginal Zone Lymphoma in the Phase 1/2 BRUIN Study summarizes the efficacy results among patients with MZL in the BRUIN study, as assessed according to Lugano criteria. At 18 months, the
- progression-free survival rate was 46.6%
- overall survival rate was 81.8%, and
- duration of response rate was 35.8%.9
Efficacy Endpointa |
All MZL Patients |
Prior cBTKi Treated |
cBTKi Naive |
ORR |
50.0 (32.9-67.1)b |
46.2 (26.6-66.6) |
60.0 (26.2-87.8) |
Best response, n (%) |
|||
CR |
1 (2.8) |
0 |
1 (10.0) |
PR |
17 (47.2) |
12 (46.2) |
5 (50.0) |
Median PFS, months |
16.5 (7.4-22.1)c |
9.2 (5.8-NE) |
NE (1.9-NE) |
Median OS, months |
NE (27.6-NE)d |
NE |
NE (11.7-NE) |
Median DOR, months |
12.7 (5.6-NE)e |
7.4 (3.8-12.7) |
NE (12.0-NE) |
Abbreviations: cBTKi = covalent Bruton's tyrosine kinase inhibitor; CR = complete response; DOR = duration of response; MZL = marginal zone lymphoma; NE = not estimable; ORR = overall response rate; OS = overall survival; PFS = progression-free survival; PR = partial response.
aEfficacy assessment based on Lugano criteria.
bMedian time-to-response was 1.9 months (range, 1.6-19.3) among 29 response-evaluable patients.
cMedian follow-up was 15.8 months among 36 response-evaluable patients.
dMedian follow-up was 21.5 months among 36 response-evaluable patients.
eMedian follow-up was 17.6 months among 18 response-evaluable patients.
Diffuse Large B-Cell Lymphoma
Efficacy Results Among Patients With Other Non-Hodgkin's Lymphomas in the Phase 1/2 BRUIN Study shows efficacy was also demonstrated in other NHLs as of September 27, 2020.
Responseb |
DLBCL |
ORRc, % (95% CI) |
24 (9-45) |
CR, n (%) |
4 (16) |
PR, n (%) |
2 (8) |
SD, n (%) |
2 (8) |
Abbreviations: CR = complete response; DLBCL = diffuse large B-cell lymphoma; ORR = overall response rate; PR = partial response; SD = stable disease.
aEfficacy evaluable patients are those who had at least one postbaseline response assessment or had discontinued treatment prior to first postbaseline response assessment.
bTotal percentage may be different than the sum of the individual components due to rounding.
cResponses were defined according to disease-specific guidelines. As of data cutoff, no responses were observed in the efficacy evaluable patients with other tumor types not shown in the table. ORR includes patients with a best response of CR and PR. Response status per Lugano criteria.
Safety Results in Phase 1/2 BRUIN Study
As of July 29, 2022, the median time on treatment for the overall safety population was 9.6 months. Treatment-related adverse events led to
- treatment discontinuations in 2.6% (n=20) of all patients, and
- dose reductions in 4.5% (n=35) of all patients.11
Adverse events that occurred in ≥15% of patients in the overall BRUIN study are summarized in Adverse Events Occurring in ≥15% of the Overall Study Population of the Phase 1/2 BRUIN Study . Adverse events of special interest in the overall BRUIN study are summarized in Adverse Events of Special Interest Among Patients in the Overall Study Population of the the Phase 1/2 BRUIN Study.
Adverse Event, % of patients |
All Doses and Patients |
|||
TEAEs |
TRAEs |
|||
Any Grade |
Grade ≥3 |
Any Grade |
Grade ≥3 |
|
Fatigue |
28.7 |
2.1 |
9.3 |
0.8 |
Diarrhea |
24.2 |
0.9 |
9.3 |
0.4 |
Neutropeniaa |
24.2 |
20.4 |
14.7 |
11.5 |
Contusion |
19.4 |
0 |
12.8 |
0 |
Cough |
17.5 |
0.1 |
2.3 |
0 |
Covid-19 |
16.7 |
2.7 |
1.3 |
0 |
Nausea |
16.2 |
0.1 |
4.7 |
0.1 |
Dyspnea |
15.5 |
1.0 |
3.0 |
0.1 |
Anemia |
15.4 |
8.8 |
5.2 |
2.1 |
Abbreviations: TEAE = treatment-emergent adverse event; TRAE = treatment-related adverse event.
aAggregate of neutropenia and neutrophil count decreased.
Adverse Event of Special Interesta, % of patients |
All Doses and Patients |
|||
TEAEs |
TRAEs |
|||
Any Grade |
Grade ≥3 |
Any Grade |
Grade ≥3 |
|
Bruisingb |
23.7 |
0 |
15.1 |
0 |
Rashc |
12.7 |
0.5 |
6.0 |
0.4 |
Arthralgia |
14.4 |
0.6 |
3.5 |
0 |
Hemorrhage/hematomad |
11.4 |
1.8 |
4.0 |
0.6 |
Hypertension |
9.2 |
2.3 |
3.4 |
0.6 |
Atrial fibrillation/fluttere |
2.8f |
1.2 |
0.8 |
0.1 |
Abbreviations: BTK = Bruton's tyrosine kinase; TEAE = treatment-emergent adverse event; TRAE = treatment-related adverse event.
aAdverse events of special interest are those that were previously associated with covalent BTK inhibitors.
bAggregate of contusion, petechiae, ecchymosis, and increased tendency to bruise.
cAggregate of all preferred terms including rash.
dAggregate of all preferred terms including hematoma or hemorrhage.
eAggregate of atrial fibrillation and atrial flutter.
fOf the 22 total atrial fibrillation/atrial flutter TEAEs in the overall safety population, 7 occurred in patients with a prior medical history of atrial fibrillation.
Patient Characteristics in Phase 1/2 BRUIN Study
Baseline patient characteristics and treatment history among patients with MCL, CLL/SLL, RT, WM, FL, and MZL in the BRUIN study are summarized in Baseline Characteristics Among Patients with MCL, CLL/SLL, RT, WM, FL, and MZL in the Phase 1/2 BRUIN Study and Treatment History Among Patients with MCL, CLL/SLL, RT, WM, FL, and MZL in the Phase 1/2 BRUIN Study, respectively.
Characteristic |
||||||
Median age, years (range) |
70 (46-88) |
69 (36-88) |
67 (26-95) |
69 (42-84) |
64.5 (37-85) |
68 (22-83) |
Male, n (%) |
120 (79) |
192 (68) |
55 (67) |
42 (67) |
29 (60) |
16 (44) |
ECOG PS, n (%) |
||||||
0 |
93 (61) |
144 (51) |
32 (39) |
34 (54) |
26 (54) |
18 (50) |
1 |
56 (37) |
118 (42) |
38 (46) |
28 (44) |
22 (46) |
17 (47) |
2 |
3 (2) |
20 (7) |
12 (15) |
1 (2) |
0 |
1 (3) |
Median lines of prior systemic therapy, (range) |
3 (1-9) |
4 (1-11) |
2 (0-13) |
3 (1-11) |
3 (1-12) |
3 (2-10) |
Progressive disease |
128 (84) |
217 (77) |
NR |
41 (65) |
NR |
20 (77) |
Toxicity/other |
21 (14) |
64 (23) |
NR |
21 (33) |
NR |
6 (23) |
Abbreviations: BTKi = Bruton's tyrosine kinase inhibitor; CLL = chronic lymphocytic leukemia; ECOG = Eastern Cooperative Oncology Group; FL = follicular lymphoma; MCL = mantle cell lymphoma; MZL = marginal zone lymphoma; NR = not reported; PS = performance status; RT = Richter's transformation; SLL = small lymphocytic lymphoma; WM = Waldenström's macroglobulinemia.
aData cutoff of May 5, 2023.
bData cutoff of July 29, 2022.
cIn the event more than one reason was noted for discontinuation, disease progression took priority.
dOne patient with WM and 3 patients with MCL had unknown reason for prior BTK inhibitor discontinuation.
Prior Therapy, n (%) |
||||||
BTK inhibitor |
152 (100) |
282 (100) |
61 (74) |
63 (100) |
4 (8) |
26 (72) |
Anti-CD20 antibody |
147 (97) |
251 (89) |
80 (98) |
58 (92) |
48 (100) |
36 (100) |
Chemotherapy |
137 (90) |
228 (81) |
73 (89) |
52 (83) |
43 (90)c |
31 (86)c |
BCL2 inhibitor |
24 (16) |
128 (45) |
56 (68) |
4 (6) |
3 (6) |
1 (3) |
PI3K inhibitor |
6 (4) |
71 (25) |
12 (15) |
3 (5) |
17 (35) |
6 (17) |
CAR-T |
13 (9) |
17 (6) |
11 (13) |
NR |
4 (8) |
NR |
Stem cell transplant |
33 (22) |
7 (3)d |
10 (12) |
4 (6) |
6 (13)e |
1 (3)e |
Immunomodulator |
26 (17) |
NR |
7 (9)f |
6 (10) |
14 (29)g |
8 (22)g |
Abbreviations: BCL2 = B-cell lymphoma-2; BTK = Bruton's tyrosine kinase; CAR-T = chimeric antigen receptor T cells; CLL = chronic lymphocytic leukemia; FL = follicular lymphoma; MCL = mantle cell lymphoma; MZL = marginal zone lymphoma; NR = not reported; PI3K = phosphatidylinositol-3-kinase; RT = Richter’s transformation; SLL = small lymphocytic lymphoma; WM = Waldenström's macroglobulinemia.
aData cutoff of May 5, 2023.
bData cutoff of July 29, 2022.
cChemotherapy plus anti-CD20 antibody.
dAllogenic stem cell transplant.
eAutologous stem cell transplant.
fImmunomodulators include lenalidomide and pomalidomide.
gLenalidomide.
BRUIN Phase 1/2 Clinical Study
The primary endpoints of the phase 1 portion of the BRUIN study are maximum tolerated dose and recommended phase 2 dose. The primary endpoint of the phase 2 portion of the study is overall response rate by independent review committee. Key secondary endpoints of the phase 2 portion of the study are
- duration of response
- overall survival
- progression free survival
- safety and tolerability, and
- pharmacokinetics.1,2
BRUIN Phase 1/2 Study Schema describes the design of the BRUIN study.
Figure 1 description: The phase 1 dose escalation study enrolled patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or B-cell non-Hodgkin's lymphoma who had received at least 2 prior standard of care regimens given in combination or sequentially or 1 prior Bruton's tyrosine kinase inhibitor-containing regimen when a Bruton's tyrosine kinase inhibitor was approved as first-line therapy. Once a maximum tolerated dose and/or recommended phase 2 dose had been determined, patients were enrolled to 1 of 7 phase 2 dose expansion cohorts depending on tumor histology and prior treatment history or phase 1b. These 7 cohorts were Cohort 1: patients with non-blastoid mantle cell lymphoma who had received prior Bruton's tyrosine kinase inhibitor; Cohort 2: patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who had received at least 2 prior lines of therapy including Bruton's tyrosine kinase inhibitor; Cohort 3: treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma; Cohort 4: patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who had received prior therapy but not Bruton's tyrosine kinase inhibitor; Cohort 5: patients with Waldenström macroglobulinemia who had received prior therapy including Bruton's tyrosine kinase inhibitor; Cohort 6: patients with marginal zone lymphoma who had received prior therapy including Bruton's tyrosine kinase inhibitor; and Cohort 7: patients who did not fit into one of the other 6 groups.
Abbreviations: BTK = Bruton's tyrosine kinase; CLL = chronic lymphocytic leukemia; MCL = mantle cell lymphoma; MTD = maximum tolerated dose; MZL = marginal zone lymphoma; NHL = non-Hodgkin's lymphoma; RP2D = recommended phase 2 dose; SLL = small lymphocytic lymphoma; SOC = standard of care; WM = Waldenström macroglobulinemia.
Note: This schema focuses on the monotherapy portion of the BRUIN study. Following the completion of phase 1, a phase 1b portion of the study was opened to assess the use of pirtobrutinib in combination with venetoclax ± rituximab.
Summary of Phase 2 Cohorts in the BRUIN Clinical Trial shows a summary of the phase 2 cohorts.
Cohort Number |
Condition of Disease |
Prior Therapy |
1 |
Non-blastoid MCL |
BTK inhibitor |
2 |
CLL/SLL |
≥2 Lines; including BTK inhibitor |
3 |
CLL/SLL |
None |
4 |
CLL/SLL |
BTK inhibitor naïve |
5 |
WM |
BTK inhibitor |
6 |
MZL |
BTK inhibitor |
7 |
Not otherwise specifieda |
NA |
Abbreviations: BTK = Bruton's tyrosine kinase; CLL = chronic lymphocytic leukemia; CNS = central nervous system; MCL = mantle cell lymphoma; MZL = marginal zone lymphoma; NA = not applicable; NHL = non-Hodgkin's lymphoma; RT = Richter's transformation; SLL = small lymphocytic lymphoma; WM = Waldenström's macroglobulinemia.
aNon-Hodgkin's lymphoma or CLL/SLL not otherwise specified in cohorts 1 through 6, inclusive of CLL/SLL, RT, or low-grade NHL with transformation, blastoid MCL, and patients with a history of CNS involvement or primary CNS lymphoma.
The estimated primary completion date for the BRUIN study is April 2024, with an estimated study completion date of April 2024.1
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1A 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
2Mato AR, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021;397(10277):892-901. https://doi.org/10.1016/S0140-6736(21)00224-5
3Cohen JB, Shah NN, Jurczak W, et al. Pirtobrutinib in relapsed/refractory (R/R) mantle cell lymphoma (MCL) patients with prior cBTKi: Updated safety and efficacy including high-risk subgroup analyses from the phase 1/2 BRUIN study. Oral presentation presented at: 65th Annual Meeting of the American Society of Hematology (ASH); December 9-12, 2023; San Diego, California. Accessed December 11, 2023.
4Woyach JA, Brown JR, Ghia P, et al. Pirtobrutinib in post-cBTKi CLL/SLL: ~30 months follow-up and subgroup analysis with/without prior BCL2i from the phase 1/2 BRUIN study. Oral presentation presented at: 65th Annual Meeting of the American Society of Hematology (ASH); December 9-12, 2023; San Diego, California. Accessed December 9, 2023.
5Wang ML, Shah NN, Jurczak W, et al. Efficacy of pirtobrutinib in covalent BTK-inhibitor pre-treated relapsed/refractory mantle cell lymphoma: additional patients and extended follow-up from the phase 1/2 BRUIN study. Poster presented at: 64th Annual Meeting of the American Society of Hematology (ASH); December 10-13, 2022; New Orleans, Louisiana. Accessed December 10, 2022.
6Wierda WG, Shah NS, Cheah CY, et al. Pirtobrutinib in Richter transformation: Updated efficacy and safety results with 18-month median survival follow-up from the phase 1/2 BRUIN study. Poster presented at: 65th Annual Meeting of the American Society of Hematology (ASH); December 9-12, 2023; San Diego, California. Accessed December 9, 2023.
7Palomba ML, Patel MR, Eyre TA, et al. Efficacy of pirtobrutinib, a highly selective, non-covalent (reversible) BTK inhibitor in relapsed/refractory Waldenström macroglobulinemia: Results from the phase 1/2 BRUIN study. Oral presentation presented at: 64th Annual Meeting of the American Society of Hematology (ASH); December 10-13, 2022; New Orleans, Louisiana. Accessed December 10, 2022.
8Shah NN, Zinzani PL, Wang ML, et al. Pirtobrutinib, a highly selective, non-covalent (reversible) BTK inhibitor in relapsed/refractory follicular lymphoma: Results from the phase 1/2 BRUIN study. Poster presented at: 65th Annual Meeting of the American Society of Hematology (ASH); December 9-12, 2023; San Diego, California. Accessed December 10, 2023.
9Patel K, Vose JM, Nasta SD, et al. Pirtobrutinib, a highly selective, non-covalent (reversible) BTK inhibitor in relapsed /refractory marginal zone lymphoma: Results from phase 1/2 BRUIN study. Poster presented at: 65th Annual Meeting of the American Society of Hematology (ASH); December 9-12, 2023; San Diego, California. Accessed December 9, 2023.
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Date of Last Review: December 11, 2023