Investor Presentaiton
SELECT TRIALS - PIRTOBRUTINIB
Study
Indication*
Chronic
NCT04666038 Lymphocytic
Leukemia
Chronic
NCT05023980 Lymphocytic
Leukemia
Chronic
NCT04965493 Lymphocytic
Leukemia
Title
Study 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)
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)
A 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)
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in
Participants With Chronic Lymphocytic Leukemia
(CLL)/Small Lymphocytic Lymphoma (SLL)
(BRUIN CLL-314)
Phase Patients
3
250
Primary Outcome*
**
To evaluate progression-free survival (PFS) of LOXO-305
monotherapy (Arm A) compared to investigator's choice of
idelalisib plus rituximab (IdelaR) or bendamustine plus
rituximab (BR) (Arm B)
Lilly
Primary
Completion
Completion
Dec 2023
May 2027
3
250
To evaluate progression-free survival (PFS) of pirtobrutinib
|(Arm A) compared to bendamustine and rituximab (Arm B)
Nov 2024
Jul 2026
3
600
To evaluate progression-free survival (PFS) of pirtobrutinib|
plus venetoclax and rituximab (Arm A) compared to
venetoclax and rituximab (Arm B)
Oct 2025
Jan 2027
Chronic
NCT05254743 Lymphocytic
Leukemia
3
650
Percentage of Participants Achieving Complete Response
(CR) or Partial Response (PR): Overall Response Rate
(ORR)
Mar 2028
Mar 2029
NCT04662255
Lymphoma,
Mantle-Cell
Study of BTK Inhibitor LOXO-305 Versus Approved BTK
Inhibitor Drugs in Patients With Mantle Cell Lymphoma
(MCL) (BRUIN MCL-321)
3
500
To compare progression-free survival (PFS) of
pirtobrutinib as monotherapy (Arm A) to investigator
choice of covalent BTK inhibitor monotherapy (Arm B) in
patients with previously treated mantle cell lymphoma
(MCL)
Apr 2025
Apr 2025
* Molecule may have multiple indications
** Trial may have additional primary and other secondary outcomes
Not for promotional use
2023 Q2 EARNINGS
Source: clinicaltrials.gov, July 11, 2023
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