INDIANAPOLIS, Nov. 4, 2021 /PRNewswire/ -- Loxo Oncology
at Lilly, a research and
development group of Eli Lilly and Company (NYSE: LLY), today
announced that study investigators will present data from the
pirtobrutinib development program at the American Society of
Hematology (ASH) Annual Meeting to be held December 11-14, 2021 in Atlanta, GA and virtually. Pirtobrutinib is an
investigational, highly selective, non-covalent (reversible)
Bruton's tyrosine kinase (BTK) inhibitor.
The pirtobrutinib oral presentations will provide updated
clinical data from the ongoing Phase 1/2 BRUIN clinical trial in
previously treated chronic lymphocytic leukemia, small lymphocytic
lymphoma, and mantle cell lymphoma. The submitted abstracts
utilized a September 2020 data
cut-off date, and the presentations will utilize a July 2021 data cut-off date.
Additionally, two real-world evidence database studies will be
shared: the first on outcomes for patients with chronic lymphocytic
leukemia previously treated with a covalent BTK inhibitor and a
BCL2 inhibitor will be presented in a poster presentation and the
second on outcomes for patients with mantle cell lymphoma following
covalent BTK inhibitor therapy will be published as an online-only
abstract.
The schedule for the oral and poster presentations are as
follows:
Presentation title: Pirtobrutinib, A Highly
Selective, Non-Covalent BTK Inhibitor in Previously Treated
CLL/SLL: Updated Results from the Phase 1/2 BRUIN Study
Publication Number: 391
Session: 642. Chronic Lymphocytic Leukemia: Clinical
and Epidemiological I
Session Date and Time: Sunday, December 12, 2021,
9:30 a.m.- 11:00 a.m. ET
Presentation Time: 9:30 AM
Location: Georgia World Congress Center, B401-B402 and
online
Presenter: Anthony R. Mato, M.D.
Presentation Title: Pirtobrutinib, A Highly
Selective, Non-Covalent BTK Inhibitor in Previously Treated Mantle
Cell Lymphoma: Updated Results from the Phase 1/2 BRUIN Study
Publication Number: 381
Session: 623. Mantle Cell, Follicular, and Other B-Cell
Lymphomas: Clinical and Epidemiological: Front-line Induction
Therapy and Novel Agents After Relapse
Session Date and Time: Sunday,
December 12, 2021, 9:30 a.m. - 11:00
a.m. ET
Presentation Time: 10:00 AM
Location: Georgia World Congress Center, Thomas Murphy
Ballroom 1-2
Presenter: Michael L. Wang,
M.D.
Presentation Title: Outcomes for Patients with Chronic
Lymphocytic Leukemia Previously Treated with a Covalent BTK
Inhibitor and BCL2 Inhibitor in the
United States: A Real-World Database Study
Publication Number: 3743
Session: 642. Chronic Lymphocytic Leukemia: Clinical and
Epidemiological: Poster III
Session Date: Monday, December 13,
2021
Presentation Time: 6:00 p.m. - 8:00
p.m. ET
Location: Georgia World Congress Center, Hall B5
Presenter: Anthony R.
Mato, M.D.
About Pirtobrutinib (LOXO-305)
Pirtobrutinib is
an investigational, highly selective, non-covalent (reversible)
Bruton's tyrosine kinase (BTK) inhibitor. BTK plays a key role in
the B-cell antigen receptor signaling pathway, which is required
for the development, activation and survival of normal white blood
cells, known as B-cells, and malignant B-cells. BTK is a validated
molecular target found across numerous B-cell leukemias and
lymphomas including chronic lymphocytic leukemia, mantle cell
lymphoma, Waldenström macroglobulinemia, and marginal zone
lymphoma. Currently available covalent BTK inhibitors irreversibly
inhibit BTK and the long-term efficacy of these therapies can be
limited by acquired resistance, most commonly through BTK C481
mutations. In rapidly growing tumors with inherently high rates of
BTK turnover, resistance to covalent BTK therapies may be the
result of incomplete target inhibition. Pirtobrutinib was
designed to reversibly bind BTK, deliver consistently high target
coverage regardless of BTK turnover rate, preserve activity in the
presence of the C481 acquired resistance mutations, and avoid
off-target kinases that have complicated the development of both
covalent and investigational non-covalent BTK inhibitors.
Interested patients and physicians can contact the Loxo Oncology at
Lilly Physician and Patient BTK Clinical Trial Hotline at
1-855-LOXO-305 or email clinicaltrials@loxooncology.com.
About the BRUIN Phase 1/2 Trial
This first-in-human,
global, multi-center Phase 1/2 trial evaluates
pirtobrutinib as a single agent in patients with previously
treated chronic lymphocytic leukemia (CLL), small lymphocytic
lymphoma (SLL), or non-Hodgkin's lymphomas (NHL). The trial
includes a Phase 1 dose escalation phase and a Phase 2 dose
expansion phase. The Phase 1 dose escalation enrolls patients with
CLL/SLL or NHL who have received at least two prior lines of
therapy and have progressed or are intolerant to standard of care.
The dose escalation phase followed a "3+3" design with
pirtobrutinib dosed orally in 28-day cycles. As dose cohorts
were cleared, additional patients could enroll in cleared cohorts
and intra-patient dose escalation was permitted. The primary
objective of the Phase 1 portion of the trial is to determine the
maximum tolerated dose and recommended Phase 2 dose. Key secondary
objectives include measures of safety, pharmacokinetics, and
anti-tumor activity (i.e. Overall Response Rate (ORR) and Duration
of Response, as determined by appropriate histology-specific
response criteria). In the Phase 2 dose expansion, patients are
enrolled across various cohorts, depending on disease type and
prior therapy. The primary endpoint for Phase 2 is ORR. Secondary
endpoints include duration of response (DOR), overall survival
(OS), safety, and pharmacokinetics (PK).
About Loxo Oncology at Lilly
Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research
Laboratories oncology organization and Loxo Oncology, which was
acquired by Lilly in early 2019.
Loxo Oncology at Lilly brings
together the focus and spirit of a biotech with the scale and
resources of large pharma, with the goal of rapidly delivering
impactful new medicines for people with cancer. Our approach
centers on creating new oncology medicines that unequivocally work
early in clinical development and will matter to patients.
About Eli Lilly and Company
Lilly is a global health care leader that
unites caring with discovery to create medicines that make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover and bring
life-changing medicines to those who need them, improve the
understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at
lilly.com and lilly.com/newsroom. P-LLY
Lilly Forward-Looking Statement
This press release
contains forward-looking statements (as that term is defined in the
Private Securities Litigation Reform Act of 1995) about
Lilly's pirtobrutinib for the
potential treatment of previously treated chronic lymphocytic
leukemia, small lymphocytic lymphoma and mantle cell lymphoma and
the timeline for future readouts, presentations, and other
milestones relating to pirtobrutinib and its clinical trials and
reflects Lilly's current beliefs
and expectations. However, as with any pharmaceutical product,
there are substantial risks and uncertainties in the process of
drug research, development and commercialization. Among other
things, there is no guarantee that studies will be completed as
planned, that future study results will be consistent with the
results to date, that pirtobrutinib will prove to be a safe and
effective treatment for relevant indications, or that pirtobrutinib
will receive regulatory approvals or be commercially successful.
For further discussion of these and other risks and uncertainties,
see Lilly's most recent Form 10-K
and Form 10-Q filings with the United States Securities and
Exchange Commission. Except as required by law, Lilly undertakes no duty to update
forward-looking statements to reflect events after the date of this
release.
Refer
to:
Lauren Cohen;
lcohen@loxooncology.com; 617-678-2067 – media
Kevin Hern; hern_kevin_r@lilly.com;
317-277-1838 – investors
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SOURCE Eli Lilly and Company