- VENCLEXTA® (venetoclax) plus obinutuzumab is the first
chemotherapy-free, fixed-duration combination regimen approved by
Health Canada for patients with previously untreated chronic
lymphocytic leukemia (CLL).
- Approval is based on data from the Phase 3 CLL14 trial, which
showed that patients treated with obinutuzumab plus one year of
treatment with VENCLEXTA had clinically meaningful and
statistically significant progression-free survival (PFS) and
higher rates of undetectable minimal residual disease compared to
patients receiving a standard of care chemoimmunotherapy regimen of
obinutuzumab and chlorambucil.1
MONTREAL, May 5, 2020
/CNW/ - AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, announced today that Health Canada has
approved VENCLEXTA® (venetoclax) in combination with
obinutuzumab for the treatment of adult patients with previously
untreated chronic lymphocytic leukemia (CLL). The regimen
combines six 28-day cycles of obinutuzumab with 12 cycles of
VENCLEXTA.
"Venetoclax in combination with obinutuzumab is an effective
treatment with a finite treatment duration. The approval by
Health Canada is good news, especially for patients that prefer not
to remain on therapy indefinitely," explains Dr. Sue Robinson, MD, FRCPC, Professor, Division of
Hematology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia. "Based on my experience
on the CLL14 clinical trial, I am looking forward to prescribing
this combination regimen for older patients with previously
untreated CLL and/or those who have concomitant medical
problems".
This is the third indication for VENCLEXTA, a first-in-class
B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that
prevents cancer cells from undergoing apoptosis, the process that
leads to the natural death or self-destruction of cancer cells.
VENCLEXTA is also approved in combination with rituximab for the
treatment of adult patients with CLL who have received at least one
prior therapy, and as a monotherapy for the treatment of CLL in the
presence or absence of 17p deletion in adult patients who have
received at least one prior therapy and for whom there are no other
available treatment options.1
"Lymphoma Canada is pleased
with the approval of VENCLEXTA in combination with obinutuzumab by
Health Canada for the treatment of chronic lymphocytic leukemia.
Due to the nature of the disease and its high relapse rate, it is
important to offer patients effective treatment options so that
they can face their cancer journey with the comfort of knowing that
there are always alternatives," says Antonella Rizza, Chief Executive Officer,
Lymphoma Canada.
This most recent approval is based on the primary analysis
(median follow up of 28 months) of the Phase 3 CLL14 clinical
trial, which demonstrated clinically meaningful and statistically
significant progression-free survival (PFS; the time during and
after treatment without disease progression, relapse, or death) as
assessed by investigators in patients treated with VENCLEXTA plus
obinutuzumab compared to patients who received a standard of care
chemotherapy regimen of chlorambucil plus obinutuzumab (hazard
ratio 0.35; 95% CI (0.23,0.53), p<0.0001, medians not yet
reached).1
"We are extremely proud of the Health Canada approval of
VENCLEXTA in combination with obinutuzumab," said Denis Hello,
General Manager, AbbVie Canada. "This third approval for VENCLEXTA
underscores our commitment to develop blood cancer treatments."
CLL, which is typically a slow-progressing cancer of the bone
marrow and blood2, is one of the most common types of
leukemia in adults. In Canada, CLL
accounts for approximately 1,745 newly diagnosed cases of leukemia
each year and is responsible for more than 600 deaths a
year.3
VENCLEXTA is jointly commercialized by AbbVie and Genentech, a
member of the Roche Group, in the U.S. and by AbbVie outside of the
U.S.
About the CLL14 Trial
The randomized, multicenter,
open-label, actively controlled Phase 3 CLL14 trial, which was
conducted in close collaboration with the German CLL Study Group
(DCLLSG), evaluated the efficacy and safety of a combined regimen
of VENCLEXTA and obinutuzumab (n=216) versus obinutuzumab and
chlorambucil (n=216) in patients with previously-untreated CLL and
coexisting medical conditions (total Cumulative Illness Rating
Scale [CIRS] score >6 or creatinine clearance <70 mL/min).
The therapies were administered for a fixed duration of 12 cycles
for VENCLEXTA in combination with six cycles of obinutuzumab.
Cycles were comprised of 28 days. The trial enrolled 432 patients,
all of whom were diagnosed according to the International Workshop
on Chronic Lymphocytic Leukemia (iwCLL) criteria and were
previously untreated. The primary efficacy outcome was PFS as
assessed by the investigator.4 Key secondary
endpoints included MRD-negativity in peripheral blood and bone
marrow, and overall and complete response rates.4,5
About AbbVie Care
Canadians prescribed VENCLEXTA can
be enrolled in AbbVie Care, AbbVie's signature care program. The
program is designed to provide a wide range of customized services
including reimbursement and financial support, pharmacy services,
lab work reminders and coordination, personalized education and
ongoing disease management support throughout the treatment. For
more information, please visit www.abbviecare.ca.
About AbbVie in Oncology
At AbbVie, we strive to
discover and develop medicines that deliver transformational
improvements in cancer treatment by uniquely combining our deep
knowledge in core areas of biology with cutting-edge technologies,
and by working together with our partners – scientists, clinical
experts, industry peers, advocates, and patients. We remain focused
on delivering these transformative advances in treatment across
some of the most debilitating and widespread cancers. We are also
committed to exploring solutions to help patients obtain access to
our cancer medicines. AbbVie's oncology portfolio now consists of
marketed medicines and a pipeline containing multiple new molecules
being evaluated worldwide in more than 300 clinical trials and more
than 20 different tumor types.
About AbbVie
AbbVie is a global, research and
development-driven biopharmaceutical company committed to
developing innovative advanced therapies for some of the world's
most complex and critical conditions. The company's mission is to
use its expertise, dedicated people and unique approach to
innovation to markedly improve treatments across four primary
therapeutic areas: immunology, oncology, virology and
neuroscience. In more than 75 countries, AbbVie employees are
working every day to advance health solutions for people around
the world. For more information about AbbVie, please visit us
at www.abbvie.ca and www.abbvie.com.
Follow @abbvieCanada and @abbvie on Twitter or
view careers on
our Facebook or LinkedIn page.
_____________
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1
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Venclexta Product
Monograph. AbbVie Corporation, Canada.
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf.
Accessed April 30, 2020.
|
2
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Lymphoma Canada.
Chronic lymphocytic leukemia.
https://www.lymphoma.ca/lymphoma/cll-sll/about-cll-sll/. Accessed
May 2020.
|
3
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Canadian Cancer
Statistics. Chronic lymphocytic leukemia statistics.
www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on.
Accessed May 2020.
|
4
|
Fischer K, et al.
Effect of fixed-duration venetoclax plus obinutuzumab (VenG) on
progression-free survival (PFS), and rates and duration of minimal
residual disease negativity (MRD–) in previously untreated patients
(pts) with chronic lymphocytic leukemia (CLL) and comorbidities.
Presented at the 2019 American Society of Clinical Oncology Annual
Meeting: June 4, 2019; Chicago.
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5
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N Engl J Med
2019;380:2225-36. DOI: 10.1056/NEJMoa1815281
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SOURCE AbbVie Canada