TIDMAZN
RNS Number : 7285M
AstraZeneca PLC
25 January 2021
25 January 2021 07:05 GMT
Calquence approved in Japan for the treatment of
relapsed or refractory chronic lymphocytic leukaemia
88% of patients on Calquence remained free of disease
progression after 12 months vs. 68% for comparators
AstraZeneca's Calquence (acalabrutinib), a next-generation,
selective Bruton's tyrosine kinase (BTK) inhibitor, has been
approved in Japan for the treatment of adult patients with relapsed
or refractory chronic lymphocytic leukaemia (CLL) (including small
lymphocytic lymphoma [SLL]).
The approval by the Japanese Ministry of Health, Labour and
Welfare was based on positive results from the ASC Phase III trial
and a Phase I trial in Japanese patients, showing Calquence
monotherapy demonstrated a statistically significant and clinically
meaningful improvement in progression-free survival (PFS) versus a
standard treatment of rituximab, a monoclonal antibody, combined
with the physician's choice of idelalisib, a PI3-kinase inhibitor
or bendamustine, a chemotherapy.
In the ASC trial, Calquence reduced the risk of disease
progression or death by 69% (hazard ratio, 0.31; 95% confidence
interval, 0.20-0.49, p<0.0001). These results were published in
Journal of Clinical Oncology in 2020.(1)
CLL is the most common type of adult leukaemia across the globe
but is considered a rare disease in Japan and East Asia,
representing between 1% and 2% of patients diagnosed with
leukaemia.(2-4)
Dai Maruyama, MD, PhD, Director, Department of Hematology and
Oncology, Cancer Institute Hospital of Japanese Foundation for
Cancer Research, Tokyo, Japan said: "Today's news marks great
progress for patients with chronic lymphocytic leukaemia in Japan.
As the ASC trial showed, Calquence provides a significant
improvement in progression-free survival compared with current
standard therapies. Treatment with a safe and tolerable regimen
remains paramount for these patients who often require ongoing
therapy for many years."
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, said: "C hronic lymphocytic leukaemia is less prevalent in
Japan than other regions, yet patients remain in need of innovative
treatment options. This approval of Calquence offers patients in
Japan a new, chemo-free, tolerable treatment option with
uncompromised efficacy and the potential to positively impact
quality of life."
In the ASC Phase III trial, an estimated 88% of patients with
relapsed or refractory CLL treated with Calquence remained alive
and free from disease progression after 12 months compared with 68%
of patients on rituximab combined with idelalisib or bendamustine.
After a median follow up of 16.1 months, median PFS was not reached
with Calquence monotherapy versus 16.5 months in the control
arm.(1)
The safety and tolerability of Calquence were consistent with
its established profile.(1) Final results of the ASC Phase III
trial were presented at the 2020 American Society of Clinical
Oncology and 2020 European Hematology Association virtual meetings
and demonstrated the long-term (median 22-month follow-up) efficacy
and tolerability of Calquence in CLL.(5,6)
Calquence is approved for the treatment of CLL and SLL in the US
and is approved for the treatment of CLL in the EU and in several
other countries worldwide in the 1st-line and relapsed or
refractory settings. Calquence is also approved in the US and
several other countries for the treatment of adult patients with
mantle cell lymphoma (MCL) who have received at least one prior
therapy. Calquence is not currently approved for the treatment of
MCL in Japan or the EU.
As part of a broad development programme, Calquence is being
assessed in more than 20 AstraZeneca-sponsored clinical trials for
the treatment of patients with B-cell malignancies including CLL,
MCL, diffuse large B-cell lymphoma, Waldenström's
macroglobulinaemia, follicular lymphoma, and other haematologic
malignancies.
A Japanese Phase I/II trial based on the ELEVATE TN Phase III
trial is currently underway for the treatment of 1st-line CLL.
CLL
CLL is the most common type of leukaemia in adults, with an
estimated 114,000 new cases globally in 2017, and the number of
people living with CLL is expected to grow with improved treatment
as patients live longer with the disease.(7-10) In CLL, too many
blood stem cells in the bone marrow become abnormal lymphocytes and
these abnormal cells have difficulty fighting infections. As the
number of abnormal cells grows there is less room for healthy white
blood cells, red blood cells, and platelets. This could result in
anaemia, infection, and bleeding.(7) B-cell receptor signalling
through BTK is one of the essential growth pathways for CLL.
ASC
ASC (ACE-CL-309) was a global, randomised, multicentre,
open-label Phase III trial evaluating the efficacy of Calquence in
patients with relapsed or refractory CLL. In the trial, 310
patients were randomised (1:1) into two arms. Patients in the first
arm received Calquence monotherapy (100mg twice daily until disease
progression or unacceptable toxicity). Patients in the second arm
received physician's choice of either rituximab, a CD20 monoclonal
antibody, in combination with idelalisib, a PI3-kinase inhibitor,
or rituximab in combination with bendamustine, a
chemotherapy.(1)
The primary endpoint was PFS assessed by an Independent Review
Committee (IRC), and key secondary endpoints included
investigator-assessed PFS, IRC- and investigator-assessed overall
response rate and duration of response, as well as overall
survival, patient-reported outcomes and time to next treatment.(1)
ASC is the first randomised Phase III trial to directly compare a
BTK inhibitor as monotherapy to these combinations in relapsed or
refractory CLL.
AstraZeneca in haematology
Leveraging its strength in oncology, AstraZeneca has established
haematology as one of four key oncology disease areas of focus. The
Company's haematology franchise includes two medicines approved in
the US and a robust global development programme for a broad
portfolio of potential blood cancer treatments. Acerta Pharma
serves as AstraZeneca's haematology research and development arm.
AstraZeneca partners with like-minded science-led companies to
advance the discovery and development of therapies to address unmet
need.
AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With seven
new medicines launched between 2014 and 2020, and a broad pipeline
of small molecules and biologics in development, the Company is
committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers.
By harnessing the power of six scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies
- and by championing the development of personalised combinations,
AstraZeneca has the vision to redefine cancer treatment and one day
eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please visit astrazeneca.com and
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References
1. Ghia P, et al. ASC: Phase III, Randomized Trial of
Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus
Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
[published online ahead of print, 2020 May 27]. J Clin Oncol. 2020;
JCO1903355. doi:10.1200/JCO.19.03355.
2. Mahlich J, Okamoto S, Tsubota A. Cost of Illness of Japanese
Patients with Chronic Lymphocytic Leukemia (CLL), and Budget Impact
of the Market Introduction of Ibrutinib. Pharmacoecon Open .
2017;1(3):195-202. doi:10.1007/s41669-017-0024-5.
3. National Cancer Institute Cancer Information Service. Chronic
Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Available at:
https://ganjoho.jp/public/cancer/CLL/index.html . Accessed January
2021.
4. Takizawa J, et al. Comparative Analysis of Japanese and
European Typical CLL Patients. Blood. 02 December
2016;128(22):5564.
5. Ghia P, et al. Acalabrutinib (Acala) vs Idelalisib plus
Rituximab (IdR) or Bendamustine plus Rituximab (BR) in
Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): ASC
Final Results. Abstract S159 at the Virtual Edition of the European
Hematology Association 25th EHA Annual Congress.
6. Ghia P, et al. Acalabrutinib Vs Idelalisib Plus Rituximab
(IdR) or Bendamustine Plus Rituximab (BR) in Relapsed/Refractory
(R/R) Chronic Lymphocytic Leukemia (CLL): ASC Final Results.
Abstract 8015 at the American Society of Clinical Oncology ASCO20
Virtual Session.
7. American Cancer Society. What is Chronic Lymphocytic
Leukemia? Available at
https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html
. Accessed January 2021.
8. National Cancer Institute. Chronic Lymphocytic Leukemia
Treatment (PDQ(R) )-Patient Version. Available at
https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq .
Accessed January 2021.
9. Global Burden of Disease Cancer Collaboration. Global,
Regional, and National Cancer Incidence, Mortality, Years of Life
Lost, Years Lived With Disability, and Disability-Adjusted
Life-Years for 29 Cancer Groups, 1990 to 2017. JAMA Oncol.
2019;5(12):1749-1768.
10. Jain N, et al. Prevalence and Economic Burden of Chronic
Lymphocytic Leukemia (CLL) in the Era of Oral Targeted Therapies.
Blood. 2015;126:871.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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