- Approved for Adult Patients with
HER2-Positive Metastatic Breast Cancer Who Have Received at Least
Two Prior Anti-HER2 Treatment Regimens -
- First HER-2 Tyrosine Kinase Inhibitor
Combination Regimen to Improve Overall and Progression-Free
Survival in Previously Treated Patients with Metastatic
HER2-Positive Breast Cancer With or Without Brain Metastases -
Seagen International (Nasdaq:SGEN) today announced that the
European Commission (EC) has granted marketing authorization for
TUKYSA® (tucatinib) in combination with trastuzumab and
capecitabine for the treatment of adult patients with HER2-positive
locally advanced or metastatic breast cancer who have received at
least two prior anti-HER2 treatment regimens. TUKYSA is an oral,
small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein
that contributes to cancer cell growth.1,2
“This approval is a significant advancement for patients in
Europe, who will for the first time have an approved medicine
demonstrating a survival benefit for HER2-positive metastatic
breast cancer after disease progression following two standard
anti-HER2 treatment regimens,” said Prof. Dr. Med Volkmar Mueller,
Deputy Director at the University Medical Center Hamburg-Eppendorf,
Hamburg, Germany and investigator for the pivotal trial. “In the
HER2CLIMB pivotal trial, the tucatinib combination regimen improved
overall and progression-free survival compared to trastuzumab and
capecitabine alone, including in patients with active, untreated or
progressing brain metastases, a population with significant unmet
need.”
“The TUKYSA combination is a landmark therapy for patients with
HER2-positive metastatic breast cancer with or without brain
metastases, extending overall survival in these patients after two
prior anti-HER2-treatment regimens,” said Clay Siegall, Ph.D.,
Chief Executive Officer at Seagen. “We are pleased TUKYSA is now
approved in Europe, and we look forward to further collaborating
with individual countries to ensure it is available to
patients.”
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency adopted a positive opinion for TUKYSA in
December 2020. The approval of TUKYSA is valid in all countries of
the European Union, as well as Norway, Liechtenstein, Iceland and
Northern Ireland.
HER2CLIMB Efficacy and Safety
Patients who received TUKYSA in combination with trastuzumab and
capecitabine in the pivotal trial had a 46 percent reduction in the
risk of cancer progression or death (PFS), the primary endpoint,
compared to patients who received trastuzumab and capecitabine
alone (hazard ratio (HR)=0.54 [95% Confidence Interval (CI): 0.42,
0.71]; p<0.00001) and improved overall survival with a reduction
in the risk of death by 34 percent (HR=0.66 [95% CI: 0.50, 0.87];
p=0.0048). The most common adverse reactions occurring in 20
percent or more of patients who received TUKYSA were diarrhea,
nausea, vomiting, stomatitis, AST increase, ALT increase, and
rash.1
The pivotal trial, HER2CLIMB, is a randomized (2:1),
double-blind, placebo-controlled, active comparator, global trial
that enrolled 612 patients with HER2-positive unresectable locally
advanced or metastatic breast cancer who had previously received,
either separately or in combination, trastuzumab, pertuzumab, and
trastuzumab emtansine (T-DM1 SmPC).
About HER2-Positive Breast Cancer
Patients with HER2-positive breast cancer have tumors with high
levels of a protein called human epidermal growth factor receptor 2
(HER2), which promotes the growth of cancer cells. In 2020, more
than two million new cases of breast cancer were diagnosed
worldwide, including 531,086 in Europe.3 Between 15 and 20 percent
of breast cancer cases are HER2-positive.4 HER2-positive breast
cancer tends to be more aggressive and more likely to recur than
HER2-negative breast cancer.4,5,6 Up to 50 percent of metastatic
HER2-positive breast cancer patients develop brain metastases over
time.7,8,9
About TUKYSA (tucatinib)
TUKYSA is an oral medicine that is a tyrosine kinase inhibitor
of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited
phosphorylation of HER2 and HER3, resulting in inhibition of
downstream MAPK and AKT signaling and cell growth (proliferation),
and showed anti-tumor activity in HER2-expressing tumor cells. In
vivo (in living organisms), TUKYSA inhibited the growth of
HER2-expressing tumors. The combination of TUKYSA and the anti-HER2
antibody trastuzumab showed increased anti-tumor activity in vitro
and in vivo compared to either medicine alone.
About Seagen
Seagen is a global biotechnology company that discovers,
develops, and commercializes transformative cancer medicines to
make a meaningful difference in people’s lives. Seagen is
headquartered in the Seattle, Washington area, and has locations in
California, Canada, Switzerland, and the European Union. For more
information on the company’s marketed products and robust pipeline,
visit www.seagen.com and follow @SeagenGlobal on Twitter.
Forward-Looking Statements
Certain statements made in this press release are forward
looking, such as those, among others, relating to the therapeutic
potential of TUKYSA including its efficacy, safety and therapeutic
uses, and the potential to make TUKYSA available to patients in
Europe. Actual results or developments may differ materially from
those projected or implied in these forward-looking statements.
Factors that may cause such a difference include the possibilities
that we may experience delays or setbacks in seeking pricing and
reimbursement approvals or otherwise in commercializing TUKYSA in
Europe; that adverse events or safety signals may occur; and that
adverse regulatory actions may occur. More information about the
risks and uncertainties faced by Seagen is contained under the
caption “Risk Factors” included in the company’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2020 and the
company’s Current Report on Form 8-K dated December 30, 2020 filed
with the U.S. Securities and Exchange Commission. Seagen disclaims
any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
1
Europeans Medicines Agency. TUKYSA Summary
of Product Characteristics (SmPC).
2
Anita Kulukian, Patrice Lee, Janelle
Taylor, et al. Preclinical Activity of HER2-Selective Tyrosine
Kinase Inhibitor Tucatinib as a Single Agent or in Combination with
Trastuzumab or Docetaxel in Solid Tumor ModelsMol Cancer
Ther2020;19:976-987.
3
Breast. Globocan 2020. World Health
Organization. 2020.
https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf
4
Loibl S, Gianni L. HER2-positive breast
cancer. Lancet. 2017; 389(10087): 2415-29.
5
Slamon D, Clark G, Wong S, et al. Human
breast cancer: correlation of relapse and survival with
amplification of the HER-2/neu oncogene. Science. 1987; 235(4785):
177-82.
6
Breast Cancer HER2 Status. American Cancer
Society website.
https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html.
Accessed March 9, 2020.
7
Freedman RA, Gelman RS, Anders CK, et al.
TBCRC 022: a phase II trial of neratinib and capecitabine for
patients with human epidermal growth factor receptor 2-positive
breast cancer and brain metastases. J Clin Oncol.
2019;37:1081-1089.
8
Olson EM, Najita JS, Sohl J, et al.
Clinical outcomes and treatment practice patterns of patients with
HER2-positive metastatic breast cancer in the post-trastuzumab era.
Breast. 2013;22:525-531.
9
Bendell JC, Domchek SM, Burstein HJ, et
al. Central nervous system metastases in women who receive
trastuzumab-based therapy for metastatic breast carcinoma. Cancer.
2003;97:2972-2977.
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Peggy Pinkston +1 (425) 527-4160 ppinkston@seagen.com
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