Incyte Announces Pivotal GEOMETRY mono-1 Study Results of Capmatinib (Tabrecta™) in Patients with METex14 Metastatic Non-Sm...
September 02 2020 - 5:04PM
Business Wire
— Tabrecta is the first and only therapy
approved by the FDA to specifically target metastatic non-small
cell lung cancer (NSCLC) with a mutation that leads to MET exon 14
skipping (METex14)
— Tabrecta is the fourth molecule discovered by
Incyte scientists to be approved by the FDA
— Novartis has exclusive worldwide development
and commercialization rights to Tabrecta
Incyte (Nasdaq: INCY) today announced that data from the
Novartis pivotal Phase 2 GEOMETRY mono-1 study demonstrating that
treatment with Tabrecta™ (capmatinib) resulted in positive overall
response rates (ORR) with durable responses among adult patients
with metastatic non-small cell lung cancer (NSCLC) whose tumors
have a mutation that leads to skipping of MET exon 14 (METex14)
have been published in The New England Journal of Medicine.1
MET, a receptor tyrosine kinase coded by the MET gene, normally
plays an important role in cell signaling, proliferation and
survival.2 Many cancers are associated with abnormal signaling
through the MET receptor pathway, caused by multiple mechanisms
including point mutations, insertions/deletions that lead to
skipping of exon 14.2 Results from the GEOMETRY mono-1 study
describe METex14 as an important biomarker for physicians to
consider when selecting metastatic NSCLC treatment options; and
emphasize the importance of broad molecular testing for NSCLC
patients.
“The GEOMETRY mono-1 study results published in The New England
Journal of Medicine further highlight the clinical benefit that
Tabrecta can provide to patients with metastatic METex14 NSCLC,”
said Steven Stein, M.D., Chief Medical Officer, Incyte. “Having a
therapy that targets a recognized oncogenic driver offers a
much-needed treatment option for patients living with this
aggressive form of lung cancer and we are proud that the
world-class discovery program at Incyte contributed to the
fulfillment of this unmet medical need.”
Published data from the GEOMETRY mono-1 study demonstrate that
in the METex14 population (n=97), the ORR as confirmed by the
Blinded Independent Radiology Committee (BIRC) was 68% (95% CI,
48-84) among treatment-naïve patients (n=28) and 41% (95% CI,
29-53) among previously treated patients (n=69).1 In patients with
METex14 who responded to treatment with Tabrecta, the study also
demonstrated a median duration of response of 12.6 months (95% CI,
5.6-not estimable) in treatment-naive patients (19 responders) and
9.7 months (95% CI, 5.6-13.0) in previously treated patients (28
responders).1
Thirteen of 14 patients with METex14 had brain metastases at
baseline (3 treatment-naïve and 10 previously treated patients) and
were considered evaluable by the BIRC.1 In a post-hoc analysis, 7
intracranial responses were observed, including 4 complete
responses.1
The most common treatment-related adverse events (incidence
≥20%) were peripheral edema (43%), nausea (34%), increased blood
creatinine (18%) and vomiting (19%). The majority of AEs were
grades 1 or 2.1
NSCLC accounts for approximately 85% of lung cancer diagnoses.3
METex14 occurs in 3-4% of newly-diagnosed metastatic NSCLC cases4
and is a recognized oncogenic driver.2,5 Tabrecta is the first and
only therapy approved by the FDA to specifically target metastatic
NSCLC with a mutation the leads to METex14.
Novartis has exclusive worldwide development and
commercialization rights to Tabrecta. Incyte is eligible for a
total of over $500 million in milestones as well as royalties of
between 12-14% on global net sales by Novartis.
Full prescribing information for Tabrecta can be found at:
https://www.novartis.us/sites/www.novartis.us/files/tabrecta.pdf.
About Tabrecta
Tabrecta (capmatinib) is a kinase inhibitor that targets MET
discovered by Incyte and licensed to Novartis in 2009. Under the
terms of the Agreement, Incyte granted Novartis exclusive worldwide
development and commercialization rights to capmatinib and certain
back-up compounds in all indications. Incyte is eligible for a
total of over $500 million in milestones as well as royalties of
between 12-14% on global net sales by Novartis.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding the clinical benefit of Tabrecta, and milestone payments
or royalties Incyte may receive from Novartis relating to Tabrecta,
contain predictions, estimates and other forward-looking
statements.
These forward-looking statements are based on the Company’s
current expectations and subject to risks and uncertainties that
may cause actual results to differ materially, including
unanticipated developments in and risks related to: unanticipated
delays; further research and development and the results of
clinical trials possibly being unsuccessful or insufficient to meet
applicable regulatory standards or warrant continued development;
the ability to enroll sufficient numbers of subjects in clinical
trials; determinations made by the FDA; the Company’s dependence on
its relationships with its collaboration partners; the efficacy or
safety of the Company’s products and the products of the Company’s
collaboration partners; the acceptance of the Company’s products
and the products of the Company’s collaboration partners in the
marketplace; market competition; sales, marketing, manufacturing
and distribution requirements; greater than expected expenses;
expenses relating to litigation or strategic activities; and other
risks detailed from time to time in the Company’s reports filed
with the Securities and Exchange Commission, including its Form
10-Q for the quarter ended June 30, 2020. The Company disclaims any
intent or obligation to update these forward-looking
statements.
References
- Wolf J, et al. Capmatinib in METex14-Mutated or MET-Amplified
Advanced NSCLC. N Engl J Med. 2020.
- Sadiq AA, Salgia R. MET as a possible target for non-small-cell
lung cancer. J Clin Oncol 2013; 31:1089-96.
- American Cancer Society. About Lung Cancer. Available at
https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.
Accessed September 1, 2020.
- Salgia R. MET in Lung Cancer: Biomarker Selection Based on
Scientific Rationale. Mol Cancer Ther. 2017;16(4):555-565.
- Smyth EC, et al. Emerging molecular targets in oncology:
clinical potential of MET/hepatocyte growth-factor inhibitors. Onco
Targets Ther. 2014; 7:1001-1014.
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Incyte Contacts Media
Catalina Loveman +1 302 498 6171 cloveman@incyte.com
Investors Michael Booth, DPhil +1 302 498 5914
mbooth@incyte.com
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