Accueil / Communiqués / Phase 2 GEOMETRY mono-1 Trial of Investigational Medicine Capmatinib Shows Positive Results in Patients with MET-mutated Advanced NSCLC

Phase 2 GEOMETRY mono-1 Trial of Investigational Medicine Capmatinib Shows Positive Results in Patients with MET-mutated Advanced NSCLC

Friday, October 19th 2018 at 2:10pm UTC
  • Phase 2 study efficacy data showed overall response rate of 72.0
    percent and 39.1 percent, respectively, in treatment-naive and
    previously treated patients with advanced MET exon-14 skipping mutated
    non-small cell lung cancer (NSCLC)
  • Clinical findings from ongoing study indicate safety profile was
    consistent with previously reported data results
  • Capmatinib, an investigational MET inhibitor, may have the
    potential to improve response rates for people diagnosed with MET
    exon-14 skipping mutated NSCLC, a known oncogenic driver
  • Novartis has exclusive development and commercialization worldwide
    rights to capmatinib

WILMINGTON, Del.–(BUSINESS WIRE)– Incyte (NASDAQ:INCY) today announced Phase 2 preliminary results of the
GEOMETRY mono-1 clinical trial of investigational MET inhibitor
capmatinib in 94 adult patients with advanced non-small cell lung cancer
(NSCLC) harboring MET exon-14 skipping mutations. The GEOMETRY mono-1 study
showed an overall response rate (ORR) of 72.0 percent (95% CI:
50.6-87.9) in treatment-naive patients and 39.1 percent (95% CI:
27.6-51.6) in previously treated patients. ORR was assessed by blinded
independent review committee (BIRC). Adverse events (AEs) were
consistent with previously reported data and no new safety signals were
observed.

Results of the Novartis-sponsored Phase 2 study were presented today at
the European Society for Medical Oncology (ESMO) 2018 Congress (October
19, 2018 at 4:45 p.m. CEST / 10:45 a.m. EDT, Abstract LBA52).1

“These preliminary findings reveal the potential of capmatinib in MET
exon-14 skipping mutated NSCLC patients. Compared to the previously
treated patient groups, the primary advantage in terms of overall
response rate reported in treatment-naive patients highlights the
clinical relevance for an earlier diagnostic testing and prompt
treatment of this challenging patient population,” said Juergen Wolf,
M.D., University Hospital Cologne, Germany.

NSCLC is the most common type of lung cancer, impacting more than 2
million people per year.2 Approximately 3-4 percent of all
patients with NSCLC have an identified MET mutation.3 Though
rare, this mutation is an indicator of especially poor prognosis and
there is currently no approved therapy designed to target this mutation.4

“We are very pleased to announce these promising, preliminary results
for capmatinib, another investigational medicine invented at Incyte that
has the potential to be the first MET-selective targeted agent approved
by the FDA,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “We
are encouraged by the results of this study and the potential for
capmatinib to help patients with advanced MET mutated NSCLC, who face a
poor prognosis and represent a clear unmet medical need.”

About GEOMETRY mono-1

The GEOMETRY mono-1 trial is a multicenter, open-label, Phase 2
study to evaluate the efficacy and safety of single-agent capmatinib
(INC280) in adult patients with EGFR wildtype, ALK-negative
rearrangement, advanced NSCLC harboring MET amplification and/or
mutations. Patients with MET exon-14 skipping were assigned to Cohorts 4
(previously treated patients) or 5B (treatment naive) regardless of MET
amplification/gene copy number (centrally confirmed), and received 400
mg capmatinib tablets twice daily. The primary endpoint was ORR based on
BIRC assessment per RECIST v1.1. The key secondary endpoint was duration
of response (DOR) by BIRC. The GEOMETRY mono-1 study found an ORR
in the treatment-naive patients (n=25) of 72.0 percent (95% CI:
50.6-87.9) and an ORR in the previously treated patients (n=69) of 39.1
percent (95% CI: 27.6-51.6). DOR was not reached by the time of
analysis, indicating sustainability of response.1,6

The most common treatment-related AEs included peripheral edema, nausea,
vomiting and increased blood creatinine levels. Of patients treated with
capmatinib, 83.8 percent experienced an AE, with 33.1 percent having
grade 3/4 AEs.1,6

About Capmatinib

Capmatinib (INC280) is an investigational, oral and selective MET
inhibitor invented at Incyte that was licensed to Novartis in 2009.
Under the Agreement, Incyte granted Novartis exclusive development and
commercialization worldwide rights to this MET inhibitor compound and
certain back-up compounds in all indications. Novartis has stated that
it expects to submit a new drug application to the U.S. Food and Drug
Administration for capmatinib as a treatment for patients with advanced
non-small cell lung cancer (NSCLC) harboring MET amplification and/or
mutations in 2019. If capmatinib is successfully developed by Novartis,
Incyte may become eligible for over $500 million in future milestones as
well as royalties of between 12 percent and 14 percent on global sales
by Novartis.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte, please
visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set
forth in this press release, including statements regarding the ongoing
clinical development program for capmatinib and its potential in
treating NSCLC, Novartis’ plans to file an NDA for capmatinib and the
expected timing of such filing, and whether and when Incyte may receive
milestone payments or royalties from Novartis relating to capmatinib,
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, 2018. The Company disclaims any
intent or obligation to update these forward-looking statements.

References

  1. Juergen Wolf. Results of the GEOMETRY mono-1 phase II study for
    evaluation of the MET inhibitor capmatinib (INC280) in patients with
    MET?ex14 mutated advanced non-small cell lung cancer. Abstract #LBA52.
    2018 European Society of Medical Oncology (ESMO), October 19-23, 2018,
    Munich, Germany.
  2. Globocan. Lung Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
    Accessed October 9, 2018.
  3. Salgia R. MET in Lung Cancer: Biomarker Selection Based on Scientific
    Rationale. Mol Cancer Ther. 2017;16(4):555-565.
  4. Tong JH, Yeung SF, Chan AWH, et al. MET Amplification and Exon 14
    Splice Site Mutation Define Unique Molecular Subgroups of Non–Small
    Cell Lung Carcinoma with Poor Prognosis. Clin Cancer Res.
    2016;22(12):3048-3056.
  5. Lungevity. Targeted Therapy: What is driver mutation? Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/treatment-options/targeted-therapy.
    Accessed October 9, 2018.
  6. A Study of Capmatinib (INC280) in NSCLC Patients With MET Exon 14
    Alterations Who Have Received Prior MET Inhibitor. (2016). Retrieved
    from http://clinicaltrials.gov/ct2
    (Identification No. NCT02750215).

Contacts

Incyte Corporation
Media
Catalina Loveman, +1 302 498
6171
cloveman@incyte.com
or
Investors
Michael
Booth, DPhil, +1 302 498 5914
mbooth@incyte.com

Source: Incyte Corporation


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