Press Release: Novartis announces FDA approval of MET inhibitor Tabrecta(TM) for metastatic non-small cell lung cancer with METex14

-- Tabrecta (capmatinib, formerly INC280) is the first and only therapy

approved by the FDA to specifically target metastatic NSCLC with a

mutation that leads to MET exon 14 skipping (METex14)1

-- 4,000-5,000 patients are diagnosed with METex14 metastatic NSCLC each

year in the US and may face poor prognosis due to presence of the

mutation2-3

-- Tabrecta demonstrated an overall response rate of 68% and 41% in

treatment-naive and previously treated METex14 patients, respectively1

-- FDA approval reinforces the company's bold vision to deliver innovative

treatment approaches for patients living with lung cancer

Basel, May 6, 2020 -- Novartis announced today that the US Food and Drug

Administration (FDA) approved Tabrecta(TM) (capmatinib, formerly INC280),

an oral MET inhibitor for adult patients with metastatic non-small cell

lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon

14 skipping (METex14) as detected by an FDA-approved test. This

indication is approved under accelerated approval based on overall

response rate and duration of response. Continued approval for this

indication may be contingent upon verification and description of

clinical benefit in confirmatory trial(s).

This approval fills a long-recognized and urgent need among METex14

patients who have not had a treatment option approved to specifically

target the driver of their lung cancer(3). Tabrecta is approved for

first-line and previously treated patients, regardless of prior

treatment type, and is expected to be available to patients in the

coming days.

The FDA also approved FoundationOne(R) CDx as the companion diagnostic

for Tabrecta, to aid in detecting mutations that lead to MET exon 14

skipping in tumor tissue.

"Non-small cell lung cancer is a complex disease, with many different

possible mutations that may encourage the cancer's growth," said Juergen

Wolf, MD, from the Center for Integrated Oncology, University Hospital

Cologne and lead investigator of the GEOMETRY study. "MET exon 14

skipping is a known oncogenic driver. With today's decision by the FDA,

we can now test for and treat this challenging form of lung cancer with

a targeted therapy, offering new hope for patients with NSCLC harboring

this type of mutation."

Novartis was previously granted Breakthrough Therapy Designation for

capmatinib. According to FDA guidelines, treatments that receive

Breakthrough Therapy Designation must target a serious or

life-threatening disease and demonstrate a substantial improvement over

existing therapies on one or more significant preliminary research

endpoints.

The approval of Tabrecta is based on results from the pivotal GEOMETRY

mono-1 Phase II multi-center, non-randomized, open-label, multi-cohort

study. In the METex14 population (n=97), the confirmed overall response

rate was 68% (95% CI, 48-84) and 41% (95% CI, 29-53) among

treatment-naive (n=28) and previously treated patients (n=69),

respectively, based on the Blinded Independent Review Committee (BIRC)

assessment per RECIST v1.1(1). In patients taking Tabrecta, the study

also demonstrated a median duration of response of 12.6 months (95% CI,

5.5--25.3) in treatment-naive patients (19 responders) and 9.7 months

(95% CI, 5.5-13.0) in previously treated patients (28 responders)(1).

The most common treatment-related adverse events (AEs) (incidence >=20%)

are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased

appetite(1).

"Today, and especially during these difficult times, we are incredibly

proud that Tabrecta is the first treatment approved by the FDA

specifically to treat patients diagnosed with this aggressive NSCLC

associated with METex14," said Susanne Schaffert, PhD, President,

Novartis Oncology. "In our quest to reimagine medicine, we have worked

tirelessly over the past decades to advance the understanding and

treatment of NSCLC, striving to make a difference in patients' lives,

one mutation at a time. We thank all the physicians, patients and

families involved in the Tabrecta clinical trials, and we remain

committed to advancing innovative solutions for the patients we work to

serve."

NSCLC accounts for approximately 85% of the 2 million new lung cancer

diagnoses each year worldwide, including about 228,000 in the United

States(4-5). Nearly 70% of NSCLC patients have a genomic mutation(6).

METex14, a recognized oncogenic driver, occurs in approximately 3%-4% of

newly diagnosed metastatic NSCLC cases (about 4,000 -- 5,000 patients in

the US annually)(7-9, 2).

"With NSCLC, understanding whether a mutation is driving the cancer is

critical, and it's important for doctors and patients to use

comprehensive biomarker testing at the time of diagnosis or progression

to check for mutations like those that cause METex14," said Andrea

Ferris, President and CEO of LUNGevity. "Knowing more about the

molecular makeup of their tumor will help patients and their healthcare

teams make informed treatment-related decisions from the start."

Novartis is committed to providing patients with access to medicines, as

well as resources and support to address a range of needs. The Novartis

Oncology Patient Support Program is available to help guide eligible

patients through the various aspects of getting started on treatment,

from providing educational information to helping them understand their

insurance coverage and identify potential financial assistance options.

Patients or providers can call 800-282-7630 or visit

Patient.NovartisOncology.com or HCP.Novartis.com/Access to learn more

about eligibility and to enroll.

Full prescribing information for Tabrecta can be found at :

https://www.novartis.us/sites/www.novartis.us/files/tabrecta.pdf

https://www.novartis.us/sites/www.novartis.us/files/tabrecta.pdf.

About Tabrecta (capmatinib)

Tabrecta (capmatinib) is a kinase inhibitor that targets MET. Tabrecta

is licensed to Novartis by Incyte Corporation in 2009. Under the

Agreement, Incyte granted Novartis worldwide exclusive development and

commercialization rights to capmatinib and certain back-up compounds in

all indications.

About GEOMETRY mono-1

GEOMETRY mono-1 is a Phase II a multi-center, non-randomized, open-label,

multi-cohort study in adult patients with EGFR wild-type, metastatic

NSCLC as measured by ORR.

The trial evaluated 97 adult patients with metastatic NSCLC harboring

mutations that lead to METex14 (centrally confirmed) who were assigned

to Cohorts 4 (n=69, previously treated patients) or 5b (n=28,

treatment-naive), and received capmatinib tablets 400 mg orally twice

daily.

The major efficacy outcome is ORR based on BIRC assessment per RECIST

v1.1. An additional efficacy outcome is duration of response by BIRC.

Novartis Commitment to Lung Cancer

Worldwide, lung cancer causes more deaths than colon, breast and

prostate cancer combined, and more than 2 million new cases of lung

cancer are diagnosed each year(4). Despite treatment advances, many

patients with NSCLC still have a poor prognosis and limited treatment

options(3). This includes the nearly 70% of NSCLC patients who have a

genomic mutation(6). To determine the most appropriate treatment,

medical organizations recommend comprehensive genomic testing for

patients with lung cancer as part of their upfront diagnosis(7).

Novartis Oncology's research has helped transform treatment approaches

for patients living with NSCLC. Novartis continues its commitment to the

global lung cancer community through ongoing studies, as well as the

exploration of investigational compounds in NSCLC, including those that

target genetic biomarkers and tumor promoting inflammation.

Indication

TABRECTA(TM) (capmatinib) tablets is a prescription medicine used to

treat adults with a kind of lung cancer called non-small cell lung

cancer (NSCLC) that has spread to other parts of the body or cannot be

removed by surgery (metastatic), and whose tumors have an abnormal

mesenchymal-epithelial transition (MET) gene.

The effectiveness of TABRECTA in these patients is based on a study that

measured 2 types of response to treatment (response rate and duration of

response). There is no clinical information available to show if

patients treated with TABRECTA live longer or if their symptoms improve.

There are ongoing studies to find out how TABRECTA works over a longer

period of time.

It is not known if TABRECTA is safe and effective in children.

Important Safety Information

TABRECTA may cause serious side effects, such as lung or breathing

problems. TABRECTA may cause inflammation of the lungs during treatment

that may lead to death. Patients should be advised to contact their

health care provider right away if they develop any new or worsening

symptoms, including cough, fever, trouble breathing, or shortness of

breath.

TABRECTA may cause abnormal blood test results, which may be a sign of

liver problems. Patients should be advised that their health care

provider will do blood tests to check their liver before starting and

during treatment with TABRECTA. Patients should be advised to contact

their health care provider right away if they develop any signs and

symptoms of liver problems including the skin or the white part of their

eyes turning yellow (jaundice), dark or "tea-colored" urine,

light-colored stools (bowel movements), confusion, loss of appetite for

several days or longer, nausea and vomiting, pain, aching, or tenderness

on the right side of the stomach area (abdomen), or weakness or swelling

in the stomach area.

The skin may be sensitive to the sun (photosensitivity) during treatment

with TABRECTA. Patients should be advised to use sunscreen or wear

clothes that cover their skin during treatment with TABRECTA to limit

direct sunlight exposure.

For women of reproductive potential, TABRECTA can harm their unborn

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May 06, 2020 14:29 ET (18:29 GMT)