- Tabrecta demonstrated an overall response rate of 68% and 41% in treatment-naive and previously treated non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METex14) respectively
- Lung cancer is the most common type of cancer in Japan and approximately 3,000 patients are diagnosed with METex14 metastatic NSCLC, a particularly aggressive form of the disease, in Japan each year1-2
- Japan follows US approval earlier this year and demonstrates the company's commitment to reimagining medicine for lung cancer patients around the world
Basel, June 29, 2020 — Novartis Pharma K.K. (“Novartis Pharma”) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta™ (capmatinib, formerly INC280), an oral MET inhibitor for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC). Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type.
“With the remarkable overall response rates seen both in treatment-naive and previously treated patients, we are thrilled that MHLW has added Tabrecta as a new treatment option for patients with advanced NSCLC with METex14,” said Brian Gladsden, President of Novartis Oncology Japan. “Today’s approval reinforces the potential benefit this new MET inhibitor can bring to thousands of patients diagnosed in Japan each year and is a positive step in our journey to transform the lives of patients with lung cancer.”
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. 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). The most common treatment-related adverse events (AEs) (incidence ≥20%) are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
The companion diagnostic to Tabrecta, FoundationOne®CDx Cancer Genomic Profile, was approved by MHLW on May 25th of this year, to aid in detecting mutations that lead to MET exon 14 skipping in tumor tissue.
About Tabrecta (capmatinib)
Tabrecta (capmatinib) is a kinase inhibitor that targets MET. Tabrecta was 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. In May 2020, Tabrecta was approved by the US Food and Drug Administration (FDA) for adult patients with metastatic NSCLC whose tumors have a mutation that leads to METex14 as detected by an FDA-approved test. This indication was 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 media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
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- Global Cancer Observatory. International Agency for Research on Cancer. World Health Organization. Japan 2018 Cancer Fact Sheet.pg 2_Published May 2019.
- Data on file. Treatment Architecture. Published 2021.
- Naidoo J, A Drilon. Molecular diagnostic testing in non-small cell lung cancer. Am J Hematol. 2014:10(4):4-12.
- Hirsch FR, Suda K, Wiens J. New and emerging targeted treatments in advanced non-small-cell lung cancer. Lancet. 2016;388:1012-1024.
- Reungwetwattana T, Ou SH. Transl Lung Cancer. 2015;4(6):820-824.
- Salgia R. MET in lung cancer: biomarker selection based on scientific rationale. Molecular Cancer Therapeutics. 2017;16(4):555-565.
- Cappuzzo F, Marchetti A, Rossi E. Increased MET gene copy number negatively affects survival of surgically resected non-small-cell lung cancer patients. J Clin Oncol. 2009;27:1667-1674.
- Tong JH, Yeung SF, Chan Al. MET amplification and exon 14 splice site mutation define unique molecular subgroups of on-small cell lung carcinoma with poor prognosis. Clin Cancer Res. 2016;22:3048-3056.
*FoundationOne and FoundationOne CDx are registered trademarks of Foundation Medicine, Inc.
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