– Recommendation for Approval in the European Union Based on Results of Pivotal HER2CLIMB Trial –<\/i><\/p>\n
BOTHELL, Wash.–(BUSINESS WIRE<\/a>)–Seagen Inc.<\/a> (Nasdaq:SGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of TUKYSA\u00ae<\/sup> (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 2 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<\/sup><\/p>\n \nThe CHMP positive opinion will now be considered by the European Commission (EC), which has the authority to approve medicines in the European Union (EU). TUKYSA is approved in the United States, Canada, Switzerland, Singapore and Australia.\n<\/p>\n \n\u201cWe are pleased the CHMP has recognized TUKYSA as a meaningful clinical advance for people with advanced HER2-positive metastatic breast cancer, including those with cancer that has spread to the brain,\u201d said Roger Dansey, M.D., Chief Medical Officer at Seagen. \u201cThis opinion brings us one step closer to making TUKYSA available to patients in the EU and aligns with our commitment to bring innovative therapies to patients around the world.\u201d\n<\/p>\n \nThe positive CHMP opinion is based on results of the pivotal trial HER2CLIMB and were published inThe New England Journal of Medicine<\/a><\/i>in December 2019.\n<\/p>\n About HER2CLIMB<\/b><\/p>\n \nHER2CLIMB is a randomized, 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 ado-trastuzumab emtansine (T-DM1). The results for the primary endpoint showed patients who received TUKYSA in combination with trastuzumab and capecitabine had a 46 percent reduction in the risk of cancer progression or death (PFS) 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). A secondary endpoint showed that the addition of TUKYSA reduced the risk of death (OS) by 34 percent compared to trastuzumab and capecitabine alone (HR=0.66 [95% CI: 0.50, 0.87]; p=0.0048). Based on the results, TUKYSA was approved in the U.S. in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.\n<\/p>\n About HER2-Positive Breast Cancer<\/b><\/p>\n \nPatients 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 2018, more than two million new cases of breast cancer were diagnosed worldwide, including 522,513 in Europe.3<\/sup> Between 15 and 20 percent of breast cancer cases are HER2-positive.4<\/sup> Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.5,4,6<\/sup> Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.7,8,9<\/sup><\/p>\n About TUKYSA (tucatinib)<\/b><\/p>\n \nTUKYSA 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.1<\/sup><\/p>\n U.S. Important Safety Information<\/b><\/p>\n Warnings and Precautions<\/b><\/p>\n If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.\n<\/li>\n<\/ul>\n Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatotoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.\n<\/li>\n<\/ul>\n Adverse Reactions<\/b><\/p>\n \nSerious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in \u22652% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.\n<\/p>\n \nAdverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in \u22651% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in \u22652% of patients were hepatotoxicity (8%) and diarrhea (6%).\n<\/p>\n \nThe most common adverse reactions in patients who received TUKYSA (\u226520%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.\n<\/p>\n Lab Abnormalities<\/b><\/p>\n \nIn HER2CLIMB, Grade \u22653 laboratory abnormalities reported in \u22655% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.\n<\/p>\n Drug Interactions<\/b><\/p>\n Use in Specific Populations<\/b><\/p>\n For more information, please see the full Prescribing Information for TUKYSA here<\/a>.<\/b><\/p>\n About Seagen <\/b><\/p>\n \nSeagen is a global biotechnology company that discovers, develops, and commercializes transformative cancer medicines to make a meaningful difference in people\u2019s 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\u2019s marketed products and robust pipeline, visit www.seagen.com<\/a><\/span> and follow @SeagenGlobal<\/a> on Twitter.\n<\/p>\n Forward-Looking Statements<\/b><\/p>\n \nCertain 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. 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 difficulty and uncertainty of pharmaceutical product development, the risk of adverse events or safety signals, the inability to show sufficient activity in clinical trials and the possibility of adverse regulatory actions. More information about the risks and uncertainties faced by Seagen is contained under the caption \u201cRisk Factors\u201d included in the company\u2019s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the 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.\n<\/p>\n \n_________________________\n<\/p>\n 1<\/sup>https:\/\/www.ema.europa.eu\/en\/documents\/smop-initial\/chmp-summary-positive-opinion-tukysa_en.pdf View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20201211005284\/en\/<\/a><\/span><\/p>\n \nPeggy Pinkston KEYWORDS:<\/b> Washington Europe United States North America<\/p>\n INDUSTRY KEYWORDS:<\/b> Research Clinical Trials Other Health Biotechnology General Health Pharmaceutical Health Science Oncology Other Science<\/p>\n\n
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2<\/sup> 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 Ther <\/i>2020;19:976-987.
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3<\/sup> Breast. Globocan 2018. World Health Organization. 2019. https:\/\/gco.iarc.fr\/today\/data\/factsheets\/cancers\/20-Breast-fact-sheet.pdf
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4<\/sup> Slamon D, Clark G, Wong S, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2\/neu onco\u00adgene. Science. 1987; 235(4785): 177-82.
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5<\/sup> Loibli S, Gianni L. HER2-positive breast cancer. Lancet. 2017; 389(10087): 2415-29.
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6<\/sup> 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<\/a>. Accessed March 9, 2020.
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7<\/sup> 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.
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8<\/sup> 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.
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9<\/sup> 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.\n<\/p>\n<\/p>\n
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(425) 527-4160
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ppinkston@seagen.com<\/a><\/p>\n
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