Seattle Genetics Completes Enrollment in Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced completion of enrollment in the potentially pivotal innovaTV 204 phase 2 clinical trial evaluating the efficacy, safety and tolerability of tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. Tisotumab vedotin is being developed in collaboration with Genmab A/S. The innovaTV 204 trial is intended to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) designed to target Tissue Factor antigen on cancer cells and deliver the cell-killing agent monomethyl auristatin E (MMAE) directly inside cancer cells. Tissue Factor is overexpressed in cervical cancer and many other solid tumors.

“Cervical cancer is a devastating disease with a significant need to develop improved therapies for patients with metastatic disease who have progressed after treatment,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “Completing enrollment in this potentially pivotal phase 2 trial marks an important step forward in evaluating tisotumab vedotin for women with previously treated recurrent and/or metastatic cervical cancer.”

For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About innovaTV 204 Trial

The innovaTV 204 trial (also known as GCT1015-04) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent and/or metastatic cervical cancer who progressed on or relapsed after treatment with doublet chemotherapy used alone or in combination with bevacizumab (Avastin^®). The study enrolled over 100 patients at multiple centers. The primary endpoint of the trial is objective response rate as assessed by blinded independent central review. Key secondary endpoints include duration of response, progression-free survival, overall survival, safety and tolerability.

About Cervical Cancer

Cervical cancer originates in the cells lining the cervix, which connects the uterus to the birth canal. About 13,000 women are expected to be diagnosed with cervical cancer in the U.S. in 2018, with an estimated 4,000 deaths.¹ Cervical cancer remains one of the leading causes of cancer death in women globally, with over 311,000 women dying annually; the vast majority of these women being in the developing world.² Routine medical examinations and the human papillomavirus (HPV) vaccine have lowered the incidence of cervical cancer in the developed world. Despite these advances, women are still diagnosed with cervical cancer, which can have a devastating impact, particularly in the recurrent and/or metastatic setting. Standard therapies for previously treated recurrent and/or metastatic cervical cancer generally result in response rates of less than 15 percent and a median overall survival of 6 to 8 months.^3-10

About Tisotumab Vedotin

Tisotumab vedotin is an ADC composed of Genmab’s human antibody that binds to Tissue Factor and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the microtubule disrupting agent monomethyl auristatin E (MMAE). In cancer biology, Tissue Factor is a protein involved in tumor signaling and angiogenesis. The Tissue Factor antigen target is overexpressed in the vast majority of patients with cervical cancer and in many other solid tumors, including ovarian, lung, pancreatic, colorectal and head and neck. Based on its high expression on many solid tumors and its rapid internalization, Tissue Factor was selected as a target for an ADC approach.

About Seattle Genetics

Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. ADCETRIS^® (brentuximab vedotin) utilizes the company’s industry-leading ADC technology and is currently approved for the treatment of multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing pivotal trials for solid tumors. Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer utilize our proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors. The company is headquartered in Bothell, Washington, and has a European office in Switzerland. For more information on our robust pipeline, visit www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

Forward Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of tisotumab vedotin, its possible benefits and uses as monotherapy, and the referenced Phase 2 clinical trial. 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 inability of tisotumab vedotin to show sufficient activity in the clinical setting referenced above and the risk of adverse events of tisotumab vedotin, including the potential for newly-emerging safety signals, delays in planned clinical trial initiations, enrollment and conduct, obtaining data from clinical trials, and anticipated regulatory submissions and approvals in each case for a variety of reasons, including the difficulty and uncertainty of pharmaceutical product development, unexpected adverse events and/or adverse regulatory action, possible required modifications to clinical trials and the inability to provide information and institute safety mitigation measures as required by the FDA or other regulatory authorities from time to time, failure to properly conduct or manage the company’s clinical trials and failure of clinical results to support continued development or regulatory approvals, in which case our clinical trials may be delayed or discontinued. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption “Risk Factors” included in the company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission. Seattle Genetics 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.

¹ National Cancer Institute SEER. “Cancer Stat Facts: Cervix Uteri Cancer.” Available at https://seer.cancer.gov/statfacts/html/cervix.html. Last accessed March 2019.
² Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 countries https://www.iarc.fr/news-events/global-cancer-statistics-2018-globocan-estimates-of-incidence-and-mortality-worldwide-for-36-cancers-in-185-countries/.
³ Miller et al., Gynecol Oncol 2008; 110:65.
⁴ Bookman et al., Gynecol Oncol 2000; 77:446.
⁵ Garcia et al., Am J Clin Oncol 2007; 30:428.
⁶ Muggia et al., J Clin Oncol 2009; 27:1069.
⁷ Monk et al., J Clin Oncol 2009; 27:1069.
⁸ Santin et al., Genecol Oncol 2011; 122:495.
⁹ Schellens, J Clin Oncol 35, 2017 (suppl; abstr 5514).
¹⁰ Hollebecque et al., J Clin Oncol 35, 2017 (suppl; abstr 6025).

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