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-Tisotumab Vedotin to be Evaluated as a Monotherapy in Patients Who Have Relapsed or Progressed After Standard of Care Treatment-
-Tisotumab Vedotin Represents Fourth Late-Stage Development Program Added to List of Ongoing Pivotal Trials Along with Enfortumab Vedotin and Tucatinib-
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced dosing of the first patient in the phase 2 innovaTV 204 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 cell surfaces and deliver the cell-killing agent monomethyl auristatin E (MMAE) directly inside cancer cells. 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.
“While significant advances have been made in the treatment and prevention of cervical cancer, there remains a need for targeted agents that are effective for patients who progress or relapse after standard treatments,” said Robert Coleman, M.D., FACOG, FACS, Professor of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX and principal investigator of the innovaTV 204 trial. “In a prior study, tisotumab vedotin demonstrated encouraging results in previously treated recurrent and/or metastatic cervical cancer, an area of unmet need where there is no established standard of care and response rates are limited.”
“With the initiation of this phase 2 study of tisotumab vedotin for women with previously treated recurrent and/or metastatic cervical cancer, we now have four late-stage development programs on registrational pathways to achieve our goal of becoming a global, multi-product oncology company,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “In addition, we plan to evaluate tisotumab vedotin in collaboration with Genmab in other solid tumors where there remains an unmet medical need for new treatment options.”
The phase 2 innovaTV 204 study (also known as GCT1015-04) is a global, multicenter, single arm trial that will enroll approximately 100 patients with recurrent and/or metastatic (2nd and 3rd line) cervical cancer who progressed on or relapsed after treatment with platinum-based chemotherapy used alone or in combination with bevacizumab (Avastin®). Patients will be treated with single-agent tisotumab vedotin every three weeks. The primary endpoint of the trial is objective response rate as assessed by independent review. Key secondary endpoints include duration of response, progression-free survival, overall survival, safety and tolerability.
The companies also plan to evaluate tisotumab vedotin in multiple solid tumors in a phase 2 trial this year.
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 US in 2018, with an estimated 4,000 deaths.1 Globally, cervical cancer remains one of the leading causes of cancer death in women globally, with over 260,000 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 antibody-drug conjugate (ADC) composed of Genmab’s human antibody that binds to Tissue Factor and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE). In cancer biology, Tissue Factor is a protein involved in tumor signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, Tissue Factor was selected as a target for an ADC approach. In an earlier study, tisotumab vedotin demonstrated an encouraging response rate and manageable safety profile in patients with relapsed, recurrent and/or metastatic cervical cancer.
Tisotumab vedotin is being co-developed by Genmab A/S and Seattle Genetics, Inc.
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 antibody-drug conjugate (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 or planned 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.
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, the referenced phase 2 clinical trial, trial design, targeted patient population and enrollment numbers, and the intention of using the data therefrom to support potential registration under FDA’s accelerated approval regulations, the company’s plan to conduct a broad clinical development program for tisotumab vedotin in collaboration with Genmab, including evaluation in earlier lines of therapy for cervical cancer and in multiple other solid tumor types and the company’s intention to become a global multi-product oncology company. 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, 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; the inherent uncertainty associated with the regulatory approval process, including the risks that submissions for approval may not be accepted for filing by, or ultimately approved by, the FDA in a timely manner or at all, and that the company may otherwise experience a more lengthy and costly regulatory approval process than anticipated; the potential for newly-emerging safety signals, failure of clinical results to support continued development or regulatory approvals; failure to properly conduct or manage the company’s clinical trials; and 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 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 Quarterly Report on Form 10-Q for the quarter ended March 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.
1 National Cancer Institute SEER. “Cancer Stat Facts: Cervix
Uteri Cancer.” Available at https://seer.cancer.gov/statfacts/html/cervix.html.
Accessed June 2018.
2 GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Last accessed June 2018 at http://globocan.iarc.fr/old/FactSheets/cancers/cervix-new.asp
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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