Media Release
- Data featured in late-breaking proffered paper oral presentation
- Biologics license application submission planned to support accelerated approval pathway with the FDA
Current therapies for previously treated recurrent and/or metastatic cervical cancer generally result in limited objective response rates of typically less than 15 percent with median overall survival ranging from 6.0 to 9.4 months.1-8
“Following resistance to or progression on first-line standard of care therapy, there are limited treatment options for women with metastatic cervical cancer,” said
“We are encouraged by the innovaTV 204 trial results, which suggests that tisotumab vedotin as a monotherapy could potentially become an important option for women with metastatic and or recurrent cervical cancer,” said
“Tisotumab vedotin has demonstrated meaningful clinical activity in patients with recurrent and/or metastatic cervical cancer for whom there is a high unmet need for new therapies,” said
Data presented at ESMO include the primary endpoint of confirmed ORR as assessed by independent central review in 101 patients treated with tisotumab vedotin in the trial. Secondary endpoints included DOR, time to response, progression-free survival (PFS), overall survival (OS), safety and tolerability.
Tisotumab Vedotin in Previously Treated Recurrent or Metastatic Cervical Cancer: Results from the Phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 Study (Abstract #3435, late-breaking proffered paper oral presentation at
Efficacy:
- The primary endpoint of ORR (complete response + partial response) showed a 24 percent confirmed ORR [95% Confidence Interval (CI): 15.9%-33.3%], including 7 patients (7 percent) with a complete response and 17 patients (17 percent) with a partial response.
- After a median follow-up of 10 months, the median DOR was 8.3 months (95% CI: 4.2, not reached).
- The median time to response was 1.4 months (range, 1.1-5.1), with activity generally observed within the first two treatment cycles.
- Subgroup analyses demonstrated that responses were generally consistent across subgroups regardless of tumor histology, lines of prior therapy, responses to prior systemic regimen, and doublet chemotherapy with bevacizumab as first-line treatment.
- The median PFS was 4.2 months (95% CI: 3.0, 4.4) and the six-month PFS rate was 30 percent (95% CI: 20.8, 40.1).
- The median OS was 12.1 months (95% CI: 9.6, 13.9) and the six-month OS rate was 79 percent (95% CI: 69.3, 85.6).
Safety:
- The most common treatment-related adverse events (greater than or equal to 20 percent) included alopecia (Grade 1/2 at 38 percent), epistaxis (nose bleeds, Grade 1/2 at 30 percent), nausea (Grade 1/2 at 27 percent), conjunctivitis (Grade 1/2 at 26 percent), fatigue (Grade 1/2 at 24 percent, Grade 3 or higher at 2 percent) and dry eye (Grade 1/2 at 23 percent). Most treatment-related adverse events were Grade 1 or 2 and no new safety signals were reported. One death due to septic shock was considered by the investigator to be related to therapy.
- Pre-specified adverse events of interest with tisotumab vedotin treatment included ocular events, bleeding and peripheral neuropathy. Ocular adverse events considered to be related to therapy that occurred in patients were mostly mild to moderate (Grade 1 at 25 percent, Grade 2 at 27 percent, Grade 3 at 2 percent) of which a majority of the events resolved (86 percent) and were managed with an eye care plan. Bleeding events considered to be related to therapy that occurred in patients were mostly mild (Grade 1 at 34 percent, Grade 2 at 3 percent, Grade 3 at 2 percent) of which a majority of the events resolved (90 percent). The most common bleeding events included Grade 1 epistaxis (28 percent). Peripheral neuropathy events considered to be related to therapy were mostly mild to moderate (Grade 1 at 17 percent, Grade 2 at 9 percent, Grade 3 at 7 percent) and managed with dose modifications. Resolution of peripheral neuropathy was limited by follow-up period.
About Cervical Cancer
Cervical cancer originates in the cells lining the cervix. Over 13,500 women are expected to be diagnosed with invasive cervical cancer in the
About the innovaTV 204 Trial
The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab. Additionally, patients were eligible if they had received up to two prior lines of therapy in the recurrent and/or metastatic setting. In the study, 101 patients were treated with tisotumab vedotin at multiple centers in the
The study was conducted in collaboration with European Network of
About Tisotumab Vedotin
Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seattle Genetics’ ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a protein that can promote tumor growth, angiogenesis and metastasis.1 Based on its high expression on many solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by
Tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule.
About
About Seattle Genetics
Seattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. ADCETRIS® (brentuximab vedotin) and PADCEV® (enfortumab vedotin-ejfv) use the Company’s industry-leading antibody-drug conjugate (ADC) technology. ADCETRIS is approved in certain CD30-expressing lymphomas, and PADCEV is approved in certain metastatic urothelial cancers. TUKYSA® (tucatinib), a small molecule tyrosine kinase inhibitor, is approved in certain HER2-positive metastatic breast cancers. The company is headquartered in the
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This Media Release contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the
Seattle Genetics Forward Looking Statement
Certain of the statements made in this press release are forward looking, such as those, among others, relating to plans to submit a Biologics License Application (BLA) to FDA under FDA’s Accelerated Approval program based on the results of the innovaTV 204, and the therapeutic potential of tisotumab vedotin. 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 possibility of delays in the submission of a BLA to the FDA, that the data from innovaTV 204 may not be sufficient to support accelerated approval of tisotumab vedotin, the difficulty and uncertainty of pharmaceutical product development, the risk of adverse events or safety signals, the inability to show sufficient activity in current and future clinical trials and the possibility of adverse regulatory actions. 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
References:
1 Van de Berg YW et al. Blood 2012;119:924.
2 Miller et al., Gynecol Oncol 2008; 110:65.
3 Bookman et al., Gynecol Oncol 2000; 77:446.
4 Garcia et al., Am J Clin Oncol 2007; 30:428.
5 Monk et al., J Clin Oncol 2009; 27:1069.
6 Santin et al., Gynecol Oncol 2011; 122:495.
7 Schilder et al., Gynecol Oncol 2005; 96:103
8 Chung HC et al. J Clin Oncol 2019; 37:1470.
9 National Cancer Institute SEER. “Cancer Stat Facts: Cervix Uteri Cancer.” Available at https://seer.cancer.gov/statfacts/html/cervix.html. Last accessed
10 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/.
Media Release no. 12
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Attachment
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