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SGEN Seagen Inc

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Seattle Genetics Announces Multiple ADCETRIS® (Brentuximab Vedotin) Presentations at the Congress of the European Hematology...

12/06/2019 1:00pm

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-Data Presentations Highlight Continued Advances in Research for Treating Blood Cancers-

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced data from its ADCETRIS® (brentuximab vedotin) clinical development program at the 24th Annual Congress of the European Hematology Association (EHA) taking place June 13-16 in Amsterdam; and the International Conference on Malignant Lymphoma (ICML) from June 18-22 in Lugano. Updated analyses from clinical trials evaluating ADCETRIS in combination with Opdivo® (nivolumab), as well as encore analyses from the phase 3 ECHELON-1, ECHELON-2 and ALCANZA clinical trials, will be highlighted in 12 presentations at EHA and ICML. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma (HL) and expressed on the surface of several types of peripheral T-cell lymphomas. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to harness the body’s own immune system to help restore anti-tumor immune response. ADCETRIS and Opdivo are not approved in combination for the treatment of relapsed or refractory primary mediastinal large B-cell lymphoma (PMBL), HL, pediatric HL or for other indications. ADCETRIS in combination with bendamustine is not approved for HL.

“This year at the EHA and ICML meetings, key ADCETRIS data will be featured that continue to support our goal of further expanding our clinical development program beyond the six ADCETRIS approved indications,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “We are excited about several ADCETRIS-related presentations including encore oral presentations from the ECHELON-1 and ECHELON-2 phase 3 trials, as well as clinical research updates on ADCETRIS combination treatment strategies.”

Details of oral and poster presentations featured at EHA include:

Abstract Title: Frontline Brentuximab Vedotin with Chemotherapy for Stage 3/4 Classical Hodgkin Lymphoma: 3-Year Update of the ECHELON-1 Study (Abstract #S820)Oral Presentation Date and Time: Saturday, June 15, 12:00-12:15 p.m. CESTLocation: Hall 5

Abstract Title: Nivolumab and Brentuximab Vedotin-based, Response-adapted Treatment in Primary Refractory and in Pediatric Patients with Relapsed/Refractory Classical Hodgkin Lymphoma in Checkmate 744 (Abstract #S822)Oral Presentation Date and Time: Saturday, June 15, 12:30-12:45 p.m. CESTLocation: Hall 5

Abstract Title: The ECHELON-2 Trial: Results of a Randomized, Double-blind Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) versus CHOP in Frontline Treatment of Patients with CD30+ Peripheral T-cell Lymphomas (Abstract #PS1070)Poster Presentation Date and Time: Saturday, June 15, 5:30-7:00 p.m. CESTLocation: Poster Area

Abstract Title: Nivolumab Combined with Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma: Efficacy and Safety Results from the Phase 2 Checkmate 436 Study (Abstract #S1601)Oral Presentation Date and Time: Sunday, June 16, 9:00-9:15 a.m. CESTLocation: Hall 5

Details of oral and poster presentations featured at ICML include:

Abstract Title: Safety and Response after 2 Cycles of Brentuximab Vedotin Substituting Vincristine in the OEPA/COPDAC Regimen for High Risk Pediatric Hodgkin Lymphoma (HL) (Abstract #025)Oral Presentation Date and Time: Wednesday, June 19, 5:25 p.m. CESTLocation: Cinema Corso

Abstract Title: Response-Adapted Treatment with Nivolumab and Brentuximab Vedotin in Young Patients with Relapsed/Refractory Classical Hodgkin Lymphoma: Checkmate 744 Subgroup Analyses (Abstract #026)Oral Presentation Date and Time: Wednesday, June 19, 5:35 p.m. CESTLocation: Cinema Corso

Abstract Title: Extended Follow-up a Phase 1 Study of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma: A Trial of the ECOG-ACRIN Research Group (E4412: Arms A-I) (Abstract #077)Oral Presentation Date and Time: Thursday, June 20, 5:45 p.m. CESTLocation: Cinema Corso

Abstract Title: Nivolumab Combined with Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma: Efficacy and Safety Results from the Phase 2 Checkmate 436 Study (Abstract #108)Oral Presentation Date and Time: Friday, June 21, 2:15 p.m. CESTLocation: Room B, Palazzo dei Congressi

Abstract Title: Response to A+CHP by CD30 Expression in the ECHELON-2 Trial (Abstract #228)Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CESTLocation: Marquee Parco Ciani

Abstract Title: Exploratory Biomarker Analysis in the Phase 3 ECHELON-1 Study: Worse Outcome with ABVD in Patients with Elevated Baseline Levels of sCD30 and TARC (Abstract #235)Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CESTLocation: Marquee Parco Ciani

Abstract Title: Brentuximab Vedotin and Bendamustine is a Feasible and Effective Drug Combination as First-line Treatment of Hodgkin Lymphoma in the Elderly (HALO trial) (Abstract #237)Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CESTLocation: Marquee Parco Ciani

Abstract Title: Final Data from the Phase 3 ALCANZA Study: Brentuximab Vedotin (BV) vs Physician’s Choice (PC) in Patients (pts) with CD30-positive (CD30+) Cutaneous T-cell Lymphoma (CTCL) (Abstract #232)Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CESTLocation: Marquee Parco Ciani

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 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 ADCETRIS, including the combination of ADCETRIS with OPDIVO or other agents, the potential expansion of the company’s ADCETRIS clinical development program and the potential for additional approved indications of ADCETRIS. 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, including the risks that Seattle Genetics or its collaborators may experience delays in planned clinical trial initiations or otherwise experience failures or setbacks in clinical development due to lack of efficacy, adverse events or other factors. Seattle Genetics or its collaborators may also be delayed or unsuccessful in regulatory submissions and in obtaining regulatory approvals for a variety of reasons including the difficulty and uncertainty of pharmaceutical product development, negative or disappointing clinical trial results, unexpected adverse events, adverse regulatory actions and the inherent uncertainty associated with the regulatory approval process. 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, 2019 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.

SOURCE: Seattle Genetics, Inc.

Opdivo® is a registered trademark of Bristol-Myers Squibb Company.

Media:Monique Greer(425) 527-4641mgreer@seagen.com

Investors:Peggy Pinkston(425) 527-4160ppinkston@seagen.com

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