Seattle Genetics Highlights Leadership in Expanding Field of Antibody-Drug Conjugates (ADCs) at the 36th Annual J.P. Morgan Healthcare Conference

-Continued Progress In Establishing ADCETRIS® (brentuximab vedotin) as the Foundation of Care for CD30-Expressing Lymphomas-

-Two Solid Tumor ADC Programs Advancing Under Accelerated Approval Pathways-

-Multiple Collaborator ADC Programs in Late-Stage Trials for Range of Tumor Types-

BOTHELL, Wash.--(BUSINESS WIRE)--Jan. 8, 2018-- Seattle Genetics, Inc. (NASDAQ: SGEN) highlighted today the progress of its pipeline of antibody-drug conjugates (ADCs) at the 36th Annual J.P. Morgan Healthcare Conference. Through both internal efforts and that of its collaborators, the company’s ADC technology is being employed in more than 20 programs in clinical trials, including multiple late-state development programs across hematologic malignancies and solid tumors.

“ADCs continue to advance as an important therapeutic modality, both as single agents and as part of various combination regimens, across hematologic malignancies and solid tumors,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are the industry leader in ADC technology driven by our scientific expertise in monoclonal antibodies, drug payloads and stable linker technologies. Our leadership is further illustrated by the continued clinical and commercial expansion of ADCETRIS (brentuximab vedotin), progress with our late-stage programs enfortumab vedotin and tisotumab vedotin, and the breadth of our pipeline of other ADCs and empowered antibodies. In addition, our collaborators are making significant advances with several programs using our technology. ADCs are an integral part of an evolving cancer treatment paradigm, and we are committed to bringing important new treatments to patients in need.”

ADCETRIS, which pioneered a new class of ADCs, is commercially available in 70 countries worldwide and generated more than $600 million in global sales in 2017. On January 2, 2018, the company announced that the FDA accepted for filing a supplemental Biologics License Application (BLA) for ADCETRIS in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The FDA granted Priority Review for the application, and the Prescription Drug User Fee Act (PDUFA) target action date is May 1, 2018. The submission of the supplemental BLA is based on positive results from a phase 3 clinical trial called ECHELON-1. In October 2017, the FDA granted Breakthrough Therapy Designation (BTD) for ADCETRIS in frontline advanced Hodgkin lymphoma based on the ECHELON-1 study results.

In addition to advancing ADCETRIS, Seattle Genetics and its collaborator Astellas have initiated a pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor (CPI) therapy. The study is designed to support potential registration under the FDA’s accelerated approval regulations. In addition, Seattle Genetics, in collaboration with its development partner Genmab, plans to initiate a phase 2 clinical trial of tisotumab vedotin for patients with recurrent and/or metastatic cervical cancer. This study is intended to support potential registration under the FDA’s accelerated approval regulations.

Seattle Genetics’ ADC technologies are also empowering several collaborator programs in late-stage clinical trials. These include:

  • GSK2857916, an ADC being developed by GlaxoSmithKline (GSK) for multiple myeloma. GSK recently reported encouraging data from the program at the 59th American Society of Hematology (ASH) annual meeting in December 2017;
  • Polatuzumab vedotin, an ADC being developed by Genentech/Roche. Positive results were presented at ASH from a phase 2 trial in advanced-stage diffuse large B-cell lymphoma. A phase 3 trial is underway; and,
  • Depatuxizumab mafodotin, an ADC for glioblastoma in development by AbbVie. Encouraging data have been reported from this ADC, which is currently in a phase 3 clinical trial.

Polatuzumab vedotin and GSK2857916 have both received BTD from the FDA and PRIority MEDicines (PRIME) designations from the European Medicines Agency. These designations signify the importance of therapies such as these in addressing significant unmet medical need.

“Through our robust internal development efforts and our strong licensing and co-development agreements, we are extending the potential of ADCs globally. We look forward to future results of studies that include Seattle Genetics’ novel technologies both as monotherapies, as well as in combination with checkpoint inhibitors and other agents,” said Dr. Siegall.

In 2018, Seattle Genetics anticipates several milestones, including:

  • Working with FDA towards the May 1 PDUFA action date for ADCETRIS in combination with chemotherapy for frontline treatment of patients with advanced classical Hodgkin lymphoma;
  • Reporting ECHELON-2 data of ADCETRIS in combination therapy in frontline CD30-expressing mature T-cell lymphoma (MTCL);
  • Continuing enrollment of the enfortumab vedotin (EV) pivotal trial in locally advanced or metastatic urothelial cancer patients previously treated with a checkpoint inhibitor;
  • Continuing enrollment of the EV phase 1b trial in combination with checkpoint inhibitors, for patients with locally advanced or metastatic urothelial cancer;
  • Initiating a phase 2 trial of tisotumab vedotin (TV) in recurrent and/or metastatic cervical cancer to potentially support registration; and,
  • Initiating a phase 2 trial of TV as part of a combination regimen for first-line cervical cancer and a phase 2 trial of TV in other solid tumor types;
  • Initiating multiple trials evaluating ladiratuzumab vedotin in combination with checkpoint inhibitors in metastatic triple negative breast cancer, as well as evaluation as a neoadjuvant therapy for early breast cancer as part of the I-SPY consortium.

ADCETRIS is currently not approved for the frontline treatment of MTCL or Hodgkin lymphoma.

About Seattle Genetics

Seattle Genetics is an innovative biotechnology company dedicated to improving the lives of people with cancer through novel antibody-based therapies. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. Seattle Genetics commercializes ADCETRIS® (brentuximab vedotin) for the treatment of several types of CD30-expressing lymphomas. The company is also advancing a robust pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information can be found at www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

Seattle Genetics Forward-Looking Statement

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company’s and its collaborators’ potential to achieve regulatory and commercial milestones with respect to their respective products and product candidates; the company’s goals of establishing ADCETRIS as foundation of care for CD30-expressing lymphomas; anticipated approval of ADCETRIS for front-line Hodgkin lymphoma including potential timing thereof; anticipated accelerated regulatory approval pathways for enfortumab vedotin and tisotumab vedotin; anticipated clinical activities, including data availability from ECHELON-2 and the timing thereof and the initiation and completion of future clinical trials for the company’s product candidates and the timing thereof; the opportunities for, and the therapeutic and commercial potential of, ADCETRIS, enfortumab vedotin, tisotumab vedotin and the company’s other product candidates; potential benefits from collaborations; as well as other statements that are not historical facts. 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 risks and uncertainties related to 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 the company’s current and potential future BLA or supplemental BLA submissions 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 September 30, 2017 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.

Source: Seattle Genetics Inc.

Seattle Genetics Inc.
Investors:
Peggy Pinkston, 425-527-4160
ppinkston@seagen.com
or
Media:
Brandi Robinson, 425-527-2910
brobinson@seagen.com