On January 8, 2018 Seattle Genetics, Inc. (NASDAQ: SGEN) reported the progress of its pipeline of antibody-drug conjugates (ADCs) at the 36th Annual J.P. Morgan Healthcare Conference (Press release, Seattle Genetics, JAN 8, 2018, View Source;p=RssLanding&cat=news&id=2325358 [SID1234523020]). 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.
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"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) (Free ASH Whitepaper) annual meeting in December 2017;
Polatuzumab vedotin, an ADC being developed by Genentech/Roche. Positive results were presented at ASH (Free ASH Whitepaper) 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.