On April 27, 2017 Seattle Genetics, Inc. (NASDAQ: SGEN), a global biotechnology company, reported financial results for the first quarter ended March 31, 2017 (Press release, Seattle Genetics, APR 27, 2017, View Source [SID1234518719]).

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The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments, vadastuximab talirine (SGN-CD33A) and enfortumab vedotin (ASG-22ME) activities, as well as progress with its pipeline of antibody-drug conjugates (ADCs) and other proprietary programs.

"We continue to successfully execute on our ADCETRIS commercial objectives, and are positioned to achieve several important clinical development milestones during 2017. Notably, we expect to report top-line data from the phase 3 ECHELON-1 trial this year. ECHELON-1 has the potential to redefine the way newly diagnosed classical Hodgkin lymphoma patients are treated for the first time in decades. In addition, we are on track to submit a supplemental BLA to the FDA in mid-2017 for ADCETRIS use in CTCL based on data from the ALCANZA trial," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Across our pipeline, enrollment in our phase 3 CASCADE trial of vadastuximab talirine (SGN-CD33A) is strong. And, based on positive feedback from the FDA, we plan to advance enfortumab vedotin (ASG-22ME) into a pivotal trial in metastatic urothelial cancer later this year. We are delivering on our goal of building Seattle Genetics into a multi-product oncology company addressing the substantial unmet medical needs of cancer patients."

ADCETRIS Program Highlights

ALCANZA Phase 3 Trial: A supplemental Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) is planned for mid-2017. The supplemental BLA is based on positive data from the phase 3 ALCANZA trial as well as data from two investigator-sponsored trials in cutaneous T-cell lymphoma (CTCL). ADCETRIS previously received Breakthrough Therapy Designation for the most common subtypes of CTCL: mycosis fungoides and primary cutaneous anaplastic large cell lymphoma.
ECHELON-1 Phase 3 Trial: Top-line data are anticipated in 2017 from the phase 3 ECHELON-1 trial in frontline classical Hodgkin lymphoma. ECHELON-1 is evaluating ADCETRIS as part of a combination regimen in newly diagnosed patients with advanced Hodgkin lymphoma.
ECHELON-2 Phase 3 Trial: Top-line data are expected in 2018 from the phase 3 ECHELON-2 trial in frontline CD30-expressing mature T-cell lymphoma (MTCL), also known as peripheral T-cell lymphoma (PTCL).
ADCETRIS is not currently approved for use in CTCL, frontline Hodgkin lymphoma or frontline MTCL.

Vadastuximab Talirine (SGN-CD33A) Program Highlights

CASCADE Phase 3 Trial: Enrollment is proceeding well in the global, randomized phase 3 CASCADE clinical trial evaluating vadastuximab talirine in combination with hypomethylating agents (HMAs) in older patients with newly diagnosed acute myeloid leukemia (AML).
Planned Phase 2 Trial: A randomized phase 2 trial in younger patients with newly diagnosed AML is planned for the second half of 2017. The trial will assess the standard-of-care regimen known as 7+3 versus 7+3 in combination with vadastuximab talirine.
Enfortumab Vedotin (ASG-22ME) Program Highlights

Planned Registrational Trial: Based on positive feedback from the FDA, Seattle Genetics and its collaborator Astellas plan to initiate in the second half of 2017 a pivotal phase 2 trial of single-agent enfortumab vedotin for metastatic urothelial cancer patients who have been previously treated with a checkpoint inhibitor therapy.
ASCO: Updated data from a phase 1 trial in metastatic urothelial cancer will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place June 2 – 6, 2017 in Chicago, IL.
Phase 1 Trial in Japan: Astellas and Seattle Genetics initiated a phase 1 trial in Japan to evaluate the tolerability and pharmacokinetics of enfortumab vedotin in patients with metastatic urothelial cancer. The trial will enable future studies and regulatory submission in Japan.
Other Recent Activities

Presence at AACR (Free AACR Whitepaper): Seattle Genetics’ ADC and immuno-oncology programs and technology advances were highlighted in 14 presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. Data described novel ADC linker technologies, the ability of ADCETRIS to activate antitumor immune responses, which support continued clinical evaluation in combination with checkpoint inhibitors, and preclinical data on two immuno-oncology agents, SEA-CD40 and SGN-2FF.
ADC Collaborations: In April 2017, Seattle Genetics generated a milestone under its ongoing ADC collaboration with AbbVie triggered by AbbVie’s exercise of an exclusive option to Seattle Genetics’ ADC technology for a specific target antigen.
First Quarter 2017 Financial Results

Total revenues in the first quarter ended March 31, 2017 were $109.1 million, compared to first quarter of 2016 revenues of $111.2 million. Revenues in the first quarter of 2017 included:

ADCETRIS net sales of $70.3 million, a 20 percent increase from net sales of $58.6 million in the first quarter of 2016.
Royalty revenues of $17.0 million, compared to $32.3 million in the first quarter of 2016. Royalty revenues are primarily driven by international sales of ADCETRIS by Takeda. Royalty revenues in the first quarter of 2016 included a $20.0 million sales milestone payment from Takeda.
Amounts earned under the company’s ADCETRIS and ADC collaborations totaling $21.8 million, compared to $20.2 million in the first quarter of 2016.
Total costs and expenses for the first quarter of 2017 were $168.4 million, compared to $132.2 million for the first quarter of 2016. The increase in 2017 costs and expenses was primarily driven by investment in enfortumab vedotin, vadastuximab talirine, ADCETRIS product supply to Takeda and the company’s pipeline programs.

Non-cash, share-based compensation cost for the first quarter of 2017 was $14.5 million, compared to $12.2 million for the first quarter of 2016.

Net loss for the first quarter of 2017 was $60.0 million, or $0.42 per share, compared to a net loss of $20.5 million, or $0.15 per share, for the first quarter of 2016.

As of March 31, 2017, Seattle Genetics had $536.4 million in cash, cash equivalents and investments.