Over the past six months, we have been able to deliver on our promise of bringing important new medicines to certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer through two U.S. FDA approvals, said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. We look forward to sharing data in the ASCO virtual scientific program that reinforce our ability to rapidly advance novel targeted agents across multiple tumor types.

An Expanding Portfolio of Marketed Therapies

Key data presentations will showcase progress for certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer as well as for patients with classical Hodgkin lymphoma (HL). Highlights include:

TUKYSA Update in Patients with Brain Metastases

Results for TUKYSA in combination with trastuzumab and capecitabine in patients with brain metastases from the HER2CLIMB pivotal trial of previously treated patients with HER2-positive metastatic breast cancer will be featured in an oral session (Abstract #1005). Data will be presented from these exploratory analyses on findings from the TUKYSA arm of the study on reduction in the risk of death (OS), reduction in the risk of intracranial progression or death (CNS-PFS) and improvement of the intracranial confirmed objective response rate (ORR-IC) compared to trastuzumab and capecitabine. Data will be presented by Nancy U. Lin, Director of the Metastatic Breast Cancer Program in the Susan F. Smith Center for Womens Cancers at Dana-Farber in Boston, MA, during an oral presentation available on demand at 8:00 a.m. ET on May 29, 2020. A separate analysis of adverse events (AE) from the same trial will be presented (Abstract #1043; poster presentation).

PADCEV (enfortumab vedotin-ejfv) in Combination and in Other Solid Tumors

Additional results and durability data from the phase 1b EV-103 trial of PADCEV plus pembrolizumab in first-line metastatic urothelial cancer will be presented (Abstract #5044), and a separate Trials-in-Progress poster will provide details about a new randomized cohort added to the EV-103 study, Cohort K, which is evaluating PADCEV as monotherapy or in combination with pembrolizumab (#TPS5092). Both presentations will be featured in the Genitourinary CancerKidney and Bladder session. Data from the Cohort K, along with other data from the EV-103 trial evaluating PADCEV combined with pembrolizumab as first-line therapy for cisplatin-ineligible patients, could potentially support registration under accelerated approval regulations in the United States.

Additionally, information about the phase 2 EV-202 trial, which is studying PADCEV in six different types of locally advanced and metastatic solid tumors (HR-positive/HER2-negative and triple-negative breast cancers, squamous and non-squamous non-small cell lung cancers, head and neck cancer and gastroesophageal cancers), will be discussed in a Trials-in-Progress poster during the Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology Poster Session (Abstracts #TPS3647).

ADCETRIS (brentuximab vedotin) Continues to Advance

Data to be presented on ADCETRIS will demonstrate the companys progress in efforts to continue expanding clinical research on combination regimens and monotherapy in a variety of HL and peripheral T-cell lymphoma (PTCL) patient populations, including in both older and younger disease settings. A poster presentation will highlight the potential of ADCETRIS in combination with nivolumab or dacarbazine and as a monotherapy for previously untreated older HL patients who typically have poorer outcomes than younger patients due to comorbidities and toxicities related to standard first-line chemotherapy (Abstract #8032). The primary analysis from an ongoing clinical trial evaluating ADCETRIS plus nivolumab in children, adolescents and young adults with standard-risk relapsed or refractory classical HL will also be presented (Abstract #8013; poster discussion). Lastly, two Trials-in-Progress poster presentations will highlight ongoing clinical trials evaluating ADCETRIS as a monotherapy in frontline older HL or CD30-expressing PTCL patients and in a combination regimen in frontline advanced-stage HL patients (Abstracts #TPS8069 and #TPS8068).

A Strong, Diverse Pipeline of Investigational Therapies

An additional four Trials-in-Progress posters for investigational therapies will showcase the companys continued clinical development of pipeline candidates in first-line cervical cancer (Abstract #TPS6095), metastatic breast cancer (Abstract #TPS1104), metastatic pancreatic ductal adenocarcinoma (PDAC) (Abstract #TPS4671) and other solid tumors (Abstract #TPS3652).

The abstracts published in advance of the ASCO meeting were made available today on the ASCO website. All data presentations will be available on-demand on May 29, 2020.

Details of Key Seattle Genetics Presentations at ASCO20 Virtual:

Abstract Title

Abstract #

Presentation Type

Presenter

ADCETRIS (brentuximab vedotin)

Nivolumab and brentuximab vedotin (BV)-based, responseadapted treatment in children, adolescents, and young adults (CAYA) with standard-risk relapsed/refractory classical Hodgkin lymphoma (R/R cHL): Primary analysis

8013

Poster discussion

P. Cole

Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients

8032

Poster presentation

C. Yasenchak

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: Durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma

5044

Poster presentation

J. Rosenberg

TUKYSA (tucatinib)

Tucatinib vs Placebo Added to Trastuzumab and Capecitabine for Patients with Previously Treated HER2+ Metastatic Breast Cancer with Brain Metastases (HER2CLIMB)

1005

Oral presentation

N. Lin

Management of adverse events in patients with HER2+ metastatic breast cancer treated with tucatinib, trastuzumab, and capecitabine (HER2CLIMB)

1043

Poster presentation

A. Okines

Trials-in-Progress

ADCETRIS (brentuximab vedotin)

Frontline brentuximab vedotin in Hodgkin lymphoma and CD30-expressing peripheral T-cell lymphoma for older patients and those with comorbidities

TPS8069

Poster presentation

C. Yasenchak

Brentuximab Vedotin in Combination with Nivolumab, Doxorubucin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma

TPS8068

Poster presentation

J. Friedman

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab for locally advanced or metastatic urothelial carcinoma

TPS5092

Poster presentation

N. Mar

EV-202: A Phase 2 Study of Enfortumab Vedotin in Patients With Select Previously Treated Locally Advanced or Metastatic Solid Tumors

TPS3647

Poster presentation

J. Bruce

Investigational Therapies

Phase 1b/2 trial of tisotumab vedotin (TV) bevacizumab (BEV), pembrolizumab (PEM), or carboplatin (CBP) in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8/GOG-3024)

TPS6095

Poster presentation

I. Vergote

SGNLVA-001: A phase 1 open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer

TPS1104

Poster presentation

H. Beckwith

SGN228-001: A phase 1 open-label dose escalation and expansion study of SGN-CD228A in select advanced solid tumors

TPS3652

Poster presentation

A. Patnik

Phase 1 study of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients (pts) with metastatic pancreatic ductal adenocarcinoma (PDAC)

TPS4671

Poster presentation

A. Coveler

About ADCETRIS (brentuximab vedotin)

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. Seattle Genetics and Takeda are jointly developing ADCETRIS.

About PADCEV (enfortumab vedotin-ejfv)

PADCEV is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis). PADCEV is co-developed by Seattle Genetics and Astellas.

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

ADCETRIS (brentuximab vedotin) U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

Administer G-CSF primary prophylaxis beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.

Most Common (20% in any study) Adverse Reactions

Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, and mucositis.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

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Seattle Genetics Highlights Data from Expanding Oncology Portfolio During Virtual Scientific Program of the 2020 ASCO Annual Meeting - BioSpace