On April 26, 2023 Seagen Inc. (Nasdaq: SGEN) reported the presentation of 17 abstracts at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2023, in Chicago (Press release, Seagen, APR 26, 2023, View Source [SID1234630544]). Data will be presented across Seagen’s portfolio of approved medicines and pipeline agents in a range of cancer types and in earlier lines of therapy.

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"Seagen has worked towards revolutionizing cancer care for 25 years by linking scientific innovation to meaningful impacts in patients’ lives," said Roger Dansey, M.D., President, Research and Development and Chief Medical Officer at Seagen. "Our data presented at ASCO (Free ASCO Whitepaper) demonstrate continued progress in our efforts to discover and develop transformative medicines."

Highlights include new data from a robust clinical development program in bladder cancer with trials across multiple lines of treatment and into earlier stages of disease for muscle-invasive and non-muscle invasive forms of bladder cancer. Long-term follow-up data from a clinical trial of PADCEV (enfortumab vedotin-ejfv) (EV-103 dose-escalation and Cohort A) will be featured in an oral presentation on Monday, June 5. The EV-103 dose-escalation/Cohort A study is evaluating PADCEV, developed in partnership with Astellas, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first-line treatment in patients with locally advanced or metastatic urothelial carcinoma who are ineligible to receive cisplatin-based chemotherapy. Merck is known as MSD outside the United States and Canada.

Updated Phase 1 data will be presented for SGN-B6A, a wholly-owned, first-in-class vedotin ADC directed to integrin beta-6, a novel target that is highly expressed in multiple solid tumors.

Additionally, initial data will be presented from studies evaluating Seagen’s approved medicines in potential new cancer types. Data from a Phase 2 basket study of TUKYSA (tucatinib) and trastuzumab in previously treated HER2-positive metastatic biliary tract cancer will be featured in an oral presentation on Friday, June 2.

Key data presentations for Seagen include:

Presentations of Company-Sponsored Trials

Abstract Title

Abstract #

Presentation Time

Lead Author

Enfortumab Vedotin

Study EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up

4505

Oral
Monday, June 5
11:30 a.m. – 2:30 p.m. CT

S. Gupta

Enfortumab vedotin in the previously treated advanced head and neck cancer (HNC) cohort of EV-202

6017

Poster Discussion

Monday, June 5
1:15 – 4:15 p.m. CT

P. Swiecicki

A first-in-human trial of intravesical enfortumab vedotin (EV), an antibody-drug conjugate (ADC), in patients with non-muscle invasive bladder cancer (NMIBC): Interim results of a phase 1 study (EV-104)

4596

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

A. Kamat

Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H

4595

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

T. Flaig

Enfortumab vedotin (EV) with or without pembrolizumab (P) in cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on Cohort K data

4568

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

T. Friedlander

EV-203: Phase 2 trial of enfortumab vedotin in patients with previously treated advanced urothelial carcinoma in China

e16574

Online Abstract

Q. Li

Enfortumab Vedotin Trials in Progress

KEYNOTE-905/EV-303: A phase 3 study to evaluate the efficacy and safety of perioperative pembrolizumab or pembrolizumab plus enfortumab vedotin (EV) for muscle-invasive bladder cancer (MIBC) (ENCORE)

TPS4601

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

A. Necchi

Tucatinib

Tucatinib and trastuzumab for previously treated HER2-positive metastatic biliary tract cancer (SGNTUC-019): A phase 2 basket study

4007

Oral
Friday, June 2
2:45 – 5:45 p.m. CT

Y. Nakamura

Real-world patient characteristics and treatment patterns associated with tucatinib therapy in patients with HER2+ metastatic breast cancer

1051

Poster
Sunday, June 4
8:00 – 11:00 a.m. CT

C. Anders

HER2 testing in the MOUNTAINEER trial: Analysis of treatment response based on central HER2 assessment using IHC/ISH and NGS

3528

Poster
Monday, June 5
8:00 – 11:00 a.m. CT

J. Strickler

Tucatinib Trials in Progress

HER2CLIMB-05: Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer (trial in progress)

TPS1115

Poster
Sunday, June 4
8:00 – 11:00 a.m. CT

E. Hamilton

MOUNTAINEER-03: Phase 3 study of tucatinib, trastuzumab, and modified FOLFOX6 as first line treatment in HER2+ metastatic colorectal cancer (trial in progress)

TPS3631

Poster
Monday, June 5
8:00 – 11:00 a.m. CT

T. Bekaii-Saab

Early-Stage/Pipeline

SGN-B6A, an integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors: Updated results from a phase 1 study (SGNB6A-001)

3024

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

A. Hollebecque

Early-Stage/Pipeline Trials in Progress

Phase 1 study of SGN-BB228, an investigational CD228 x 4-1BB costimulatory antibody anticalin bispecific, in patients with advanced melanoma and other solid tumors (SGNBB228-001: trial in progress)

TPS9597

Poster
Saturday, June 3
1:15 – 4:15 p.m. CT

J. Henry

Presentations of Investigator-Sponsored Trials

Abstract Title

Abstract #

Presentation Time

Lead Author

Enfortumab Vedotin
Real-world use, dose intensity, and adherence to an antibody-drug conjugate (ADC) in metastatic urothelial cancer (mUC)
e16567

Online Abstract

R. Mamtani

Tucatinib

UCLA B-13: A phase 1b trial evaluating the safety of ribociclib, tucatinib, and trastuzumab in patients with metastatic, HER2+ breast cancer and a multicenter, randomized, open-label, phase 2 study of preoperative treatment with ribociclib, trastuzumab, tucatinib, with or without fulvestrant versus docetaxel, carboplatin, trastuzumab, and pertuzumab in HR+/HR-, HER2+ breast cancer

TPS1116

Poster
Sunday, June 4
8:00 – 11:00 a.m. CT

N. McAndrew

Disitamab Vedotin

Disitamab vedotin, a novel humanized anti-HER2 antibody-drug conjugate (ADC) combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma: an open-label phase 1b/2 study

4566

Poster
Saturday, June 3
8:00 – 11:00 a.m. CT

X. Sheng