– Data from 26 abstracts, including four oral presentations, underscore Seagen progress toward addressing unmet needs across multiple tumor types –
Seagen Inc. (Nasdaq:SGEN) today announced upcoming presentations of new data from its expanding pipeline of marketed and investigational therapies at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held June 3-7, 2022 in Chicago. The accepted abstracts demonstrate the growth of Seagen’s portfolio and clinical progress across multiple cancer types, including cervical and urothelial cancers and pediatric and adult Hodgkin lymphoma. Groundbreaking overall survival data for Stage III/IV Hodgkin lymphoma patients who were treated with ADCETRIS® (brentuximab vedotin) as part of a first-line therapy combination will be detailed in one of three oral presentations for the antibody-drug conjugate medicine.
Other important data include interim results from the dose-expansion cohorts of the innovaTV 205 trial of TIVDAK® (tisotumab vedotin-tftv) in combination with other anticancer agents in patients with recurrent metastatic cervical cancer, which will also be featured in an oral presentation. Long-term outcomes from the phase 3 EV-301 trial of PADCEV® (enfortumab vedotin-ejfv) in patients with previously treated advanced urothelial carcinoma will be shared in a poster discussion.
“Significant improvements in overall and event-free survival are important new findings in adult and pediatric Hodgkin lymphoma patients, respectively,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We look forward to the presentations and plan to submit supplemental applications to the Food and Drug Administration to update overall survival in the ADCETRIS prescribing information for Hodgkin lymphoma and expand its indication to include children.”
Key data presentations for Seagen include:
Presentations of Company-Sponsored Trials
Abstract Title |
Abstract # |
Presentation |
Lead Author |
ADCETRIS® (brentuximab vedotin) |
|||
First-line brentuximab vedotin plus chemotherapy to improve overall survival in patients with Stage III/IV classical Hodgkin lymphoma: An updated analysis of ECHELON-1 |
7503 |
Oral
|
S. M. Ansell |
Brentuximab vedotin in combination with lenalidomide and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma: Safety and efficacy results from the safety run-in period of the phase 3 ECHELON-3 study |
7559 |
Poster
|
N. L. Bartlett |
Updated safety and efficacy data from an open-label, phase 1/2 study of frontline brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A+AVD) in pediatric patients with advanced-stage classical Hodgkin lymphoma (cHL) |
10000 |
Oral
|
A. R. Franklin |
The impact of classic Hodgkin lymphoma (cHL) on informal caregivers: Results from the cHL: Real-world observations from physicians, patients, and caregivers on the disease and its treatment (CONNECT) study |
E24004
|
Online Publication |
D. R. Flora |
PADCEV® (enfortumab vedotin-ejfv) |
|||
Long-term outcomes in EV-301: 24-month findings from the phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma |
4516 |
Poster Discussion
|
J. E. Rosenberg |
Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle-invasive bladder cancer who are cisplatin-ineligible |
4582 |
Poster
|
D. P. Petrylak |
Benchmarking maintenance therapy survival in first-line advanced urothelial carcinoma using disease modeling |
4575 |
Poster
|
M. D. Galsky |
Real world treatment patterns and clinical outcomes with first-line therapy in cisplatin-eligible and ineligible patients with advanced urothelial carcinoma |
4565 |
Poster
|
G. P. Sonpavde |
TIVDAK ® (tisotumab vedotin-tftv) |
|||
Factors associated with receipt of second-line recurrent or metastatic cervical cancer treatment in the United States: A retrospective administrative claims analysis |
5532 |
Poster
|
K. Sonawane |
Cervical cancer geographical burden analyzer: An interactive, open-access tool for understanding geographical disease burden in patients with recurrent or metastatic cervical cancer |
5523 |
Poster Discussion
|
T. Castellano |
Tisotumab vedotin (TV) + pembrolizumab (pembro) in first-line (1L) recurrent or metastatic cervical cancer (r/mCC): Interim results of ENGOT Cx8/GOG 3024/innovaTV 205 |
5507 |
Oral
|
D. Lorusso |
Productivity losses under various second-line recurrent or metastatic cervical cancer treatment scenarios in the United States |
E17520 |
Online Publication |
J. Ting |
Patterns of care in Medicaid-enrollees with recurrent or metastatic cervical cancer |
E17525 |
Online Publication |
C. A. Leath |
TIVDAK® (tisotumab vedotin-tftv) Trials in Progress |
|||
Trial in progress update on ENGOT-cx8/GOG-3024/innovaTV 205: Addition of a new cohort with first-line (1L) tisotumab vedotin (TV) + pembrolizumab (pembro) + carboplatin (carbo) ± bevacizumab (bev) in recurrent/metastatic cervical cancer (r/mCC) |
TPS5603 |
Poster
|
I. Vergote |
innovaTV 207: New combination dosing cohorts in the open label phase 2 study of tisotumab vedotin in solid tumors |
TPS6100 |
Poster
|
X. Le |
TUKYSA® (tucatinib) Trials in Progress |
|||
Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer (HER2CLIMB-05, trial in progress) |
TPS1108 |
Poster
|
E. P. Hamilton |
Phase 2 trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastases (HER2CLIMB-04, trial in progress) |
TPS1111 |
Poster
|
I. E. Krop |
Disitamab vedotin |
|||
Preliminary results of a phase Ib/II combination study of RC48-ADC, a novel humanized anti-HER2 antibody-drug conjugate (ADC) with toripalimab, a humanized IgG4 mAb against programmed death-1 (PD-1) in patients with locally advanced or metastatic urothelial carcinoma |
4518 |
Poster Discussion
|
X. Sheng |
A phase II study of RC48-ADC in HER2-negative patients with locally advanced or metastatic urothelial carcinoma |
4519 |
Poster Discussion
|
H. Xu |
RC48-ADC for metastatic urothelial carcinoma with HER2 -positive: Combined analysis of RC48-C005 and RC48-C009 trials
|
4520 |
Poster Discussion
|
X. Sheng |
Pipeline Trials in Progress |
|||
Phase 1 study of SGN-B7H4V, a novel, investigational vedotin antibody–drug conjugate directed to B7-H4, in patients with advanced solid tumors (SGNB7H4V-001, trial in progress) |
TPS3155 |
Poster
|
A. Patnaik |
Phase 1 study of SGN-PDL1V, a novel, investigational vedotin antibody–drug conjugate directed to PD-L1, in patients with advanced solid tumors (SGNPDL1V-001, trial in progress) |
TPS3154 |
Poster
|
A. Patnaik |
Phase 1 study of SGN-ALPV, a novel, investigational vedotin antibody–drug conjugate directed to ALPP/ALPPL2 in advanced solid tumors (SGNALPV-001, trial in progress) |
TPS3159 |
Poster
|
N. Lakhani |
Phase 1b/2 study of ladiratuzumab vedotin (LV) in combination with pembrolizumab for first-line treatment of triple-negative breast cancer (SGNLVA-002, trial in progress) |
TPS1127 |
Poster
|
J. L. Meisel |
Presentations of Investigator-Sponsored or Cooperative Group Trials
Abstract Title |
Abstract # |
Presentation |
Lead Author |
Brentuximab vedotin and association with event-free survival (EFS) in children with newly diagnosed high-risk Hodgkin lymphoma (HL): A report from the Children's Oncology Group phase 3 study AHOD1331 (NCT 02166463) |
7504 |
Oral
|
S. M. Castellino |
Brentuximab vedotin and nivolumab alone and then combined with rituximab, cyclophosphamide, doxorubicin, and prednisone for frontline therapy of patients with primary mediastinal large B-cell lymphoma |
TPS7589 |
Poster
|
R. E. Steiner |
About Seagen
Seagen is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on our marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.
Forward-Looking Statements
Certain statements made in this press release are forward looking, such as those, among others, relating to the company’s pipeline and the therapeutic potential of ADCETRIS, PADCEV, TUKYSA, TIVDAK, disitamab vedotin, ladiratuzumab vedotin and the company’s other product candidates, including their efficacy, safety and potential therapeutic uses. 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 without limitation the difficulty and uncertainty of pharmaceutical product development, including the risks that the company may experience delays in its clinical trials or otherwise experience failures or setbacks in its clinical development programs due to lack of efficacy, adverse events or other factors, and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seagen is contained under the caption “Risk Factors” included in the company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Contacts
For Media
David Caouette
Vice President, Corporate Communications
(310) 430-3476
dcaouette@seagen.com
For Investors
Peggy Pinkston
Senior Vice President, Investor Relations
(425) 527-4160
ppinkston@seagen.com
