Seagen to Highlight Research in Urothelial and Colorectal Cancers at 2022 European Society for Medical Oncology (ESMO) Congress
Seagen Inc. (NASDAQ:SGEN) will showcase significant findings from its EV-103 trial involving PADCEV® at the ESMO Congress on September 12. This trial assesses PADCEV, alone or with KEYTRUDA®, for patients with advanced urothelial cancer. Additionally, data from the Phase 2 MOUNTAINEER trial will be presented, focusing on TUKYSA® for HER2-positive metastatic colorectal cancer. The FDA recently granted Breakthrough Therapy Designation for TUKYSA's combination with trastuzumab.
- Data presentation for PADCEV at ESMO may enhance investor confidence.
- FDA granted Breakthrough Therapy Designation for TUKYSA, indicating strong potential for market approval.
- None.
– Results from EV-103 trial evaluating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) in urothelial cancer to be featured as late-breaking oral session –
A second late-breaking oral presentation will include additional results from the phase 2 MOUNTAINEER trial evaluating TUKYSA® (tucatinib) in combination with trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer (mCRC). Patient-reported outcomes from MOUNTAINEER also will be detailed in a separate presentation. Data from the MOUNTAINEER trial formed the basis of a supplemental New Drug Application submitted to the
“These important data to be shared at the
Presentations of Company-Sponsored Trials
ABSTRACT TITLE |
PRESENTATION # |
PRESENTATION TYPE |
LEAD AUTHOR |
PADCEV® (enfortumab vedotin-ejfv) |
|||
Study EV-103 Cohort K: Antitumor activity of enfortumab vedotin (EV) monotherapy or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC) |
LBA73 |
Oral Presentation / Proffered Paper Session 2: GU Tumours, Non-prostate,
|
|
TUKYSA® (tucatinib) |
|||
Additional analyses of MOUNTAINEER: A phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC |
LBA27 |
Mini Oral Presentation / |
|
Tucatinib plus trastuzumab in patients (Pts) with HER2-positive metastatic colorectal cancer (mCRC): Patient-reported outcomes (PROs) from ph 2 study MOUNTAINEER |
361P |
Poster Session 7, |
|
TUKYSA® (tucatinib) Trials in Progress |
|||
MOUNTAINEER-03: Phase 3 study of tucatinib, trastuzumab, and mFOLFOX6 as first-line treatment in HER2+ metastatic colorectal cancer (trial in progress) |
438TiP |
Poster Session 8, |
T. André |
Disitamab vedotin Trials in Progress |
|||
Phase 2 clinical study evaluating the efficacy and safety of disitamab vedotin in patients (pts) with HER2-expressing urothelial carcinoma (RC48G001, trial in progress) |
1779TiP |
Poster Session 12, |
V. S. Koshkin |
|
|||
Impact of anti-EGFR therapies on HER2-positive metastatic colorectal cancer (HER2+ mCRC): A systematic literature review and meta-analysis of clinical outcomes |
376P |
Poster Session 8, |
T. S. Bekaii-Saab |
About
Forward-Looking Statements
Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of PADCEV, TUKYSA, disitamab vedotin and the company’s other products and product candidates, including their potential efficacy, safety and therapeutic uses, and the potential for TUKYSA to receive accelerated approval from the FDA based on data from the MOUNTAINEER trial. 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 possibility that data from the MOUNTAINEER trial and other trials may not be sufficient to support any regulatory approvals; the risk of adverse events, including the potential for newly-emerging safety signals; adverse regulatory actions; delays, setbacks or failures in clinical development activities, the submission of regulatory applications and the regulatory review process for a variety of reasons, including the difficulty and uncertainty of pharmaceutical product development. More information about the risks and uncertainties faced by
View source version on businesswire.com: https://www.businesswire.com/news/home/20220907005258/en/
For Media
(310) 430-3476
dcaouette@seagen.com
For Investors
(425) 527-4881
dmaffei@seagen.com
Source:
FAQ
What are the key findings from Seagen's EV-103 trial concerning SGEN?
When will Seagen present the MOUNTAINEER trial data?
What new designation did the FDA grant to TUKYSA?
How does the ESMO Congress affect SGEN's stock performance?