Seattle Genetics Reports Third Quarter 2018 Financial Results
-ADCETRIS® (Brentuximab Vedotin) Net Sales in U.S. and Canada of $127.0 Million in the Third Quarter-
-Positive Top-line Data from ADCETRIS Phase 3 ECHELON-2 Trial in Frontline PTCL; Supplemental BLA Planned for November 2018; Full Data to be Presented at ASH Annual Meeting-
-Top-line Data from Enfortumab Vedotin Pivotal Trial in Metastatic Urothelial Cancer Expected in the First Quarter of 2019-
-Conference Call Today at 4:30 p.m. ET-
BOTHELL, Wash. — October 25, 2018 — Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial results for the third quarter and nine months ended September 30, 2018. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments and progress with its late-stage clinical programs for cancer.
“ADCETRIS net sales during the third quarter and year-to-date increased by more than 50 percent over the same periods in 2017, as we continue to expand into the frontline Hodgkin lymphoma setting following FDA approval earlier this year. In addition, we recently reported positive top-line results from the phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphoma, including a statistically significant improvement in overall survival for the ADCETRIS regimen,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We plan to submit an application for approval to the FDA in November and look forward to highlighting results from ECHELON-2 at the American Society of Hematology Annual Meeting in December. Our late-stage programs continue to progress, and we believe they have the potential to transform Seattle Genetics into a multi-product oncology company. We now plan to report top-line results from the pivotal trial of enfortumab vedotin in metastatic urothelial cancer in the first quarter of 2019. Additionally, we expect to complete enrollment of 480 patients in the HER2CLIMB pivotal trial of tucatinib in metastatic breast cancer in early 2019 to support analysis of the primary endpoint.”
ADCETRIS Program Highlights
Positive ECHELON-2 Phase 3 Results: Seattle Genetics and its partner Takeda Pharmaceutical Company Limited (Takeda) reported positive top-line results from the ECHELON-2 phase 3 clinical trial in frontline CD30-expressing peripheral T-cell lymphoma (PTCL). The trial demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS) of ADCETRIS in combination with CHP (cyclophosphamide, doxorubicin, prednisone) versus the control arm, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). The ADCETRIS plus CHP arm also demonstrated superior overall survival, a key secondary endpoint, compared to CHOP. The safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with chemotherapy. Additional data will be presented at the 60th Annual Meeting of the American Society of Hematology (ASH), taking place December 1-4, 2018, in San Diego, Calif.
The following information was filed by Seattle Genetics Inc Wa (SGEN) on Thursday, October 25, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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Ticker: SGEN CIK: 1060736 Form Type:10-Q Quarterly Report Accession Number: 0001060736-18-000021 Submitted to the SEC: Fri Oct 26 2018 12:21:09 PM EST Accepted by the SEC: Fri Oct 26 2018 Period: Sunday, September 30, 2018 Industry: Biological Products No Disgnostic Substances