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Seattle Genetics and Astellas Announce Antibody-Drug Conjugate Enfortumab Vedotin Produced Tumor Response Rate of 44 Percent in Patients with Most Common Type of Advanced Urothelial (Bladder) Cancer
June 3, 2019 at 7:30 AM EDT
-First Investigational Therapy in a Pivotal Trial to Address Unmet Need for Patients with Advanced Urothelial Cancer After Treatment with Platinum Chemotherapy and a PD-1 or PD-L1 Inhibitor-
-Data Featured in Official Press Program and Presented in Late-Breaking Oral Session Today at 2019 ASCO Annual Meeting-
The data will be featured today in the official press program of the
Despite recent advances in treatment, approximately 80 percent of people do not respond to PD-1/L1 inhibitors, which are the standard of care after platinum-containing therapy has failed as an initial treatment for advanced disease.1,2,3 These patients have few treatment options and new therapies are urgently needed.
Enfortumab vedotin is an investigational antibody-drug conjugate (ADC)
that targets Nectin-4, a protein that is highly expressed in urothelial
cancers.4,5 Based on the results of the EV-201 trial, the
companies plan to submit a Biologics License Application (BLA) for
enfortumab vedotin to the
“Outcomes for patients diagnosed with locally advanced or metastatic
urothelial cancer are generally poor, and treatment options after
initial chemotherapy and immunotherapy are very limited,” said Daniel P.
Petrylak, M.D., Professor of Medicine and of Urology,
“We are encouraged that enfortumab vedotin is the first novel therapy to
demonstrate substantial clinical activity in these difficult-to-treat
patients who currently have limited treatment options,” said
“Even with the recent introduction of new therapies, there remains a
need for continued innovation in the treatment of urothelial cancer, and
if approved, we hope to bring this potential treatment to physicians and
patients as quickly as possible,” said
A global, randomized phase 3 confirmatory clinical trial (EV-301) is ongoing and is intended to support global registrations. Another trial (EV-103) is underway to evaluate enfortumab vedotin in earlier lines of treatment for patients with locally advanced or metastatic urothelial cancer, including in combination with pembrolizumab and/or platinum chemotherapy in newly diagnosed patients as well as patients who progressed from earlier-stage disease.
EV-201 Study Results
In the first cohort of the EV-201 study, 125 patients were treated with enfortumab vedotin. The primary endpoint of confirmed objective response rate (ORR) was 44 percent per blinded independent central review (BICR) [(55/125; 95% CI: 35.1-53.2)]. The overall duration of response (DoR), a key secondary endpoint, was 7.6 months (range 0.95-11.3+).
Most responses occurred within the first cycle of treatment, and were observed across all pre-specified patient subgroups irrespective of lines of therapy, response to prior PD-1/L1 inhibitor, or presence of liver metastases:
Median overall survival (OS) was 11.7 months (95% CI:9.1-not reached), and the median progression-free survival (PFS) was 5.8 months (95% CI:4.9-7.5).
About the EV-201 Trial
EV-201 is an ongoing single-arm, pivotal phase 2 clinical trial of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy and who are ineligible for cisplatin (cohort 2). EV-201 continues to enroll patients in cohort 2. In cohort 1, 128 patients were enrolled at multiple centers internationally.6 The primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability.
More information about enfortumab vedotin clinical trials can be found at clinical trials.gov.
About Urothelial Cancer
Urothelial cancer is the most common type of bladder cancer (90 percent
of cases).7 In 2018, more than 82,000 people were diagnosed
with bladder cancer in
About Enfortumab Vedotin
Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule that is expressed on many solid tumors, and that has been identified as an ADC target by Astellas.
The safety and efficacy of enfortumab vedotin are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval or become commercially available for the uses being investigated.
About the Astellas and Seattle Genetics Collaboration
Seattle Genetics Forward Looking Statement
Certain statements made in this press release are forward looking, such
as those, among others, relating to the companies’ plan to submit a
Biologics License Application (BLA) to the
Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.
1 Kim HS, Seo HK, Immune checkpoint inhibitors for urothelial
carcinoma. Investig Clin Urol 2018 Sep;59(5):285-296
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