Seagen Inc. - SGEN STOCK NEWS

Seagen and Astellas have completed patient enrollment in Cohort K of the EV-103 clinical trial, evaluating PADCEV in combination with KEYTRUDA for patients with advanced urothelial cancer unable to receive cisplatin chemotherapy. The FDA previously granted Breakthrough Therapy designation for this combination. If the trial yields positive results, the companies may pursue accelerated approval from the FDA. The trial aims to assess the safety and efficacy of this treatment approach, which could significantly impact the treatment landscape for urothelial cancer.

Astellas Pharma and Seagen have completed patient enrollment in Cohort K of the EV-103 clinical trial, testing PADCEV in combination with KEYTRUDA against metastatic urothelial cancer. This phase 1b/2 trial focuses on patients unable to receive cisplatin-based chemotherapy. The FDA granted Breakthrough Therapy designation for this combination in February 2020. Positive trial results may lead to an accelerated approval application to the FDA. Urothelial cancer comprises a significant portion of bladder cancer cases, with an estimated 83,730 diagnoses in the U.S. in 2021.

Seagen Inc. (Nasdaq: SGEN) will report its Q3 2021 financial results on October 28, 2021, after U.S. market close. A conference call will follow at 4:30 p.m. ET to discuss the results and provide a business update. Interested participants can join via telephone or webcast, with access details provided in the release. Seagen, a biotechnology company focused on cancer treatments, operates from Seattle, Washington, with additional locations in California, Canada, Switzerland, and the European Union.

Seagen has completed patient enrollment for the Phase 2 MOUNTAINEER clinical trial, assessing TUKYSA® (tucatinib) in HER2-positive metastatic colorectal cancer patients. This trial aims to support an accelerated approval application in the U.S. Early results show promising anti-tumor activity and a favorable safety profile. The trial involves 117 patients and focuses on the objective response rate and various survival metrics, addressing a critical unmet medical need.

Enfortumab vedotin has received approval in Japan for patients with advanced urothelial carcinoma that cannot be surgically removed. The approval by Japan's MHLW follows a priority review and is mainly based on the global Phase 3 EV-301 clinical trial. In the trial, patients treated with enfortumab vedotin showed a median overall survival of 12.9 months, compared to 9.0 months for those receiving chemotherapy, indicating improved outcomes. This ADC targets Nectin-4, a protein commonly found in bladder cancer cells, addressing a significant unmet medical need in the region.

Astellas Pharma and Seagen announced on Sept. 27, 2021 that Japan's Ministry of Health, Labour and Welfare has approved PADCEV (enfortumab vedotin) for treatment of radically unresectable urothelial carcinoma post-chemotherapy. The approval followed a six-month priority review based on the Phase 3 EV-301 trial, which showed a median overall survival of 12.9 months for PADCEV versus 9.0 months for chemotherapy. This treatment addresses a significant need, as over 24,300 bladder cancer cases are diagnosed annually in Japan, with about 9,500 deaths.

Seagen Inc. (NASDAQ: SGEN) will hold a conference call on September 21, 2021, at 6:00 a.m. PT to discuss the FDA approval of TIVDAK™ (tisotumab vedotin-tftv). Investors can access the call via telephone at 844-763-8274 in the U.S. or +1 412-717-9224 internationally, using conference ID 10160278. A webcast will also be available on the Seagen website, featuring slides and a replay. Seagen, based in Seattle, Washington, focuses on developing transformative cancer therapies.

The FDA has granted accelerated approval to TIVDAK (tisotumab vedotin-tftv), the first antibody-drug conjugate for adult patients with recurrent or metastatic cervical cancer after chemotherapy. This decision is based on the innovaTV 204 clinical trial, which showed a 24% confirmed objective response rate and a median duration of response of 8.3 months. However, continuous approval is contingent on further verification of clinical benefits. The drug carries significant safety warnings, including ocular toxicity.

TIVDAK (tisotumab vedotin-tftv) has received accelerated approval from the FDA as the first approved antibody-drug conjugate for adults with recurrent or metastatic cervical cancer after chemotherapy. This decision is based on tumor response and its duration, with ongoing trials for further verification. The innovaTV 204 trial showed a confirmed objective response rate of 24% among 101 patients, with a median duration of response of 8.3 months. The approval includes warnings for serious adverse effects, particularly ocular toxicity.