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Seagen Inc. (Nasdaq:SGEN) reported strong financial results for Q3 and the first nine months of 2020, with revenues reaching $1.1 billion and $1.6 billion, respectively, compared to $213.3 million and $626.9 million in 2019.
This growth was driven by product sales of ADCETRIS, PADCEV, and TUKYSA, along with significant collaborations with Merck, yielding $725 million in upfront license revenue. Net income for Q3 was $636.2 million, or $3.50 per diluted share, a notable turnaround from a loss in Q3 2019. Seagen's cash and investments total $1.7 billion, facilitating continued pipeline development.
Astellas and Seagen announced positive topline results from the second cohort of the pivotal phase 2 EV-201 clinical trial for PADCEV (enfortumab vedotin-ejfv), targeting patients with advanced urothelial cancer. The trial showed an impressive 52% objective response rate and a median duration of response lasting 10.9 months. These findings may support regulatory discussions for expanding PADCEV’s use in patients previously treated with PD-1/L1 inhibitors and ineligible for cisplatin. Adverse events were reported, including neutropenia and rash, but the overall response appears promising.
Astellas Pharma and Seagen announced promising topline results from the second cohort of their pivotal phase 2 clinical trial (EV-201) for PADCEV (enfortumab vedotin-ejfv), aimed at treating advanced urothelial cancer. The study reported a 52% objective response rate and a median duration of response of 10.9 months among patients previously treated with a PD-1/L1 inhibitor and ineligible for cisplatin. The trial's findings will be submitted for discussion with regulatory authorities and presentation at scientific congresses, indicating potential for extended approval of PADCEV in the U.S.
Astellas Pharma and Seattle Genetics announced positive results from a phase 3 trial of PADCEV® (enfortumab vedotin-ejfv) for patients with advanced urothelial cancer. The trial demonstrated a significant 30% reduction in the risk of death (Hazard Ratio [HR]=0.70; p=0.001) compared to chemotherapy, meeting its primary endpoint of overall survival. Additionally, there was a 39% reduction in the risk of disease progression or death (HR=0.61; p<0.00001). Data will be submitted to the FDA as a confirmatory trial. The results are anticipated for presentation at an upcoming scientific congress.
Astellas Pharma and Seattle Genetics announced that their phase 3 trial of PADCEV (enfortumab vedotin-ejfv) achieved its primary endpoint, demonstrating a significant improvement in overall survival for patients with locally advanced or metastatic urothelial cancer compared to chemotherapy. Specifically, the trial showed a 30% reduction in the risk of death (HR=0.70; p=0.001) and a 39% reduction in the risk of disease progression (HR=0.61; p<0.00001). Results will be submitted to the FDA for confirmatory approval and are intended to support global registrations.