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Seagen, Astellas Data Support Broader Indication For Padcev/Keytruda Combo

Data May Facilitate Closing Of Pfizer Merger

 
• By Joseph Haas

With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval.

Antibody-drug conjugate
Seagen/Astellas's Padcev might now be appropriate treatment in more bladder cancer patients • Source: Shutterstock

Seagen Inc. and Astellas Pharma, Inc.’s antibody-drug conjugate Padcev met both overall and progression-free survival endpoints in a top-line readout from the Phase III EV-302/KEYNOTE-A39 trial testing the ADC in combination with Merck & Co., Inc.’s anti-PD-1 stalwart Keytruda, results that analysts said could increase Padcev’s addressable market in urothelial cancer to the $5bn range and de-risk the expected close of Seagen’s merger with Pfizer Inc.

Although the companies did not provide numerical data, saying full details will be disclosed at an upcoming medical conference, the Padcev/Keytruda regimen tested against chemotherapy hit the OS and PFS endpoints in patients with previously untreated, locally advanced or metastatic urothelial cancer

Key Takeaways

  • Seagen and Astellas unveiled data that may lead to a full approval for the combination of Padcev and Keytruda in advanced urothelial cancer.

  • Study met endpoints for overall and progression-free survival at interim data look

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