Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Keytruda, Tecentriq Face Efficacy Questions In Urothelial Cancer

Executive Summary

Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.

You may also be interested in...



Bladder Cancer Accelerated Approvals: Merck’s Keytruda and Genentech’s Tecentriq Each May Have One Last Lifeline

US FDA will ask advisory committee whether data from the trial supporting full approval of Merck’s Keytruda for second-line setting can be used to confirm clinical benefits for earlier setting of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy following a failed confirmatory study. Genentech’s Tecentriq is also at risk of losing its accelerated approval in that space but it could buy some time as its confirmatory study is not yet complete. New competitor entrant since accelerated approvals also lessens degree of unmet need.

Bladder Cancer: Positive Signs For Tecentriq, Seattle Genetics Shines

Middling data for Roche’s IO plus chemo combo were presented at ESMO, while Seattle's rival drug antibody conjugate posted an impressive Phase I response rate.

Tecentriq Plus Chemo Data Could Re-Enforce Roche's Position In Bladder Cancer

Roche's PD-L1 inhibitor Tecentriq in combination with chemotherapy improved progression-free survival in first-line bladder cancer, after the immunotherapy failed a confirmatory trial as monotherapy.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS123146

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel