Data show lower survival in some patients with low levels of cancer protein PD-L1

Early data from two clinical trials show reduced survival with Keytruda (pembrolizumab) and Tecentriq (atezolizumab) when used as first-line treatments for urothelial cancer (cancer of the bladder and urinary tract) in patients with low levels of a protein called PD-L1. The data indicate that Keytruda and Tecentriq may not work as well as chemotherapy medicines in this group of patients.

As a result, the European Medicines Agency (EMA) has recommended restricting the use of these medicines as first line-treatments for urothelial cancer.

Keytruda and Tecentriq should now only be used for first-line treatment of urothelial cancer in patients with high levels of PD-L1 (see full indications below).

There are no changes to how these medicines should be used in patients with urothelial cancer who have had chemotherapy or in patients with other cancers for which these medicines are approved.

The two clinical trials are continuing but no new patients with low levels of PD-L1 will be given only Keytruda or Tecentriq. Patients in the trials who have any questions should speak to the doctor treating them.

The review of data on Keytruda and Tecentriq was carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP).

Posted on the EMA website on 1 June 2018