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Urothelial cancer: EMA restricts use of Keytruda and Tecentriq


Early data from two clinical trials have shown 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 have indicated 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.

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.

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

Preliminary data from Keynote-361 and IMvigor130 have shown a reduced survival with Keytruda and Tecentriq compared with chemotherapy in patients with locally advanced or metastatic urothelial cancer who have not received prior therapy and whose tumours have low expressions of PD-L1.

Based on the data from the trials, which are still ongoing, the urothelial cancer indications for Keytruda and Tecentriq are being revised as follows:

Keytruda - Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior Platinum-containing chemotherapy.
Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for Cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score ( CPS ) greater than or equal to 10.

Tecentriq - Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma: after prior Platinum‑containing chemotherapy, or who are considered Cisplatin ineligible, and whose tumours have a PD-L1 expression greater than or equal to 5%.

There are no changes to the use of Keytruda or Tecentriq in patients who have had chemotherapy for urothelial cancers or in patients with other cancers for which these medicines are approved.

Keytruda is authorised in the European Union ( EU ) for urothelial cancer, melanoma, non-small cell lung cancer and classical Hodgkin lymphoma; Tecentriq is authorised for urothelial cancer and non‑small cell lung cancer.

Some cancer cells have a protein ( PD-L1 ) which can attach to a receptor on immune cells ( PD-1 ) and stop the immune cells from attacking them.
Keytruda and Tecentriq work in different ways to stop the cancer from disabling the immune cells: Keytruda by targeting PD-1 on immune cells and Tecentriq by targeting PD-L1 on the cancer cells. ( Xagena )

Source: EMA, 2018

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