FDA Warns of Decreased Survival in Some Patients Treated with Keytruda, Tecentriq Monotherapy


Officials with the FDA alerted health care professionals about reduced efficacy for some patients taking pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for metastatic urothelial cancer in ongoing clinical trials.

Officials with the FDA are warning about decreased survival associated with the use of cancer immunotherapies pembrolizumab (Keytruda) and atezolizumab (Tecentriq) in ongoing clinical trials, according to a safety announcement.

The use of these 2 treatments as a monotherapy in clinical trials have been associated with decreased efficacy in clinical trials among patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1), according to the FDA.

The warning is based on the findings from 2 ongoing clinical trials, KEYNOTE-361 and IMVIGOR-130, which show patients in the monotherapy arms with low PD-L1 status had decreased survival compared with patients who received cisplatin- or carboplatin-based chemotherapy.

According to the FDA, the manufacturers have stopped enrolling patients whose tumors have PD-L1 low status to the monotherapy arms. The monotherapy arms of the trials remain open only to patients whose tumors have PD-L1 high status. The combination arms and the chemotherapy arms also remain open.

Pembrolizumab and atezolizumab are both currently under accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin-containing chemotherapy, irrespective of PD-L1 status.

FDA officials also noted that the populations enrolled in the ongoing clinical trials were eligible for platinum-containing chemotherapy and differ from those enrolled in the trials that led to the accelerated approvals of both drugs.

Additionally, the agency recommends that health care providers select patients for the treatment of locally advanced or metastatic urothelial cancer using the criteria described in Section 14 of each label.

In addition, pembrolizumab is being evaluated as first-line monotherapy treatment of locally advanced or metastatic non-small cell lung cancer. Positive results from the pivotal phase 3 KEYNOTE-042 trial were announced in April 2018. Atezolizumab plus chemotherapy is also currently

being explored as a monotherapy and combination therapy in 8 lung cancer trials, with recent positive findings from the

phase 3 IMpower 131 clinical trial.


FDA Alerts Health Care Professionals and Oncology Clinical Investigators about an Efficacy Issue Identified in Clinical Trials for Some Patients Taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as Monotherapy to Treat Urothelial Cancer with Low Expression of PD-L1 [safety announcement]. FDA’s website. https://www.fda.gov/Drugs/DrugSafety/ucm608075.htm. Accessed May 21, 2018.

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