The US Food and Drug Administration (FDA) has alerted practitioners, investigators, and the public about the heightened health risk in patients with metastatic urothelial cancer taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as a monotherapy.
The monoclonal antibody (mAb) therapies – designed to bind with protein PD-L1 – are approved in the US for the treatment of locally advanced or metastatic urothelial carcinoma patients not eligible for cisplatin-containing chemotherapy.
Earlier this month, Roche received FDA priority review for a combination therapy of Tecentriq and Avastin (bevacizumab) to treat patients with metastatic non squamous non-small lung cancer.
Roche spokesperson Ulrike Engels-Lange told us the Switzerland-headquartered firm informed study investigators and sites of its intention to stop the Tecentriq trial on April 24.
“After an independent data monitoring committee (IDMC) review of IMvigor130 (Phase III study evaluating the efficacy of Tecentriq with or without chemotherapy in 1L mUC, including cisplatin-eligible and ineligible patients), the IDMC recommended to cease further enrolment of patients with PD-L1 IC0/1 tumours onto the Tecentriq monotherapy arm of the study,” she told us.
“No recommendation to changes in current treatment of patients on the monotherapy arm were made, and no new safety signals were identified,” she added.
Roche will continue to discuss the implications of the IDMC review with the FDA and the European Medicines Agency (EMA), we were told.
Merck & Co. (known as Merck Sharp & Dohme outside of North America) has similarly ceased patient enrolment in the Keytruda trial: “Merck takes the safety and efficacy of our medicines very seriously and will continue to work closely with the agencies as additional data are generated in the course of the trial,” the firm said in a statement.
Merck & Co.’s Keytruda has attracted increased regulatory attention over the past year.
In an FDA first, the Agency approved a Keytruda indication in May last year, based on a common biomarker, rather than the location in the body where the tumour developed in patients.
In June 2017, the firm paused two Ph III clinical trials designed to test Keytruda in combination with other therapies following reports of patient deaths.
Additionally, Merck & Co. in Februrary of this year announced plans to build a biologics facility in Ireland, which the company told us told us aims to support production of its immune-oncology portfolio, including Keytruda.