Roche withdraws Tecentriq combo application in first-line renal cell carcinoma
The EMA has revealed that Roche has chosen to withdraw its marketing application for immunotherapy Tecentriq (atezolizumab) in combination with Genentech’s Avastin (bevacizumab) as a first-line treatment for renal cell carcinoma (RCC) due to insufficient data.
Specifically, Roche pulled the application because study findings on the drug combo’s efficacy “are not sufficient to support an extension of indication at this time,” it said. The company was seeking approval for the Tecentriq combination in the treatment of locally advanced of metastatic RCC in tumours with a PD-L1 expression of at least 1%.
Data submitted with the original application demonstrated that Tecentriq plus Avastin reduced the risk of disease progression or death by 26% compared to Pfizer’s Sutent (sunitinib) when used in the first-line against advanced or metastatic RCC. However, overall survival data was too immature at the time of submission, though Roche called them “encouraging”, and
Roche’s decision comes just before the agency’s expert panel, the Committee for Medicinal Products for Human Use (CHMP), was able to come to a recommendation on whether to approve the combo.
“We are waiting for the data to mature,” said the company. “We believe that the combination of Tecentriq and Avastin may play a role in the treatment of metastatic RCC [which] remains an area of high unmet medical need.”
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