12:50 PM
Dec 05, 2018
 |  BC Extra  |  Company News

Tecentriq could be first front-line SCLC therapy approved in two decades

FDA accepted and granted Priority Review to an sBLA from Genentech Inc. for anti-PD-L1 mAb Tecentriq atezolizumab as first-line treatment of extensive-stage small cell lung cancer. Its PDUFA date is March 18, 2019.

Genentech CMO and Head of Global Product Development Sandra Horning said in a statement that Tecentriq could be the first drug approved in more than 20 years for the indication.

In September, Genentech reported that first-line treatment with Tecentriq plus chemotherapy led to a two-month overall survival (OS) benefit over chemotherapy alone in the Phase III IMpower133 trial to treat extensive-stage SCLC. The combination did not show an overall response rate (ORR) benefit (see "Genentech's Immunotherapy Improves Survival by Two Months in First-Line SCLC").

At least two other checkpoint inhibitors are in late-stage testing for first-line treatment of extensive-stage SCLC. PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) is in the Phase III KEYNOTE-604 trial, and PD-L1 inhibitor Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) is in the Phase III CASPIAN trial. According to ClinicalTrials.gov, the estimated primary completion dates for KEYNOTE-604 and CASPIAN are in January 2019 and September 2019, respectively.

Tecentriq is approved in the U.S. and EU to treat metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed during or following platinum-containing chemotherapy, and for locally advanced or metastatic urothelial carcinoma.

Genentech is a unit of Roche (SIX:ROG; OTCQX:RHHBY).

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