FDA sets June decision date for Tecentriq monotherapy in NSCLC

The US Food and Drug Administration has granted Roche’s Tecentriq a priority review as a first-line, monotherapy treatment in non-small cell lung cancer, a market which is dominated by rival checkpoint inhibitor Keytruda. 

Roche is seeking approval for Tecentriq (atezolizumab) as a first-line treatment for people with advanced non-squamous and squamous NSCLC, without EGFR or ALK mutations and high PD-L1 expression.

The application is based on results from the phase 3 IMpower110 study, which demonstrated that Tecentriq monotherapy improved overall survival by 7.1 months compared with chemotherapy, in people with high PD-L1 expression.

Roche also reported that Tecentriq’s safety profile remained consistent in the IMpower110 study, with no new safety signals identified.

Tecentriq also beat chemotherapy in terms of patients who experienced grade 3-4 treatment-related adverse events, with 12.9% of people treated with the PD-L1 inhibitor experiencing one compared to 44.1% of those receiving chemotherapy.

“In the IMpower110 study, Tecentriq alone demonstrated a significant improvement in overall survival compared with chemotherapy for people newly diagnosed with certain types of advanced non-small cell lung cancer,” said Levi Garraway, chief medical officer and head of global product development.

“We are working closely with the FDA to bring this chemotherapy-free option to these patients as quickly as possible,” he added.

Tecentriq is already approved in NSCLC, but not as a first-line monotherapy treatment. It is indicated for use in combination with chemotherapy and Roche’s older cancer antibody Avastin (bevacizumab) as a first-line treatment for non-squamous NSCLC.

The triple regimen was also approved by the European Commission as a second-line treatment after targeted therapy for patients whose tumours are EGFR mutated or ALK-positive.

In December, Roche also won approval for Tecentriq in combination with a chemotherapy regimen of Abraxane and carboplatin in NSCLC patients, whose cancer has metastasized and does not have EGFR or ALK mutations.

However, the NSCLC therapy area is dominated by Merck’s rival PD-1 inhibitor Keytruda (pembrolizumab), with revenues from this particular market helping the drug to achieve a blockbuster status.

Roche is not the only company looking to steal some of that success. Bristol-Myers Squibb’s own PD-1 inhibitor Opdivo (nivolumab) is currently under review with the FDA, in combination with low-dose CTLA4 inhibitor Yervoy (ipilimumab) in previously-untreated NSCLC patients without EGFR or ALK mutations.

A decision on BMS’ combination is due by the 15 May, a month before the agency makes its decision on the Tecentriq monotherapy, which is due by 19 June.