Results

Gaining steam in PD-1/L1 race, Roche reports positive PhIII OS data on Tecentriq combo in NSCLC

Roche trotted out some early OS data Monday morning from its combo study of Tecentriq in lung cancer, reporting that the combo met its co-primary endpoint and helped patients live longer.

The data will back up the company’s upcoming bid for approval of the drug combo as a front-line therapy, making Roche a stronger contender among rivals Bristol-Myers Squibb and Merck as the PD-1/L1 market leader war wages on.

Sandra Horning

Roche’s closely watched Phase III IMpower150 study of a triple combo of Tecentriq, Avastin and chemo showed a survival benefit “across key subgroups,” including those with varying levels of PD-L1 expression. Genentech, a member of the Roche group, said its combo helped patients live “significantly longer” than those taking Avastin plus carboplatin and paclitaxel.

“We are pleased that the IMpower150 study demonstrated a clinically meaningful survival benefit for people receiving their initial treatment for this type of advanced lung cancer,” said Sandra Horning, Genentech’s CMO and head of global product development, in a statement. “These results add to the growing body of evidence supporting the role of combining Tecentriq with Avastin. We will submit these additional data to global health authorities and hope to bring this potential treatment option to patients as soon as possible.”

While the combo with Tecentriq, Avastin, and chemo met its OS co-primary endpoint, the company noted that leaving out Avastin didn’t perform so well.

At this interim analysis, the study found that substituting Avastin with Tecentriq in the combination with carboplatin and paclitaxel did not show a statistically significant OS benefit in people with advanced NSCLC compared to a combination of Avastin plus carboplatin and paclitaxel. The study will continue as planned to the final analysis.

The new OS data comes after Roche reported out solid PFS data in December. The combo demonstrated a doubling in 12-month progression-free survival rates among a broad group of frontline lung cancer patients, setting the stage for a quick regulatory OK on both sides of the Atlantic. Comparing the triple against Avastin and chemo alone, researchers tracked a 38% reduction in the risk of disease progression, with the progression-free survival rate hitting 8.3 months for the triple against 6.8 months for the double. The hazard ratio (HR) was 0.62. In a subgroup of people defined by a biomarker (T-effector “Teff” gene signature expression Teff WT), the PFS hit an impressive 11.3 months for the triple.

Roche also reported out good news just days ago from the same combo in squamous NSCLC. At an interim point, that trial, called IMpower131, showed the combo beat out chemo on PFS with a statistically significant outcome but had yet to show an overall survival benefit.

IMpower150 is one of eight Phase III lung cancer studies underway at Genentech, evaluating Tecentriq alone or in combination with other medicines. Three more Phase III lung cancer studies are expected to report this year.

 


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