FDA Warns Against Roche’s Tecentriq Combined with Paclitaxel for Triple-Negative Breast Cancer Following IMpassion131 Trial Failure

Compiled by Rainbow

On Tuesday, the FDA issued a warning to the public that the Phase III IMpassion131 clinical trial evaluating Roche’s anti-PD-L1 therapy Tecentriq (atezolizumab) in combination with chemotherapy (paclitaxel) as first-line treatment for metastatic triple-negative breast cancer (TNBC) had previously been announced as a failure, and cautioned physicians against using this regimen in clinical practice.

IMpassion131 is a multicenter, randomized, double-blind study conducted in patients with previously untreated, unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) to evaluate the efficacy and safety of Tecentriq plus paclitaxel versus placebo plus paclitaxel. In this study, 651 patients were randomized in a 2:1 ratio to receive either Tecentriq plus paclitaxel or placebo plus paclitaxel. The primary endpoint was progression-free survival (PFS) in the PD-L1-positive population, followed by PFS in the intention-to-treat (ITT) population. Secondary endpoints included overall survival (OS), objective response rate (ORR), and duration of response (DOR) in both the PD-L1-positive and ITT populations.

However, in the IMpassion131 clinical study results, among the PD-L1-positive patient population, the Tecentriq plus paclitaxel regimen did not achieve statistical significance for the primary endpoint of progression-free survival (PFS) compared to placebo plus paclitaxel. Data for the secondary endpoint of overall survival (OS) showed a negative trend and were immature at the time of analysis.

In fact, as early as March 2019, Genentech, a member of the Roche Group, announced that Tecentriq had received accelerated approval from the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The FDA stated that this approval was primarily based on the demonstrated clinical benefit of this regimen in the Phase III IMpassion130 trial.

In the Phase 3 IMpassion130 trial, patients with triple-negative breast cancer (TNBC) were randomized into two groups: one received Tecentriq (840 mg infused on Days 1 and 15 of each 28-day cycle) plus paclitaxel (100 mg/m² infused on Days 1, 8, and 15 of each 28-day cycle), while the other received placebo plus paclitaxel. The trial results demonstrated that the combination of Tecentriq and paclitaxel reduced the risk of disease progression and death by 40% compared to the control group.

In light of the recent trial failure, the FDA stated that it would review the trial results and subsequently issue updates to the prescribing information for Tecentriq. Roche declined to comment on whether this trial failure would impact the approved indication for Tecentriq in triple-negative breast cancer (TNBC), stating only that it would actively engage in discussions with the FDA.

Reference Source: FDA Puts Roche’s Tecentriq Under the Lens in Breast Cancer After Recent Trial Flop