By: Victoria Forster, PhD From: cancertherapyadvisor.com On September 8, 2020, the US Food and Drug Administration (FDA) issued an alert regarding the IMpassion131 trial (ClinicalTrials.gov Identifier: NCT03125902), citing efficacy and potential safety concerns.1 The trial which aimed to recruit 600 patients was testing the combination of atezolizumab and paclitaxel in patients with advanced or metastatic triple-negative metastatic breast cancer (mTNBC). …
FDA Issues Alert Regarding Efficacy and Safety of Atezolizumab/Paclitaxel in Breast Cancer
By: Kristi Rosa From: onclive.com The FDA has issued an alert that the phase 3 IMpassion131 trial failed to show the effectiveness of atezolizumab plus paclitaxel in treatment-naïve patients with inoperable locally advanced or metastatic triple-negative breast cancer. The FDA has issued an alert to professionals, investigators, and patients that the phase 3 IMpassion131 trial (NCT03125902) failed to show the …
Adjuvant I/O in TNBC
Insights: Sara M. Tolaney, MD, MPH From: onclive.com Very recently, we’ve seen some exciting data that came out from KEYNOTE-522, which looked at a preoperative trial of adding pembrolizumab to chemotherapy in patients with triple-negative breast cancer. In this trial, patients received chemotherapy with anthracycline, Cytoxan, taxane, and platinum and then were randomized to receive that chemo [chemotherapy] backbone with …