Adverse Reactions Were Consistent With the Known Safety Profiles of TECENTRIQ and Nab-Paclitaxel 2,3

Most adverse reactions (ARs) were grade 1 or 2 with TECENTRIQ + nab-paclitaxel (nab-pac) 2

ITT=intent to treat; PD-L1=programmed death-ligand 1.
*Incidence ≥10% in the TECENTRIQ + nab-pac arm, graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
Includes peripheral neuropathy, peripheral sensory neuropathy, paresthesia, and polyneuropathy.   

  • The safety profile of TECENTRIQ + nab-pac was generally consistent between the PD-L1+ and ITT populations 7

Additional ARs reported in IMpassion130

Additional ARs and treatment discontinuation rates 2,3,7
  • Six patients (1.3%) who were treated with TECENTRIQ + nab-pac experienced fatal ARs; these included septic shock, mucosal inflammation, auto-immune hepatitis, aspiration, pneumonia, and pulmonary embolism
  • Serious ARs occurred in 23% (103/452) of patients. The most frequent were pneumonia (2%), urinary tract infection (1%), dyspnea (1%), and pyrexia (1%) 
  • ARs led to discontinuation of TECENTRIQ or placebo in 6% vs 1% of patients, respectively
  • ARs leading to interruption of TECENTRIQ occurred in 31% of patients. The most common (≥2%) were neutropenia, neutrophil count decreased, hyperthyroidism, and pyrexia
  • Immune-related ARs requiring corticosteroid therapy occurred in 13% of patients in the TECENTRIQ + nab-pac arm vs 6% of patients in the placebo + nab-pac arm
Most common ARs 2,3
  • The most common ARs (rate ≥20%) and laboratory abnormalities (≥50%) in patients who received TECENTRIQ with nab-pac for mTNBC were decreased hemoglobin (79%), decreased leukocytes (76%), decreased neutrophils (58%), alopecia (56%), decreased lymphocytes (54%), peripheral neuropathies (47%), fatigue (47%), nausea (46%), diarrhea (33%), constipation (25%), cough (25%), headache (23%), vomiting (20%), and decreased appetite (20%)

Laboratory abnormalities worsening from baseline occurring in ≥20% of TECENTRIQ patients 2

ALT=alanine aminotransferase; AST=aspartate aminotransferase; INR=international normalized ratio.
Graded per NCI CTCAE v4.0, except for increased creatinine, which only includes patients with creatinine increase based on upper limit of normal definition for grade 1 events (NCI CTCAE v5.0).
§Based on the number of patients with available baseline and at least one on-treatment laboratory test.