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
*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 4
Additional ARs reported in IMpassion130
Additional ARs and treatment discontinuation rates 2-4
- ARs led to discontinuation of TECENTRIQ or placebo in 6% vs 1% of patients, respectively
- 15.9% of patients in the TECENTRIQ + nab-pac arm discontinued treatment due to ARs vs 8.2% of patients in the placebo + nab-pac arm
- ARs leading to interruption of TECENTRIQ occurred in 31%
of patients. The most common (≥2%) were neutropenia, neutrophil
count decreased, hyperthyroidism, and pyrexia
- Serious ARs occurred in 23% (103/452) of patients. The most frequent were pneumonia (2%), urinary tract infection (1%), dyspnea (1%), and pyrexia (1%)
- 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
- 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
Most common ARs
- The most common ARs (≥20%)
in patients receiving TECENTRIQ with nab-pac were alopecia (56%),
peripheral neuropathies (47%), fatigue (47%), nausea (46%), diarrhea
(33%), anemia (28%), constipation (25%), cough (25%), headache
(23%), neutropenia (21%), vomiting (20%), and decreased appetite
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.