Overall Safety Was Consistent With the Established TECENTRIQ Safety Profile 2,5

Immune-related adverse reactions (ARs) reported in >1% of patients receiving TECENTRIQ + carbo/etop 5

ARs occurring in ≥20% of patients receiving TECENTRIQ + carbo/etop 2,5

*Immune-related ARs were defined using MedDRA Preferred Terms that included both diagnosed immune conditions and signs and symptoms potentially representative of immune-related reactions, regardless of investigator-assessed causality.
Graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
 

  • The most common grade 3-4 ARs (≥2%) were fatigue/asthenia (5%), febrile neutropenia (3.5%), pneumonia (3%), asthenia (2.5%), diarrhea (2%), and infusion-related reaction (2%)
  • TECENTRIQ was discontinued due to ARs in 11% of patients

Similar rate of serious adverse events reported with TECENTRIQ + carbo/etop (37%) vs placebo + carbo/etop (35%) 5

Additional ARs reported in IMpower133 2

  • Four patients (2%) who were treated with TECENTRIQ + carbo/etop experienced fatal ARs; these included pneumonia, respiratory failure, neutropenia, and death
  • ARs leading to interruption of TECENTRIQ occurred in 59% of patients
    • The most common (>1%) were neutropenia (22%), anemia (9%), leukopenia (7%), thrombocytopenia (5%), fatigue (4%), infusion-related reaction (3.5%), pneumonia (2%), febrile neutropenia (1.5%), increased ALT (1.5%), and nausea (1.5%)
  • Serious ARs occurred in 37% of patients treated with TECENTRIQ
    • The most frequent (>2%) were pneumonia (4.5%), neutropenia (3.5%), febrile neutropenia (2.5%), and thrombocytopenia (2.5%)
  • Of all grade laboratory abnormalities that worsened from baseline in ≥20% of patients receiving TECENTRIQ, grade 3 or 4 abnormalities with TECENTRIQ + carbo/etop vs placebo + carbo/etop included anemia (17% vs 19%), neutropenia (45% vs 48%), thrombocytopenia (20% vs 17%), lymphopenia (14% vs 11%), hyperglycemia (10% vs 8%), increased alkaline phosphatase (1% vs 2%), hyponatremia (15% vs 11%), hypoalbuminemia (1% vs 0%), hypomagnesemia (5% vs 6%), hypocalcemia (3% vs 5%), increased ALT (3% vs 1%), increased blood creatinine (4% vs 1%), and increased AST (1% vs 2%)†‡

ALT=alanine aminotransferase; AST=aspartate aminotransferase; carbo/etop=carboplatin/etoposide; MedDRA=Medical Dictionary for Regulatory Activities.

Each test incidence is based on the number of patients who had both baseline and at least 1 on-study laboratory measurement available: TECENTRIQ (range: 181-193); placebo (range: 181-196).