IMpower133: Landmark Study of TECENTRIQ + Carbo/Etop

Phase III multicenter, randomized, double-blind, placebo-controlled trial in patients who had received no prior chemotherapy for ES-SCLC 2,5

*Administration of TECENTRIQ was permitted beyond RECIST-defined disease progression.

During induction, patients were assigned to receive carboplatin AUC 5 mg/mL/min on Day 1 and etoposide 100 mg/m2 on Days 1 to 3 of each 21-day cycle for a maximum of 4 cycles, with either TECENTRIQ 1200 mg or placebo intravenously (IV) on Day 1 of each cycle. The induction phase was followed by a maintenance phase during which patients received either TECENTRIQ or placebo every 3 weeks until disease progression or unacceptable toxicity. Randomization was stratified by gender, ECOG PS, and the presence of brain metastases; analyses were stratified by gender and ECOG PS only. This study excluded patients who had active or untreated CNS metastases; history of autoimmune disease; administration of a live, attenuated vaccine within 4 weeks prior to randomization; or administration of systemic immunosuppressive medications within 1 week prior to randomization. Prophylactic cranial irradiation was permitted during maintenance phase, but thoracic radiation therapy was not.

Coprimary endpoints 2
  • Overall survival (OS)
  • Progression-free survival (PFS)
Select secondary efficacy endpoints 5
  • 12-month OS rate
  • Objective response rate (ORR)

Baseline characteristics were well balanced between treatment arms 5

PD-L1 testing is not required to prescribe TECENTRIQ for ES-SCLC 2

AUC=area under the concentration-time curve; carbo/etop=carboplatin/etoposide; CNS=central nervous system; ECOG=Eastern Cooperative Oncology Group; ES-SCLC=extensive-stage small cell lung cancer; PD-L1=programmed death-ligand 1; PS=performance score; q6w=every 6 weeks; q9w=every 9 weeks; RECIST=Response Evaluation Criteria In Solid Tumors.

As determined by investigator per RECIST v1.1.