IMpassion130: The First Positive Phase III Trial for a Cancer Immunotherapy Combination in First-Line Metastatic Triple-Negative Breast Cancer 3

Multicenter, international, double-blind, randomized trial in patients who had not received prior chemotherapy for metastatic triple-negative breast cancer (mTNBC) 3

Patients received IV infusions of TECENTRIQ 840 mg or placebo on Days 1 and 15 and nab-pac 100 mg/m2 on Days 1, 8, and 15 as assigned for every 28-day cycle. This study included patients with ECOG PS of 0 or 1. Prior chemotherapy in the curative setting, including taxanes, was permitted if completed ≥12 months prior to randomization. This study excluded patients who had a history of autoimmune disease; administration of a live, attenuated vaccine within 4 weeks prior to randomization; administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomization; or untreated or corticosteroid-dependent brain metastases.

Coprimary endpoints 3
  • Progression-free survival* in ITT and PD-L1+ populations
  • Overall survival in ITT and PD-L1+ populations (testing of OS in PD-L1+ dependent on significance in ITT)

At this interim analysis, OS in ITT is immature and not statistically significant.

Select secondary efficacy endpoints 3
  • Objective response rate and duration of response in ITT and PD-L1+ populations*
Stratification factors included PD-L1 expression status,§ liver metastases, and prior taxane treatment 3
  • 41% of patients in IMpassion130 were PD-L1+ (n=369/902)
  • PD-L1+ was defined as PD-L1–stained tumor-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumor area

PFS results in the PD-L1+ population led to the accelerated approval of TECENTRIQ + nab-pac in PD-L1+ mTNBC 2

ECOG=Eastern Cooperative Oncology Group; ITT=intent to treat; IV=intravenous; nab-pac=nab-paclitaxel; OS=overall survival; PD-L1=programmed death-ligand 1; PFS=progression-free survival; PS=performance status; q8w=every 8 weeks; q12w=every 12 weeks; RECIST=Response Evaluation Criteria In Solid Tumors.
*Investigator assessed per RECIST v1.1.
Patients with measurable disease at baseline.
§PD-L1–stained IC <1% of tumor area vs ≥1% of tumor area, as determined by the VENTANA PD-L1 (SP142) Assay.

Baseline characteristics were well balanced between treatment arms

PD-L1+ population baseline characteristics 2,3
  • PD-L1+ population demographics and baseline disease characteristics were generally representative of the broader study population
    • 41% of patients in both treatment arms were PD-L1+ (n=185/451 for TECENTRIQ + nab-pac; n=184/451 for placebo + nab-pac)

Patients who received neoadjuvant or adjuvant chemotherapy completed treatment ≥12 months prior to randomization.

  • At baseline in the ITT population, median age was 55 years (range: 20-86), ECOG PS was 0 (58%) or 1 (41%), 100% of patients were female, 52% had lung metastases, 7% had brain metastases, 27% had liver metastases, and 51% had received prior taxane treatment and 54% prior anthracycline in the (neo)adjuvant setting