IMpassion130 Efficacy Results in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer

Significantly improved progression-free survival (PFS) with TECENTRIQ + nab-paclitaxel (nab-pac)

40% reduced risk of disease progression or death with TECENTRIQ + nab-pac vs placebo + nab-pac 2

CI=confidence interval; HR=hazard ratio; NE=not estimable; PD-L1=programmed death-ligand 1.

  • 1-year PFS was 29% with TECENTRIQ + nab-pac vs 16% with placebo + nab-pac (not prespecified and not powered to demonstrate statistically significant differences) 3

Interim OS analysis in 1L PD-L1+ mTNBC 4

Important limitations
  • TECENTRIQ was approved under the accelerated (conditional) approval, based on PFS results, and there are no final survival data available at this point
  • OS in the PD-L1+ population was a coprimary endpoint in IMpassion130 that was dependent upon the OS results in the ITT population. Therefore, OS in the PD-L1+ population was not formally tested due to the statistical hierarchy plan
  • At the time of the second interim analysis, OS data were immature, with 59% deaths (80% of planned events) in the ITT population, and did not reach statistical significance. As a result, statistical significance for OS could not be determined in the PD-L1+ population
  • These data should not be interpreted to suggest the TECENTRIQ confers a survival benefit in this population
Interim OS data
  • OS results in the PD-L1+ population should be considered descriptive, and therefore exploratory
    • Kaplan-Meier analysis of immature data in the PD-L1+ population showed a median OS of 25 months in the TECENTRIQ + nab-pac arm and 18 months in the placebo + nab-pac arm (HR=0.71; 95% CI, 0.54, 0.94)
    • These results are subject to change as the data mature. Final survival data are not yet available

Test for PD-L1 to identify patients who could benefit from TECENTRIQ + nab-pac in 1L mTNBC.
The VENTANA PD-L1 (SP142) Assay is the only FDA-approved PD-L1 test to identify mTNBC patients who could benefit from TECENTRIQ + nab-pac, and was also the test used in the IMpassion130 trial. 2,5,6

Select Important Safety Information

Serious and sometimes fatal adverse reactions occurred with TECENTRIQ treatment. Warnings and precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis and renal dysfunction, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, increased mortality in mTNBC when used with paclitaxel, and embryo-fetal toxicity.
 

Please see below and the TECENTRIQ Prescribing Information for additional Important Safety Information.

TECENTRIQ + nab-pac: response achieved in more patients vs placebo + nab-pac

More than half of patients responded to TECENTRIQ + nab-pac 2*

1L=first-line; CR=complete response; DoR=duration of response; HSCT=hematopoietic stem cell transplantation; mTNBC=metastatic triple-negative breast cancer; ORR=objective response rate; PR=partial response.
*Confirmed responses in patients with measurable disease at baseline.

  • 9% of patients (17/185) had a complete response to TECENTRIQ + nab-pac vs <1% (1/183) with placebo + nab-pac
  • Median DoR was 9.2 months (95% CI, 7.5, 11.9) with TECENTRIQ + nab-pac vs 6.2 months (95% CI, 5.5, 8.8) with placebo + nab-pac

Lack of efficacy in combination with paclitaxel in locally advanced or metastatic TNBC 1

TECENTRIQ is not indicated for use in combination with paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic TNBC

  • In a study of 651 patients with mTNBC, an increase in the risk of death (HR=1.11) was observed in patients treated with TECENTRIQ + paclitaxel compared with placebo + paclitaxel in the PD-L1+ population