Icon depicting a tumor In a woman's breast

ENHERTU monotherapy: the antibody-drug conjugate with demonstrated durable response.1,2 Click on each data point to take a closer look:

60.3% confirmed ORR
(n=111/184; 95% CI: 52.9,
67.4) = 4.3% CR (n=8) +
56.0% PR (n=103)a

14.8-month mDOR
(n=111; 95% CI: 13.8, 16.9)b

16.4-month mPFS
(N=184; 95% CI: 12.7, NR)c

  • Median overall survival had not been reached at median follow-up of 11.1 months (data cutoff August 1, 2019)2
  • ENHERTU received accelerated approval from FDA based on tumor response rate and duration of response. FDA has not reviewed the PFS and OS data. Multiple confirmatory Phase 3 studies are underway3
ENHERTU was assessed in a single-arm trial of 184 females with HER2+ unresectable and/or mBC who had received ≥2 prior anti-HER2 therapies. Patients received ENHERTU 5.4 mg/kg IV once every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was confirmed ORR assessed by ICR using RECIST v1.1. Secondary endpoints included OS, DOR, PFS, CBR, DCR, and best percent change from baseline in sum of diameters of target lesions by ICR.1,2

aORR (CR+PR) in ITT population.1,2 bDOR based on a median duration of follow-up of 11.1 months. Median DOR based on Kaplan-Meier estimate.1 cBased upon median duration of follow-up of 11.1 months at data cutoff date of August 1, 2019.2

CBR, clinical benefit rate; CI, confidence interval; CR, complete response; DCR, disease control rate; DOR, duration of response; FDA, Food and Drug Administration; HER2, human epidermal growth factor receptor 2; ICR, independent central review; ITT, intent-to-treat; IV, intravenous; mBC, metastatic breast cancer; mDOR, median duration of response; mPFS, median progression-free survival; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.

Indication

ENHERTU is a HER2-directed
antibody and topoisomerase inhibitor
conjugate indicated for the treatment
of adult patients with unresectable
or metastatic HER2-positive breast
cancer who have received two or more
prior anti-HER2-based regimens in the
metastatic setting.

This indication is approved under
accelerated approval based on tumor
response rate and duration of response.
Continued approval for this indication
may be contingent upon verification
and description of clinical benefit in a
confirmatory trial.

Please click here for full Prescribing Information, including Boxed WARNINGS, and click here for Medication Guide.

aORR (CR+PR) in ITT population.1,2 bDOR based on a median duration of follow-up of 11.1 months. Median DOR based on Kaplan-Meier estimate.1 cBased upon median duration of follow-up of 11.1 months at data cutoff date of August 1, 2019.2

CBR, clinical benefit rate; CI, confidence interval; CR, complete response; DCR, disease control rate; DOR, duration of response; FDA, Food and Drug Administration; HER2, human epidermal growth factor receptor 2; ICR, independent central review; ITT, intent-to-treat; IV, intravenous; mBC, metastatic breast cancer; mDOR, median duration of response; mPFS, median progression-free survival; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.