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Based on data from DESTINY-Gastric01,

ENHERTU is the first and only HER2-directed treatment to surpass 1 year median overall survival in aGC following a trastuzumab-based regimen1-4

ENHERTU is the first and only HER2-directed treatment to surpass 1 year median overall survival in aGC following a trastuzumab-based regimen1-4

ENHERTU
12.5 months mOS
(95% CI: 9.6, 14.3)
HR=0.59 (95% CI: 0.39, 0.88); P=0.00971

Irinotecan or paclitaxel
8.4 months mOS
(95% CI: 6.9, 10.7)

 

ENHERTU
40.5% confirmed ORR

(n=51/126; 95% CI: 31.8, 49.6)

7.9% CR (n=10)
32.5% PR (n=41)

P<0.00011,a
Irinotecan or paclitaxel

11.3% confirmed ORR
(n=7/62; 95% CI: 4.7, 21.9)
0% CR
11.3% PR (n=7)

DESTINY-Gastric01: A multicenter, open-label, randomized, Phase 2 trial in Japan/South Korea of 188 adult patients with HER2+ locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who had progressed on ≥2 prior regimens, including trastuzumab, a fluoropyrimidine- and a platinum-containing chemotherapy regimen. Patients in the ENHERTU arm received 6.4 mg/kg IV once every 3 weeksb until unacceptable toxicity or disease progression. The major efficacy outcomes were ORR assessed by ICR according to RECIST v1.1 and OS. Additional efficacy outcomes were PFS and DOR.1,2

GRANTED BREAKTHROUGH THERAPY DESIGNATION BY FDA5

The most common (≥20%) adverse reactions, including laboratory abnormalities, were1:

  • Hemoglobin decreased, white blood cell count decreased, neutrophil count decreased, lymphocyte count decreased, platelet count decreased, nausea, decreased appetite, anemia, aspartate aminotransferase increased, fatigue, blood alkaline phosphatase increased, alanine aminotransferase increased, diarrhea, hypokalemia, vomiting, constipation, blood bilirubin increased, pyrexia, and alopecia

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

The most common (≥20%) adverse reactions, including laboratory abnormalities, were1:

  • Hemoglobin decreased, white blood cell count decreased, neutrophil count decreased, lymphocyte count decreased, platelet count decreased, nausea, decreased appetite, anemia, aspartate aminotransferase increased, fatigue, blood alkaline phosphatase increased, alanine aminotransferase increased, diarrhea, hypokalemia, vomiting, constipation, blood bilirubin increased, pyrexia, and alopecia
Important Safety Information

Indication ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

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

2L, second-line; aGC, advanced gastric cancer; CI, confidence interval; CR, complete response; DOR, duration of response; GEJ, gastroesophageal junction; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; ICR, independent central review; mOS, median overall survival; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.

aConfirmed ORR was defined as a response (CR+PR according to RECIST v1.1) as confirmed on a follow-up scan ≥4 weeks after an initial response as designated by ICR.2

bPatients in the chemotherapy arm received either irinotecan monotherapy 150 mg/m2 IV every 2 weeks or paclitaxel monotherapy 80 mg/m2 IV weekly for 3 weeks.1