NCCN
RECOMMENDED
Fam-trastuzumab deruxtecan-nxki (ENHERTU®):
THE ONLY PREFERRED 2L+ ANTI-HER2 TREATMENT OPTION (CATEGORY 2A)2,3,b THE ONLY PREFERRED 2L+ ANTI-HER2 TREATMENT OPTION (CATEGORY 2A)2,3,a

Based on data from DESTINY-Gastric01,

Based on data from DESTINY-Gastric01,

ENHERTU is the first and only HER2-directed treatment to surpass 1 year mOS in aGC following progression on a trastuzumab-based regimen1,4-6

ENHERTU is the first and only HER2-directed treatment to surpass 1 year mOS in aGC following progression on a trastuzumab-based regimen1,4-6

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,b
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 weeksc 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.1,4

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.

ENHERTU has serious Warnings and Precautions. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

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.4

bFam-trastuzumab deruxtecan-nxki (ENHERTU®) is recommended (Category 2A) as a preferred 2L or subsequent therapy for HER2 overexpression positive gastric or gastroesophageal junction adenocarcinoma, where local therapy is not indicated for unresectable locally advanced, recurrent or metastatic disease. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. For detailed recommendations, see the NCCN Guidelines® for Gastric Cancer and for Esophageal and Esophagogastric Junction Cancers at NCCN.org.2,3

cPatients 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

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; IV, intravenous; mOS, median overall survival; NCCN, National Comprehensive Cancer Network® (NCCN®); ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.

aFam-trastuzumab deruxtecan-nxki (ENHERTU®) is recommended (Category 2A) as a preferred 2L or subsequent therapy for HER2 overexpression positive gastric or gastroesophageal junction adenocarcinoma, where local therapy is not indicated for unresectable locally advanced, recurrent or metastatic disease. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. For detailed recommendations, see the NCCN Guidelines® for Gastric Cancer and for Esophageal and Esophagogastric Junction Cancers at NCCN.org.2,3

bConfirmed 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.4

cPatients 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

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; IV, intravenous; mOS, median overall survival; NCCN, National Comprehensive Cancer Network® (NCCN®); ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.