...ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

Primary analysis, 267 patients received treatment across seven tumor cohorts: endometrial, cervical, ovarian, bladder, biliary tract, pancreatic, and other. Median follow-up was 12.75 months. In all patients: ORR, 37.1% (n=99; 95% CI, 31.3-43.2) with responses in all cohorts; median DOR, 11.3 months (95% CI, 9.6-17.8); median PFS, 6.9 months (95% CI, 5.6-8.0); median OS, 13.4 months (95% CI, 11.9-15.5)...Our study demonstrates durable clinical benefit, meaningful survival outcomes, and safety consistent with the known profile (including ILD) in pre-treated patients with HER2-expressing tumors receiving T-DXd.

In addition to NSCLC and colorectal cancer, responses were also observed across a number of other tumor types, including HER2-expressing or HER2-amplified salivary gland cancer, biliary tract cancer, and endometrial cancer, and HER2-mutant nonamplified breast cancer (Fig. 3). In this group, the ORR was 6 of 22 (27.3%) and the median DoR was not reached (95% CI, 3.0–not reached). The median PFS was 11.0 months (95% CI, 2.8–NE; Table 3).