FDA approves Datroway for advanced breast cancer
Key takeaways:
- The FDA approved datopotamab deruxtecan-dlnk for treatment of certain patients with advanced breast cancer.
- The agent improved PFS but not OS vs. investigator’s choice of chemotherapy.
The FDA approved datopotamab deruxtecan-dlnk for treatment of certain patients with advanced breast cancer.
The indication applies to use of the agent by adults with hormone receptor-positive, HER2-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
Datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) is a Trop-2-directed antibody-drug conjugate.
The FDA based approval on results of the randomized phase 3 TROPION-Breast01 trial, which included 732 adults with inoperable or metastatic hormone receptor-positive, HER2-low or HER2-negative breast cancer whose disease progressed on endocrine-based therapy. All participants had been deemed unsuitable for additional endocrine therapy and had received one or two lines of prior chemotherapy for unresectable or metastatic disease.
Exclusion criteria included history of or ongoing interstitial lung disease or pneumonitis, clinically active brain metastases, clinically significant corneal disease or ECOG performance status greater than 1.
Researchers assigned 365 patients to datopotamab deruxtecan. The other 367 received investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine).
PFS assessed by independent central review committee and OS served as dual primary endpoints. Key secondary endpoints included objective response rate, duration of response, investigator-assessed PFS, disease control rate and time to first subsequent therapy.
Results showed improved PFS (median, 6.9 months vs. 4.9 months; HR = 0.63; 95% CI, 0.52-0.76) in the datopotamab deruxtecan-dlnk group. The difference in OS did not reach statistical significance (median, 18.6 months vs. 18.3 months; HR = 1.01; 95% CI, 0.83-1.22).
Confirmed ORR (36% vs. 23%) and median duration of response (6.7 months vs. 5.7 months) favored datopotamab deruxtecan-dlnk.
The most common adverse reactions in the datopotamab deruxtecan-dlnk group included stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, keratitis, and increased alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase.