The approval was based on data from 3 clinical trials: DESTINY-PanTumor02 (ClinicalTrials.gov Identifier:
NCT04482309), DESTINY-Lung01 (ClinicalTrials.gov Identifier:
NCT03505710), and DESTINY-CRC02 (ClinicalTrials.gov Identifier:
NCT04744831). The study population included 192 adults with previously treated unresectable or metastatic HER2-positive (IHC3+) solid tumors. The primary endpoint was confirmed objective response rate (ORR).
DESTINY-PanTumor02 included 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. DESTINY-Lung01 and DESTINY-CRC02 included patients with non-small cell lung cancer and colorectal cancer, respectively.
The following efficacy results were reported across the 3 trials:
- DESTINY-PanTumor02: ORR was 51.4% (95% CI, 41.7-61.0); median duration of response (DOR) was 19.4 months (range 1.3, 27.9+).
- DESTINY-Lung01: ORR was 52.9% (95% CI, 27.8-77.0); median DOR was 6.9 months (range 4.0, 11.7+).
- DESTINY-CRC02: ORR was 46.9% (95% CI, 34.3-59.8); DOR was 5.5 months (range 1.3+, 9.7+).
The most common adverse reactions included decreased white blood cell count, nausea, decreased hemoglobin, decreased neutrophil count, fatigue, decreased lymphocyte count, decreased platelet count, increased aspartate aminotransferase, increased alanine aminotransferase, increased blood alkaline phosphatase, vomiting, decreased appetite, alopecia, diarrhea, decreased blood potassium, constipation, decreased sodium, stomatitis, and upper respiratory tract infection.