Dr. Rimawi on the Promise of the HER2CLIMB-02 Trial in HER2+ Breast Cancer

Mothaffar Fahed Rimawi, MD, professor, Department of Medicine, Section of Hematology and Oncology, executive medical director, associate director of clinical affairs, co-leader, Breast Cancer Program, chief of oncology service line, Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, discusses the promise of the phase 3 HER2CLIMB-02 trial (NCT03975647) in HER2-positive metastatic breast cancer.

The results of the phase 3 DESTINY-Breast03 trial (NCT03529110) demonstrated that fam-trastuzumab deruxtecan-nxki (Enhertu) improved progression-free survival vs ado-trastuzumab emtansine (T-DM1; Kadcyla) in patients with metastatic HER2-positive breast cancer, indicating that trastuzumab deruxtecan is a valid second-line option for this patient population.

Tucatinib (Tukysa) is also being evaluated in the second-line metastatic setting in combination with T-DM1 vs T-DM1 plus placebo in the ongoing phase 3 HER2CLIMB-02 trial (NCT03975647) for patients with advanced or metastatic HER2-positive breast cancer, Rimawi explains.

The data will show what efficacy tucatinib plus T-DM1 has in the second-line setting, Rimawi says. Moreover, it will be interesting to see whether the regimen has efficacy across subgroups, particularly in patients with central nervous system metastases where tucatinib has demonstrated significant activity. If the study yields positive results, sequencing questions with T-DM1 will need to be answered, Rimawi concludes.