The Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
The approval was supported by data from the phase 3 KATHERINE study which evaluated the safety and efficacy of Kadcyla vs trastuzumab as an adjuvant therapy in 1486 patients with HER2-positive, early breast cancer. The primary endpoint of the study was invasive disease-free survival (IDFS), defined as the time from the date of randomization to first occurrence of ipsilateral invasive breast tumor recurrence, ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.
Results showed that after a median follow-up of 40 months, a statistically significant improvement in IDFS was observed in patients who received Kadcyla compared with trastuzumab (hazard ratio [HR] 0.50, 95% CI 0.39-0.64; P <.0001). In addition, at 3 years, 88.3% of the Kadcyla arm did not have a recurrence of breast cancer vs 77.0% of the trastuzumab group. With regard to safety, the most common adverse reactions associated with Kadcyla were fatigue, nausea, increased transaminases, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, peripheral neuropathy, and arthralgia.
Kadcyla, a HER2-targeted antibody and microtubule inhibitor conjugate, is also currently approved to treat patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease or developed disease recurrence during or within 6 months of completing adjuvant therapy.
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