Next Steps for Trastuzumab Emtansine After the KAMILLA Trial

Rachel Würstlein, MD, Universität München, lead investigator of the KAMILLA study (NCT01702571), discusses the use of trastuzumab emtansine (T-DM1) following the KAMILLA trial which evaluated the agent in patients with HER2-positive locally advanced or metastatic breast cancer who have brain metastases.

KAMILLA was a 2-cohort, open-label, multicenter trial. Investigators aimed to evaluate the safety and efficacy of T-DM1 in patients with metastatic breast cancer. In the trial, over 2000 patients were enrolled and 182 patients were included in the Asian cohort.

In the KAMILLA trial, patients with HER2-positive locally advanced or metastatic breast cancer who had brain metastases received T-DM1 at a dose of 3.6 mg/kg given intravenously every 3 weeks until they experienced unacceptable toxicity, withdrew consent, or had disease progression. The median treatment duration was 4.9 months (range, 0-44 months) in patients with brain metastases.

Findings from the exploratory analysis of T-DM1 in the trial revealed that this patient population had promising activity as well as tolerability on the therapy. In addition, findings confirmed the safety and efficacy of T-DM1, and there were no new safety signals demonstrated.

Transcription.

0:08 | It’s an interesting question to think about what’s going to happen now with T-DM1. There is a well-described track in metastatic breast cancer in the second-line or further. But as we already know, also in the past-neoadjuvant treatment, we have been working on this question [and I believe] it’s time to move it to the neoadjuvant setting. We have to define the patient population. There have been some interesting presentations at [last] year’s ASCO, and I think safety populations like this are the backbone to start use of these tracks in the earliest setting. I think that it is now been moved from metastatic to first-line and we’ll have it also in the neoadjuvant setting.