Key Findings From the NATALEE Trial in HR+/HER2- Early Breast Cancer

Dennis J. Slamon, MD, director of clinical/translational research, UCLA Jonsson Comprehensive Cancer Center and chairman and executive director of Translational Research In Oncology, discusses the key findings from the phase 3 NATALEE trial (NCT03701334) of ribociclib (Kisqali) with endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer which were presented at ASCO 2023.

Transcription:

0:08 | The trial was more than 5000 patients, 5101 patients, and it was designed to include more patients than that have been traditionally included in these types of studies. So stage II node-negative patients that are considered of lower risk, but still at risk to have a recurrence. We know that for stage II disease, a third of those patients will ultimately recur as long as 2 or 3 decades out. And for stage III disease, more than half will recur. So we tested it in that whole group. Just the very lowest grade or lowest risk patients were not tested, and what we found so far is that there's a benefit that is across all subgroups. Some of them are statistically significant, some close to reaching significance, but the trial is still early in its follow-up, so more follow-up will be done, but we already know that it's impacted in a positive way, the recurrence rate, and it's impacted the distant metastatic rate by decreasing those 2 things by 25% and 26%, respectively.

1:18 | The key findings are that we're able to reduce the invasive disease-free recurrences by 25%. We're able to reduce metastatic distant metastatic disease by 26%. Right now, at an early point, it looks like there may be a trend for survival, but it's still too early to call that there will be further follow-up. I think what is encouraging is that only 20% of the patients so far have gone to the end of the treatment, so the other 80% are continuing on this treatment. We will see how that evolves over time, but I think that bodes favorably for this drug.