Adjuvant Ribociclib May Be ‘Promising’ in HR+/HER2– Breast Cancer

“Reassuring” findings may support the use of ribociclib (Kisqali) as a treatment escalation option in the adjuvant setting for patients with hormone receptor (HR)–positive, HER2-negative breast cancer, said Neil M. Iyengar, MD, in a discussion with CancerNetwork^® at the 2023 San Antonio Breast Cancer Symposium (SABCS).

Iyengar, a breast oncologist in in the Department of Medicine at Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine in New York City, New York, as well as the co–editor-in-chief of the journal ONCOLOGY®, stated that ribociclib appeared to be well tolerated among the aforementioned patient population based on updated results from the phase 3 NATALEE trial (NCT03701334).

Longer-term follow-up data from the trial highlighted that no adverse effects (AEs) of special interest or clinically relevant AEs increased by more than 1% since the time of the initial analysis, and that the treatment discontinuation rate increased by 0.8%. Additionally, patients mostly discontinued treatment with ribociclib following liver-related AEs.

Transcript:

We’re getting a lot of data for the CDK4/6 inhibitors. We’ve now seen more updated data from NATALEE for adjuvant ribociclib, and what’s reassuring about those data is we continue to see that the toxicity profile is pretty good. It’s well tolerated, and this is particularly important because ribociclib is dosed differently in the adjuvant setting than in the metastatic setting. These longer-term follow-up data are important from a toxicity perspective. We are continuing to await longer-term follow-up from NATALEE, but the initial data and the follow-up data here at [SABCS] are looking very promising for the use of ribociclib in the adjuvant setting.

What’s also unique about NATALEE is the inclusion of patients with higher-risk but node-negative breast cancer. This is a population for which we don’t have an approval yet for CDK4/6 inhibitors, and it could potentially give us an option for escalating therapy in this patient population.

Reference

Hortobagyi G, Stroyakovsky D, Yardley D, et al. Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2− early breast cancer: final invasive disease–free survival (iDFS) analysis from the NATALEE trial. Presented at the 2023 San Antonio Breast Cancer Symposium; December 5-9, 2023; San Antonio, TX; abstract GS03-03.