Cancer Treatment Today

Verzenio was initially s FDA approved in combination with fulvestrant to treat women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), whose disease has progressed after hormonal therapy alone to treat adults with HR–positive, HER2–negative advanced breast cancer or metastatic breast cancer whose disease has progressed after hormonal therapy and prior chemotherapy.

FDA also approved Verzenio (abemaciclib) in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) advanced or metastatic breast cancer.
Data is limited for glioblastoma. At the 2020 Society for Neuro-Oncology meeting, there was a presentation of the initial results of the abemaciclib arm in the INSIGhT trial. The trial is still active and continuing. The INSIGhT trial, or the Individualized Screening Trial of Innovative Glioblastoma Therapy, is a platform trial using Bayesian adaptive randomization. In this trial, patients with newly diagnosed glioblastomas with the unmethylated MGMT promoter are randomized to one of four arms. There’s a control arm with standard radiation therapy and temozolomide, and currently there are three other arms. One is abemaciclib, a CDK4/6 inhibitor. Another arm is CC-115, a DNA-PK mTOR inhibitor. The final arm is neratinib, an EGFR inhibitor.

Altogether, there were approximately 70 patients in the abemaciclib arm and approximately 50 patients in the control arm. The abemaciclib was generally well tolerated, and there were no new toxicity signals found. In terms of the primary outcome, overall survival, the study is not sufficiently mature to give data for that outcome. But for progression-free survival, there is an approximately 1.5 month improvement in PFS in the abemaciclib arm compared to the control arm, and this was statistically significant. Whether this will translate into an improvement in overall survival remains to be seen once the data is sufficiently mature.
There is no mature data and no guidelines recommendations.

https://www.practiceupdate.com/content/abemaciclib-for-the-treatment-of-newly-diagnosed-glioblastoma/110361