Ruxolitinib is Well-Tolerated and Shows Promise in High-Grade Gliomas

Manmeet Ahluwalia, MD, the chief of Medical Oncology, chief scientific officer & deputy director at Miami Cancer Institute of Baptist Health South Florida, discusses what early results from the CRUX trial (NCT03514069) of ruxolitinib (Jakafi) for the treatment of patients with newly-diagnosed high-grade gliomas may mean for future research.

CRUX is a non-randomized, prospective, phase 1 study which included 60 patients with WHO grade 3-4 newly-diagnosed high-grade gliomas. Once enrolled, the trial utilized a 3+3 dose-escalation design where patients were treated with standard of care therapy with ruxolitinib.

The primary end point evaluated in the study was the determination of the maximum tolerated dose of ruxolitinib in combination with chemoradiation, and the secondary end points were the determination of safety, overall survival (OS), and progression-free survival.

According to data from the study that were presented at the 2023 American Society of Clinical Oncology annual meeting, from the study, patients treated with ruxolitinib and 75 mg/m2 of temozolomide with radiation of 60 Gy over 6 weeks achieved OS rates at 1 year, and the combination was safe and feasible.

Now, a randomized phase 2 trial to evaluate the combination is planned.

Transcription:

0:10 | We were very excited to present a final report of CRUX study, which was looking at the JAK/STAT inhibitor ruxolitinib in patients with newly diagnosed high-grade gliomas. ​​

0:20 | Patients with glioblastomas have dismal outcomes with standard of care treatments, and hence, clinical trials are urgently needed. The initial promising results of ruxolitinib offer a new and promising opportunity for patients with this disease, with a novel agent that is extremely well-tolerated, and one that is also showing a high degree of preliminary efficacy compared with the historical benchmarks, which is a great potential for both the patient and the researchers alike who are treating this disease.