Ruxolitinib and methylprednisolone for treatment of patients with relapsed/refractory multiple myeloma

Results from the I-RUX Study published online in the British Journal of Haematology

WEST HOLLYWOOD, Calif., Dec. 20, 2022 /PRNewswire/ -- ONCOtherapeutics and Dr. James Berenson published promising new data demonstrating that ruxolitinib (RUX), an oral JAK1/2 inhibitor, with only methylprednisolone (MP) well tolerated and shows efficacy for treating heavily previously treated multiple myeloma (MM) patients.

Recently published results from a Phase 1 trial conducted by ONCOtherapeutics among 28 heavily previously treated MM patients administered RUX, lenalidomide (LEN) and MP demonstrated that the therapy was well tolerated and RUX overcame refractoriness to LEN and steroids (Berenson et al., Clin Cancer Res. 2020). The clinical benefit rate (CBR) and overall response rate (ORR) were 46% and 28%, respectively, and all 12 responding patients were refractory to LEN. A recent update that included 49 MM patients showed similar results with a CBR of 49% and 36%, respectively (Berenson et al. Hematol Oncol. 2022)

To further evaluate whether the combination of RUX and MP without LEN demonstrates clinical activity and its tolerability in a similar MM patient population, an ongoing Phase I trial was expanded to also include a cohort of patients treated with only this two-drug combination (NCT03110822). RUX (15 mg BID) was given orally twice a day continuously and oral MP (40 mg every other day).

Twenty-nine previously treated patients were planned to be enrolled on the part of the trial with only RUX and MP treatment. Median lines of prior therapy were 6 (range,  3-12). The ORR was 31% (n=9). The median duration of response was more than 13 months (range, 2.8-22) and progression free survival ranged from 0.5-24.6 months (median 3.4). The combination was well tolerated with no unanticipated adverse effects.

As noted by lead investigator Dr. James R. Berenson, "Multiple myeloma patients continue to need new treatment options, especially for those who have become refractory to previously effective treatment options. We previously demonstrated ruxolitinib's ability to resensitize lenalidomide for patients who were refractory to this immunomodulatory agent, and now have shown that the combination of only ruxolitinib and methylprednisolone is active and well tolerated in a heavily previously treated multiple myeloma patient population."

With these promising results, ONCOtherapeutics has expanded the current study to further investigate the potential of this novel two-drug combination for treating similarly heavily previously treated MM patients using a higher dose of RUX (20 mg BID) with MP. In addition, the combination of RUX, LEN and MP is being evaluated among MM patients with poor renal function.

ONCOtherapeutics is a West Hollywood-based oncology-specific Contract Research Organization (CRO) specializing in the oversight and management of clinical trials for cancer. With expertise in phase I-IV clinical trials and pharmacokinetic studies, ONCOtherapeutics offers a wide array of services that are custom tailored to meet the needs of pharmaceutical and biotech partners. Nationally recognized research oncologists and Key Opinion Leaders in oncology work in parallel with our senior level clinical research teams. ONCOtherapeutics has an excellent track record of short start-up times and adherence to enrollment and completion timelines. For more information, visit www.oncotherapeutics.com

Contact:

Afra Yehwalashet
Director, Clinical Trials
[email protected]
(310) 623-1200
www.oncotherapeutics.com

SOURCE ONCOtherapeutics