Three fascinating studies were presented at ASH among the many approaches to providing heavily pretreated patients with effective and tolerable new treatments.  This research and future clinical trials are among the ones to stay on top of. 

Takeda's TAK-079

Dr. Amitra Krishnan reported the results of a Phase 1/2a dose escalation first in human study with 31 patients on TAK-079 which selectively targets high density CD38+targets. It has a stronger binding to the CD38 protein expressed by myeloma cells and less cross reactivity with the CD38 antigen present on red blood cells and platelets.

• Eligibility Criteria included more than 3 lines of therapy with an immunomodulator, proteasome inhibitor, with or without prior use of an anti-CD38 agent
• Excellent safety and tolerability profile was seen up through 1200mg
• TAK-079 SC can be given as a subcutaneous injections performed in less than a minute, giving it potential for home-based self-administration.  Now wouldn’t you love that as a patient?

Celgene's CC-93269

Dr. Luciano Costa presented early results from Celgene's bi-specific antibody targeting BCMA for relapsed/refractory myeloma patients. CC-93269 connects T cells to the BCMA target on myeloma cells. Patients in the study had over 3 prior lines of treatment (without BCMA therapy). Thirty patients were enrolled and among patients receiving 10 mg, the Overall Response Rate was 88.9% which stimulated great enthusiasm in the Myeloma Community.

Interestingly, 44% of patients who received 10mg doses achieved a complete response or stringent complete response and all of these patients were minimal residual disease negative. Dr. Costa noted that the effectiveness was dose dependent and administration was convenient.  

CLR 131

Dr. Sikander Ailawadhi gave a presentation on CLR 131, which is a new targeted radiotherapy. It takes advantage of the fact that cancer cells take in and retain phospholipid ethers (PLEs). Based on initial preclinical and clinical experience and the radiosensitivity of multiple myeloma, divided dosing into several administrations (also called fractionated dosing) of CLR 131 is being examined in relapsed/refractory multiple myeloma in a Phase 1 trial (NCT02278315) and a Phase 2 trial, CLOVER-1 (NCT02952508).

Patients joining this study have to have relapsed on at least one proteasome inhibitor and one immunomodulatory (IMiD) drug. Prior autologous stem cell transplant and external beam radiation therapy were allowed (< 20% of total marrow irradiated).

CLR 131 is the first time this technique has been used for relapsed/refractory myeloma and showed an acceptable safety profile. The divided (fractionated) dosing at 37.5 mCi/m² has been adopted as the standard for CLR 131 dosing in ongoing and future trials. 

Thank you to our Myeloma Coach ASH 2019 sponsors: 

 Written by  Myeloma Coach Bonnie Falbo