Meeting with Corbus Pharmaceuticals to discuss the DETERMINE Phase 3 results
Monday, June 28, 2021
Yesterday we met with Corbus Pharmaceuticals to discuss the phase 3 lenabasum clinical trial results for #dermatomyositis.
Lindsey Smith, Director of Patient Engagement, and a friend to many in the myositis community facilitated a discussion for MSU and TMA to hear directly from Dr. Barbara White, Corbus’ Chief Medical Officer and Head of Research, and Dr. Victoria Werth, Principal Investigator, to discuss the data, the realities, and help us to better understand what’s next for lenabasum in the treatment of dermatomyositis.
In DETERMINE, the phase 3 trial, regulatory authorities called for a mix of patients with and without muscle involvement and/or skin disease to be included, as well as the introduction of a different primary endpoint called the Total Improvement Score (TIS), instead of the previously used Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) in phase 2.
Currently, the team at Corbus Pharmaceuticals is working on the full data analysis to understand all these different scores and outcomes. This will take some time, and once that is finished, Corbus looks forward to discussing the data from the phase 2 and phase 3 dermatomyositis studies with the FDA and seeking their input on the next steps. This is not the end.
There is still a lot to learn and we are committed to keeping you updated and involved. We need treatments. If the data continue to show this has the potential to effectively treat those with dermatomyositis, MSU will be sure to activate the community to advocacy, together with The Myositis Association, and other organizations.
We will keep you updated and informed as we continue to learn more. Below you will find our original statement along with the press release from Corbus.
Corbus Pharmaceuticals Announces Topline Results from DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis
As part of MSU’s commitment to you, the myositis community, we are sharing with you the newly released clinical trial results for DETERMINE, an international phase 3 clinical trial of lenabasum in dermatomyositis.
While this study did not meet its primary endpoint, there are some otherwise encouraging results, and we will continue working together with Corbus Pharmaceuticals to learn more and to help you better understand the information.
We had the pleasure of visiting Corbus Pharmaceuticals for an opportunity to share our myositis patient experiences, share about the work we do at Myositis Support and Understanding (MSU), and the chance to talk to the team and one-on-one. We were truly impressed by their passion for working with myositis patients and caregivers, and I trust they will continue working hard on our behalf.
MSU would also like to take this opportunity to thank the participants in the study. Thank you for taking action!
- Study did not meet primary endpoint of Total Improvement Score (TIS) at Week 28
- Additional findings included nominally significant improvements in TIS (p = 0.0302) and CDASI (p = 0.0166) depending on the dermatomyositis subtype
- Lenabasum treatment was safe and well-tolerated in this study
“We are disappointed that the trial did not meet the primary endpoint of TIS at Week 28,” said Barbara White, M.D., Chief Medical Officer and Head of Research at Corbus. “Nonetheless, we are encouraged by the results when the outcome is matched to the subtype of dermatomyositis in the study. We believe we see clinical activity of lenabasum 20 mg administered twice daily compared to the control group just receiving standard background treatments, with higher TIS scores in classic dermatomyositis subjects with muscle weakness and skin involvement and greater reduction in CDASI activity score in subjects with active skin disease but normal muscle strength. We thank the participants, investigators and clinical site study staff, and the patient advocacy community for their support of this study.”
This is not the end!
In the press release, Yuval Cohen, Ph.D., Chief Executive Officer, tells us, “We look forward to discussing the data from the Phase 2 and Phase 3 dermatomyositis studies with regulatory authorities and seeking their input on next steps.”