More good news about Mike Barron and his successful run with daratumumab. Mike wants all to know that his latest cycle picks up where the last on left off: daratumumab and dex is doing the trick. “It’s like a miracle,” Mike wrote me.
Next up, Takeda has announced the schedule of clinical trial results it’s team will be presenting at ASH:
• Ixazomib, an Investigational Oral Proteasome Inhibitor (PI), in Combination with Lenalidomide and Dexamethasone (IRd), Significantly Extends Progression-Free Survival (PFS) for Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM): The Phase 3 Tourmaline-MM1 Study (NCT01564537)
o Presenter: Philippe Moreau, M.D., University of Nantes, France
o Abstract 727, Oral Presentation, Monday, December 7, 2015, 2:45 PM, Orange County Convention Center, Tangerine 2 (WF2)
• Randomized Phase 2 Study of the All-Oral Combination of Investigational Proteasome Inhibitor (PI) Ixazomib Plus Cyclophosphamide and Low-Dose Dexamethasone (ICd) in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Who Are Transplant-Ineligible (NCT02046070)
o Presenter: Meletios A. Dimopoulos, MD, University Athens School of Medicine, Athens, Greece
o Abstract 26, Oral Presentation, Saturday, December 5, 2015, 7:45 AM, Orange County Convention Center, Tangerine (WF2)
ADCETRIS (Brentuximab vedotin)
• Five-year Survival Data Demonstrating Durable Responses from a Pivotal Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma
o Presenter: Robert Chen, MD, City of Hope National Medical Center, Duarte, CA
o Abstract 2736, Poster, Sunday, December 6, 2015, 6:00 PM, Orange County Convention Center, Hall A, Level 2
* Updated Efficacy and Safety Data from the AETHERA Trial of Consolidation with Brentuximab Vedotin after Autologous Stem Cell Transplant (ASCT) in Hodgkin Lymphoma Patients at High Risk of Relapse
o Presenter: John Sweetenham, MD, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah
o Abstract 3172, Poster, Sunday, December 6, 2015, 6:00 PM, Orange County Convention Center, Hall A, Level 2
• Randomized Phase 2 Open-Label Study of R-CHOP ± Bortezomib in Patients (Pts) with Untreated Non-Germinal Center B-Cell-like (Non-GCB) Subtype Diffuse Large Cell Lymphoma (DLBCL): Results from the Pyramid Trial (NCT00931918)
o Presenter: John P. Leonard, MD, New York Presbyterian Hospital
o Abstract 811, Oral Presentation, Monday, December 7, 2015, 4:30 PM, Orange County Convention Center, Tangerine 3 (WF3-4)
• First Multicenter, Randomized Phase 3 Study in Patients (Pts) with Relapsed/Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL): Alisertib (MLN8237) Versus Investigator’s Choice (Lumiere trial; NCT01482962)
o Presenter: Owen O’Connor, MD, Center for Lymphoid Malignancies, Columbia University Medical Center, New York Presbyterian Hospital, New York, NY
o Abstract 341, Oral Presentation, Sunday, December 6, 2015, 5:30 PM, Orange County Convention Center, Hall E2
Ixazomib is an investigational oral proteasome inhibitor which is being studied in multiple myeloma, systemic light-chain (AL) amyloidosis, and other malignancies. Ixazomib was granted orphan drug designation in multiple myeloma in both the United States and Europe in 2011 and for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory AL amyloidosis in 2014. It is also the first oral proteasome inhibitor to enter Phase 3 clinical trials.
Ixazomib’s clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. Five global Phase 3 trials are ongoing:
• TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma
• TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
• TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)
• TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT
• TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis
For additional information on the ongoing Phase 3 studies please visit www.clinicaltrials.gov.
Alisertib is a lymphoma drug that doesn’t have much to do with most of us. But everything I’ve read and heard about ixazomib (MLN9708), Takeda’s oral proteasome inhibitor has been positive. It’s going to be a blockbuster!
I spoke with Dr. Tricot about how well daratumumab has been working for his patients. He painted a far different picture than Mike. “But most of my patients are trying the drug as a last resort,” Dr. Tricot admitted. We both agreed it works best in patients that aren’t too far along. Not sure if the same applies to ixazomib.
Dr. Tricot affirmed that I’m a different case; that my tumor burden should be low enough to allow daratumumab to work for me–it I’m one of the lucky one out of three or one out of four.
First I’ll need to know what additional benefit my latest tandem transplant gave me. I’m hoping for a complete response (CR). Lord knows considering all I’ve been through these past four months, I’m expecting some measurable benefit. Not needing my skull radiated would be nice.
Feel good and keep smiling! Pat