New Orleans, LA December 9, 2013--As I mentioned previously, today is Myeloma Monday, meaning the first oral presentation began at 7 a.m. and the last one ended at 6 p.m. Yes, we had some breaks, but I used them to review the new posters (none will be mentioned here) and walk to different rooms in the large Convention Center. Each oral presentation is about 13 minutes with 2 minutes of questions and answers. The 15-minute time limit is monitored very closely.
Here's a sample title of the first presentation I attended (remember, it's 7 a.m.): "Novel AKT Inhibitor Afuresertib in Combination With Bortezomib and Dexamethasone Demonstrates Favorable Safety Profile and Significant Activity in Patients with Relapsed/Refractory Multiple Myeloma." The Power Point presentation topics typically cover Background, Trial Rationale, Treatment Plan, Patient Demographics, Trial Results (Responses, Survival Outcomes, Adverse Side Effects), Conclusion, and Future Directions.
I'm watching densely written slides fly by at real time speed, all the while trying to record accurate information and listen to what's being said. It's pretty intense as you listen to the terminology (for example, we know bortezomib as Velcade) and try to interpret the results.
In these trials, I look for Clinical Trial Phase (the one above was at Phase I), "n" representing number of patients, Responses (e.g. Complete Response, Overall Response), Survivals (e.g. Progression Free Survival, Overall Survival), Adverse Events/toxicity (both hematologic-blood and non-hematologic) and Conclusion/Summary. Phase I trials consists of a handful of patients to determine Maximum Tolerated Dose (MTD); Phase II, with roughly 50-100 patients, examines treatment efficacy; and Phase III, with several hundred patients, compares that new treatment/drug with a current standard of care. Finally, I look at who the trial is intended for such as newly diagnosed patients or relapsed/refractory myeloma (RRMM) patients.
Just a few of these talks are mentioned below all for RRMM patients unless otherwise noted:
Drugs I heard about today in Phase I trials include:
- SAR650984...CD38 monoclonal antibody that has single agent activity.
This adds to other monoclonal antibodies Elotuzumab and Daratumumab, definitely a hot area for MM research.
Phase II trials I found interesting include:
- ARRY-520 (KSP Inhibitor) which had single agent activity combined with Vel-Rev or just Dex. Most interesting was the detection of a biomarker called AAG that can help determine if a patient will respond to ARRY-520.
- Vel-Mel-Pred 9 cycles followed by Rev-dex 9 cycles versus alternating each cycle for newly diagnosed elderly patients. Results didn't seem to matter overall but it might for a given individual.
- Oral MLN9708 (Ixazomib) + Rev + Dex is an effective all-oral regimen containing a proteasome inhibitor and IMID for newly diagnosed patients.
- Carfilzomib + Rev + Dex followed by Rev maintenance in newly diagnosed patients.
- Carfilzomib + Cytoxan + Dex for newly diagnosed patients
- Pomalidomide + Dex for high-risk del 17p or t(4:14) patients
Phase III trials of interest were:
- Velcade Induction followed by transplant followed by Velcade maintenance
- The measurement of PFS2 was defined as Progress Free Survival through relapse and another treatment therapy. PFS2 was proposed to show in a large French Phase III study that Revlimid maintenance didn't result in Overall Survival improvement over no maintenance. However, this was argued by other myeloma experts. Maintenance still needs more study.
That's enough for now. There are so many others I attended and even more I couldn't attend since there were 835 Myeloma abstracts at this year's ASH.
While typing this, I'm watching a wonderful IMWG Conference Series live webcast, "Making Sense of Treatment," featuring myeloma experts Drs. Brian Durie, Antonio Palumbo, Joseph Mikhael, and Ola Landgren. Among these four experts, there's both agreement and disagreement. We all want the "best" treatment and get frustrated not having definitive answers.
Well, let me tell you what's worse--having only two treatment options: Melphalan-Prednisone or VAD induction + SCT, and told the average life-span is only 2-3 years. That was my choice when I was diagnosed 19 years ago. Personally, I'm much happier having more and much more effective/less toxic options.
ASH ends tomorrow morning so my final blog report will probably be written from the airport or after I return home. I'm looking forward to both.
-- Jack Aiello