A Look At The Myeloma-Related Poster Presentations At The EHA Congress (EHA 2013)
Published: Jun 14, 2013 6:13 pm; Updated: Jun 21, 2013 2:30 pm
This year’s Congress of the European Hematology Association (EHA) is currently being held in Stockholm. It started earlier this week and will run through Sunday, June 16.
A substantial amount of myeloma-related research will be presented during the EHA meeting during both oral presentations and poster presentations.
This article summarizes some of the important myeloma-related findings that are expected to be presented during poster sessions today and tomorrow. A previous article covered the key findings that will be presented during oral presentations.
The studies covered in this article are primarily ones which have not been presented at previous scientific meetings. The study findings summarized here are based on the currently available presentation abstracts.
Such abstracts, it should be noted, often contain preliminary results which are further updated at the actual meeting. This article will therefore be revised from time to time as newer data become available during and after the meeting.
Ixazomib (MLN9708) Plus Revlimid And Dexamethasone In Older Patients
One of the posters presented today showed the results of a sub-analysis of data from a Phase 1/2 study of ixazomib (MLN9708) in combination with Revlimid (lenalidomide) and dexamethasone (Decadron) in newly diagnosed multiple myeloma patients. The sub-analysis focuses on the efficacy of ixazomib in older patients (abstract).
Ixazomib is an orally-administered proteasome inhibitor, the same class of drugs to which Velcade (bortezomib) and Kyprolis (carfilzomib) belong; it is being developed by Millennium Pharmaceuticals, the same company that developed and markets Velcade.
Initial results of the entire study show that ixazomib may be highly effective in newly diagnosed patients (see related Beacon news).
The study included 65 patients of whom 52 percent were 65 years and older and 18 percent were 75 years and older.
Overall, 91 percent of patients aged 65 and older and 82 percent of patients aged 75 and older responded to the treatment, compared to 94 percent of patients under the age of 65.
According to the researchers, the rate of severe and life-threatening side effects was similar across the age groups.
MDX-1097 For Relapsed Kappa Myeloma
MDX-1097, which is being developed by the biotechnology company Immune System Therapeutics, targets myeloma cells that produce kappa light chain proteins and triggers the immune system to kill the cancer cells.
The study included 19 patients who received eight weekly infusions of the antibody; 26 percent of the participants concurrently received Revlimid maintenance therapy.
Overall, 5 percent of patients achieved and maintained a very good partial response for a year, and 11 percent achieved a partial response.
MDX-1097 was well tolerated, with 21 percent of patients experiencing a serious side effect, such as a complete heart block, pneumonia, low red blood cell counts, or inflammation of the pancreas, and 21 percent of patients experiencing mild to moderate infusion reactions.
ACY-1215 In Combination With Velcade or Revlimid
One of tomorrow’s posters will present two clinical trials involving ACY-1215 for the treatment of relapsed myeloma (abstract; poster [pdf] courtesy of Dr. Noopur Raje). The first trial is studying ACY-1215 alone and in combination with Velcade and dexamethasone. The second trial is studying ACY-1215 in combination with Revlimid and dexamethasone.
At the time of the analysis, the first study included 28 relapsed and refractory myeloma patients with a median age of 66 years who had received a median of more than four prior lines of therapy. Among the 15 patients who received only ACY-1215, 40 percent achieved stable disease. Among the 13 patients who received ACY-1215 plus Velcade and dexamethasone, 23 percent achieved a partial response.
The second study included 13 relapsed and refractory myeloma patients with a median age of 64 years who had received a median of three prior lines of therapy. Among the 10 patients evaluated for response, 10 percent achieved a complete response, 20 percent a very good partial response, and 40 percent a partial response.
The most common severe side effects experienced while taking ASC-1215 alone were elevated creatinine levels (33 percent), fatigue (27 percent), elevated calcium levels (27 percent), and upper respiratory infections (27 percent).
Amifostine For The Prevention Of Peripheral Neuropathy
Another poster to be presented tomorrow will include results of a Chinese study that tested whether amifostine (Ethyol) can protect myeloma patients against peripheral neuropathy without affecting the efficacy of their treatment (abstract). Peripheral neuropathy is nerve damage that can cause pain, tingling, and numbness in the hands and feet.
Amifostine, which is approved to reduce certain side effects of chemotherapy and radiation, has previously been shown to prevent neuropathy caused by certain types of chemotherapy.
The study included 47 newly diagnosed myeloma patients. All of the participants were treated with Velcade, thalidomide (Thalomid), and dexamethasone; half also received amifostine prior to each Velcade treatment.
The results show that amifostine did not affect the efficacy of the myeloma therapy; complete response rates were 35 percent for those who received amifostine and 38 percent for those who did not.
Overall, amifostine did not significantly reduce the rate of peripheral neuropathy (62 percent for those who received amisfostine versus 78 percent for those who did not); however, it did significantly lower the rate of severe peripheral neuropathy (8 percent versus 39 percent, respectively).
Another of today’s posters summarized the first results of an analysis of secondary cancers in a large, ongoing British Phase 3 trial involving initial and maintenance therapy with Revlimid (abstract).
The trial compares the efficacy and safety of initial therapy with Revlimid, cyclophosphamide (Cytoxan), and dexamethasone to initial therapy with thalidomide, cyclophosphamide, and dexamethasone. Patients can then receive further Velcade-based therapy if needed and a stem cell transplant if eligible. Half of the patients will then receive Revlimid maintenance therapy, and half will not.
So far, 2,110 patients have been recruited to the trial; almost all have been begun induction therapy; 696 have entered the maintenance phase of the study.
At a median follow-up time of 1.3 years, the researchers report that the rate of secondary cancers has been very low; 14 cases of secondary cancers have been reported, of which 64 percent were observed in patients receiving initial therapy with thalidomide.
However, the researchers point out that longer follow-up is needed to fully assess the risks.
Bone Biomarker CTX-1 For Predicting Myeloma Relapse
Multiple blood samples were taken over time from 27 patients with newly diagnosed myeloma, 30 myeloma patients in remission, 22 relapsed myeloma patients, and 27 healthy individuals; CTX-1 levels in each of these samples were measured.
The results show that newly diagnosed and relapsed patients have significantly higher CTX-1 levels than healthy individuals and myeloma patients in remission. CTX-1 levels rose at least two-fold a median of three months prior to relapse.
The researchers state that CTX-1 testing is more cost effective and accessible than imaging and suggest that it should be used routinely.
Identification Of Very High-Risk Myeloma Patients
Another poster to be presented tomorrow will report results of an analysis that identified several characteristics that could be used to identify patients with very high-risk myeloma (abstract).
The study, which was carried out in Greece, included 246 myeloma patients; they had a median progression-free survival of 26 months and a median overall survival of 51 months; however, 5 percent of the patients died within two months of starting treatment.
The researchers found that 4 percent of the patients had International Staging System stage 3 myeloma, high-risk chromosomal abnormalities, and high LDH levels and were at much higher risk of early progression (one year) and shorter survival (two years).
The researchers suggest that patients in this very high-risk group participate in clinical trials to expand their available treatment options.
Effects Of Autoimmune Diseases On MGUS Survival
One of today’s posters summarized the results of a retrospective analysis that assessed the impact of autoimmune diseases on survival of people with monoclonal gammopathy of undetermined significance (MGUS) and people with multiple myeloma (abstract).
The analysis is based on Swedish data for 4,432 patients with MGUS, who were diagnosed between 1988 and 2006; 2,765 patients with multiple myeloma, who were diagnosed between 2000 and 2006 (before novel agents were approved to treat myeloma); and 28,119 healthy individuals.
The results show that a history of autoimmune diseases was linked to an increased risk of death in MGUS patients and in myeloma patients. However, the results also show that having an autoimmune disease has a bigger impact on the survival of healthy individuals than patients with MGUS or multiple myeloma.
The researchers suggest that underlying conditions, including autoimmune diseases, should be taken into account when managing MGUS and myeloma.
ABT-199, which is being developed by the biopharmaceutical company AbbVie, is a compound that targets Bcl-2 and Bcl-2-related proteins, which regulate cell death.
The results show that the ABT-199 may be effective in myeloma cells with the chromosomal abnormality t(11;14).
Two clinical trials studying ABT-199 are currently recruiting myeloma patients.
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For more information on the 18th EHA Congress, including the final presentation schedule, abstracts, and information on attending, please see the Congress of the European Hematology Association website.
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- Revlimid-Treanda-Prednisone Combo Is Active And Well Tolerated For Relapsed/Refractory Myeloma (EHA 2012)