Monday was the third and next-to-last day of the 2012 American Society of Hematology (ASH) annual meeting.

It also was the busiest day of the meeting in regard to myeloma-related research.

The day ended with a poster session in the evening that featured over 1000 posters displayed throughout a large conference hall.  More than a hundred of the posters reported on the results of myeloma-related research.

Compared to the research summarized during oral presentations, the findings in poster summaries generally are in earlier stages of development.  They may involve laboratory research, clinical trials with just a small number of patients, or early results from ongoing clinical trials.

Monday’s session included several posters on new treatments being developed for myeloma.

This article will summarize the findings about these new treatments.

Amrubicin

One poster summarized the results of a Phase 1 study of amrubicin in combination with Revlimid (lena­lidomide) and dexamethasone (Decadron) in patients with relapsed and refractory multiple myeloma (abstract).

Amrubicin belongs to the same class of drugs as doxorubicin, called anthracyclines. Amrubicin is not associated with heart-related side effects, which are frequently seen at higher doses with other anthracyclines.  It is approved in Japan as a treatment for lung cancer, but it is not yet approved for use outside of clinical trials in any other country.

Celgene (NASDAQ: CELG), the company that markets Revlimid and thalidomide (Thalomid) worldwide, owns the North American and European rights to amrubicin.  Celgene is studying amrubicin as a single agent and in combination with other anti-cancer therapies as a treatment for a variety of different cancers.

The study of amrubicin in combination with Revlimid and dexamethasone included 10 patients with a median age of 63 years. The patients had received a median of two prior therapies.

Of the nine patients evaluable for response, 29 percent responded, with 14 percent achieving a very good partial response, and 15 percent a partial response.

The most common severe side effects included low red blood cell counts (60 percent of patients), fatigue (40 percent), diarrhea (40 percent), and hair loss (40 percent). So far, the researchers have not observed any heart-related side effects.

ARRY-520

Another poster displayed initial results from a Phase 1 study of ARRY-520 (filanesib) in combination with Kyprolis (carfilzomib) in relapsed and refractory multiple myeloma patients (abstract).

ARRY-520 is being developed by Array BioPharma (NASDAQ: ARRY). It inhibits kinesin spindle protein, which plays an important role in actively dividing cells.  It is being studied alone and in combination with other drugs for several blood cancers.

The study has enrolled nine patients so far, and these patients have received a median of four prior therapies. The median patient age was 67 years.

So far, 22 percent of patients have responded to the treatment, including 11 percent who achieved a complete response and 11 percent who achieved a partial response. In addition, 33 percent achieved a minor response.

According to the investigators, the combination treatment was well tolerated. The most common severe side effects included low white blood cell counts (22 percent), lung infections (22 percent), low red blood cell counts (11 percent), and diarrhea (11 percent).

BT-062

Another poster summarized the results of a Phase 1/2 study of BT-062 in relapsed and refractory multiple myeloma patients (abstract).

BT-062, which is being developed by the German pharmaceutical company Biotest, is a compound that combines a chemotherapeutic drug with an antibody that helps deliver the drug to myeloma and other cancer cells. When the compound enters a cancer cell, it releases the drug that ultimately kills the cell.

The study included 31 patients with a median age of 65 years who had received a median of five prior therapies.

Of the 27 patient evaluable for response, 4 percent achieved a partial response and 11 percent a minor response.

The most common side effects included low red blood cell counts (37 percent), diarrhea (30 percent), and fatigue (26 percent).

The investigators mentioned that a Phase 1/2 of BT-062 in combination with Revlimid and dexamethasone has been initiated.

IPH 2101

Interim results of a Phase 1 trial of IPH 2101 in combination with Revlimid were summarized in one of the posters presented during the session (abstract).

IPH 2101, which is being developed by Innate Pharma, belongs to a class of drugs called monoclonal antibodies. Monoclonal antibodies induce the patient’s own immune system into attacking and eliminating tumors. Specifically, IPH 2101 activates anti-tumor immune cells known as natural killer cells.

So far, the study has enrolled 14 relapsed myeloma patients who have received one to two prior lines of therapy.

Of those patients, 29 percent have responded to treatment, including 7 percent with a complete response and 22 percent with a partial response.

The most common severe side effects were low white blood cell counts and fever.

MFGR1877S

Another poster summarized the results of a Phase 1 study of MFGR1877S in relapsed and refractory multiple myeloma patients with the chromosomal abnormality t(4;14) (abstract).

The t(4;14) chromosomal abnormality is typically associated with shorter overall survival in multiple myeloma patients.  Researchers believe that overproduction of a protein known as FGFR3 may be one reason for the shorter survival of myeloma patients with the abnormality.

MFGR1877S, which is being developed by the pharmaceutical company Genentech, is a monoclonal antibody that targets FGFR3.

The current study included 14 relapsed and refractory myeloma patients who have the t(4;14) abnormality. The patient median age was 64 years. Patients had received two or more prior therapies.

The best response observed after a median of 3.5 doses has been stable disease in 50 percent of patients.

According to the investigators, MFGR1877S was well tolerated. The most common severe side effect was low platelet counts (14 percent of patients).

Although stable disease was the best response observed in this study, the investigators believe further studies of MFGR1877S in myeloma patients with t(4;14) are warranted.

MLN0128

Another poster showed the results of a Phase 1 study of MLN0128 in patients with various blood cancers, including multiple myeloma (abstract).

MLN0128 is being developed by Millennium Pharmaceuticals, the company that markets Velcade (bortezomib) in the United States.  The drug belongs to the same class of drugs as Torisel (temsirolimus) and Afinitor (everolimus), called mTor inhibitors. It works by inhibiting the protein mTor, which is essential for cancer cell growth and division.

The study included 37 patients, 30 of whom had multiple myeloma. The median patient age was 60 years. Patients had received a median of three prior therapies.

Among the 25 multiple myeloma patients who were evaluated for response, the best response achieved was a minor response in 4 percent of patients.

The most common side effects included nausea (46 percent), fatigue (43 percent), high blood sugar levels (35 percent), and low platelet counts (32 percent).

Ricolinostat

Another poster showed the initial results of a Phase 1/2 study of ricolinostat (ACY-1215) alone and in combination with Velcade in relapsed and refractory multiple myeloma patients (abstract).

Ricolinostat, which is being developed by Acetylon Pharmaceuticals, belongs to a class of drugs called histone deacetylase (HDAC) inhibitors. Other HDAC inhibitors under investigation for multiple myeloma include Zolinza (vorinostat) and panobinostat. However, ricolinostat is believed to be more selective than other HDAC inhibitors, which means that it could be more effective and have fewer side effects.

So far, the study has enrolled 22 multiple myeloma patients with a median age of 68 years. The patients had received a median of three prior therapies.

Sixty-eight percent of patients received ricolinostat alone; the remaining 32 percent received ricolinostat in combination with Velcade.

The best response in patients receiving ricolinostat alone was stable disease in 40 percent of patients.  Among the patients receiving ricolinostat in combination with Velcade, 14 percent of patients achieved a partial response.

The most common side effects in patients receiving ricolinostat alone were elevated creatinine levels (33 percent), low red blood cell counts (27 percent), fatigue (27 percent), high calcium levels in the blood (27 percent), and upper respiratory infections (27 percent).

Zalypsis

Another poster presented the results of a Phase 1 study of Zalypsis (PM00104) in relapsed and refractory multiple myeloma patients (abstract).

Zalypsis, which is being developed by the Spanish biotech company Pharmar, is a marine-based anti-tumor agent that is obtained from mollusks and sponges.

The study included 20 patients who had received a median of two prior therapies. The median patient age was 62 years.

Overall, 10 percent of patients responded to treatment; they all showed a partial response.

The most common severe side effects included low platelet counts (80 percent) and low white blood cell counts (60 percent).

The researchers pointed out that the expansion phase of the trial is ongoing.

Myeloma presentations from yesterday, the final day of the ASH 2012 meeting, will be summarized in a final ASH daily update to be published at The Beacon later today or tomorrow.  Additional coverage of key research results from the meeting will continue in the next few weeks with individual, topic-specific news articles.  For all Beacon articles related to this year’s ASH meeting, see The Beacon’s full ASH 2012 coverage.