This year’s American Society of Hematology (ASH) meeting, which is taking place in Atlanta, came to a close earlier today.  However, yesterday, the third day of the meeting, was packed with myeloma-related presentations.

Given the number of myeloma presentations made yesterday, The Beacon will summarize the four most important of yesterday’s oral presentation sessions as well as a number of the most important poster presentations in updates such as this one.  Summaries of the first three key oral presentation sessions were published yesterday and earlier today.  This update covers presentations from the final of those four key oral presentation sessions.

The session summarized in this update featured a number of important studies, including two presentations about com­bi­na­tion ther­a­pies involving the recently-approved Kyprolis (car­filz­o­mib) and another presentation about lorvotuzumab mertansine, a unique new drug that combines a chemotherapeutic agent and an anti­body.

Pomalidomide, Velcade, And Dexamethasone

Dr. Paul Richardson from the Dana-Farber Cancer Institute in Boston gave the first presentation of the session.  He presented results from a Phase 1 study of a com­bi­na­tion of pomalidomide, Velcade (bor­tez­o­mib), and dexamethasone (Decadron) in re­lapsed and refractory multiple myeloma patients (abstract; presentation slide deck (pdf) made available by Dr. Richardson as a courtesy to the Beacon's readers).

Pomalidomide is an immuno­modu­la­tory agent, meaning that it works by inducing a patient’s immune system to attack and destroy myeloma cells. It belongs to the same class of drugs as thalidomide (Thalomid) and Revlimid (lena­lido­mide).

Pomalidomide is being developed by Celgene Corporation (NASDAQ: CELG), the same com­pany that markets Revlimid and thalido­mide in the United States and inter­na­tionally. It is cur­rently being reviewed by the U.S. Food and Drug Administration for approval for use in re­lapsed and refractory multiple myeloma patients.

The study included 15 re­lapsed and refractory multiple myeloma patients who had received a median of two prior ther­a­pies. All patients had pre­vi­ously been treated at some point with Revlimid and Velcade.

Overall, 73 per­cent of patients responded to the treat­ment, with 27 per­cent achieving a very good partial response and 46 per­cent a partial response. The median time to response was one treat­ment cycle.

The most common side effects were fatigue (60 per­cent), edema (40 per­cent), and low platelet counts (40 per­cent).  The researchers did not observe any cases of severe periph­eral neu­rop­athy (pain, tingling, or loss of sensation in the extremities).

Lorvotuzumab Mertansine Plus Revlimid And Dexamethasone

The second presentation was given by Dr. Jesus Berdeja from the Sarah Cannon Research Institute in Nashville, Tennessee.  He presented results from a Phase 1 study of lorvotuzumab mertansine in com­bi­na­tion with Revlimid and dexa­meth­a­sone (abstract, presentation slide deck (pdf) made available by Dr. Berdeja as a courtesy to the Beacon's readers).

Lorvotuzumab mertansine (IMGN901) is being developed by the U.S. bio­tech com­pany ImmunoGen (NASDAQ: IMGN).  It is a chemotherapy agent (mertansine) attached to an anti­body (lovortuzumab) that directs the chemotherapy to the cancer cell.  The lorvotuzumab portion of the drug recognizes the CD56 protein found on the surface of myeloma cells.  Approximately 70 per­cent of myeloma patients have myeloma cells with the CD56 protein.

The study included 44 multiple myeloma patients who had been treated with a median of two prior ther­a­pies. The median patient age was 63 years.

Of the 39 patients evaluated for response, 57 per­cent of the participants responded to the com­bi­na­tion ther­apy, including 3 per­cent who achieved a stringent complete response, 28 per­cent a very good partial response, and 26 per­cent a partial response.

The most common side effects of all grades (both mod­er­ate and severe) included periph­eral neu­rop­athy (56 per­cent), fatigue (42 per­cent), low white blood cell counts (32 per­cent), and low platelet counts (32 per­cent).

Kyprolis, Cyclophosphamide, And Dexamethasone

Dr. Antonio Palumbo from the University of  Torino in Italy discussed the results from a Phase 1 study of Kyprolis, cyclophosphamide (Cytoxan), and dexa­meth­a­sone in older newly diagnosed myeloma patients, who were not eligible for stem cell trans­plan­ta­tion (abstract; presentation slide deck (pdf) made available by Dr. Palumbo as a courtesy to the Beacon's readers).

The study included 58 patients with a median age of 71 years.

All study participants responded to ther­apy, with 23 per­cent achieving a stringent complete response, 30 per­cent a complete or near complete response, 24 per­cent a very good partial response, and 23 per­cent a partial response.

The one-year pro­gres­sion-free survival rate was 88 per­cent, and the one-year over­all survival rate was 87 per­cent.

The most common severe side effects included low white blood cell counts (15 per­cent), low red blood cell counts (12 per­cent), in­fec­tion (10 per­cent), heart-related issues (5 per­cent), and low platelet counts (5 per­cent).

Kyprolis, Revlimid, And Low-Dose Dexamethasone

The final talk of the session was also about Kyprolis.  Dr. Neha Korde from the National Institutes of Health in Bethesda, Maryland, presented results from a Phase 2 study of Kyprolis in com­bi­na­tion with Revlimid and low-dose dexa­meth­a­sone in newly diagnosed multiple myeloma patients (abstract; presentation slide deck (pdf) made available by Dr. Korde as a courtesy to the Beacon's readers).

The researchers plan to enroll 45 newly diagnosed patients. All patients will receive treat­ment with Kyprolis, Revlimid, and low-dose dexa­meth­a­sone for eight treat­ment cycles. Patients who are in stable disease or better at that point will receive a year of Revlimid main­te­nance ther­apy.

Currently, the study includes 28 patients with a median age of 60 years.

So far, 95 per­cent of the patients responded to the com­bi­na­tion ther­apy, including 65 per­cent who achieved a stringent complete response, 20 per­cent a very good partial response, and 10 per­cent a partial response.

The most common severe side effects were low white blood cell counts (60 per­cent), elevated liver function tests (20 per­cent), fatigue (15 per­cent), rash (15 per­cent), heart failure (10 per­cent), and shortness of breath (10 per­cent).

Myeloma presentations from Day 4 of the ASH 2012 meeting also will be summarized in ASH daily updates to be published at The Beacon the next few days.  Additional coverage of key research results from the meeting will con­tinue throughout the rest of the week in individual, topic-specific news articles.  For all Beacon articles related to this year’s ASH meeting, see The Beacon’s full ASH 2012 coverage.