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ASH 2013 Multiple Myeloma Update – Day One

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Published: Dec 8, 2013 5:16 pm

This year’s meeting of the American Society of Hematology (ASH) began yesterday morning in New Orleans.

Myeloma-related presentations were made during several sessions yesterday.

Two sessions were designed to better educate physicians about multiple myeloma and how to treat the disease.

The key myeloma-related research presented yesterday was made public during a poster session in the evening about the biology of myeloma as well as preclinical and clinical studies testing new and existing treatments for myeloma.

During the session, research results were made available for review by meeting attendees in the form of posters, each of which summarized the results of a single study. As is typically the case during such sessions, each poster was about two feet high by three or four feet in length. All the posters — of which there were literally hundreds — were displayed in an exhibit hall covering an area larger than a football field.

Education Sessions

Three presentations were given by myeloma experts during the morning’s Education Session.

The first talk was given by Dr. Ola Landgren from the National Cancer Institute and National Institutes of Health.  Dr. Landgren spoke about biological insights into the myeloma precursor diseases monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma.  He also discussed treatment strategies for high-risk smoldering myeloma, also more recently being called early myeloma.

Dr. Maria-Victoria Mateos from the University Hospital of Salamanca in Spain gave the second presentation.  Dr. Mateos discussed how to treat newly diagnosed myeloma patients, particularly those who are ineligible for stem cell transplantation.

The final talk of the session was given by Dr. Philip McCarthy from Roswell Park Cancer Institute.  Dr. McCarthy continued Dr. Mateos’ discussion of how to treat myeloma patients, focusing on treatment options for transplant-eligible myeloma patients.

In a separate session later in the morning, Dr. Andrzej Jakubowiak from the University of Chicago Medical Center further continued the discussion of how to treat multiple myeloma patients.

Posters About Combinations Of Approved Therapies

A number of posters presented results from clinical studies testing combinations of already approved anti-myeloma drugs.

In particular, there were several studies of Kyprolis (carfilzomib)-based combinations as well as several studies of Pomalyst (pomalidomide, Imnovid)-based combinations.

One poster summarized results from a Phase 1 study of once-weekly (rather than twice-weekly) Kyprolis plus dexamethasone (Decadron) for relapsed or refractory myeloma (abstract).  The results show that two-thirds of the patients responded to weekly Kyprolis and dexamethasone therapy, which compares favorably to the 55 percent to 60 percent response rate seen with twice-weekly Kyprolis. The median time to response was one month, which the investigators described as rapid.

Results were also presented from a Phase 1/2 study of Kyprolis in combination with melphalan and prednisone for older newly diagnosed myeloma patients (abstract).  Overall, 91 percent of patients responded, with 55 percent achieving at least a very good partial response.  The median event-free survival was 22 months, and the two-year overall survival was 84 percent.  In addition, only 6 percent of the study participants developed moderate or severe peripheral neuropathy (pain, tingling, or loss of sensation in the extremities), making it a safe and effective option for older patients.

Another poster summarized results from a pilot study of Kyprolis in combination with Revlimid (lenalidomide) and dexamethasone followed by extended Revlimid dosing for high-risk smoldering myeloma (abstract).  Among the 12 patients evaluated for response, all achieved at least a near complete response.  In addition, 92 percent had no minimal residual disease detected.

Two studies of Pomalyst in combination with Velcade (bortezomib) and dexamethasone for relapsed or refractory myeloma were presented during tonight’s poster session (abstract and abstract).  In the two studies, 71 percent to 94 percent of patients, including those resistant to previous Revlimid therapy, responded to the Pomalyst-based combination.

Another poster summarized results from a Phase 2 study of Pomalyst in combination with clarithromycin (Biaxin) and dexamethasone for relapsed or refractory myeloma (abstract).  Overall, 61 percent of study participants responded, and 56 percent of patients previously resistant to both Revlimid and Velcade therapy responded.  The median progression-free survival was 9 months, more than double the progression-free survival of Pomalyst plus dexamethasone alone, and the median overall survival was 19 months.

Another study presented at tonight’s poster presentation session looked at how prior Revlimid or thalidomide (Thalomid) therapy affected response to Pomalyst (abstract).  The results show that patients whose last line of therapy contained Revlimid or thalidomide are less likely to respond to Pomalyst (29 percent response rate compared to 44 percent for those who did not receive either of these drugs in their last line of therapy) and their median duration of treatment was also shorter (5.7 months versus 7.3 months).  Among those previously treated with Revlimid or thalidomide at any point, those who had a shorter duration of Revlimid or thalidomide treatment and those who had more time between Revlimid/thalidomide treatment and start of Pomalyst treatment were more likely to respond to Pomalyst.

Another study that looked at sequencing of Pomalyst and Kyprolis (abstract) suggests that heavily pretreated patients achieve deeper responses if treated first with Kyprolis and then with Pomalyst; however, the researchers state that longer follow-up is needed to assess duration of response before any conclusions can be drawn.

In addition, several posters were presented this evening that reported on Velcade and Revlimid studies.

One poster showed that reduced-doses of Velcade, cyclophosphamide (Cytoxan), and dexamethasone are safe and effective for older, frail newly diagnosed or refractory myeloma patients (abstract).  Overall, 91 percent of patients responded to the Velcade-based therapy.  Overall survival was 81 percent at one year, 63 percent at two years, and 46 percent at three years.  The researchers state that these results are similar to those seen for this combination using standard doses; however, side effects were less common with the reduced-dose regimen.

Another study showed that Velcade-based therapy is effective after treatment with Kyprolis (abstract).  Overall, 81 percent of patients previously treated with Kyprolis later responded to Velcade-based therapy, including those who had also been treated with Velcade prior to Kyprolis therapy and those who were resistant to Kyprolis therapy.

Another poster summarized results of a study that investigated the efficacy of adding clarithromycin to Revlimid plus dexamethasone therapy for myeloma patients who progressed on the two-drug combination (abstract).  Overall, 42 percent of patients responded to the three-drug combination; patients who initially responded to Revlimid plus dexamethasone were more likely to respond when clarithromycin was added compared to those who did not initially respond to the two-drug combination (60 percent versus 29 percent).  The median progression-free survival was four months, and the median overall survival was 25 months.

Another poster presented results from an analysis of second cancers among myeloma patients treated with Revlimid (abstract).  Half of the patients received Revlimid therapy as part of their initial treatment, transplant-eligible patients underwent stem cell transplantation, and half of the patients received Revlimid maintenance therapy.  Among the 2,371 patients included in the study, 0.7 percent developed a second cancer within a median follow-up time of 1.36 years from the start of treatment.  About half (47 percent) of the patients who developed a second cancer received Revlimid as part of their treatment.  The researchers therefore conclude that their data do not confirm previous findings that Revlimid and stem cell transplantation increase a patient’s risk of developing a second cancer.

Posters About New Myeloma Treatments

As previously highlighted in The Beacon’s ASH Previews, a number of poster presentations are being made at ASH about results from clinical and preclinical studies of new drugs being developed for the treatment of multiple myeloma.

Yesterday evening’s poster session included presentations about filanesib (ARRY-520), AT7519M, Cialis (tadalafil), daratumumab, FV-162, ixazomib (MLN9708), KW-2478, NOX-A12, panobinostat, quisinostat, rocilinostat (ACY-1215), selinexor (KPT-330), SNS01-T, TH-302, tivantinib (ARQ197), veliparib, and myeloma vaccines called ImMucin and Prevnar.

A number of these drugs look very promising.

One of the posters summarized initial findings from an ongoing Phase 1/2 trial investigating dara­tu­mu­mab in com­bi­na­tion with Revlimid and dex­a­meth­a­sone in re­lapsed and refractory multiple myeloma patients (abstract, full poster [PDF]).  Of the 11 patients evaluable for response, 73 percent have so far responded to the three-drug treatment. Depth of re­sponse also has been promising, with 46 percent of the patients achieving a very good partial re­sponse or complete re­sponse. According to the investigators, these results merit further clinical development of the three-drug combination.

Another poster from the session presented results from a Phase 1/2 study of panobinostat plus Kyprolis (abstract).  Among the 44 relapsed and refractory patients enrolled in the study, nearly two-thirds (64 percent) of the patients responded.  The one-year progression-free survival rate was 41 percent, and the one-year over­all survival rate was 85 percent.

One of the posters presented results from a Phase 2a study of NOX-A12 in combination with Velcade and dexamethasone for relapsed myeloma (abstract).  Among the nine patients evaluated for response so far, 67 percent responded to the combination.

Results were also presented from a Phase 1/2 study of KW-2478 plus Velcade for the treatment of re­lapsed and refractory myeloma (abstract).  Among the 79 patients from Phase 2 of the study who were evaluated for response, 38 percent responded.  Median progression-free survival was 7 months.

Another poster presented updated results from a Phase 1 study of veliparib in combination with Velcade and dexamethasone in relapsed and refractory myeloma patients (abstract).  Of the 18 patients evaluated for response, 39 percent of patients responded.  The median progression-free survival was 5 months, and 71 percent were alive at 18 months.

A poster presenting results from a Phase 1/2 study showed that AT7519M is active when administered in combination with Velcade (abstract; full poster [PDF]).  Among the nine relapsed and refractory patients treated in Phase 2 of the study, 33 percent responded to the combination.

One of the posters presented yesterday summarized initial findings of a Phase 1 trial of filanesib in com­bi­na­tion with Velcade (and, in many cases, dex­a­meth­a­sone) in re­lapsed and refractory multiple myeloma patients (abstract; full poster [PDF]). So far, 28 patients have been treated with varying doses of filanesib and Velcade.  The over­all re­sponse rate at the higher doses of filanesib was about 42 percent.

Initial results were also presented for a Phase 2 study of newly diagnosed myeloma patients who underwent stem cell transplantation and then received ixazomib plus Revlimid as maintenance therapy (abstract). Among 20 patients enrolled in the study, three have dis­con­tinued maintenance therapy and the rest have remained on therapy for up to 11 cycles. According to the investigators, the com­bi­na­tion seems to be well tol­er­ated.

Another ixazomib-related poster summarized results of a trial investigating the drug as a single agent in re­lapsed myeloma patients who are not resistant to treatment with Velcade (abstract).  This trial included 32 patients who were initially treated with only ixazomib; 63 percent of the patients had dex­a­meth­a­sone added to their treatment due to minimal re­sponse to ixazomib alone or disease progression.  Thus far, the over­all re­sponse rate has been 16 percent among patients treated with ixazomib alone, and 34 percent in those treated with both ixazomib and dex­a­meth­a­sone.

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Myeloma presentations from Day 2, Day 3, and Day 4 of the ASH 2013 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 a list of all myeloma-related ASH abstracts, a schedule of the myeloma-related ASH sessions, and all Beacon articles related to this year’s ASH meeting, see The Beacon’s ASH 2013 Myeloma Gateway.

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  • Terri J said:

    Instead of drugs are they discussing the Gene Therapy of T-cell alteration done by researchers especially those at University of Pennsylvania Hospital in Philadelphia?

  • Mike F. said:

    Uh, did they say Cialis?

  • Julie Shilane (author) said:

    Terri — gene therapy and T-cell modification are being discussed at ASH as well. Several of those studies were summarized in an article we published prior to ASH previewing novel immunotherapies that are being presented at ASH: http://www.myelomabeacon.com/news/2013/11/23/ash-2013-preview-immunotherapy-multiple-myeloma/

    Mike — yes, that’s right. Cialis was studied in a myeloma clinical trial. It was added to Revlimid-based regimens to which patients had previously failed to respond; however, it did not re-sensitize patients to their prior regimens: http://www.myelomabeacon.com/resources/mtgs/ash2013/abs/1959/

  • Mike F. said:

    Thanks, Julie.

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