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ASCO 2012 Multiple Myeloma Update – Day Four: Poster Presentations On New Myeloma Treatments

By: Julie Shilane; Published: June 4, 2012 @ 8:23 pm | Comments Disabled

This year’s American Society of Clinical Oncology (ASCO) annual meeting, which is being held in Chicago, began on Friday and goes through tomorrow. How­ever, to­day is the last day with any myeloma-related sessions.

Several myeloma-related oral pre­sen­ta­tions were given this morn­ing and were summarized in an up­date pub­lished earlier to­day (see re­lated Beacon [1] news).

This afternoon featured a poster session in which im­por­tant new re­search findings were summarized on posters throughout a large conference hall.

The stud­ies pre­sented this afternoon were on a wide variety of myeloma-related topics ranging from new treat­ments being devel­oped for myeloma, to cur­rently used regi­mens, to sec­ond­ary cancers, to precursor myeloma dis­eases, and much more.

This up­date covers some of the myeloma-related stud­ies pre­sented during the poster session. In par­tic­u­lar, this article covers posters about new treat­ments that are being devel­oped for myeloma.  Some of the posters in­cluded pre­lim­i­nary re­­sults from on­go­ing clin­i­cal trials.  Others described the design of on­go­ing clin­i­cal trials for which re­­sults are not yet avail­able.

Additional up­dates will summarize posters from this afternoon that were about other myeloma-related topics.

Carfilzomib

The session in­cluded posters about three dif­fer­en­t carfilzomib [2] (Kyprolis [3]) stud­ies, one of which -- described a bit fur­ther below -- studied the com­bi­na­tion of car­filz­o­mib and panobinostat [4] (Farydak [5]).

Carfilzomib is being devel­oped by Onyx Pharma­ceu­ticals (NASDAQ: ONXX). It works similarly to Velcade [6] (bor­tez­o­mib) and is cur­rently being reviewed by the U.S. Food and Drug Admin­istra­tion for po­ten­tial ap­prov­al as a new myeloma treat­ment.

One poster highlighted re­­sults from a Phase 1/2 study of the safety and ef­fi­cacy of car­filz­o­mib as a replacement ther­apy for Velcade in patients who progressed while taking Velcade-containing regi­mens (abstract [7]). Early re­­sults of the study sug­gest that car­filz­o­mib is an ef­fec­tive and tol­er­able re­place­ment for Velcade in these patients.

The study in­cluded 27 patients who had re­ceived a median of six pre­vi­ous lines of ther­apy.  Of the 27 patients, 22 of whom were eval­u­ated for re­sponse. The over­all re­sponse rate was 51 per­cent, with 23 per­cent of patients achieving a com­plete re­sponse, 5 per­cent a very good partial re­sponse, and 23 per­cent a partial re­sponse.

The median pro­gres­sion-free sur­vival time was 9.8 months.

The most common severe side effects were low platelet and lym­pho­cyte counts as well as fever, pneu­monia, and sepsis.

Another car­filz­o­mib poster summarized re­­sults of an analysis of the safety of car­filz­o­mib in re­lapsed and re­frac­tory myeloma patients. In the analysis, re­searchers assessed the rate of var­i­ous blood-related side effects in 526 myeloma patients treated with single-agent car­filz­o­mib across four dif­fer­en­t Phase 2 stud­ies (abstract [8]).

According to the study in­ves­ti­ga­tors, 70 per­cent of patients treated with car­filz­o­mib ex­peri­enced blood-related side effects.  However, severe to life-threatening blood-related side effects were both infrequent and lasted for short periods of time. These in­cluded low platelet, lym­pho­cyte, neu­tro­phil, and red blood cell counts.

Based on their re­­sults, the re­searchers concluded that the safety profile of car­filz­o­mib was similar to or better than that of cur­rently approved myeloma ther­a­pies.

Carfilzomib Plus Panobinostat

The final car­filz­o­mib-related poster described an on­go­ing Phase 1/2 clin­i­cal trial eval­u­ating the safety and ef­fi­cacy of the com­bi­na­tion of car­filz­o­mib plus panobinostat for the treat­ment of re­lapsed and re­frac­tory mul­ti­ple myeloma (abstract [9]).  Results are not yet avail­able for this trial.

Panobinostat is an oral drug that is being devel­oped by the pharma­ceutical com­pany Novartis (NYSE: NVS) for a variety of dif­fer­en­t cancers. It belongs to a class of drugs called histone deacetylase (HDAC) in­hib­i­tors, which work by in­creas­ing the pro­duc­tion of pro­teins that slow cell division and cause cell death.

The study plans to en­roll up to 52 re­lapsed or re­frac­tory myeloma patients.

The Phase 1 portion of the study will in­clude approx­i­mately 24 patients and will de­ter­mine the max­i­mum tol­er­ated doses of car­filz­o­mib and panobinostat when admin­istered to­geth­er.

In the Phase 2 portion of the study, approx­i­mately 25 patients will re­ceive treat­ment with the optimal doses of the car­filz­o­mib-panobinostat com­bi­na­tion. Re­searchers will then eval­u­ate the over­all re­sponse rate, time to pro­gres­sion, pro­gres­sion-free sur­vival, and over­all sur­vival of patients treated with this regi­men as well as the safety of the regi­men.

Elotuzumab

The session also in­cluded four dif­fer­en­t posters about elotuzumab [10] stud­ies.

Elotuzumab is a mono­clonal anti­body being devel­oped by Bristol-Myers Squibb (NYSE: BMY).  It works by identifying pro­teins on the surface of myeloma cells and signalling for the im­mune sys­tem to destroy the cancer cells.

Three posters described the designs of on­go­ing clin­i­cal trials investigating elotuzumab-containing regi­mens. Results are not yet avail­able for these trials.

Two of the stud­ies are Phase 3 clin­i­cal trials investigating the com­bi­na­tion of elotuzumab, Revlimid [11] (lena­lido­mide), and dexamethasone [12] (Decadron) com­pared to Revlimid plus dexa­meth­a­sone alone.

One of these trials plans to test the com­bi­na­tion in 750 newly diag­nosed myeloma patients who are in­eli­gible for stem cell trans­plan­ta­tion (abstract [13]).  The other plans to test the com­bi­na­tion in 640 re­lapsed and re­frac­tory myeloma patients (abstract [14]).

Another on­go­ing study is a Phase 2 clin­i­cal trial investigating the com­bi­na­tion of elotuzumab, Velcade, and dexa­meth­a­sone com­pared to Velcade plus dexa­meth­a­sone alone (abstract [15]).  The trial plans to test the com­bi­na­tion in 150 re­lapsed and re­frac­tory myeloma patients.

In each of these trials, patients will be eval­u­ated for re­sponse.  Progression-free sur­vival and over­all sur­vival will also be tracked.

Another poster pre­sented a laboratory study in which re­searchers in­ves­ti­gated whether the com­bi­na­tion of elotuzumab plus Revlimid dem­onstrates greater anti-myeloma ac­­tiv­ity com­pared to elotuzumab or Revlimid alone (abstract [16]).

The re­searchers found that when myeloma cells and blood cells were incubated with elotuzumab or Revlimid alone, some of the myeloma cells died.  However, sig­nif­i­cantly more myeloma cells were killed when treated with the com­bi­na­tion of elotuzumab and Revlimid.  The re­searchers also showed that elotuzumab activated cer­tain im­mune cells known as natural killer cells, which kill myeloma cells.

SNS01-T

Another poster from the session described the design of an on­go­ing Phase 1/2 trial investigating the safety and tol­er­a­bil­ity of SNS01-T [17] in re­lapsed and re­frac­tory mul­ti­ple myeloma patients (abstract [18]).  Results are not yet avail­able for this trial (see up­date below).

SNS01-T is being devel­oped by the pharma­ceu­tical com­pany Senesco (NYSEAMEX: SNT). It sel­ectively causes cells to die by targeting a pro­tein called eIF5A, which is be­lieved to be an im­por­tant regulator of cell growth and cell death.

The trial plans to en­roll 15 patients who are not eli­gible for any standard treat­ment op­tions.  They will be divided into sev­er­al groups, each of which will re­ceive a higher dose of SNS01-T.

Participants will be eval­u­ated for re­sponse, and pro­gres­sion-free and over­all sur­vival will also be tracked.

Update (June 6, 2012; 11:00 am) - In a press re­lease [19] issued on Monday, Senesco re­leased initial re­­sults from the trial that were not in­cluded in the poster pre­sented at ASCO.   The com­pany reported that five patients have been en­rolled in the study so far.  Additionally one has com­pleted treat­ment and has achieved stable dis­ease.  However, two patients dis­con­tinued ther­apy due to dis­ease pro­gres­sion. No dose-limiting side effects have been reported.

Myeloma Vaccine

The search for vaccines [20] to treat mul­ti­ple myeloma and other cancers has been under way for sev­er­al years.  Another poster from this afternoon’s session described the design of an on­go­ing Phase 1 clin­i­cal trial investigating a vaccine for the treat­ment of myeloma patients undergoing stem cell trans­plan­ta­tion (abstract [21]). Results are not yet avail­able for this trial.

The vaccine, which is being devel­oped by GlaxoSmithKline (NYSE: GSK), targets the pro­tein MAGE-A3, which is present on the surface of myeloma and other cancer cells, but not nor­mal cells.  The vaccine trains im­mune cells to attack cells with MAGE-A3 on their surface.  The vaccine is in Phase 3 trials for lung cancer and mel­anoma.  However, this is the first time the vaccine is being tested for myeloma or in patients undergoing stem cell trans­plan­ta­tion.

The trial plans to en­roll 16 patients who have been diag­nosed with mul­ti­ple myeloma within the last year and achieved at least a very good partial re­sponse to their induction ther­apy.

Patients will be vaccinated six weeks before their stem cell trans­plant.  Three weeks after vaccination, lym­pho­cytes (a type of im­mune cell that have hopefully been trained by the vaccine to attack myeloma cells) will be collected.  These will be re-infused three days after stem cell trans­plan­ta­tion.  Patients will be vaccinated seven more times within the nine months fol­low­ing their trans­plant.

Additional myeloma-related posters from to­day, Day 4 of the ASCO 2012 meeting, also will be summarized in ASCO daily up­dates to be pub­lished tomorrow.  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 ASCO meeting, see The Beacon’s full ASCO 2012 [22] coverage.


Article printed from The Myeloma Beacon: https://myelomabeacon.org

URL to article: https://myelomabeacon.org/news/2012/06/04/asco-2012-multiple-myeloma-update-day-four-poster-presentations-on-new-myeloma-treatments/

URLs in this post:

[1] Beacon: https://myelomabeacon.org/news/2012/06/04/asco-2012-multiple-myeloma-update-day-four-immunotherapy-for-myeloma/

[2] carfilzomib: https://myelomabeacon.org/resources/2009/06/04/carfilzomib/

[3] Kyprolis: https://myelomabeacon.org/tag/Kyprolis/

[4] panobinostat: https://myelomabeacon.org/resources/2009/12/03/panobinostat/

[5] Farydak: https://myelomabeacon.org/tag/farydak/

[6] Velcade: https://myelomabeacon.org/resources/2008/10/15/velcade/

[7] abstract: http://abstract.asco.org/AbstView_114_98181.html

[8] abstract: http://abstract.asco.org/AbstView_114_91894.html

[9] abstract: http://abstract.asco.org/AbstView_114_98335.html

[10] elotuzumab: https://myelomabeacon.org/resources/2009/12/03/elotuzumab/

[11] Revlimid: https://myelomabeacon.org/resources/2008/10/15/revlimid/

[12] dexamethasone: https://myelomabeacon.org/resources/2008/10/15/dexamethasone/

[13] abstract: http://abstract.asco.org/AbstView_114_92792.html

[14] abstract: http://abstract.asco.org/AbstView_114_92317.html

[15] abstract: http://abstract.asco.org/AbstView_114_92855.html

[16] abstract: http://abstract.asco.org/AbstView_114_92226.html

[17] SNS01-T: https://myelomabeacon.org/tag/sns01-t/

[18] abstract: http://abstract.asco.org/AbstView_114_99926.html

[19] press re­lease: http://www.businesswire.com/news/home/20120604005312/en/Senesco-SNS01-T-Update-Phase-1b2a-Multiple-Myeloma

[20] vaccines: https://myelomabeacon.org/tag/cancer-vaccine/

[21] abstract: http://abstract.asco.org/AbstView_114_96605.html

[22] ASCO 2012: https://myelomabeacon.org/tag/asco-2012-meeting/

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