This forum thread can be used to discuss the proceedings of the American Society of Clinical Oncology that take place on Day 4 (Monday, June 6) of the conference. Feel free to use this space to highlight interesting abstracts, summarize the presentations as they happen, ask questions, and discuss any relevant topics. Everyone is encouraged to participate.
Feel free to also check out the discussions for Day 1 & 2, and Day 3.
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Re: ASCO 2011 Multiple Myeloma Discussion - Day 4
This morning started with a session recapping yesterday’s highlights. Researchers representing four different types of cancer were each allowed to talk for 15 minutes about the highlights from their disease area that were presented at the meeting yesterday. Among all of the cancers being discussed at the meeting, breast cancer, lung cancer, multiple myeloma, and pediatric oncology were each represented during the session. Dr. Ivan Borrello from the Johns Hopkins University School of Medicine recapped the myeloma highlights.
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Julie Shilane - Name: Julie Shilane, Beacon Staff
Re: ASCO 2011 Multiple Myeloma Discussion - Day 4
The rest of today’s myeloma-related presentations are poster presentations. There was one poster session this morning with three myeloma-related posters. There will also be a poster session this afternoon with a number of myeloma-related posters.
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Julie Shilane - Name: Julie Shilane, Beacon Staff
Re: ASCO 2011 Multiple Myeloma Discussion - Day 4
Elotuzumab is an antibody that is being tested for the treatment of multiple myeloma. It recognizes certain proteins called CS1 that are on the surface of myeloma cells, but not normal cells, and then triggers natural killer cells of the immune system to kill the cancer cells. A study presented during the poster session showed that elotuzumab also directly activates natural killer cells by recognizing the same CS1 proteins on the surface of the natural killer cells. Once elotuzumab activates these natural killer cells, they then kill the myeloma cells.
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Julie Shilane - Name: Julie Shilane, Beacon Staff
Re: ASCO 2011 Multiple Myeloma Discussion - Day 4
This poster session also highlighted two multiple myeloma clinical trials that are in progress.
The first is a large Phase 3 clinical trial comparing the efficacy of carfilzomib-Revlimid (lenalidomide)-dexamethasone (Decadron) combination therapy in relapsed patients with a current standard of care, Revlimid-dexamethasone alone. This combination is of particular interest because Velcade (bortezomib)-Revlimid-dexamethasone is extremely effective; however, some patients have difficulty tolerating the peripheral neuropathy (pain and tingling in the extremities) that can accompany Velcade therapy. Carfilzomib, which works similarly to Velcade, appears to be more tolerable. This trial is still enrolling relapsed / refractory myeloma patients who have received one to three prior therapies. As of April, 149 participants have been enrolled, with a final accrual goal of 700.
The first is a large Phase 3 clinical trial comparing the efficacy of carfilzomib-Revlimid (lenalidomide)-dexamethasone (Decadron) combination therapy in relapsed patients with a current standard of care, Revlimid-dexamethasone alone. This combination is of particular interest because Velcade (bortezomib)-Revlimid-dexamethasone is extremely effective; however, some patients have difficulty tolerating the peripheral neuropathy (pain and tingling in the extremities) that can accompany Velcade therapy. Carfilzomib, which works similarly to Velcade, appears to be more tolerable. This trial is still enrolling relapsed / refractory myeloma patients who have received one to three prior therapies. As of April, 149 participants have been enrolled, with a final accrual goal of 700.
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Julie Shilane - Name: Julie Shilane, Beacon Staff
Re: ASCO 2011 Multiple Myeloma Discussion - Day 4
The second ongoing study is a large Phase 3 clinical trial, which is testing whether the addition of panobinostat, an oral agent being developed for multiple myeloma, improves the efficacy of Velcade plus dexamethasone. The study is still enrolling relapsed / refractory myeloma patients who have received one to three prior therapies. A previous Phase 1b study showed that 72 percent of relapsed / refractory patients responded to panobinostat plus Velcade. As of May, about 400 participants have been enrolled, with a final accrual goal of 672 by the end of the year.
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Julie Shilane - Name: Julie Shilane, Beacon Staff
Re: ASCO 2011 Multiple Myeloma Discussion - Day 4
In the afternoon, there were a number of interesting posters on myeloma studies.
One poster presentation was on pomalidomide, an immunomodulatory drug like Revlimid (lenalidomide) and thalidomide (Thalomid) that is being studied for the treatment of multiple myeloma. Preliminary results from the Phase 2 study presented during the afternoon poster session showed that pomalidomide plus dexamethasone is effective in relapsed myeloma patients, including those previously treated with Revlimid. The study included 61 patients with a median age of 65 years. The overall response rate was 35 percent (12 percent very good partial response and 23 percent partial response). Patients responded quickly to this combination, with median time to response being 1.1 months. With a median follow-up of 4.1 months, almost all participants (97 percent) are still alive and two-thirds have not yet progressed.
One poster presentation was on pomalidomide, an immunomodulatory drug like Revlimid (lenalidomide) and thalidomide (Thalomid) that is being studied for the treatment of multiple myeloma. Preliminary results from the Phase 2 study presented during the afternoon poster session showed that pomalidomide plus dexamethasone is effective in relapsed myeloma patients, including those previously treated with Revlimid. The study included 61 patients with a median age of 65 years. The overall response rate was 35 percent (12 percent very good partial response and 23 percent partial response). Patients responded quickly to this combination, with median time to response being 1.1 months. With a median follow-up of 4.1 months, almost all participants (97 percent) are still alive and two-thirds have not yet progressed.
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Julie Shilane - Name: Julie Shilane, Beacon Staff
Re: ASCO 2011 Multiple Myeloma Discussion - Day 4
Another poster included results from a Phase 1b study of panobinostat plus Velcade in 62 relapsed / refractory myeloma patients. Dexamethasone was added for patients who didn’t respond to panobinostat and Velcade alone. The optimal dosing determined during this trial was 20 mg panobinostat three times a week for two weeks followed by a week off. The overall response rate was 55 percent (6 percent complete response, 11 percent very good partial response, 37 percent partial response), and 40 percent of Velcade-refractory patients achieved a partial response. Serious side effects were mostly low blood cell counts but also weakness. Other common side effects included gastrointestinal issues, nausea, fatigue, fever, dizziness, respiratory issues, and peripheral neuropathy. A Phase 3 trial studying this combination is underway, as was highlighted in this morning’s poster session.
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Julie Shilane - Name: Julie Shilane, Beacon Staff
Re: ASCO 2011 Multiple Myeloma Discussion - Day 4
Another poster included results from a Phase 1 study of elotuzumab, Revlimid, and low-dose dexamethasone in 29 relapsed / refractory myeloma patients. Three doses of elotuzumab were tested. The overall response rate was 82 percent for all patients (4 percent complete response, 39 percent very good partial response, and 39 percent partial response) and 95 percent for Revlimid-naïve patients (5 percent complete response, 45 percent very good partial response, and 45 percent partial response). The median time to response was 7 weeks. At the highest dose tested, the median time to progression was not yet reached at a median of 16.4 months follow-up. The combination was generally well tolerated with serious side effects mainly limited to low blood cells counts due to Revlimid and infusion site reactions during the first cycle due to elotuzumab. Other common side effects included fatigue, diarrhea, nausea, and constipation. The middle dose of elotuzumab appeared to have a slightly better response rate than the highest dose, so a Phase 2 study that was presented yesterday during the oral session is currently further evaluating those two doses.
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Julie Shilane - Name: Julie Shilane, Beacon Staff
Re: ASCO 2011 Multiple Myeloma Discussion - Day 4
In addition to the oral presentations on Revlimid and secondary cancers that were held yesterday, there was also a poster on the topic today. The study presented was an analysis of 11 Celgene (the company that markets Revlimid)-sponsored studies in which relapsed / refractory myeloma patients were treated with Revlimid or Revlimid plus dexamethasone. A total of 3,839 patients were included in the analysis.
57 cases of secondary cancers were reported, including 8 cases of myelodysplastic syndromes, 1 acute myeloid leukemia, 2 B-cell malignancies, and 46 solid tumors. 39 percent of the secondary cancers occurred in patients who were treated with Revlimid for more than two years.
Overall, 2.08 percent of the patients developed a secondary cancer each year. The rate of patients developing secondary cancers was similar regardless of length of time on therapy; however, there appeared to be a slight trend toward higher risk with longer therapy (2.12 percent per year for at least one year of treatment, 2.13 percent for at least 18 months of treatment, 2.35 percent for at least two years of treatment, and 2.45 for at least three years of treatment). Although rates of cancers increase with age, there was no correlation between age and rates of secondary cancers: 1.34 percent per year risk in patients less than 65 years, 3.59 percent in patients 65 to 75 years, and 2.46 percent in patients over 75 years.
Rates of secondary cancers varied by type of therapy. The risk of developing a secondary cancer was 2.60 percent per year for Revlimid monotherapy and 2.16 percent for Revlimid plus dexamethasone; 3.96 percent for a cumulative Revlimid dose of less than 2,400 mg and 1.84 percent for a cumulative dose of at least 2,400 mg; and 2.24 percent for patients who had undergone a prior stem cell transplant and 2.15 percent for patients who had not undergone a transplant.
After a median follow-up of almost five years, 4 percent of participants had developed a second hematological cancer, 10 percent developed a solid tumor, and 24 percent died, showing that myeloma patients are at greater risk of dying from myeloma or other causes than developing a second cancer. At three years, the overall survival was similar between patients who developed a secondary cancer and those who did not (51 percent for all participants and 55 percent for patients with a secondary cancer).
The study investigators concluded that the benefit-risk profile for Revlimid therapy remains strongly positive.
The investigators also pointed out, though, that their analysis has a number of limitations: side effect reporting is only robust during active treatment, side effect reporting is not required during long-term follow-up after patients have progressed or discontinued therapy, only survival is followed during long-term follow-up, and early stage secondary cancers may not be readily detected in patients with progressive myeloma.
57 cases of secondary cancers were reported, including 8 cases of myelodysplastic syndromes, 1 acute myeloid leukemia, 2 B-cell malignancies, and 46 solid tumors. 39 percent of the secondary cancers occurred in patients who were treated with Revlimid for more than two years.
Overall, 2.08 percent of the patients developed a secondary cancer each year. The rate of patients developing secondary cancers was similar regardless of length of time on therapy; however, there appeared to be a slight trend toward higher risk with longer therapy (2.12 percent per year for at least one year of treatment, 2.13 percent for at least 18 months of treatment, 2.35 percent for at least two years of treatment, and 2.45 for at least three years of treatment). Although rates of cancers increase with age, there was no correlation between age and rates of secondary cancers: 1.34 percent per year risk in patients less than 65 years, 3.59 percent in patients 65 to 75 years, and 2.46 percent in patients over 75 years.
Rates of secondary cancers varied by type of therapy. The risk of developing a secondary cancer was 2.60 percent per year for Revlimid monotherapy and 2.16 percent for Revlimid plus dexamethasone; 3.96 percent for a cumulative Revlimid dose of less than 2,400 mg and 1.84 percent for a cumulative dose of at least 2,400 mg; and 2.24 percent for patients who had undergone a prior stem cell transplant and 2.15 percent for patients who had not undergone a transplant.
After a median follow-up of almost five years, 4 percent of participants had developed a second hematological cancer, 10 percent developed a solid tumor, and 24 percent died, showing that myeloma patients are at greater risk of dying from myeloma or other causes than developing a second cancer. At three years, the overall survival was similar between patients who developed a secondary cancer and those who did not (51 percent for all participants and 55 percent for patients with a secondary cancer).
The study investigators concluded that the benefit-risk profile for Revlimid therapy remains strongly positive.
The investigators also pointed out, though, that their analysis has a number of limitations: side effect reporting is only robust during active treatment, side effect reporting is not required during long-term follow-up after patients have progressed or discontinued therapy, only survival is followed during long-term follow-up, and early stage secondary cancers may not be readily detected in patients with progressive myeloma.
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Julie Shilane - Name: Julie Shilane, Beacon Staff
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