The Beacon will be publishing a news item Sunday morning (Eastern time) with an update on the key news from Day Two of the ASCO annual meeting. Here, however, is quick update.
Some of the key highlights of the day were the clinical study results presented at the symposium late Saturday afternoon. The symposium's theme was "Novel Therapies for Myeloma," and the results of four studies were presented and then discussed.
The first study presented was the Phase 2 carfilzomib single agent study in relapsed/refractory patients. Response was much higher in Velcade-naïve patients (45- 55 percent versus 21 percent). Duration of response was significant even in patients achieving only minimal response. Side effects were described as clinically manageable. Due to a lack of significant adverse events, Dr. Ravi Vij of Washington University (St. Louis) said that the results suggest carfilzomib is favorable for use in combination with other treatments. Additionally, due to the lack of side effects, there is interest in studying carfilzomib at much higher doses, similar to doses being tested in solid tumors.
The second study presented was a Phase 1b study of panobinostat in combination with Velcade and dexamethasone in relapsed/refractory patients. The overalll response rate (ORR) was 70 percent overall, and 60 percent in Velcade-refractory patients. The researchers have only collected about 3 months of data, so no time to progression data have been gathered yet. A significant percent of patients experienced low blood cell counts, but Dr. Kenneth Anderson of Harvard University said these side effect cases were manageable. Dr. Anderson also said that this is the most responsive combination in Velcade-refractory patients. A phase 3 trial of panobinostat and Velcade vs. Velcade alone is ongoing.
The third study presented was a Phase 2 study of pomalidomide in combination with dexamethasone in heavily pre-treated myeloma patients. The presentation was made by Dr. Martha Lacy of the Mayo Clinic. The ORR was 26 percent, and 54 percent achieved at least a minimal response. Time to response was only 1 month, which is considered very rapid. Dr. Bart Barlogie of the University of Arkansas suggested that maybe this combination should be used upfront since the response is so rapid. Overall survival was 86 percent at 6 months. Responses were similar in low and high risk patients, which is atypical. Future studies are likely to examine the safety and efficacy of a higher dose of pomalidomide.
The fourth study presented was a Phase 1 trial of elotuzomab plus Velcade in relapsed/refractory patients. The ORR was 48 percent, and 64 percent achieved at least a minimal response. Time to progression was 9.5 months overall and also in Velcade-refractory patients. The most common side effects were fatigue, anemia, and diarrhea. The most common serious side effect was lymphopenia (lymphocytopenia, or low levels of lymphocyte white blood cells). The elotuzumab plus Velcade combination appeared to be well tolerated with no dose limiting toxicities. The researchers believe that elotuzumab and Velcade may have a synergistic effect.
Forums
2 posts
• Page 1 of 1
Re: ASCO 2010: Day Two Highlights (Quick Update)
There also was some news worth reporting from Saturday's poster session on lymphoma, myeloma, and other hematologic cancers.
The poster session on Saturday (ASCO 2010 Day Two) was much larger than the poster session on Friday (Day One). There were nearly 40 posters relating to multiple myeloma at Saturday's session. Of those 40, we thought three were particularly worth highlighting.
One poster reported on a study that tested whether Velcade is able to overcome the chromosomal abnormality “translocation t(4;14),” which has been shown to have a significantly negative impact on patient response to treatment. The results showed that the abnormality had less of a negative effect on survival in patients treated with Velcade (bortezomib) and dexamethasone (Decadron) followed by high-dose melphalan compared to standard treatment with vincristine, doxorubicin (Adriamycin), plus dexamethasone.
In order to test carfilzomib’s effects on kidney function, a Phase 2 study presented in another poster tested carfilzomib in patients with a range of kidney function. Side effects were similar among patients with normal, mild, or moderate kidney impairment, and the study authors concluded that carfilzomib can be administered safely to patients with significant kidney impairment. Additionally, blood concentrations of the drug were similar in each group of patients, suggesting that no dose adjustments are necessary based on kidney function.
The third poster reported on two studies currently looking at the combination of Zolinza (vorinostat) and Velcade in pretreated myeloma patients. The first, a Phase 3 study, is investigating Zolinza in combination with Velcade compared to Velcade alone. No efficacy results are available yet. However, the treatment has been well tolerated with low platelet counts being the most common side effect. The second study covered in the poster is a Phase 2b study of Zolinza plus Velcade in heavily pre-treated, Velcade-refractory myeloma patients. Overall, 16 percent of patients achieved at least a partial response.
The poster session on Saturday (ASCO 2010 Day Two) was much larger than the poster session on Friday (Day One). There were nearly 40 posters relating to multiple myeloma at Saturday's session. Of those 40, we thought three were particularly worth highlighting.
One poster reported on a study that tested whether Velcade is able to overcome the chromosomal abnormality “translocation t(4;14),” which has been shown to have a significantly negative impact on patient response to treatment. The results showed that the abnormality had less of a negative effect on survival in patients treated with Velcade (bortezomib) and dexamethasone (Decadron) followed by high-dose melphalan compared to standard treatment with vincristine, doxorubicin (Adriamycin), plus dexamethasone.
In order to test carfilzomib’s effects on kidney function, a Phase 2 study presented in another poster tested carfilzomib in patients with a range of kidney function. Side effects were similar among patients with normal, mild, or moderate kidney impairment, and the study authors concluded that carfilzomib can be administered safely to patients with significant kidney impairment. Additionally, blood concentrations of the drug were similar in each group of patients, suggesting that no dose adjustments are necessary based on kidney function.
The third poster reported on two studies currently looking at the combination of Zolinza (vorinostat) and Velcade in pretreated myeloma patients. The first, a Phase 3 study, is investigating Zolinza in combination with Velcade compared to Velcade alone. No efficacy results are available yet. However, the treatment has been well tolerated with low platelet counts being the most common side effect. The second study covered in the poster is a Phase 2b study of Zolinza plus Velcade in heavily pre-treated, Velcade-refractory myeloma patients. Overall, 16 percent of patients achieved at least a partial response.
2 posts
• Page 1 of 1
Return to Treatments & Side Effects