June 2, 2014
MMRF Newsflash from ASCO 2014 - Volume 2
Welcome to our second day of on-site coverage of the 2014 American Society of Clinical Oncology (ASCO) Annual meeting featuring the oral sessions presented this morning.
Exciting results for three new, novel drugs studied in patients with relapsed/refractory myeloma were presented.
- Results of a large Phase III trial of panobinostat, a new type of myeloma drug called a HDAC inhibitor, were reported. Panobinostat is likely to be the next new agent to be approved by the FDA for relapsed/refractory multiple myeloma. This study evaluated panobinostat in combination with Velcade-dex and showed significantly improved outcomes as compared to Velcade-dex alone. The Multiple Myeloma Research Consortium (MMRC), an affiliation organization of the MMRF, participated in the early Phase I study of this combination. See the press release describing today’s results and the FDA review status.
- In the Phase III study, time without progression of myeloma was prolonged –an average of 12 months with the panobinostat-Velcade-dex versus 8.1 months with Velcade-dex alone. While there was no difference in overall response rates, complete/near complete responses were much higher with panobinostat (28% versus 15% with Velcade-dex) and patients with high-risk myeloma appeared to benefit.
- However, there were severe side effects including low platelet counts (which led to hemorrhage in a few patients), diarrhea and fatigue.
- One of the experts commented on the data, stating that panobinostat offered an advance and was worthy of FDA approval. Of note, there are other HDAC inhibitors in development that may potentially have the potential to offer benefits with possibly of fewer side effects.
- Impressive data from small early studies was presented for two new monoclonal antibodies, SAR650984 and daratumumab.
- Dr. Thomas Martin reported the results of the study evaluating the combination of SAR650984 and Revlimid-dex in highly refractory patients who had previously received six prior myeloma treatments. 58% of patients responded to this combination and side effects tended to be mild. This study was conducted by the MMRC and the MMRC is closely collaborating with Dr. Martin and Sanofi, the manufacturer of SAR650984, on the development of this drug.
- 67% of patients who had previously received an average of 4-5 prior therapies responded to daratumumab. This is the first trial in which anti-myeloma activity was seen with a monoclonal antibody used as a single agent. Daratumumab was also well tolerated. Phase III trials evaluating daratumumab in combination with Revlimid-dex are ongoing.
The question of how long newly diagnosed patients should be treated has been the subject of debate. One large study with Revlimid-dex previously reported that better outcomes were achieved when patients were treated continuously as opposed to a fixed duration of therapy. Today, an analysis of three large studies, including approximately 1200 newly diagnosed patients, confirmed these findings. Myeloma treatments included both Revlimid and Velcade-based therapies.
- Patients receiving continuous treatment lived longer: 4 year survival was 69% versus 60%
- Time without progression of myeloma was doubled in patients receiving continuous therapy: 32 months versus 16 months
One of the experts discussing this presentation, noted that questions still remain about which patients will derive the greatest benefit from continuous therapy based on the specific characteristics of their disease. The answer to this question is a potential outcome of the MMRF CoMMpass Study in which 1,000 newly diagnosed patients will be followed for at least 5 years.
MMRF ASCO Coverage
To see the full MMRF coverage from ASCO with ongoing updates, please visit: www.themmrf.org/asco.