Rob Miani joined the MMRF team as Chief Financial Officer in 2016. Most recently he was the Vice President of Finance and Corporate Controller of Aptuit, LLC, a global contract research organization providing integrated early discovery to mid-phase drug development services in the pharmaceutical industry. Rob has over 20 years of leadership experience in the private and public sectors, holding managerial positions in the renewable energy, private equity, Internet and technology industries, including Davenport Newberry, Oak Investment Partners and INT Media Group. He began his career with Arthur Anderson LLP in the Assurance and Business Advisory Services Division. Rob is a CPA and received his BS degree in Accounting from Fairfield University.
Day One: ASCO 2016
Day One: ASCO 2016
American Society of Clinical Oncology (ASCO) 2016, the largest international meeting focused specifically on oncology, opened yesterday. Late in the afternoon, the first presentations focused on multiple myeloma (MM) were given. Topics ranged from research centered around better defining and identifying patients with smoldering multiple myeloma (SMM) that is likely to progress toward active MM (i.e. that requires treatment), treatments for patients with newly diagnosed MM to novel treatments and combinations for relapsed and refractory MM.
American Society of Clinical Oncology (ASCO) 2016, the largest international meeting focused specifically on oncology, opened yesterday. Late in the afternoon, the first presentations focused on multiple myeloma (MM) were given. Topics ranged from research centered around better defining and identifying patients with smoldering multiple myeloma (SMM) that is likely to progress toward active MM (i.e. that requires treatment), treatments for patients with newly diagnosed MM to novel treatments and combinations for relapsed and refractory MM.
Here are a few of the highlights:
- Data continue to confirm that superiority of triplet therapy (i.e. three drugs together, typically a proteasome inhibitor, an IMiD and the steroid dexamethasone) vs. doublet therapy for newly diagnosed patients, whether they are planning to have high-dose chemotherapy and a stem cell transplant (HDT/SCT) or not.
- HDT/SCT continues to provide patients with the greatest chance of a durable remission.
- Large data sets continue to support the use of maintenance post-HDT/SCT in terms of prolonging the time before MM returns and overall survival (a new meta-analysis of three studies suggested a 2.5 year improvement in survival), though the data are not entirely consistent, particularly for patients who have higher risk disease.
- The new proteasome inhibitor Ninlaro (ixazomib), which received FDA approval late last year for patients who had had 1 to 3 prior treatments, continues to show promise in new combinations and in earlier disease, and is very well tolerated. More data are needed though to define optimal combinations at various points of the disease course.
- Just like patients with active MM, SMM patients are a diverse group. Two presentations given at this session looked at different ways to predict which SMM patients would be at a greater risk of progression in relatively short timeframe (
- More data continue to emerge on the role of antibodies in treating active MM. Josh Richter from Hackensack presented data on the anti CD38 antibody isatuximab (in the same class as Darzalex or daratumumab) as a single agent in patients with relapsed and refractory disease. This trial, which is currently ongoing, is being conducted in partnership with the MMRF’s clinical network – the MMRC.
- –Patients in the study had received at least three lines of therapy, with the vast majority being refractory to Velcade and Revlimid and nearly one-third refractory to those drugs plus Pomalyst and Kyprolis.
- –Overall, 24% of patients responded to for a median duration of nearly 13 months, which is promising as a single agent in patients for whom so many treatments no longer worked.
- –Most of the toxicities were low blood counts; more than half of patients had infusion reactions, but the vast majority were just with the first or second dose. Infusion times ranged from 3-5 hours.
- –The trial will be re-opening for enrollment this summer, so check the MMRF CoMMunity Gateway for updates!
- Combining Pomalyst with newer proteasome inhibitors like Kyprolis and Ninlaro are yielding promising results. The MMRC had previously conducted a trial led by Paul Richardson of Pomalyst-Velcade-dex, and these newer studies, both also conducted through the MMRC, switched out the Velcade for Kyprolis in one case and Ninlaro in the second.
- Andrzej Jakubowiak presented the data on Kyprolis-Pom-dex in a Revlimid refractory population that had received at least one line of treatment. The study helped to identify a dose of Kyprolis (together with the standard dose of Pomalyst and of dex) to be studied in a larger Phase 2 trial. Thus far, 72% of patients have responded and more than half of patients enrolled have not relapsed after 1 year (and 22% after 2 years). Side effects were generally mild – primarily hematologic as can be expected, and there were no cases of renal failure of heart attack.
- Amrita Krishnan presented very early results from an MMRC study of Ninlaro plus Pom-dex, also intended to find the right dose of Ninlaro to move the combination into a larger Phase 2 trial. Overall, 44% of patients responded (out of 25) with side effects primarily hematologic, fatigue and gastro-intestinal.
Stay tuned as we bring you continued coverage of the MM sessions straight from the meeting in Chicago!
