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.
ASCO 2017 – Monday Blog
ASCO 2017 – Monday Blog
Today at ASCO, there were several sessions reporting new and interesting information for patients.
Today at ASCO, there were several sessions reporting new and interesting information for patients. Topics included:
- Advances in Immune Therapy
- Optimizing stem cell transplant
- Controlling side effects from therapy
Advances in Immune Therapy
- An exciting update of a new CAR-T cell therapy for relapsed/refractory MM (RRMM) patients was presented. These are T cells engineered to recognize a target called BCMA on the surface of MM cells so that they can be recognized and killed by a patient’s own immune system. In this study, 21 patients were treated. The data showed that MM cells were cleared from the bone marrow by as early as day 14 after the T cell infusion. In all, 20 of the 21 treated patients had a partial to complete response, which, though preliminary, is very promising in these heavily pre-treated patients. Responses lasted more than a year in some patients. CAR-T therapy is a very promising new therapy for MM patients, but a small number of studies in very few patients have been done so far; more studies are underway from a number of companies.
- MMRC member institution Memorial Sloan Kettering Cancer Center gave a presentation on a new cancer vaccine for patients following stem cell transplant. The target of the vaccine is WT1, which is present on the surface of MM cells. This small Ph1 study of 18 patients showed encouraging results in overall and progression free survival; a Ph2 study is planned.
- A small study of 62 heavily pretreated relapsed refractory MM patients (KEYNOTE-023) looked at antitumor activity of the checkpoint inhibitor Keytruda (pembrolizumab), a checkpoint inhibitor that is FDA approved for the treatment of other cancers, in combination with Revlimid. Results showed promising activity with manageable side effects. Ph3 trials of this combination are planned.
Optimizing Stem Cell Transplant
- A report on the StaMINA trial, a large Phase 3 trial of almost 750 patients comparing RVD induction followed by a single or double transplant and Revlimid maintenance, showed that depth of response in first line therapy, pre-transplant, did not affect the overall survival or, how long patients were able to live without a relapse after transplant. In this study, patients who received Revlimid after transplant, as maintenance, did better regardless of their pre-transplant disease status.
- A presentation on the Myeloma XI study showed a similar result; in this large study of 2042 newly diagnosed transplant eligible MM patients, patient who received Revlimid as front line therapy pre-transplant, and then again as maintenance therapy post-transplant, showed improved response rates. This positive data, as well as data from other studies, helped win approval for Revlimid as a maintenance therapy earlier this year.
Managing MM treatment side effects
- Cardiotoxicity of Kyprolis – cardiovascular side effects with Kyprolis such as heart failure, high blood pressure, and change in heart rhythms are uncommon but well-documented and very serious. Researchers analyzed 24 MM trials of Kyprolis and analyzed how often cardiac events occurred. High blood pressure (12.2% of patients) and congestive heart failure (4% of patients) were the most common serious side effects of Kyprolis, and mainly occurred at higher doses. This data emphasizes the importance of closely monitoring patients taking Kyprolis and indicates new research to prevent these side effects is warranted.
- IMiDs treatment can increase the incidence of blood clots. A study on a new blood thinner called apixaban showed that this drug, which is taken orally, is effective in preventing blood clots in patients taking IMiDs and did not increase the bleeding events that can come with blood thinner use. More studies are planned.
- New technology has enabled the counting of MM cells circulating in the blood. These are called CPC, or circulating plasma cells. In a study of 247 patients, the number of CPC found in MM patients before transplant was a strong predictor of how well these newly diagnosed patients would respond to treatment. The ability to predict outcome was superior than cytogenetics, or FISH assays. Measurement of CPC may in the future be able to replace a bone marrow biopsy as a leading indicator of disease status in MM patients, but more work is needed to increase the sensitivity of the assay.
