The market for monoclonal antibodies to treat the blood cancer multiple myeloma may soon become more competitive, following the presentation of Phase III clinical trial data at a cancer conference.
At the American Society of Clinical Oncology’s 2019 annual conference in Chicago Sunday, data from the ICARIA-MM study on Paris-based drugmaker Sanofi’s drug, isatuximab, combined with Celgene’s Pomalyst (pomalidomide) and the steroid dexamethasone, showed it to be highly active in patients with relapsed or refractory multiple myeloma. The meeting concluded Tuesday.
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Sanofi said that it had filed for approval with the Food and Drug Administration and the European Medicines Agency, the latter of which had accepted its application.
According to the data, the three-drug combination prolonged progression-free survival – a key clinical endpoint in myeloma – by five months compared with Pomalyst and dexamethasone alone. Serious side effects occurred in a higher percentage of patients taking the three drugs – 86.8 percent, compared with 70.5 percent. However, the rate of patients who discontinued treatment or died due to side effects was lower for those receiving isatuximab than for those on Pomalyst and dexamethasone alone – 7.2 and 7.9 percent, versus 12.8 percent and 9.4 percent, respectively.
Isatuximab is a CD38-targeting monoclonal antibody, similar to Darzalex (daratumumab), which is marketed by Johnson & Johnson’s Janssen subsidiary and was developed with Denmark-based Genmab. However, one particular difference is that unlike Darzalex, it is not associated with complement activation, meaning it can be more readily given to patients with asthma or chronic obstructive pulmonary disease.
“It’s not a trivial population,” said Dr. Paul Richardson, who heads the multiple myeloma program at the Dana-Farber Cancer Institute in Boston and presented the isatuximab data, in an interview at ASCO. A Sanofi spokesperson also noted that the presentation included data on difficult-to-treat populations, including elderly patients and those with comorbidities like asthma and COPD.
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The ability for isatuximab to distinguish itself on the market will be critical to its success, given the well-established position of Darzalex, which the FDA originally approved as a single agent in November 2015 and is now widely used in combination with numerous multiple myeloma therapies. In addition, data presented in the same oral session showed a subcutaneous formulation of Darzalex to work just as well and with fewer toxicities than the approved intravenous formulation, which takes hours to administer.
Richardson noted that isatuximab binds to a distinct epitope of CD38 from Darzalex, which could position the drug for use in cases when the latter fails.
Photo: Alaric DeArment, MedCity News
