The prognosis for brain cancer is generally quite grim, but hope is emerging for glioblastoma patients in the form of a cancer vaccine from Boston immunotherapy player Celldex.
The vaccine, Rintega, works specifically for those glioblastoma patients that have a EGFRvIII mutation – about 30 percent of patients.
The company just released mature survival data from its Phase 2 study on its drug, Rintega, and it’s fairly promising: It’s showing unprecedented survival benefits from taking this vaccine in conjunction with standard glioblastoma therapy. Further, the side effect profile is minimal and the drug seems to help improve the quality of life in this devastating disease.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
“It’s not a home run – the trial was very small,” said lead investigator Dr. David Reardon, clinical director at the center of neuro-oncology at Dana-Farber Cancer Institute. “But the proof of concept that immunotherapy can make a difference for this disease will inspire a lot of hope. It’s a step in the right direction, and we can certainly try to build on that.”
Rintega received a breakthrough therapy designation from FDA last year. The reach for this drug fits into the orphan category: It could be used in about 4,000 patients in the U.S. and 5,500 in the European Union, said CEO Anthony Marucci. The drug could be ready for commercialization in the next year or two, depending on how Phase 3 results read out.
“We already have a small commercial team in place, so that when the drug does succeed we can get it up and running fairly quickly,” Marucci said.
The standard of care for this form of brain cancer is surgery, radiation, and treatment with monoclonal antibody drug Avastin. Each of the patients in the trial were dosed with Avastin.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Notably, a third of the patients taking Rintega were able to stop using steroids for six months or longer, compared to none of the control set.
Another rather compelling aspect of this medication is that the side effect profile is extremely innocuous – patients experience a bit of redness at the site of injection for a day, but nothing more, Reardon said.
“One very exciting aspect of this drug is it can help patients maintain a good quality of life while living longer,” he said. “That’s very important for diseases like this.”
