|MRI image of a glioblastoma tumor--Courtesy of NIH|
Celldex ($CLDX) touted what it called the "consistent, impressive story" of its brain cancer vaccine Rintega this week as it released positive long-term survival data.
In a 73-patient Phase II trial of glioblastoma patients with the EGFRvIII mutation, 25% of those who received Rintega plus Roche's ($RHHBY) Avastin were alive after two years, while no patients who received only Avastin were alive. Rintega's advantages were further shown over endpoints such as overall survival, progression-free survival, objective response rate and need for steroids, Celldex added.
Celldex's chief medical officer, Thomas Davis, said in a statement that patients with the cancer face a "staggering diagnosis" and the new results "replicate what we have seen in earlier Rintega studies conducted in newly-diagnosed patients, supporting our belief that Rintega will be an important treatment option for all patients with EGFRvIII-positive glioblastoma."
In May, the Hampton, NJ-based company said the vaccine demonstrated a survival edge over the standard of care for patients with the mutation. At the time, it said it was conducting regulatory discussions, with CEO Anthony Marucci saying that the patient group has "extremely limited treatment options, with only three new drugs approved in more than 20 years." Rintega won the FDA's breakthrough therapy designation in February.
With the first data set from its Phase III trial anticipated in the coming months, Rintega could become only the second cancer vaccine approved in the U.S., Roth Capital Partners predicted this summer. Peak sales projections for the vaccine are anywhere between a few hundred million dollars to more than $1 billion annually.
The first approved cancer vaccine in the U.S., Provenge, faced challenges that contributed to the bankruptcy of its maker Dendreon, which was picked up by Valeant Pharmaceuticals ($VRX) at auction early this year for $400 million. Dendreon's promising future was done in largely by the complex and expensive methods of manufacturing and delivering the personalized immune stimulator for prostate cancer.
Celldex is operating in a space where few have succeeded to this point, with last year's late-stage failures from Merck KGaA and GlaxoSmithKline ($GSK) serving as recent reminders of the challenges in cancer vaccines. However, a recent wave of activity, including new startups and partnerships, has breathed enthusiasm into the space that was this year predicted to grow at a CAGR of 27.24% through 2019.
- here's the release