Chimeric Antigen Receptor T-Cell (CAR-T) Therapies Set To Gain Approval By 2017

A new kind of therapy aimed at addressing an immune system’s powerful T-cells could be out as early as next year if two pharmaceutical companies regulatory approval gains ground.

The two companies in mention are Kite Pharma Inc. and Juno Therapeutics Inc. who both bared that they have gained initial regulators approvals next year for a type of immunotherapy treatment known better as chimeric antigen receptor or “CAR-T” therapies.

The whole process of CAR-T involves the extraction of immune system T cells which eventually affect a patient’s DNA in an effort to spot and kill cancer cells. Once that is done, the T cells are re-infused back.

While the practice of CAR-T is being used on a wide array of cancer types, blood cancer is the first target. For Kite Pharma Inc., the group plans to garner U.S. Food and Drug Administration approval for its KTE-C19 with diffuse of large B-cell lymphoma (DLBCL).

On the other side, Juno hopes to focus on adults with acute lymphoblastic leukemia (ALL) with its JCAR015. They are now in the mid-stage trials enrolling adult patients for JCAR015 which could gain approval in 2017.

Per claims of Juno Chief Executive Officer Hans Bishop, 77% of patients with advanced ALL rendered a complete response (cancer remission) when chemotherapy was followed by their Juno cell therapy. The trial patients with minimal disease returned 90% achieved remission.

Moreover, 27% of patients in the JCAR15 trial experienced severe inflammatory response from the altered cells while 15% churned out serious nervous system side effects.

"Some of these responses are amazing in patients who would never have responded to anything," said ASCO President Dr Julie Vose. "The question is, is it practical? We are now seeing results for more patients, and longer follow up."

The breakthrough is indeed something worth checking out though there are still questions surrounding relapses and refractory. For now, the therapies are in the experimental stages but its viability or longevity still leaves a big question on whether additional treatment may be required.

But as far as Juno’s CEO is concerned, the benefit of turning ton CAR-T therapies may eventually outweigh these risks.

"These are patients that are relapsed and refractory. They are going to die of their disease," he said. "We can get 90 to 100 percent of them into remission, and a meaningful percentage of them have durable remission."