The Tecartus Breakthrough
- Kite Pharma and Christi Shaw, the company’s CEO, are pushing innovative cancer treatments forward as leaders in the field. And this time, adult patients with acute lymphoblastic leukemia are the ones who will benefit.
- Last week, Kite had a major breakthrough — the FDA approved the company’s second CAR-T cell therapy, Tecartus, for patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
- Shaw is now leading a major pharmaceutical company in its treatment advancements for patients with blood cancer, just three years after her sister, whom she cared for, died from blood cancer.
Last week, Kite had a major breakthrough — the U.S. Food and Drug Administration approved the pharmaceutical company’s second CAR-T cell therapy, Tecartus, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Last year, the FDA gave Kite its approval to use Tecartus in adult patients with relapsed or refractory mantle cell lymphoma. The latest FDA approval means this cell therapy can now be used to treat two different types of blood cancer — great news for relapsed leukemia patients.Read More
In August 2017, the FDA issued a historic action on the gene therapy front — the Novartis-manufactured CD19-directed drug, Kymriah, became the first CAR-T cell therapy available in the United States. The therapy was approved for use in children and young adults up to 25 years old with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Kite’s approval of Tecartus somewhat overlaps into Novartis territory, but Kite’s drug is specifically for adult patients with ALL, while Kymriah is for children and young adults. There are other types of CAR-T federally approved as well, but for different kinds of blood cancers, such as lymphoma.
“Our data shows that the response (to Tecartus) is extremely high — 65 percent complete response,” Shaw says, “and that the response is very durable. So we are hoping to give a lot more life to patients.”
But what’s really extraordinary is Shaw’s story — she’s now leading a major pharmaceutical company in its treatment advancements for patients with blood cancer, just three years after her sister, Sherry, whom she cared for, died from blood cancer.
Shaw’s Sister and Cancer Connections
Shaw has worked in the cancer therapy field for about 12 years. And this isn’t her only connection to cancer. She, like so many others across the U.S. and the world, has had loved ones — yes, plural — die from the disease. She tells SurvivorNet that her mother died from breast cancer and her sister died after a hard-fought battle with multiple myeloma — a rare type of blood cancer.
In order to care for her sister, Shaw actually took a year off of work. Her sister’s multiple myeloma was being treated with CAR-T cell therapy; she was enrolled in a phase 1 clinical drug trial, “and it didn’t work for her,” Shaw says. Sherry died at age 51.
“When you have cell therapy, you really have to have a caregiver with you,” Shaw says of her decision to take an extended break from work to care for her sister. And there are a few reasons for needing a caregiver, she says.
“One is you need to go to an authorized treatment center. So (for) many of these patients, as I did with my sister — we stayed in (American Cancer Society) Hope Lodge, or you could stay in a hotel — you need to be local for a period of time,” Shaw says. “That’s because of the monitoring for those adverse events … which I saw my sister actually get.”
Some of the adverse events that cell therapy causes include something called CRS, short for cytokine release syndrome, which is “an overreaction of your immune system to fight things very hard, kind of like when you get a fever,” Shaw says. Neurotoxicity is another one that “occurs when the exposure to natural or manmade toxic substances alters the normal activity of the nervous system.”
“But when I came back to work,” she tells SurvivorNet, “I was so excited to be offered a job to lead Kite. (What) I saw in our first indications in lymphoma, after the first three years, half of the patients were still alive, (and) at four years, 44 percent of the patients are still alive.”
What is CAR-T Cell Therapy?
“Cell therapy is different (from) most other medicines and therapies in that it actually harnesses your own immune system,” Shaw tells SurvivorNet.
Our immune system was designed to fight off foreign invaders such as viruses, bacteria and yes, cancer. But sometimes, cancer cells can evade detection and continue to grow. But CAR-T cell therapy essentially re-trains your immune system to make it a more efficient, and more effective, cancer fighter.
“CAR-T is a revolution in cancer therapy; it is paradigm changing,” says Dr. Siddhartha Ganguly, previously the director of the lymphoma and myeloma program at the University of Kansas, and now the section chief of hematology at Houston Methodist Oncology Partners.
The process, as Shaw and SurvivorNet experts explain, starts when your doctor intravenously removes a sample of your blood. With a procedure called leukapheresis — the removal of blood to collect specific blood cells — your blood flows into a machine that separates out the T cells; it then returns the other blood components, such as red blood cells, platelets, etc.
The T cells are then sent out to a lab, where technicians insert an anti-cancer gene into them. That new gene causes special receptors called chimeric antigen receptors to pop up on the surface of the T cells. Those receptors are like homing devices that will lock onto the matching antigen on the surface of your cancer cells. “It’s kind of like increasing your army to fight and embolden them by giving them better tools, if you will,” Shaw says.
Once the T cells are back from the lab, you’ll first need treatment to prepare your body to receive the new, genetically modified T cells. “Patients are primed with three to four days of a mild form of chemotherapy, so that their body does not reject those genetically modified cells,” Dr. Ganguly says. “And then those cells are infused, just like a blood transfusion.”
This is a process Shaw was able to watch firsthand while caring for her sister, and something she’s now able to help make possible for other blood cancer patients with Tecartus.
Contributing: SurvivorNet staff