What Does the New Yescarta Approval Mean?
- The FDA granted approval to Yescarta (axicabtagene ciloleucel) CAR T-cell therapy as a treatment for certain patients with large B-cell lymphoma that has returned.
- CAR T-cell therapy takes T-cells from a patient’s immune system and genetically modifies them to recognize and kill cancer cells.
- In the ZUMA-7 phase 3 clinical trial, patients showed significant improvement in event-free survival when given Yescarta. Event-free survival measures the period of time after treatment that a patient doesn’t have a specific symptom or complication. The hope is that this therapy can significantly improve quality of life for patients.
- Patients on Yescarta were 2.5x more likely to be alive at two years without cancer progression or a need for additional cancer treatment.
The U.S. Food and Drug Administration approved Yescarta (axicabtagene ciloleucel) CAR T-cell therapy as a treatment for certain adult patients with large B-cell lymphoma (LBCL) that comes back. More specifically, the approval is for adult patients with large B-cell lymphoma that is refractory (stopped responding) to first-line chemo-immunotherapy or relapsed (came back) within 12 months of first-line chemo-immunotherapy. First-line therapy is the first treatment given for a disease.
Read MoreWho Will Benefit From the Approval?
Yescarta is already approved for LBCL patients who’ve had their second relapse, but this new approval is for patients who experience their first relapse within a year, or patients who didn’t respond to treatment at all.
“(The current standard of care) doesn’t work very well in that population, and that population is a pretty big group of people, unfortunately,” Dr. Alison Sehgal, a hematologist and medical oncologist at UPMC Hillman Cancer Center in Pittsburgh, Penn., and study investigator for the landmark trial, told SurvivorNet.
This patient group showed a “really notable difference in event-free survival. I don’t want to tell you the exact amount, but it was it was well over 20 percent,” Dr. Sehgal continued.
“So, that spares all those people going through the stem cell transplant, which was a pretty grueling experience. And then when it doesn’t work, they would have to do CAR T-cell therapy anyway,” she added. “And so this is really practice-changing for a big portion of people with large B-cell lymphoma.”
Christi Shaw, the chief executive officer of Kite, a Gilead Company, which created the therapy, told SurvivorNet that the approval will have a remarkable impact on patients’ lives.
‘Remarkable’ Results
“The data is remarkable and also, what it means to patients’ lives and the standard of care that has been there for over 30 years, how that’s about to change,” Shaw said.
The CEO said that through the clinical trial, patients were followed for two years and “what we found was that Yescarta patients were two and a half times more likely to be alive without cancer progression or the need for additional cancer treatment after those two years versus the standard of care.”
This new therapy shows promise for improving the standard of care, Shaw added. Previously, patients who had relapsed or refractory LBCL would go through high doses of chemotherapy higher than what they were given in the first-line treatment in an attempt to get their body ready for an autologous stem cell transplant.
“With aggressive non-Hodgkin lymphoma, particularly diffuse large B-cell lymphoma, we really feel that we need to put patients into remission and attempt to cure them when they’ve relapsed after their first-line therapy,” Dr. Michael Jain, medical oncologist at Moffitt Cancer Center, previously told SurvivorNet.
Dr. Michael Jain explains how stem cell transplants work for relapsed LBCL.
However, not all patients are eligible for a stem cell transplant, and some who begin a high-dose chemotherapy regimen prior to the transplant end up not being able to go through with the transplant. The results of the ZUMA-7 trial offer hope in this aspect of treatment, as well.
“You know (with) the standard of care, a patient needs to go through a high-dose chemotherapy regimen before they actually get to a stem cell transplant,” Shaw said. “It’s a high-dose chemo, plus a stem cell transplant, and only 35 percent of patients who actually start the process actually get to the transplant.”
However, in the ZUMA-7 trial, “we showed that patients on Yescarta, 94 percent of those patients were able to receive the cell therapy, so 94 percent actually get the full therapy.”
Shaw also noted that this method allowed patients to get back to their everyday lives faster, according to the study’s findings.
“So, it’s not just the data, but also the quality of life for the patients that’s improved,” Shaw added.
What is CAR T-Cell Therapy?
CAR T-cell therapy is a groundbreaking treatment that can be used for several different types of non-Hodgkin lymphoma, as well as other cancers. Chimeric antigen receptor (CAR) T-cell therapy takes the patients’ own immune system cells and sends them to a manufacturer. Those T-cells are then genetically modified, multiplied into the millions, and returned to the patient. Once they are placed back into the patients body, these modified cells have a new ability to recognize and kill cancer cells.
Dr. Nina Shah explains why there is so much hope surrounding CAR T-cell therapy.
Currently, CAR T-cell therapy is approved to treat several types of blood cancer, including:
- Lymphomas
- Some forms of leukemia
- Multiple myeloma.
CAR T-Cell Therapy Side Effects
Like all cancer therapies, CAR T-cell therapy can come with side effects, but in a previous conversation about the treatment, Dr. Nina Shah, a hematologist who specializes in the treatment of multiple myeloma at University of California San Francisco Health, explained to SurvivorNet that many patients tolerate this therapy exceptionally well.
CAR T-cell therapy “actually improves when we talk about pain, fatigue, and emotional and social functioning. And so whether or not you experience side effects, we hope that this therapy will improve your quality of life," Dr. Shah said.
Potential side effects include fatigue and cytokine release syndrome (CRS), which comes with its own symptoms like headache, fever, chills, scratchy throat, nausea, vomiting, diarrhea, muscle or joint pain and lack of energy. In serious cases, CRS can cause shortness of breath, low blood pressure and fast heart rate. Most people who develop CRS will have mild to moderate symptoms, but sometimes CRS can be serious and even life-threatening.
However, Dr. Shah stressed that doctors have methods to control these side effects and they won’t affect the CAR T-cell therapy.
"We certainly are excited to use this new tool that we have to hopefully give people a longer chance to live," Dr. Shah added.
Questions to Ask Your Doctor
- Am I eligible for CAR T-cell therapy as part of my treatment for non-Hodgkin’s lymphoma?
- How can CAR T-cell therapy help treat my cancer?
- What do I experience during CAR T-cell therapy?
- Are there side effects I should be aware of?
- How do I know if CAR T-cell therapy is helping my cancer?
- Can I afford CAR T-cell therapy? Is there someone on staff that can explain the costs to me?
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