Breyanzi for Treating CLL
- Breyanzi has been approved for CLL patients whose disease has returned even after multiple treatments.
- In a major study, nearly half of patients taking Breyanzi saw benefits for at least 35 months.
- Nearly 20% of patients saw their disease greatly reduce or vanish with just a one-time treatment with Breyanzi.
- Breyanzi belongs to a class of drugs known as CAR-T cell therapy which is a personalized form of immunotherapy that engineers the patient’s own cells to attack the cancer to fight cancer.
- Breyanzi side effects are generally mild but can include a serious condition called cytokine release syndrome, which gives patients flu-like symptoms
Many patients given a new drug called Breyanzi (lisocabtagene maraleucel) can live longer, healthier lives — and some may even see their cancer completely vanish.
Who is Breyanzi for?
Read MoreBreyanzi is recommended for CLL patients who have received at least two previous therapies including:
- A BTK inhibitor such as Brukinsa, which is a type of medication that blocks the protein involved in the growth and survival of certain cancer cells
- A BCL2 inhibitor such as Venclexta, which is a type of medication that regulates cell death
It is also approved for patients with or small lymphocytic lymphoma (SLL) under similar circumstances.
“The approval of Breyanzi as the first CAR T cell therapy available for relapsed or refractory CLL or SLL brings new hope to these patients with the potential for durable responses after a single CAR T infusion,” said Dr. Brian Koffman, physician, CLL patient and cofounder, executive vice president and chief medical officer of CLL Society.
Related: Venetoclax As A Treatment For CLL
What are the benefits of Breyanzi?
The approval was based on the impressive findings from the TRANSCEND CLL 004 trial that studied the effectiveness of Breyanzi in patients with known as relapsed or refractory CLL, a type of disease that has either come back or has not responded well to treatment.
The study found:
- At 12 months, an incredible 91.3% of patients did not have cancer that grew or spread
- 45% responded to treatment and on average the duration of the response lasted for 35 months
- Patients on Breyanzi lived about 43 months from the start of the treatment, which is a significant improvement over other treatments
- At higher dose levels, 18% of patients achieved a complete response or remission, including partial bone marrow recovery, meaning that the cancer was significantly reduced or even disappeared entirely.
“The CAR-T therapy demonstrated durable CR/CRi, high [undetectable] MRD rates, and a manageable safety profile” in patients with heavily pretreated, high-risk relapsed or refractory CLL/SLL and “high unmet need,” wrote the investigators, lead by Dr. Tanya Siddiqi, from the division of lymphoma at the City of Hope National Medical Center.
Related: Active Surveillance for CLL
What is Breyanzi?
Breyanzi is made by Bristol Myers Squibb and is approved for the treatment of adults with relapsed or refractory CLL who have not responded to two or more prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
“The problem with cancer in general is that the patient’s own T cells — the cells that help fight cancer — unfortunately don’t recognize their own cancer anymore,” Dr. Julie Vose, chair of the Department of Oncology and Hematology at the University of Nebraska Medical Center’s Buffett Cancer Center, tells SurvivorNet.
CAR-T-cell therapy “helps to wake up those cells to be able to fight their own cancer, whereas their own, unmodified cells cannot do that,” she says.
Therapy with Breyanzi works this way:
- Doctors take a sample of T cells from your blood through a process called leukapheresis and then send out the sample to a lab.
- Lab experts change the T cells in such a way so that they can find and destroy tumor cells.
- After modification, the lab then multiples the CAR-T cells to create a large population of engineered cells.
- The expanded CAR-T cells are then put back into the patient’s bloodstream, where they can recognize and attack cancer cells.
A patient undergoing CAR-T cell therapy will usually receive about three days of chemotherapy. This chemo helps to get rid of damaged immune systems and gives the new T cells a better chance to fight cancer.
The introduction of Breyanzi has the potential to reshape the treatment landscape, offering the possibility of one-time infusion therapy instead of continuous treatment. This could reduce the frequency of clinic visits and hospital stays, potentially improving quality of life and treatment outcomes.
Related: What are BTK Inhibitors?
What are the potential for side effects with Breyanzi?
CAR-T cell therapies are gaining more popularity, but, as with any drug, they can come with side effects.
The most common side effects associated with the medication include:
- Cytokine release syndrome (CRS), an immune system response that can range from mild flu-like symptoms to life-threatening illness
- Neurologic toxicity leading to damage of the nervous system
- Infections
- Laboratory abnormalities including low levels of hemoglobin, neutrophils, and platelet which can lead to fatigue or uncontrolled bleeding
- Secondary cancers. Patients receiving Breyanzi are at risk of developing other cancers.
CRS and neurotoxicity in particular are the biggest worry for patients taking Breyanzi. They can lead to serious problems including headaches, fever, rash, fast heartbeat, difficulty breathing, and low blood pressure.
In more serious cases, it can cause inflammation of the central nervous system leading to neurological symptoms.
In the TRANSCEND CLL 004, the occurrences of CRS and neurologic events were mostly mild and non-life-threatening, with. 83% of patients experienced CRS and 46% of patients experienced neurologic toxicity.
However, about 1% of those who experienced side effects in the trial died. This is a reminder that despite all the amazing benefits of CAR-T, they are not without risk.
What is CLL?
CLL is a slow-growing blood cancer involving white blood cells (WBCs).
CLL starts in bone marrow, the red spongy tissue in the center of your long bones where new blood cells are made. CLL affects the immature blood cells produced by the bone marrow that give rise to an abnormal number of WBCs or lymphocytes.
Patients with CLL can live for years without any symptoms or needing treatment.
Many patients, however, will require treatment at some point in time, often with BTKs and BCL2s. Chemotherapy, and stem cell transplant are also available for patients with relapsed/refractory CLL.
“It’s important for patients diagnosed with CML to understand that their prognosis is quite favorable,” Dr. Jay Yang, hematologist, medical oncologist, and leader of the Hematology Oncology Multidisciplinary Team at the Barbara Ann Karmanos Cancer Institute in Detroit, tells SurvivorNet. “With modern treatments, most patients will go on to live healthy and productive lives with a normal life expectancy.”
Breyanzi is a welcome addition to the arsenal doctors have to treat CLL, when previously there were very limited options. While the drug is not a cure, it provides a chance for better outcomes.
Related: Western Diet May be Linked to CLL, Study Says
Questions to Ask Your Doctor
Here are some questions you may consider asking your doctor to help understand your options.
- What will my new treatment with Breyanzi cost and how much will my insurance cover?
- How will I feel during treatment?
- Will I have side effects that last after the treatment?
- Should I get a second opinion?
- What are the advantages and disadvantages of Breyanzi
- What is my prognosis?
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