Resilience and Hope: Gail’s Journey with Multiple Myeloma

(BPT) – For years, 69-year-old Gail from Houston has started her mornings with devotion and exercise. Her love for family and community shines through in everything she does as she dedicates her time to volunteering, reading, mentoring members of her church group, and nurturing her garden.

In 2010, everything changed. While on a trip, Gail felt a tingling sensation in her wrist but didn’t think much of it. On the way home, the tingling spread to her right shoulder and eventually developed into a deeper pain that would not go away.

“That’s when things began to change,” Gail says.

Once home, she sought medical attention. Her doctor ordered X-rays that identified lesions on her shoulder. She was quickly referred to a hematologist, who ordered blood work and a bone marrow biopsy. Gail was in shock when the doctors diagnosed her with multiple myeloma, a type of blood cancer where patients typically experience multiple relapses, with fewer treatment options available after each one.

In the beginning, Gail didn’t know what multiple myeloma was and had to advocate for herself and ask lots of questions of her care team.

“In those early days, I just wanted to get treatment and then get on with my life. I was scared, but I said to myself, ‘I’m going to beat it, whatever it takes.’ And I still have that mentality,” Gail says. “My doctor told me I probably wouldn’t live another five years, and I told her that would not be the case with me.”

Since her diagnosis, Gail often struggles with activities she loves given fatigue and other symptoms from her disease but maintains a positive attitude and hope about her future.

“I can still do the things I want to — I can go in my yard, look at my flowers and just enjoy them. For anyone dealing with this — don’t give up,” she says.

Nearly 14 years later, though, Gail is still living with and fighting this incurable disease.

“I love living, I love living well and I have learned so much about life,” she says.

The treatment landscape for multiple myeloma has changed significantly in recent years, with newer treatments like bispecific antibody therapies that are making a difference for patients and changing how the disease is treated.

Throughout Gail’s journey with multiple myeloma, she has experienced several relapses and has gone through multiple lines of therapy. Her doctor recently introduced TALVEY^® (talquetamab-tgvs) to her treatment plan.

TALVEY^® is a prescription medicine to treat adults with multiple myeloma who have already received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody to treat their multiple myeloma, and their cancer has come back or did not respond to prior treatment. TALVEY^® is approved based on patient response. Data are not yet available to show if TALVEY^® improves survival or symptoms. It is not known if TALVEY^® is safe and effective in children.

TALVEY^® is a bispecific antibody therapy, a type of medicine that targets two different proteins in the body. TALVEY^® is the only therapy available that attaches to a protein called GPRC5D, which is found on multiple myeloma cells as well as some healthy cells in the body. It also binds to proteins called CD3 found on T-cells, a type of immune cell. Binding to both proteins may activate the immune system to help destroy the multiple myeloma cells. TALVEY^® is available as an every-two-week or once-weekly subcutaneous injection after an initial step-up dosing phase. Once the patient and their care team have chosen a treatment plan, they begin a step-up dosing schedule where the patient receives the first 2 or 3 doses of TALVEY^® at a smaller dose and increases up to the full treatment dose. Patients should be hospitalized for at least 48 hours after administration of all doses within the step-up dosing schedule, which allows them to be monitored for any potential serious or life-threatening side effects, including cytokine release syndrome (CRS) and neurologic problems. If you are being treated with TALVEY^®, talk to your healthcare provider if you think you may be experiencing any signs or symptoms of a side effect.

TALVEY^® was studied in 219 people with relapsed or refractory multiple myeloma who had previously been on at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. People in the clinical trial received TALVEY^® either as a once-every-two-weeks dose or once-weekly dose. 73.6% of patients receiving TALVEY^® every two weeks responded to treatment. For patients receiving a weekly dose, 73% responded to treatment.

During her hospital stay for the initial step-up dosing phase of treatment, Gail’s care team supported her and answered her questions to make her feel comfortable and help prepare her for continued treatment on TALVEY^®, and to educate her on the signs and symptoms of potential side effects. Gail has been on TALVEY^® since December 2023, and her myeloma continues to respond to treatment.

“My doctor is happy with my recent test results. I love my doctor and appreciate that she’s very honest. I have so much confidence in her,” Gail says. “My doctor keeps telling me to keep up what I’m doing, and keep up my positivity and spirit. It’s like my personality is back.”

As a patient on TALVEY^®, Gail recognizes that there are some challenges with being treated for multiple myeloma.

In addition to CRS and neurotoxicity, side effects that may occur with TALVEY^® include mouth problems, such as taste alterations, dry mouth, weight loss, or skin changes. Along with working with your treatment team, the Leukemia & Lymphoma Society (LLS) has a tip sheet with recommendations on how to cope with common side effects affecting the mouth and skin with cancer treatment. For more information about being treated with TALVEY^® and to access support and resources, including coping tips for patients, visit www.talvey.com.

“Side effects can be difficult and may be different for everyone. It is important to work with your treatment team to help manage them. You can do it,” Gail says.

Gail continues to share her experience with her myeloma support group and mentors others who are living with this disease.

“Mentoring is important to me because there are so many people hurting when they are diagnosed, and they don’t always see the light at the end of the tunnel,” Gail says. “You have to hear it from someone who knows what it’s like to live with this disease. And since I do, I want to share my experience with others so that they know there is hope. I live hope.”

Please review the Important Safety Information and see the full Prescribing Information including the Boxed Warning below. You can talk to your doctor if you have any questions. For more information, visit www.Talvey.com.

If one of Johnson & Johnson’s treatments has made a difference in your life or the life of a loved one, consider joining the SHARE Network. Every story is unique. If you or a loved one are living with multiple myeloma, your story could have the ability to provide hope and inspiration to other patients. To learn more about the SHARE Network and how to share your story, visit www.sharemyjanssenstory.com.

What is TALVEY^® (talquetamab-tgvs)?

TALVEY^® is a prescription medicine to treat adults with multiple myeloma who:

• have already received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody to treat their multiple myeloma, and
• their cancer has come back or did not respond to prior treatment

TALVEY^® is approved based on patient response. Data are not yet available to show if TALVEY^® improves survival or symptoms.
It is not known if TALVEY^® is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TALVEY^®?

TALVEY^® may cause side effects that are serious, life-threatening, or lead to death, including Cytokine Release Syndrome (CRS) and neurologic problems.

Call your healthcare provider or get medical help right away if you develop any of the signs or symptoms of CRS or neurologic problems listed below at any time during your treatment with TALVEY^®:

Cytokine Release Syndrome (CRS). CRS is common during treatment with TALVEY^® and can also be serious or life-threatening. Signs and symptoms of CRS may include:

fever (100.4°F or higher)	feeling anxious
dizziness or lightheadedness	headache
chills	fast heartbeat
difficulty breathing

Neurologic problems. Symptoms of neurologic problems with TALVEY^® may include:

headache	feeling sleepy
feeling confused	feeling very sleepy with low energy
being less alert or aware	slow or difficulty thinking
feeling disoriented	seizures
trouble speaking or writing	muscle weakness
shaking (tremors)	memory loss
numbness and tingling (feeling like “pins and needles”)	burning, throbbing, or stabbing pain

• Due to the risk of CRS and neurologic problems, you should be hospitalized for 48 hours after all doses of TALVEY^® that are part of the “step-up dosing schedule.” The “step-up dosing schedule” is when you receive the first 2 or 3 doses of TALVEY^®, which are smaller “step-up” doses, and also the first full “treatment dose” of TALVEY^®.
• TALVEY^® is given weekly or every 2 weeks. Your healthcare provider will decide the number of days to wait between your doses of TALVEY^® as well as how many treatments you will receive.
  • If you receive TALVEY^® weekly, “Step-up dose 1” is given on day 1 of treatment. “Stepup dose 2” is usually given on day 4 of treatment. The first “treatment dose” is usually given on day 7 of treatment.
  • If you receive TALVEY^® every 2 weeks, “Step-up dose 1” is given on day 1 of treatment. “Step-up dose 2” is usually given on day 4 of treatment. “Step-up dose 3” is usually given on day 7 of treatment. The first “treatment dose” is usually given on day 10 of treatment.
• If your dose of TALVEY^® is delayed for any reason, you may need to repeat the “step-up dosing schedule” to receive TALVEY^®.
• Before each “step up” dose of TALVEY^®, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.
• Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems as well as other side effects, and treat you as needed.

TALVEY^® is available only through the TECVAYLI^® and TALVEY^® Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems.

You will receive a Patient Wallet Card from your healthcare provider. Carry the Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Patient Wallet Card lists signs and symptoms of CRS and neurologic problems.

Get medical help right away if you develop any of the signs and symptoms listed on the Patient Wallet Card. You may need to be treated in a hospital.

• If you have any questions about TALVEY^®, ask your healthcare provider.
• Your healthcare provider may temporarily stop or completely stop your treatment with TALVEY^® if you develop CRS, neurologic problems, or any other side effects that are severe.

See “What are the possible side effects of TALVEY^®?” for more information about side effects.

Before you receive TALVEY^®, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• are pregnant or plan to become pregnant. TALVEY^® may harm your unborn baby. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with TALVEY^®.

Females who are able to become pregnant:

• • Your healthcare provider should do a pregnancy test before you start treatment with TALVEY^®.
  • You should use effective birth control (contraception) during treatment and for 3 months after your last dose of TALVEY^®.

• are breastfeeding or plan to breastfeed. It is not known if TALVEY^® passes into your breast milk. Do not breastfeed during treatment and for 3 months after your last dose of TALVEY^®.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive TALVEY^®?

• TALVEY^® will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in the stomach area (abdomen). TALVEY^® may also be injected into your thigh or another area of your body.

• See “What is the most important information I should know about TALVEY^®?” at the beginning of the Medication Guide for information about how you will receive TALVEY^®.

• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What should I avoid while receiving TALVEY^®?

Do not drive, operate heavy machinery, or do other dangerous activities during and for 48 hours after your TALVEY^® “step-up dose” is completed or at any time during treatment with TALVEY^®, if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness, until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

See “What is the most important information I should know about TALVEY^®?” for more information about signs and symptoms of CRS and neurologic problems.

What are the possible side effects of TALVEY^®?

TALVEY^® may cause serious side effects, including:

• See “What is the most important information I should know about TALVEY^®?”
• Mouth problems and weight loss. Tell your healthcare provider or get medical help right away if you develop any of the following symptoms of mouth problems:

• • changes in sense of taste
  • dry mouth
  • trouble swallowing
  • mouth sores

Your healthcare provider will monitor you for these symptoms and will monitor your weight during treatment with TALVEY^®. Tell your healthcare provider if you lose weight during treatment with TALVEY^®.

• Infections. TALVEY^® can cause serious infections that can be life-threatening and may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection before and during treatment with TALVEY^®. Tell your healthcare provider right away if you get or develop any signs or symptoms of infection during treatment with TALVEY^®, including:

• • fever of 100.4°F (38°C) or higher
  • chills
  • cough
  • chest pain
  • tiredness
  • shortness of breath
  • painful rash
  • sore throat
  • pain during urination
  • feeling weak or generally unwell

• Decreased blood cell counts. Decreased blood cell counts are common during treatment with TALVEY^® and can also be severe. Your healthcare provider will check your blood cell counts during treatment with TALVEY^®.
• Skin problems. Skin problems are common during treatment with TALVEY^® and can also be serious. Tell your healthcare provider if you get skin problems such as skin rash, raised red bumps, or redness of the skin.
• Liver problems. Abnormal liver tests can happen during treatment with TALVEY^®. Your healthcare provider will do blood tests before and during treatment with TALVEY^® to check your liver. Tell your healthcare provider if you develop any of the following symptoms of liver problems:

• • tiredness
  • loss of appetite
  • pain in your right upper stomach area (abdomen)
  • dark urine
  • yellowing of your skin or the white part of your eyes

The most common side effects of TALVEY^® include:

• changes in your sense of taste
• nail problems
• muscle and joint pain
• feeling very tired
• weight loss
• dry mouth
• fever
• very dry skin that may affect the mucous membranes (such as the mouth and eyes)
• difficulty swallowing
• infected nose, sinuses or throat (cold)
• diarrhea