Shirley’s Story: Continuing Life’s Adventures with Acute Myeloid Leukemia (AML)

For Shirley*, a retired professor and author living in Arizona, life has always been about travel, new adventures and musical performance. Alongside her husband, Jim, and their beloved dog, Parker, they spent retirement traveling the country in their motorhome, performing at festivals and embracing new experiences. But an unexpected health concern led her down a different kind of journey she never anticipated.

A Life-Changing Diagnosis

Shirley's medical journey began when routine bloodwork revealed lower-than-normal white blood cell counts. What initially seemed like a minor issue quickly escalated. A bone marrow biopsy confirmed she had myelodysplastic syndrome (MDS).

"I remember the oncologist looking at me and saying, 'You need to begin chemotherapy immediately.' I thought, 'I'll do it, and then I'll be done.' But he told me, 'You will need chemotherapy for the rest of your life," Shirley recalled.

She underwent over three years of chemotherapy, which consisted of seven days of infusions every 28 days, hoping for improvement. However, the treatment was becoming less and less effective, and all of her blood values were dropping well below normal. Her doctors began discussing alternative approaches.

Exploring Other Options

Shirley and Jim sought multiple medical opinions nationwide, determined to explore all possibilities. Many specialists emphasized the potential benefits of a bone marrow transplant, but Shirley continued searching for other options. Meanwhile, her oncologist informed her that her MDS had transformed into acute myeloid leukemia (AML).

Essential cells such as red blood cells, white blood cells and platelets are produced in healthy bone marrow. These specialized cells transport oxygen, help fight infections and assist in blood clotting. AML is a cancer that disrupts this vital process and affects a type of white blood cell in the bone marrow called a myeloblast. In people with AML, the myeloblasts are abnormal. These cells do not mature or work as they should. As more and more myeloblasts are produced, they prevent healthy cells from forming and working.

Shirley's doctor then informed her about TIBSOVO^® (ivosidenib), an FDA-approved targeted therapy for patients with AML with an isocitrate dehydrogenase 1 (IDH1) mutation. The IDH1 mutation plays an important role in the development of AML because it prevents myeloblasts from becoming healthy white blood cells. About one in six people with AML have an IDH1 mutation.

See below for additional Important Safety Information, including the benefits and risks of TIBSOVO^® (ivosidenib). Click here for Prescribing Information and discuss with your doctor.

"Genetic mutations are changes in the DNA of a cell," said Dr. Curtis Lachowiez**, Assistant Professor of Medicine, Division of Hematology/Medical Oncology, School of Medicine, Oregon Health & Science University. Note, Dr. Lachowiez was not Shirley's healthcare provider.

"Mutations play a role in the development of AML and can offer opportunities to utilize therapies such as TIBSOVO that target specific mutations. That is why it's important to get tested for genetic mutations to help your healthcare team understand which AML treatments may work best for you."

On December 23, 2015, at 1:30 p.m., Shirley started taking TIBSOVO.

"I remember taking a selfie because I knew—this was hope."

TIBSOVO is a targeted therapy that works against an abnormal protein created by a mutation in the IDH1 gene. This abnormal protein plays an important role in the development of AML because it prevents myeloblasts from becoming healthy white blood cells.

"As a targeted therapy, TIBSOVO works differently from traditional chemotherapy," added Dr. Lachowiez. "Traditional chemotherapy kills cells that divide quickly, including cells in healthy tissues. It is typically given by infusion, usually in the hospital. TIBSOVO is an oral treatment that helps myeloblasts to grow into healthy blood cells by inhibiting the abnormal protein created by mutations in the IDH1 gene."

Embracing the Journey

Today, Shirley's blood counts remain stable.

"Being able to continue doing the things I love means everything to me," said Shirley.

Shirley and Jim live between their home on the Oregon Coast in the summer and their villa in a Life Plan Community in Arizona in winter. They perform in parades, festivals and at senior community centers in summer and winter. Often, Shirley is asked to speak about her MDS/AML experience.

She closes her talk by saying: "I was in the right place and time with the right mutation."

"There are benefits and risks associated with TIBSOVO. It is important for patients to speak with a doctor to learn more," said Dr. Lachowiez.

For more information, please visit www.TIBSOVO.com/AML.

*Shirley is a paid consultant for Servier in the U.S. Last name withheld to protect personal privacy.
**Dr. Curtis Lachowiez is a paid consultant for Servier in the U.S.

What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat adults with an isocitrate dehydrogenase-1 (IDH1) mutation with:

• acute myeloid leukemia (AML):
  • with newly diagnosed AML treated in combination with azacitidine or alone who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments
  • when the disease has come back or has not improved after previous treatment(s)
• myelodysplastic syndrome (MDS):
  • when the disease has come back or has not improved after previous treatment(s)

Your healthcare provider will perform a test to make sure that TIBSOVO is right for you. It is not known if TIBSOVO is safe and effective in children.

IMPORTANT SAFETY INFORMATION

TIBSOVO may cause serious side effects, including:

• Differentiation Syndrome. Differentiation syndrome is a common condition that affects your blood cells and may be life-threatening or lead to death. Differentiation syndrome in adults with AML and MDS has happened as early as 1 day and up to 3 months after starting TIBSOVO. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome during treatment with TIBSOVO:

If you develop signs and symptoms of differentiation syndrome, your healthcare provider may treat you with a corticosteroid medicine or a medicine called hydroxyurea and may monitor you in the hospital.

• Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) before and during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint

• Guillain-Barré syndrome has happened in people treated with TIBSOVO. Your healthcare provider will monitor you for nervous system problems and will permanently stop your treatment with TIBSOVO if you develop Guillain-Barré syndrome. Tell your healthcare provider right away if you develop any signs or symptoms of Guillain-Barré syndrome, including:

The most common side effects of TIBSOVO when used in combination with azacitidine or alone in adults with AML include:

The most common side effects of TIBSOVO when used in adults with MDS include:

Your healthcare provider will do blood tests before you start and during treatment with TIBSOVO. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with TIBSOVO if you develop certain side effects.

TIBSOVO may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of TIBSOVO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking TIBSOVO, tell your healthcare provider about all of your medical conditions, including if you:

• have any heart problems, including a condition called long QT syndrome
• have problems with abnormal electrolytes, such as sodium, potassium, calcium or magnesium levels
• have nervous system problems
• have problems with your kidneys or are on dialysis
• have any liver disorders, including cirrhosis
• are pregnant or plan to become pregnant. TIBSOVO may cause harm to your unborn baby. You should avoid becoming pregnant during treatment with TIBSOVO. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with TIBSOVO
• are breastfeeding or plan to breastfeed. It is not known if TIBSOVO passes into your breast milk. Do not breastfeed during your treatment with TIBSOVO and for 1 month after your last dose of TIBSOVO

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

Especially tell your healthcare provider if you take hormonal contraceptives. TIBSOVO may affect how hormonal contraceptives work and may cause them to not work as well.

Please see Full Prescribing Information, including BOXED WARNING for AML and MDS patients.

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Servier and the Servier Logo are registered trademarks of LES LABORATOIRES SERVIER.
TIBSOVO is a registered trademark of SERVIER PHARMACEUTICALS LLC, a wholly owned, indirect subsidiary of LES LABORATOIRES SERVIER.
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