ATC

How was TECELRA studied and what were the results?

TECELRA brought on a remarkable change for certain adults who had previous synovial sarcoma treatment†

In a clinical study, 44 patients with advanced synovial sarcoma were given TECELRA to evaluate the efficacy and safety of the treatment. This study was open-label, meaning all patients knew they received TECELRA.

EXPLORE THE PATIENT POPULATION

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Not an actual patient.

EXPLORE THE PATIENT POPULATION

In the study, patients:

Icon of a test tube and a tumor sample

Had the 2 required biomarkers†

Icon of a patient silhouette

Had a median age of 41 years (age range: 19-73 years old)

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Were 50% men and 50% women

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Had previously received systemic therapy or therapies, including chemotherapy, for their advanced synovial sarcoma (median: 3; range: 1-12 lines)

TECELRA is approved based on patient response data. A study is ongoing to confirm the clinical benefit of TECELRA.

TECELRA was able to shrink or eliminate synovial sarcoma tumors in the study

43%

of patients saw their tumor shrink or disappear‡

Icon of a synovial sarcoma tumor and decreasing arrow

39%

of patients saw their tumor shrink

Icon of a synovial sarcoma tumor and an X

5%

of patients saw their tumor disappear

AMONG PATIENTS WHO SAW THEIR TUMOR SHRINK OR DISAPPEAR‡:

HALF saw results with TECELRA by

4.9 WEEKS

HALF maintained their results with TECELRA for

6 MONTHS OR LONGER

(median: 6 months;
range: 1.9, 36.1+ months)

39%

were likely to respond for 1 year or longer

HLA=human leukocyte antigen; MAGE=melanoma-associated antigen.

Median is the middle number in a group of numbers arranged from lowest to highest.
†

TECELRA is for people with certain HLA-A*02 types whose tumor expresses the MAGE-A4 antigen.

‡

43.2% of a total of 44 patients in the study saw results with TECELRA.

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INDICATION and IMPORTANT SAFETY INFORMATION

What is TECELRA?

TECELRA is a medicine, called a genetically modified autologous T cell immunotherapy, that is used to treat synovial sarcoma. It is used when other kinds of treatment do not work. TECELRA is different from other cancer medicines because it is made from your own white blood cells that are made to recognize and attack your cancer cells. Your healthcare provider will perform tests to see if TECELRA is right for you. TECELRA is approved based on patient response data. Additional data are needed to confirm the clinical benefit of TECELRA. It is not known if TECELRA is safe and effective in children.

Please see Medication Guide, including Important Warning.

IMPORTANT SAFETY INFORMATION

Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.

After getting TECELRA, you will be monitored daily at the healthcare facility for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 4 weeks. Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 4 weeks after you get TECELRA. Your healthcare provider will do blood tests to follow your progress. It is important that you have your blood tested. If you miss a scheduled appointment for your collection of blood, call your healthcare provider as soon as possible to reschedule.

Before you receive TECELRA, tell your healthcare provider about all the medicines and supplements you take and your medical conditions, including: seizure, stroke, confusion, or memory loss; heart, liver, or kidney problems; low blood pressure; lung or breathing problems; recent or active infection; past infections that can be reactivated following treatment with TECELRA; low blood counts; pregnancy, you think you may be pregnant, or plan to become pregnant; breastfeeding; or taking a blood thinner.

The most common side effects of TECELRA include nausea, vomiting, fatigue, infection, constipation, fever (100.4°F/38°C or higher), abdominal pain, difficulty breathing, decreased appetite, diarrhea, low blood pressure, back pain, fast heart rate, chest pain, general body swelling, low white blood cells, low red blood cells, and low platelets.

You are encouraged to report side effects to the FDA at (800) FDA‑1088 or www.fda.gov/medwatch or to Adaptimmune at 1‑855‑24MYADAP (1-855‑246‑9232).

Please see Medication Guide, including Important Warning.

INDICATION and IMPORTANT SAFETY INFORMATION

What is TECELRA?

TECELRA is a medicine, called a genetically modified autologous T cell immunotherapy, that is used to treat synovial sarcoma. It is used when other kinds of treatment do not work. TECELRA is different from other cancer medicines because it is made from your own white blood cells that are made to recognize and attack your cancer cells. Your healthcare provider will perform tests to see if TECELRA is right for you. TECELRA is approved based on patient response data. Additional data are needed to confirm the clinical benefit of TECELRA. It is not known if TECELRA is safe and effective in children.

Please see Medication Guide, including Important Warning.

IMPORTANT SAFETY INFORMATION

Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.

After getting TECELRA, you will be monitored daily at the healthcare facility for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 4 weeks. Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 4 weeks after you get TECELRA. Your healthcare provider will do blood tests to follow your progress. It is important that you have your blood tested. If you miss a scheduled appointment for your collection of blood, call your healthcare provider as soon as possible to reschedule.

Before you receive TECELRA, tell your healthcare provider about all the medicines and supplements you take and your medical conditions, including: seizure, stroke, confusion, or memory loss; heart, liver, or kidney problems; low blood pressure; lung or breathing problems; recent or active infection; past infections that can be reactivated following treatment with TECELRA; low blood counts; pregnancy, you think you may be pregnant, or plan to become pregnant; breastfeeding; or taking a blood thinner.

The most common side effects of TECELRA include nausea, vomiting, fatigue, infection, constipation, fever (100.4°F/38°C or higher), abdominal pain, difficulty breathing, decreased appetite, diarrhea, low blood pressure, back pain, fast heart rate, chest pain, general body swelling, low white blood cells, low red blood cells, and low platelets.

You are encouraged to report side effects to the FDA at (800) FDA‑1088 or www.fda.gov/medwatch or to Adaptimmune at 1‑855‑24MYADAP (1-855‑246‑9232).

Please see Medication Guide, including Important Warning.

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