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Now FDA Approved & Available

TECELRA is the first and only engineered TCR T-cell therapy approved to treat certain adults with advanced synovial sarcoma¹

TECELRA is a MAGE-A4–directed genetically modified autologous T‑cell immunotherapy administered as a one-time, single-dose treatment

TECELRA is indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA‑A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Have questions? Contact AdaptimmuneAssist at
1‑855‑24MYADAP (855‑246‑9232) or adaptimmuneassist@adaptimmune.com.

HLA=human leukocyte antigen; MAGE=melanoma-associated antigen; TCR=T-cell receptor.

About TECELRA

TECELRA is the first and only, single-infusion, engineered TCR T-cell therapy¹

TECELRA is a T-cell therapy with cells that are genetically engineered to express affinity-enhanced TCRs specific for a peptide on the tumor¹

Autologous T cells are transduced with a lentiviral vector to create TECELRA, which expresses MAGE-A4-specific
affinity-enhanced TCRs on the surface of the cells. MAGE-A4 is an intracellular cancer-testis antigen that has restricted expression in normal tissues and is expressed in synovial sarcoma.¹

how tecelra works img1

RECOGNIZE

The engineered TCR on the TECELRA cell recognizes an HLA-A*02-restricted MAGE-A4 peptide.^1,†

how tecelra works img2

KILL

Antigen-specific activation of TECELRA, via the engineered TCR-peptide-HLA-A*02^† complex, results in T-cell proliferation, cytokine secretion, and killing of
MAGE-A4/HLA-A*02^†-expressing synovial sarcoma cells.¹

TECELRA is the first and only single-infusion therapy to recognize and kill MAGE-A4+ cells¹

HLA=human leukocyte antigen; MAGE=melanoma-associated antigen; TCR=T-cell receptor.

^†In patients who are positive for HLA‑A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and negative for HLA-A*02:05P.¹

TECELRA Clinical Experience

TECELRA was evaluated in a multicenter, single-arm, open-label clinical trial¹

ORR^† was the major efficacy outcome measure¹

KEY INCLUSION CRITERIA¹

Inoperable or metastatic synovial sarcoma, and prior systemic therapy with doxorubicin and/or ifosfamide
Measurable disease by RECIST v1.1
ECOG PS: 0 or 1
GFR ≥60 mL/min
HLA‑A*02:01P, HLA‑A*02:02P, HLA‑A*02:03P, or HLA‑A*02:06P by high-resolution HLA typing
MAGE-A4 expression by IHC

KEY EXCLUSION CRITERIA¹

HLA-A*02:05P in either allele
Systemic corticosteroids within 14 days of leukapheresis and lymphodepletion
Prior allogeneic hematopoietic stem cell transplants

BASELINE PATIENT CHARACTERISTICS (TREATED PATIENTS)¹

Median age: 41 years (range: 19-73 years)
50% female/50% male
HLA-A*02 type: 96% HLA-A*02:01P
Median number of prior lines of systemic therapies: 3 (range: 1-12 lines)

STUDY DESIGN^1,‡

High-resolution HLA typing (blood) and MAGE-A4 expression testing (tumor)

at a centralized testing site

Leukapheresis (N=52)

for collection of autologous cells for processing and manufacturing into TECELRA

Lymphodepleting chemotherapy (n=45)

Fludarabine 30 mg/m²/day for 4 days (Day -7 to Day -4)
Cyclophosphamide 600 mg/m²/day for 3 days (Day -7 to Day -5)

TECELRA administered as a single IV infusion on Day 1 (n=44)

ECOG PS=Eastern Cooperative Oncology Group performance status; GFR=glomerular filtration rate; HLA=human leukocyte antigen; IHC=immunohistochemistry; IV=intravenous; MAGE=melanoma-associated antigen; ORR=overall response rate; RECIST=Response Evaluation Criteria in Solid Tumours.

^†ORR was defined as partial response or better based on RECIST v1.1. Evaluated by independent review.¹

^‡Eight patients did not receive TECELRA due to death (n=3), loss of eligibility prior to lymphodepleting chemotherapy (n=3), withdrawal by patient (n=1), and investigator decision (n=1). The subject who withdrew consent did so after starting lymphodepleting chemotherapy but before receiving TECELRA.¹

Resources and Support

AdaptimmuneAssist is your dedicated support team

AdaptimmuneAssist provides access support for patients, their caregivers, and healthcare providers throughout the TECELRA treatment journey. Your Cell Therapy Navigator (CTN) can help you and your patients access helpful resources.

Have questions or want to learn about support options?

Connect with a CTN at 1‑855‑24MYADAP (855‑246‑9232) or adaptimmuneassist@adaptimmune.com

Visit the AdaptimmuneAssist website to learn more

Downloadable resources

Here are some important resources that may help you and your patients

How to Order TECELRA Guide

How to Order TECELRA Guide

Instructions on how to order TECELRA through the AdaptimmuneAssist Order Portal.

Companion Diagnostic Guide

Companion Diagnostic Guide

A comprehensive guide on biomarker testing for eligibility for TECELRA, including what tests are needed and how to test.

Billing and Coding Guide

Billing and Coding Guide

A quick reference guide for billing and coding questions.

Sample Letter of Medical Necessity

Sample Letter of Medical Necessity

A sample letter indicating medical necessity for TECELRA.

Sample Letter of Appeal

Sample Letter of Appeal

A sample template you can use to appeal a denial of insurance coverage for your patient’s TECELRA treatment.

Advocacy and support groups for you and your patients

Select the logos below to visit these sites and learn more about how they can provide support and community for you and your patients.

Please note: AdaptimmuneAssist is not affiliated with these independent third-party organizations and is not responsible for their views or services.

SFA

Northwest Sarcoma Foundation

Rein In Sarcoma

Mercy Medical Angels

CAN

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INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

TECELRA is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA‑A*02:01P, ‑A*02:02P, ‑A*02:03P, or ‑A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: DO NOT use TECELRA in adults who are heterozygous or homozygous for HLA-A*02:05P.

BOXED WARNING: Cytokine release syndrome (CRS), which may be severe or life-threatening, occurred in patients receiving TECELRA. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care. Ensure that healthcare providers administering TECELRA have immediate access to medications and resuscitative equipment to manage CRS.

INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

TECELRA is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA‑A*02:01P, ‑A*02:02P, ‑A*02:03P, or ‑A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: DO NOT use TECELRA in adults who are heterozygous or homozygous for HLA-A*02:05P.

BOXED WARNING: Cytokine release syndrome (CRS), which may be severe or life-threatening, occurred in patients receiving TECELRA. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care. Ensure that healthcare providers administering TECELRA have immediate access to medications and resuscitative equipment to manage CRS.

CRS

CRS occurred in 75% of patients (2% Grade ≥3) with a median onset of 2 days (range: 1 to 5 days) and median resolution of 3 days (range: 1 to 14 days). CRS (including Grade 1) was managed with tocilizumab in 55% of patients who experienced CRS.
In patients who experienced CRS, the most common symptoms included fever, tachycardia, hypotension, nausea/vomiting, and headache.

Immune Effector Cell–associated Neurotoxicity Syndrome (ICANS)

ICANS has been observed following administration of TECELRA. One patient (2%) had Grade 1 ICANS with a median onset of 2 days and resolution of 1 day.
ICANS symptoms can include mental status changes, disorientation to time and place, drowsiness, inattention, altered level of consciousness, seizures, cerebral edema, impairment of cognitive skills, progressive aphasia, and motor weakness.
Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy machinery or potentially dangerous machinery for 4 weeks following infusion due to the potential for neurologic events, including dizziness and presyncope.

Monitoring for CRS and ICANS During and Following TECELRA Infusion

Ensure that healthcare providers administering TECELRA have immediate access to medications and resuscitative equipment to manage CRS and ICANS. Ensure patients are euvolemic prior to initiating TECELRA.
During and following TECELRA administration, closely monitor patients for signs and symptoms of CRS and ICANS. Following treatment with TECELRA, monitor patients for at least 7 days at the healthcare facility. Continue to monitor patients for at least 4 weeks following treatment with TECELRA. Counsel patients to seek medical attention should signs or symptoms of CRS or ICANS occur.
At the first sign of CRS or ICANS, immediately evaluate patients for hospitalization and administer supportive care based on severity and consider further management per clinical practice guidelines.

Prolonged Severe Cytopenia

Anemia, neutropenia, and/or thrombocytopenia can occur for several weeks following lymphodepleting chemotherapy and TECELRA infusion. Patients with Grade ≥3 cytopenia not resolved by week 4 included anemia (9%), neutropenia (11%), and thrombocytopenia (5%). The median time to resolution was 7.3 weeks (range: 6.1 to 8.4 weeks) for anemia, 9.3 weeks (range: 6.4 to 12.3 weeks) for neutropenia, and 6.3 weeks (range: 6.1 to 6.4 weeks) for thrombocytopenia.
Monitor blood counts after TECELRA infusion. Manage cytopenia with growth factor and blood product transfusion according to clinical practice guidelines.

Infections

Infections may occur following lymphodepleting chemotherapy and TECELRA infusion and occurred in 32% of patients (14% Grade 3).
Do not administer TECELRA to patients with active infections and/or inflammatory disorders.
Monitor patients for signs and symptoms of infection before and after TECELRA infusion and treat patients appropriately.
Febrile neutropenia was observed in patients after TECELRA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated.
Viral reactivation has occurred in patients following TECELRA. Perform screening for Epstein-Barr virus, cytomegalovirus, hepatitis B virus, hepatitis C virus, and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated. Consider antiviral therapy to prevent viral reactivation per local guidelines.

Secondary Malignancies

Patients treated with TECELRA may develop secondary malignancies or recurrence of their cancer. Monitor for secondary malignancies.

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) in TECELRA. Observe patients for hypersensitivity reactions during infusion.

Potential for HIV Nucleic Acid Test False-Positive Results

The lentiviral vector used to make TECELRA has limited, short spans of genetic material that are identical to HIV. Therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients who have received TECELRA.

Adverse Reactions

Most common adverse reactions (incidence ≥20%) were CRS, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema.
Most common Grade 3 or 4 laboratory abnormalities (incidence ≥20%) were lymphocyte count decreased, neutrophil count decreased, white cell blood count decreased, red blood cell decreased, and platelet count decreased.
Most common serious adverse reactions (≥5%) were cytokine release syndrome and pleural effusion.

INDICATION

TECELRA is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA‑A*02:01P, ‑A*02:02P, ‑A*02:03P, or ‑A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Please see full Prescribing Information, including Boxed Warning.

References: 1. TECELRA. Prescribing information. Adaptimmune; 2024. 2. Wang T, Navenot JM, Rafail S, et al. Identifying MAGE-A4-positive tumors for TCR T cell therapies in HLA-A*02-eligible patients. Mol Ther Methods Clin Dev. 2024;32(2):101265. doi:10.1016/j.omtm.2024.101265 3. Lim WC, Marques Da Costa ME, Godefroy K, et al. Divergent HLA variations and heterogeneous expression but recurrent HLA loss-of- heterozygosity and common HLA-B and TAP transcriptional silencing across advanced pediatric solid cancers. Front Immunol. 2024;14:1265469. doi:10.3389/fimmu.2023.1265469 4. TECELRA. Instructions for Use. Adaptimmune; 2024. 5. Reddy V, Winston NR. Mesna. StatPearls Publishing. 2024:1-11.