TECELRA
Generic: AFAMITRESGENE AUTOLEUCEL
Basic Information
Manufacturer
USWM CT, LLC
Product Type
CELLULAR THERAPY
Route of Administration
INTRAVENOUS
FDA Set ID
2ddd66e1-8036-4a4e-babe-4d673e660bf5
Indications & Usage
1 INDICATIONS AND USAGE 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 [see Clinical Studies ( 14 )].
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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 duration of response ( 14 ).
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
This indication is approved under accelerated approval based on overall response rate and durability of response [see Clinical Studies ( 14 )].
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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 duration of response ( 14 ).
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥ 20%) were, cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema.
Grade 3 or 4 laboratory abnormalities (≥20%) were lymphocyte count decreased, neutrophil count decreased, white cell blood count decreased, red blood cell decreased, and platelet count decreased ( 6.1 ).
The most common serious adverse reactions (≥ 5%) were cytokine release syndrome and pleural effusion ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact USWM CT, LLC at 1-855-246-9232 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described in this section reflects the exposure to TECELRA in 44 patients with advanced synovial sarcoma treated in the SPEARHEAD-1 clinical trial (Cohort 1).
Patients with synovial sarcoma received TECELRA across a dose of 2.68 x 10 9 to 10 x 10 9 MAGE-A4 TCR positive T cells [see Clinical Studies ( 14 )].
Serious adverse reactions occurred in 52% of patients with synovial sarcoma.
The most common serious adverse reactions (occurring in ≥ 5%) included CRS (9%) and pleural effusion (7%).
Table 1 summarizes adverse reactions that occurred in at least 10% of patients.
Table 1.
Adverse Reactions Occurring in ≥10% of Patients in SPEARHEAD-1 (Cohort 1) SOC Grouped Term (N=44) All Grades n (%) Grade ≥ 3 n (%) Investigations Weight decreased 5 (11) 1 (2) Gastrointestinal disorders Nausea 29 (66) 1 (2) Vomiting 16 (36) 0 (0) Constipation 14 (32) 0 (0) Abdominal pain 11 (25) 2 (5) Diarrhea 9 (21) 0 (0) General disorders and administration site conditions Fatigue 15 (34) 0 (0) Pyrexia 14 (32) 2 (5) Non-cardiac chest pain 10 (23) 1 (2) Chills 7 (16) 0 (0) Edema 9 (21) 0 (0) Asthenia 7 (16) 1 (2) Chest pain 6 (14) 0 (0) Immune system disorders Cytokine Release Syndrome As per American Society for Transplantation and Cellular Therapy (ASTCT) criteria 1 33 (75) 1 (2) Infections and infestations Any infection Any infection includes all infection terms under the 'Infections and infestations' System Organ Class 14 (32) 6 (14) Nervous system disorders Headache 8 (18) 1 (2) Dizziness 5 (11) 0 (0) Metabolism and nutrition disorders Decreased appetite 10 (23) 1 (2) Musculoskeletal and connective tissue disorders Back pain 9 (21) 2 (5) Pain in extremity 6 (14) 0 (0) Respiratory, thoracic, and mediastinal disorders Dyspnea 11 (25) 2 (5) Cough 8 (18) 0 (0) Vascular disorders Hypotension 9 (21) 0 (0) Hypertension 7 (16) 1 (2) Cardiac disorders Sinus Tachycardia/ Tachycardia 9 (21) 0 (0) Skin and subcutaneous tissue disorders Alopecia 6 (14) 0 (0) Other clinically important adverse reactions occurring in patients receiving TECELRA include Grade 1 ICANS reported in one patient (2%).
Table 2.
Laboratory Abnormalities Abnormalities are laboratory values that were considered an adverse event Worsened from Baseline in ≥10% of Patients in SPEARHEAD-1 (Cohort 1) Laboratory Abnormalities N=44 All Grades n (%) Grade 3 or 4 n (%) Grading based on NCI CTCAE version 5.0.
Lymphocyte count decreased 43 (98) 43 (98) Neutrophil count decreased 42 (96) 40 (91) White blood cell decreased 42 (96) 38 (86) Red blood cell decreased 42 (96) 14 (32) Platelet count decreased 36 (82) 9 (21) Alanine aminotransferase increased 20 (46) 2 (5)
Grade 3 or 4 laboratory abnormalities (≥20%) were lymphocyte count decreased, neutrophil count decreased, white cell blood count decreased, red blood cell decreased, and platelet count decreased ( 6.1 ).
The most common serious adverse reactions (≥ 5%) were cytokine release syndrome and pleural effusion ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact USWM CT, LLC at 1-855-246-9232 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described in this section reflects the exposure to TECELRA in 44 patients with advanced synovial sarcoma treated in the SPEARHEAD-1 clinical trial (Cohort 1).
Patients with synovial sarcoma received TECELRA across a dose of 2.68 x 10 9 to 10 x 10 9 MAGE-A4 TCR positive T cells [see Clinical Studies ( 14 )].
Serious adverse reactions occurred in 52% of patients with synovial sarcoma.
The most common serious adverse reactions (occurring in ≥ 5%) included CRS (9%) and pleural effusion (7%).
Table 1 summarizes adverse reactions that occurred in at least 10% of patients.
Table 1.
Adverse Reactions Occurring in ≥10% of Patients in SPEARHEAD-1 (Cohort 1) SOC Grouped Term (N=44) All Grades n (%) Grade ≥ 3 n (%) Investigations Weight decreased 5 (11) 1 (2) Gastrointestinal disorders Nausea 29 (66) 1 (2) Vomiting 16 (36) 0 (0) Constipation 14 (32) 0 (0) Abdominal pain 11 (25) 2 (5) Diarrhea 9 (21) 0 (0) General disorders and administration site conditions Fatigue 15 (34) 0 (0) Pyrexia 14 (32) 2 (5) Non-cardiac chest pain 10 (23) 1 (2) Chills 7 (16) 0 (0) Edema 9 (21) 0 (0) Asthenia 7 (16) 1 (2) Chest pain 6 (14) 0 (0) Immune system disorders Cytokine Release Syndrome As per American Society for Transplantation and Cellular Therapy (ASTCT) criteria 1 33 (75) 1 (2) Infections and infestations Any infection Any infection includes all infection terms under the 'Infections and infestations' System Organ Class 14 (32) 6 (14) Nervous system disorders Headache 8 (18) 1 (2) Dizziness 5 (11) 0 (0) Metabolism and nutrition disorders Decreased appetite 10 (23) 1 (2) Musculoskeletal and connective tissue disorders Back pain 9 (21) 2 (5) Pain in extremity 6 (14) 0 (0) Respiratory, thoracic, and mediastinal disorders Dyspnea 11 (25) 2 (5) Cough 8 (18) 0 (0) Vascular disorders Hypotension 9 (21) 0 (0) Hypertension 7 (16) 1 (2) Cardiac disorders Sinus Tachycardia/ Tachycardia 9 (21) 0 (0) Skin and subcutaneous tissue disorders Alopecia 6 (14) 0 (0) Other clinically important adverse reactions occurring in patients receiving TECELRA include Grade 1 ICANS reported in one patient (2%).
Table 2.
Laboratory Abnormalities Abnormalities are laboratory values that were considered an adverse event Worsened from Baseline in ≥10% of Patients in SPEARHEAD-1 (Cohort 1) Laboratory Abnormalities N=44 All Grades n (%) Grade 3 or 4 n (%) Grading based on NCI CTCAE version 5.0.
Lymphocyte count decreased 43 (98) 43 (98) Neutrophil count decreased 42 (96) 40 (91) White blood cell decreased 42 (96) 38 (86) Red blood cell decreased 42 (96) 14 (32) Platelet count decreased 36 (82) 9 (21) Alanine aminotransferase increased 20 (46) 2 (5)