Well-characterized safety profile demonstrated in the phase 2 clinical trial1
CRS: Manageable, with quick resolution1
Nearly all mild or moderate cases of CRS quickly resolved within days with treatment and supportive care1
Incidence and resolution of CRS in patients receiving TECELRA1
All grades
72%
(n=98/137)
Grade ≥3
2%
(n=3/137)
Median time to onset
2 days
(range: 1-7 days)
Median time to resolution
3 days
(range: 1-14 days)
- In patients who experienced CRS, the most common symptoms included fever (97%), tachycardia (58%), hypotension (31%), nausea/vomiting (26%), and headache (21%)1
Incidence and resolution of ICANS in patients receiving TECELRA1
Grade 1-2
4%
(n=6)
Time to onset
2-8 days
Time to resolution
1-7 days
CRS and ICANS monitoring1
-
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 CRS and ICANS for at least 2 weeks following treatment with TECELRA, including the 7 days at the healthcare facility following infusion
- Counsel patients to seek medical attention should signs or symptoms of CRS or ICANS occur
CRS and ICANS management1
- 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
- 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
AR=adverse reaction; CRS=cytokine release syndrome; ICANS=immune effector cell-associated neurotoxicity syndrome.
Safety data demonstrated in the clinical trial
Serious adverse reactions1
- TECELRA can cause serious side effects, including CRS, ICANS, prolonged severe cytopenia, infections, secondary malignancies, and hypersensitivity reactions
- Serious adverse reactions occurred in 35% of patients; the most common serious adverse reactions (≥5%) were CRS (7%) and infections (8%)
Laboratory abnormalities1,†
- The most common Grade 3 or 4 laboratory abnormalities (incidence ≥10%) were lymphocyte count decreased (100%), neutrophil count decreased (89%), white blood cell decreased (88%), red blood cell decreased (24%), and platelet count decreased (18%)
Grading based on NCI CTCAE v5.0.
†AR=adverse reaction; CRS=cytokine release syndrome; ICANS=immune effector cell-associated neurotoxicity syndrome; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.
†Abnormalities are laboratory values that were considered an adverse event.1
Most common adverse reactions observed in the clinical trial (n=137)1,†
|
Adverse reactions (occurring in ≥20% of patients) |
All Grades n (%) |
Grade ≥3 n (%) |
|---|---|---|
| Gastrointestinal disorders | ||
| Nausea | 88 (64) | 5 (4) |
| Vomiting | 38 (28) | 2 (2) |
| Constipation | 40 (29) | 1 (1) |
| Diarrhea | 34 (25) | 0 |
| Abdominal pain‡ | 25 (18) | 5 (4) |
| General disorders and administration site conditions | ||
| Fatigue‡ | 72 (53) | 2 (2) |
| Pyrexia‡ | 41 (30) | 5 (4) |
| Edema§ | 29 (21) | 3 (2) |
| Chills | 21 (15) | 0 |
| Immune system disorders | ||
| Cytokine release syndrome‖ | 98 (72) | 3 (2) |
| Infections and infestations | ||
| Any infection¶ | 48 (35) | 16 (12) |
| Nervous system disorders | ||
| Headache | 36 (26) | 2 (2) |
| Dizziness‡ | 22 (16) | 0 |
| Encephalopathy# | 17 (12) | 0 |
| Neuropathy peripheral‡ | 14 (10) | 0 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 25 (18) | 3 (2) |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal pain‡ | 60 (44) | 5 (4) |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cough‡ | 34 (25) | 0 |
| Dyspnea‡ | 27 (20) | 5 (4) |
| Renal and urinary disorders | ||
| Renal insufficiency‡ | 15 (11) | 1 (1) |
| Vascular disorders | ||
| Hemorrhage‡ | 26 (19) | 2 (2) |
| Hypotension‡ | 25 (18) | 2 (2) |
| Hypertension | 15 (11) | 3 (2) |
| Cardiac disorders | ||
| Tachycardia‡ | 30 (22) | 0 |
| Skin and subcutaneous tissue disorders | ||
| Rash‡ | 28 (20) | 3 (2) |
| Alopecia | 17 (12) | 0 |
| Psychiatric disorders | ||
| Insomnia | 16 (12) | 0 |
†AR=adverse reaction.
†Includes all adverse reactions reported following lymphodepleting chemotherapy and TECELRA, regardless of attribution to TECELRA.1
‡Is a composite that includes multiple related terms.1
§Edema includes ascites, fluid retention, hypervolemia, edema peripheral, pleural effusion, face edema, localized edema, peripheral swelling, and swelling.1
‖As per American Society for Transplantation and Cellular Therapy criteria.1
¶Any infection includes all infection terms under the “Infections and infestations” System Organ Class.1
#Encephalopathy includes confusional state, dysgeusia, cognitive disorder, somnolence, aphasia, dysarthria, and amnesia.1