Adverse reactions (≥10%) in patients with RRMM who received TALVEY® in the MonumenTAL-1 primary analysis
Clinically relevant adverse reactions reported in <10% of patients who received TALVEY® included ICANS and viral infection
Serious adverse reactions occurred in 47% of patients who received TALVEY®. Serious adverse reactions reported in ≥2% of patients included CRS (13%), bacterial infection (8%) including sepsis, pyrexia (4.7%), ICANS (3.8%), COVID-19 (2.7%), neutropenia (2.1%), and upper respiratory tract infection (2.1%).Fatal adverse reactions occurred in 3.2% of patients who received TALVEY®, including COVID-19 (0.6%), dyspnea (0.6%), general physical health deterioration (0.6%), bacterial infection (0.3%) including sepsis, basilar artery occlusion (0.3%), fungal infection (0.3%), infection (0.3%), and pulmonary embolism (0.3%).
Dosage interruptions of TALVEY® due to an adverse reaction occurred in 56% of patients. Adverse reactions which required dosage interruption in >5% of patients included pyrexia (15%), CRS (12%), upper respiratory tract infection (9%), COVID-19 (9%), bacterial infection (7%) including sepsis, neutropenia (6%), and rash (6%).
The most common adverse reactions (≥20%) were pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, weight decreased, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension, and headache.
Adverse reactions were graded based on CTCAE version 4.03, with the exception of CRS, which was graded per ASTCT 2019 criteria.
*Includes other related terms.
†Only Grade 3 reactions occurred.
‡Dysgeusia: ageusia, dysgeusia, and taste disorder.
§Per CTCAE version 4.03, maximum toxicity grade for dysgeusia is 2 and maximum toxicity grade for dry mouth is 3.
∥Stomatitis: cheilitis, glossitis, glossodynia, mouth ulceration, oral discomfort, oral mucosal erythema, oral pain, stomatitis, swollen tongue, tongue discomfort, tongue erythema, tongue edema, and tongue ulceration.
¶Oral disorder: oral disorder, oral dysethesia, oral mucosal exfoliation, oral toxicity, and oropharyngeal pain.
#Nail disorder: koilonychia, nail bed disorder, nail cuticle fissure, nail discoloration, nail disorder, nail dystrophy, nail hypertrophy, nail pitting, nail ridging, nail toxicity, onychoclasis, onycholysis, and onychomadesis.
**Skin disorder: palmar-plantar erythrodysesthesia syndrome, palmoplantar keratoderma, skin discoloration, skin exfoliation, and skin fissures.
††Rash: dermatitis, dermatitis acneiform, dermatitis contact, dermatitis exfoliative, dermatitis exfoliative generalized, erythema, exfoliative rash, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, and stasis dermatitis.
‡‡Xerosis: dry eye, dry skin, and xerosis.
§§Bacterial infection including sepsis: campylobacter infection, carbuncle, cellulitis, citrobacter infection, clostridium diiffcile colitis, clostridium diiffcile infection, cystitis escherichia, cystitis klebsiella, diverticulitis, escherichia pyelonephritis, folliculitis, gastroenteritis escherichia coli, helicobacter gastritis, human ehrlichiosis, impetigo, klebsiella sepsis, moraxella infection, otitis media acute, pitted keratolysis, pseudomonal bacteremia, pyuria, relapsing fever, renal abscess, skin infection, staphylococcal infection, tooth abscess, tooth infection, urinary tract infection enterococcal, and urinary tract infection pseudomonal.
∥∥Contains fatal outcome(s).
¶¶Fungal infection: body tinea, candida infection, fungal foot infection, fungal infection, fungal skin infection, genital candidiasis, esophageal candidiasis, onychomycosis, oral candidiasis, oral fungal infection, oropharyngeal candidiasis, tinea pedis, vulvovaginal candidiasis and vulvovaginal mycotic infection.
##Encephalopathy: agitation, altered state of consciousness, amnesia, aphasia, bradyphrenia, confusional state, delirium, depressed level of consciousness, disorientation, encephalopathy, hallucination, lethargy, memory impairment, mood altered, restlessness, sleep disorder, and somnolence.
***Sensory neuropathy: dysesthesia, hyperesthesia, hypoesthesia, hypoesthesia oral, immune-mediated neuropathy, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, polyneuropathy, sciatica, and vestibular neuronitis.
†††Motor dysfunction: dysarthria, dysgraphia, dysmetria, dysphonia, gait disturbance, muscle atrophy, muscle spasms, muscular weakness, and tremor.
The most common Grade 3 or 4 laboratory abnormalities (≥30%) were lymphocyte count decreased, white blood cell decreased, neutrophil count decreased, and hemoglobin decreased
The most common Grade 3 or 4 laboratory abnormalities (≥30%) were lymphocyte count decreased, white blood cell decreased, neutrophil count decreased, and hemoglobin decreased.
Select laboratory abnormalities (≥30%) that worsened from baseline in patients with RRMM who received TALVEY® in MonumenTAL-1
Select laboratory abnormalities (≥30%) that worsened from baseline in patients with RRMM who received TALVEY® in MonumenTAL-1
*The denominator used to calculate the rate varied from 326 to 338 based on the number of patients with a baseline value and at least 1 post-treatment value. Laboratory toxicity grades are derived based on the CTCAE Version 4.03.
Duration of exposure for Q2W was 3.7 months (range: 0.0–17.9; n=153) and for QW was 5.9 months (range: 0.0–25.3; n=186).
Longer-term follow-up safety analysis
Longer-term follow up of up to 37 months*
You are now viewing a subsequent follow-up analysis of the MonumenTAL-1 trial. This information is not included in the current full Prescribing Information.
Adverse reactions (≥20%) in patients with RRMM who received TALVEY® in the MonumenTAL-1 longer-term follow-up analysis
| LONGER- TERM DATA | System organ class Adverse reaction | TALVEY® (N=375) | |
|---|---|---|---|
| Any Grade (%) | Grade 3 or 4 (%) | ||
| General disorders and administration site conditions | |||
| Pyrexia† | 83.2 | 4.5‡ | |
| Fatigue† | 43.7 | 3.5‡ | |
| Pain† | 24.3 | 2.4‡ | |
| Chills | 20.3 | 0.3‡ | |
| Immune system disorders | |||
| Cytokine release syndrome | 76.3 | 1.3‡ | |
| Gastrointestinal disorders | |||
| Dry mouth | 35.2 | 0 | |
| Diarrhea | 26.1 | 1.3‡ | |
| Dysphagia | 23.7 | 0.8‡ | |
| Stomatitis§ | 20.8 | 1.1‡ | |
| Nausea | 20.5 | 0 | |
| Constipation | 20 | 0 | |
| Skin and subcutaneous tissue disorders | |||
| Nail disorder∥ | 57.3 | 0 | |
| Skin disorder¶ | 43.7 | 0 | |
| Rash# | 39.5 | 3.2‡ | |
| Xerosis** | 35.5 | 0 | |
| Pruritus | 24.3 | 0.3‡ | |
| Musculoskeletal and connective tissue disorders | |||
| Musculoskeletal pain† | 52.8 | 3.5‡ | |
| Investigations | |||
| Weight decreased | 40.5 | 3.5‡ | |
| Infections and infestations | |||
| Upper respiratory tract infection† | 35.7 | 2.1‡ | |
| COVID-19*† †† | 20.8 | 3.7 | |
| Vascular disorders | |||
| Hypotension‡‡ | 22.4 | 3.2 | |
| Nervous system disorders | |||
| Dysgeusia§§ | 72.8 | 0 | |
| Headache† | 21.9 | 0.5‡ | |
| Metabolism and nutrition disorders | |||
| Decreased appetite | 24.8 | 1.3‡ | |
| Respiratory, thoracic, and mediastinal disorders | |||
| Cough† | 24.5 | 0 | |
LONGER-TERM DATA
Note: Output includes Phase 1 RP2D treatment groups and Phase 2 cohorts A, B, and C.
Note: CRS was originally graded by Lee criteria (Lee et al 2014) in Phase 1 and by ASTCT consensus grading system (Lee et al 2019) in Phase 2, with conversion of grade in Phase 1 to ASTCT based on data in eCRF. Toxicity grade by ASTCT is presented in this table for both Phase 1 and Phase 2.
Note: Adverse events are reported until 100 days (Phase 1) or 30 days (Phase 2) after the last dose of TALVEY® or until the start of subsequent anticancer therapy, if earlier.
Note: The output includes the diagnosis of CRS; the symptoms of CRS are included.
Note: Subjects are counted only once for any given event, regardless of the number of times they actually experienced the event. Adverse events are coded using MedDRA Version 27.0.
*Median follow-up for MonumenTAL-1 cohorts: T-cell redirection–naïve Q2W was >30 months; T-cell redirection–exposed was >28 months; T-cell redirection–naïve QW was >37 months.
†Includes other related terms.
‡Only Grade 3 reactions occurred.
§Stomatitis: cheilitis, glossitis, glossodynia, mouth ulceration, oral discomfort, oral mucosal erythema, oral pain, stomatitis, swollen tongue, tongue discomfort, tongue erythema, tongue edema, and tongue ulceration.
∥Nail disorder: koilonychia, nail bed disorder, nail cuticle fissure, nail discoloration, nail disorder, nail dystrophy, nail hypertrophy, nail pitting, nail ridging, nail toxicity, onychoclasis, onycholysis, and onychomadesis.
¶Skin disorder: palmar-plantar erythrodysesthesia syndrome, palmoplantar keratoderma, skin discoloration, skin exfoliation, and skin fissures.
#Rash: dermatitis, dermatitis acneiform, dermatitis contact, dermatitis exfoliative, dermatitis exfoliative generalized, erythema, exfoliative rash, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, and stasis dermatitis.
**Xerosis: dry eye, dry skin, and xerosis.
††Contains fatal outcome(s).
‡‡Hypotension: hypotension and orthostatic hypotension.
§§Dysgeusia: ageusia, dysgeusia, and taste disorder.
Low rate of Grade 3 or 4 infections (8.3%) and death due to infections (1.3%)2*
You are now viewing a subsequent follow-up analysis of the MonumenTAL-1 trial. This information is not included in the current full Prescribing Information.
Occurrence and death due to infection in patients receiving TALVEY®2
| LONGER- TERM DATA | Infection type | Patients in the MonumenTAL-1 trial longer-term* follow-up population (N=375) | |
|---|---|---|---|
| Any Grade (%) | Grade 3 or 4 (%) | ||
| Infections and infestations | 55.7 | 8.3 | |
| Upper respiratory tract infection† | 35.7 | 2.1 | |
| COVID-19†‡ | 20.8 | 3.7 | |
| Bacterial infection§ | 12.5 | 3.2 | |
| Fungal infection∥ | 10.7 | 0.3 | |
LONGER-TERM DATA
*Median follow-up for MonumenTAL-1 cohorts: T-cell redirection–naïve Q2W was >30 months; T-cell redirection–exposed was >28 months; T-cell redirection–naïve QW was >37 months.
†Includes other related terms.
‡Contains fatal outcome(s).
§Bacterial infection: campylobacter infection, carbuncle, cellulitis, citrobacter infection, clostridium difficile colitis, clostridium difficile infection, cystitis escherichia, cystitis klebsiella, diverticulitis, escherichia pyelonephritis, folliculitis, gastroenteritis escherichia coli, helicobacter gastritis, human ehrlichiosis, impetigo, klebsiella sepsis, moraxella infection, otitis media acute, pitted keratolysis, pseudomonal bacteremia, pyuria, relapsing fever, renal abscess, skin infection, staphylococcal infection, tooth abscess, tooth infection, urinary tract infection enterococcal, and urinary tract infection pseudomonal.
∥Fungal infection: body tinea, candida infection, fungal foot infection, fungal infection, fungal skin infection, genital candidiasis, esophageal candidiasis, onychomycosis, oral candidiasis, oral fungal infection, oropharyngeal candidiasis, tinea pedis, vulvovaginal candidiasis, and vulvovaginal mycotic infection.
ASTCT, American Society for Transplantation and Cellular Therapy; COVID, coronavirus disease; CRS, cytokine release syndrome; CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03; eCRF, electronic case report form; ICANS, immune effector cell-associated neurotoxicity syndrome; MedDRA, Medical Dictionary for Regulatory Activities; QW, once weekly; Q2W, every 2 weeks; RP2D, recommended phase 2 dose; RRMM, relapsed or refractory multiple myeloma.
- TALVEY® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
- Data on file. Janssen Biotech, Inc.