Drug Trials Snapshot: TALVEY
How to Use This Snapshot
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
Limitations of This Snapshot
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the TALVEY Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
TALVEY (talquetamab-tgvs)
tal-vay
Janssen Biotech, Inc
Original Approval date: August 10, 2023
DRUG TRIAL SNAPSHOT SUMMARY
What is the drug for?
TALVEY is an antibody that is used to treat a form of blood cancer called multiple myeloma. It is used to treat adult patients whose cancer came back after, or did not respond to, at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody to treat their multiple myeloma.
How is this drug used?
TALVEY is given as an injection under the skin by a healthcare provider. You should be hospitalized for 48 hours after administration of all doses in the step-up dosing schedule. After completing the step-up dosing schedule, TALVEY will be given as an injection under the skin by a healthcare provider once a week or every two weeks.
Who participated in the clinical trials?
The safety of TALVEY was based on evidence from a clinical trial which enrolled 339 patients with relapsed or refractory multiple myeloma. The efficacy of TALVEY was based on 100 patients treated with the 0.4 mg/kg weekly dose and 87 patients treated with the 0.8 mg/kg biweekly dose who received four prior systemic therapies and were not exposed to prior T-cell redirection therapy. The trial was conducted at 47 sites in nine countries. The same trial was used to assess safety and efficacy.
How were the trials designed?
One clinical trial provided data for the approval of TALVEY. The trial included patients with multiple myeloma whose disease came back after or did not respond to at least three prior systemic therapies including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Patients received treatment with TALVEY until their disease progressed or the side effects were too toxic. The benefit of TALVEY was determined by the number of patients who achieved a clinically relevant improvement in their disease (overall response rate).
How were the trials designed?
The efficacy population to determine how well TALVEY worked included 187 patients who were not exposed to prior T-cell redirection treatment and received at least four prior lines of therapy. How well the drug worked was based on overall response rate and duration of response determined by an independent review committee using the International Myeloma Working Group Criteria. The safety population was 339 patients which included patients treated at either of the two doses.
DEMOGRAPHICS SNAPSHOT
Figure 1 summarizes how many male and female patients were enrolled in the clinical trial used to evaluate the efficacy of TALVEY.
Figure 1. Baseline Demographics by Sex, Efficacy Population
Source: Adapted from FDA Review
Figure 2 summarized how many male and female patients were enrolled in the clinical trial to evaluate the side effects of TALVEY.
Figure 2. Baseline Demographics by Sex, Safety Population
Source: Adapted from FDA Review
Figure 3 summarizes the percentage of patients by race enrolled in the clinical trial used to evaluate the efficacy of TALVEY.
Figure 3. Demographics by Race, Efficacy Population
Source: Adapted from FDA Review
Figure 4 summarizes the percentage of patients by race enrolled in the clinical trial used to evaluate the side effects of TALVEY.
Figure 4. Baseline Demographics by Race, Safety Population
Source: Adapted from FDA Review
Figure 5 summarizes the percentage of patients by age enrolled in the clinical trial used to evaluate the efficacy of TALVEY.
Figure 5. Demographics by Age, Efficacy Population
Source: Adapted from FDA Review
Figure 6 summarizes the percentage of patients by age enrolled in the clinical trial used to evaluate the side effects of TALVEY.
Figure 6. Demographics by Age, Safety Population
Source: Adapted from FDA Review
Figure 7 summarizes the percentage of patients by ethnicity enrolled in the clinical trial used to evaluate the efficacy of TALVEY.
Figure 7. Demographics by Ethnicity, Efficacy Population
Source: Adapted from FDA Review
Figure 8 summarizes the percentage of patients by ethnicity enrolled in the clinical trial used to evaluate the side effects of TALVEY.
Figure 8. Demographics by Ethnicity, Safety Population
Source: Adapted from FDA Review
Who participated in the trials?
Table 1 summarizes the efficacy and safety population from the clinical trial.
Table 1. Baseline Demographics
| TALVEY | TALVEY | |
| Efficacy Population | Safety Population | |
| N=187 | N=339 | |
| Demographic | n (%) | n (%) |
| Sex | ||
| Male | 106 (57) | 192 (57) |
| Female | 81 (43) | 147 (43) |
| Race | ||
| White | 169 (90) | 300 (89) |
| Black or African American | 10 (5) | 24 (7) |
| Asian | 5 (3) | 8 (2) |
| Native Hawaiian or other Pacific Islander | 1 (<1) | 1 (<1) |
| Other1 | 2 (<1) | 6 (2) |
| Age, years | ||
| <65 | 75 (40) | 161 (47) |
| 65 to <75 | 71 (38) | 121 (36) |
| ≥75 | 41 (22) | 57 (17) |
| Ethnicity | ||
| Hispanic or Latino | 15 (8) | 31 (9) |
| Not Hispanic or Latino | 172 (92) | 306 (90) |
| Not reported | 0 (0) | 2 (1) |
| Region | ||
| European | 140 (75) | 213 (63) |
| North American | 42 (22) | 121 (36) |
| Asia | 5 (2.7) | 5 (1.5) |
Source: Adapted from FDA Review
1 Includes unknown, multiple, or not reported
What are the benefits of this drug?
In the trial, for the weekly dose, 73 of 100 patients (73%) treated with TALVEY experienced an improvement in their multiple myeloma. For the 73% of patients who responded, the improvement lasted an average of nine and a half months.
In the trial, for the biweekly dose, 65 of 87 patients (73.6%) treated with TALVEY experienced an improvement in their multiple myeloma. For the biweekly dose, approximately 85% of patients who had improvement continued to have improvement for at least nine months.
TALVEY was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.
What are the benefits of this drug (results of trials used to assess efficacy)?
The efficacy of TALVEY was evaluated by overall response rate, as determined by an independent review committee based on the International Myeloma Group Criteria.
Table 2. Efficacy Results for Patients Who Received the Weekly Dose
| TALVEY | |
| 0.4 mg/kg Weekly | |
| Efficacy Endpoint | N=100 |
| Overall response rate1, n (%) | 73 (73) |
| 95% CI | 63.2, 81.4 |
| Stringent complete response (sCR), % | 26 |
| Complete response (CR), % | 9 |
| Very good partial response (VGPR), % | 22 |
| Partial response (PR), % | 16 |
| Duration of response, months | |
| Median (95% CI) | 9.5 (6.5, NE) |
Source: Adapted from TALVEY Prescribing Information
1 Overall response rate = sCR+CR+VGPR+PR
Abbreviations: CI, confidence interval; NE, not estimable
Table 3. Efficacy Results for Patients Who Received Biweekly (Every 2 Weeks) Dose
| TALVEY | |
| 0.8 mg/kg Biweekly | |
| Efficacy Endpoint | N=87 |
| Overall response rate1, n (%) | 65 (73.6) |
| 95% CI | 63.0, 82.4 |
| Stringent complete response (sCR), % | 20 |
| Complete response (CR), % | 13 |
| Very good partial response (VGPR), % | 25 |
| Partial response (PR), % | 16 |
| Duration of response, months | |
| Median (95% CI) | NE |
Source: Adapted from TALVEY Prescribing Information
1 Overall response rate = sCR+CR+VGPR+PR
Abbreviations: CI, confidence interval; NE, not estimable
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
- Sex: TALVEY worked similarly in males and females for weekly and biweekly doses.
- Race: Most of the patients were White. Differences in how well the drug worked among races could not be determined because of the small number of patients in other races.
- Age: TALVEY worked similarly in patients younger and older than 65 years of age for weekly and biweekly doses.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Table 4 and Table 5 summarize efficacy results by sex, age, and race. Because of the small sample sizes, these exploratory analyses should be interpreted with caution.
Table 4. Subgroup Analyses of Overall Response Rate for Patients Who Received the Weekly Dose
| TALVEY | ||
| 0.4 mg/kg Weekly | ||
| Subgroup | N=100 | Overall Response Rate1 |
| % | % | |
| Sex | ||
| Male | 53 | 74 |
| Female | 47 | 72 |
| Age group, years | ||
| <65 | 41 | 73 |
| 65 to <75 | 42 | 76 |
| ≥75 | 17 | 65 |
| Race | ||
| White | 95 | 72 |
| Other2 | 5 | 100 |
Source: Adapted from FDA Review
1 Overall response rate = sCR+CR+VGPR+PR
2 Other includes Black or African American (n=4) and Asian (n=1).
Abbreviations: CR, complete response; PR, partial response; sCR, stringent complete response; VGPR, very good partial response
Table 5. Subgroup Analyses of Overall Response Rate for Patients Who Received the Biweekly (Every 2 Weeks) Dose
| 0.8 mg/kg Biweekly | ||
| N=87 | Overall Response Rate1 | |
| Subgroup | % | % |
| Sex | ||
| Male | 53 | 66 |
| Female | 34 | 85 |
| Age group, years | ||
| <65 | 34 | 68 |
| 65 to <75 | 29 | 76 |
| ≥75 | 24 | 79 |
| Race | ||
| White | 74 | 73 |
| Other2 | 13 | 77 |
Source: Adapted from FDA Review
1 Overall response rate = sCR+CR+VGPR+PR
2 Other includes Black or African American (n=6), Asian (n=4), Native Hawaiian or other Pacific Islander (n=1), Multiple (n=1), and Unknown (n=1).
Abbreviations: CR, complete response; PR, partial response; sCR, stringent complete response; VGPR, very good partial response
What are the possible side effects?
TALVEY may cause side effects that are serious, life-threatening, or lead to death, including cytokine release syndrome (CRS) and neurologic problems, including a neurologic problem called immune effector cell-associated neurotoxicity syndrome (ICANS). Because of CRS and neurologic problems including ICANS, TALVEY is only available through a drug safety program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS). Other serious side effects include oral side effects and weight loss, infections, low blood counts including neutrophils and platelets, skin side effects, liver problems, and harm to an unborn baby. The most common side effects of TALVEY are fever, CRS, abnormal taste, nail side effects, musculoskeletal pain, skin disorder, rash, tiredness, a decrease in weight, dry mouth, dry skin, painful swallowing, upper respiratory tract infections, diarrhea, low blood pressure, and headache.
What are the possible side effects (results of trials used to assess safety)?
Table 6 summarizes the adverse reactions in the 339 patients who received TALVEY at the recommended doses in the clinical trial.
Table 6. Adverse Reactions (≥10%) in Patients Who Received TALVEY, Safety Population
| TALVEY, N =339 | ||
| System Organ Class | Any Grade | Grade 3 or 4 |
| Adverse Reactions | % | % |
| General disorders and administration site conditions | ||
| Pyrexiaa | 83 | 4.7c |
| Fatiguea | 37 | 3.5c |
| Chills | 19 | 0 |
| Paina | 18 | 1.8c |
| Edemaa | 14 | 0 |
| Injection site reactiona | 13 | 0 |
| Immune system disorders | ||
| Cytokine release syndrome | 76 | 1.5c |
| Gastrointestinal disorders | ||
| Dysgeusia1,d | 70 | 0 |
| Dry mouthd | 34 | 0 |
| Dysphagia | 23 | 0.9c |
| Diarrhea | 21 | 0.9c |
| Stomatitis2 | 18 | 1.2c |
| Nausea | 18 | 0 |
| Constipation | 16 | 0 |
| Oral disorder3 | 12 | 0 |
| Skin and subcutaneous tissue disorders | ||
| Nail disorder4 | 50 | 0 |
| Skin disorder5 | 41 | 0.3c |
| Rash6 | 38 | 3.5c |
| Xerosis7 | 30 | 0 |
| Pruritus | 19 | 0.3c |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal paina | 43 | 3.2c |
| Investigations | ||
| Weight decreased | 35 | 1.5c |
| Infections and infestations | ||
| Upper respiratory tract infectiona | 22 | 2.7c |
| Bacterial infection including sepsis8,b | 19 | 9 |
| COVID-19a,b | 11 | 2.7 |
| Fungal infection9,b | 10 | 0.6 |
| Vascular disorders | ||
| Hypotensiona | 21 | 2.9 |
| Nervous system disorders | ||
| Headachea | 21 | 0.6c |
| Encephalopathy10 | 15 | 1.8c |
| Sensory neuropathy11 | 14 | 0 |
| Motor dysfunction12 | 10 | 0.6c |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 19 | 1.2c |
| Respiratory, thoracic and mediastinal disorders | ||
| Cougha | 17 | 0 |
| Dyspneaa,b | 11 | 1.8 |
| Hypoxiaa | 10 | 1.5c |
| Cardiac disorders | ||
| Tachycardiaa | 11 | 0.6c |
Source: Adapted from TALVEY Prescribing Information
Adverse reactions were graded based on CTCAE Version 4.03, with the exception of CRS, which was graded per ASTCT 2019 criteria.
a Includes other related terms.
b Includes fatal outcome(s): COVID-19 (N=2), dyspnea (N=2), bacterial infection including sepsis (N=1), fungal infection (N=1).
c Only grade 3 adverse reactions occurred.
d Per CTCAE v4.03, maximum toxicity grade for dysgeusia is 2 and maximum toxicity grade for dry mouth is 3.
1 Dysgeusia: ageusia, dysgeusia, hypogeusia, and taste disorder.
2 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.
3 Oral disorder: oral disorder, oral dysesthesia, oral mucosal exfoliation, oral toxicity, and oropharyngeal pain.
4 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.
5 Skin disorder: palmar-plantar erythrodysesthesia syndrome, palmoplantar keratoderma, skin discoloration, skin exfoliation, and skin fissures.
6 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.
7 Xerosis: dry eye, dry skin, and xerosis.
8 Bacterial infection including sepsis: bacteremia, bacterial prostatitis, carbuncle, cellulitis, oraxellaa infection, clostridium difficile colitis, clostridium difficile infection, cystitis oraxellaa, cystitis klebsiella, diverticulitis, oraxellaa bacteremia, oraxellaa pyelonephritis, oraxellaa sepsis, folliculitis, gastroenteritis oraxellaa coli, helicobacter gastritis, human ehrlichiosis, klebsiella bacteremia, klebsiella sepsis, oraxella infection, otitis media acute, pitted keratolysis, pneumococcal sepsis, pneumonia, pneumonia streptococcal, pseudomonal bacteremia, pyuria, renal abscess, salmonella sepsis, sepsis, septic shock, skin infection, staphylococcal bacteremia, staphylococcal infection, staphylococcal sepsis, streptococcal bacteremia, tooth abscess, tooth infection, urinary tract infection enterococcal, and urinary tract infection pseudomonal.
9 Fungal infection: body tinea, candida infection, ear infection fungal, esophageal candidiasis, fungal infection, fungal sepsis, fungal skin infection, genital candidiasis, onychomycosis, oral candidiasis, oral fungal infection, oropharyngeal candidiasis, tinea pedis, vulvovaginal candidiasis, and vulvovaginal mycotic infection.
10 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.
11 Sensory neuropathy: dysesthesia, hyperesthesia, hypoesthesia, hypoesthesia oral, immune-mediated neuropathy, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, polyneuropathy, sciatica, and vestibular neuronitis.
12 Motor dysfunction: dysarthria, dysgraphia, dysmetria, dysphonia, gait disturbance, muscle atrophy, muscle spasms, muscular weakness, and tremor.
Abbreviations: ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events
Were there any differences in side effects among sex, race, and age?
- Sex: The occurrence of side effects was similar in males and females.
- Race: Most patients were White. Differences in side effect among races is difficult to determine because of the small number of patients in other races. Skin toxicity and oral toxicity were higher in African American patients.
- Age: The occurrence of side effects was similar in patients younger than 65 and patients between 65 and 74 years of age. Fatal adverse reactions were numerically higher in patients 75 and older.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Table 7, Table 8, and Table 9 summarize the adverse reactions by subgroups. Table 7. Adverse Reactions by Sex, Safety Population
Table 7. Adverse Reactions by Sex, Safety Population
| Female | Male | Total | |
| N=147 | N=192 | N=339 | |
| Adverse Reaction | n (%) | n (%) | n (%) |
| Grades 3, 4 TEAE | 116 (78.9) | 137 (71.4) | 253 (74.6) |
| Fatal TEAE (grade 5 TEAE) | 5 (3.4) | 6 (3.1) | 11 (3.2) |
| Serious TEAE | 74 (50.3) | 87 (45.3) | 161 (47.5) |
| CRS | 108 (73.5) | 149 (77.6) | 257 (75.8) |
| Neurotoxicity1 | 90 (61.2) | 95 (49.5) | 185 (54.6) |
| Oral toxicity2 | 113 (76.9) | 159 (82.8) | 272 (80.2) |
| Skin toxicity3 | 94 (63.9) | 117 (60.9) | 211 (62.2) |
Source: Adapted from FDA Review
1 Includes System Organ Class of Psychiatric Disorders and Nervous System Disorders (without dysgeusia [grouped term]), includes additional terms regrouped to headache, motor dysfunction, and sensory neuropathy
2 Includes Stomatitis (grouped term), dysgeusia (grouped term), dry mouth, dysphagia, oral disorder, oral dysaesthesia, and oral pain
3 Includes rash (grouped term) and skin disorder (grouped term)
Abbreviations: CRS, cytokine release syndrome; TEAE, treatment-emergent adverse event
Table 8. Adverse Reactions by Race, Safety Population
| Black or African American | Other4 | White | Total | |
| N=24 | N=15 | N=300 | N=339 | |
| Adverse Reaction | n (%) | n (%) | n (%) | n (%) |
| Grades 3, 4 TEAE | 21 (87.5) | 14 (93.3) | 218 (72.7) | 253 (74.6) |
| Fatal TEAE (grade 5 TEAE) | 0 | 1 (6.7) | 10 (3.3) | 11 (3.2) |
| Serious TEAE | 11 (45.8) | 11 (73.3) | 139 (46.3) | 161 (47.5) |
| CRS | 17 (70.8) | 14 (93.3) | 226 (75.3) | 257 (75.8) |
| Neurotoxicity1 | 15 (62.5) | 9 (60.0) | 161 (53.7) | 185 (54.6) |
| Oral toxicity2 | 22 (91.7) | 13 (86.7) | 237 (79.0) | 272 (80.2) |
| Skin toxicity3 | 20 (83.3) | 5 (33.3) | 186 (62.0) | 211 (62.2) |
Source: Adapted from FDA Review
1 Includes System Organ Class of Psychiatric Disorders and Nervous System Disorders (without dysgeusia [grouped term]), includes additional terms regrouped to headache, motor dysfunction and sensory neuropathy
2 Includes Stomatitis (grouped term), dysgeusia (grouped term), dry mouth, dysphagia, oral disorder, oral dysaesthesia, and oral pain
3 Includes rash (grouped term) and skin disorder (grouped term)
4 Includes Asian, Native Hawaiian or other Pacific Islander, unknown, multiple, or not reported
Abbreviations: CRS, cytokine release syndrome; TEAE, treatment-emergent adverse event
Table 9. Adverse Reactions by Age, Safety Population
| <65 | 65 to <75 | ≥75 | Total | |
| N=161 | N=121 | N=57 | N=339 | |
| Adverse Reaction | n (%) | n (%) | n (%) | n (%) |
| Grades 3, 4 TEAE | 123 (76.4) | 93 (76.9) | 37 (64.9) | 253 (74.6) |
| Fatal TEAE (grade 5 TEAE) | 3 (1.9) | 3 (2.5) | 5 (8.8) | 11 (3.2) |
| Serious TEAE | 75 (46.6) | 60 (49.6) | 26 (45.6) | 161 (47.5) |
| CRS | 127 (78.9) | 87 (71.9) | 43 (75.4) | 257 (75.8) |
| Neurotoxicity1 | 85 (52.8) | 70 (57.9) | 30 (52.6) | 185 (54.6) |
| Oral toxicity2 | 129 (80.1) | 98 (81.0) | 45 (78.9) | 272 (80.2) |
| Skin toxicity3 | 100 (62.1) | 75 (62.0) | 36 (63.2) | 211 (62.2) |
Source: Adapted from FDA Review
1 Includes System Organ Class of Psychiatric Disorders and Nervous System Disorders (without dysgeusia [grouped term]), includes additional terms regrouped to headache, motor dysfunction and sensory neuropathy
2 Includes Stomatitis (grouped term), dysgeusia (grouped term), dry mouth, dysphagia, oral disorder, oral dysaesthesia, and oral pain
3 Includes rash (grouped term) and skin disorder (grouped term)
Abbreviations: CRS, cytokine release syndrome; TEAE, treatment-emergent adverse event
GLOSSARY
Clinical Trial: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
Comparator: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
Efficacy: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
Placebo: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
Subgroup: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.