Drug Trials Snapshot: TALVEY

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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

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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 I}ncludes 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.

Link to Drug Package Insert