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TALVEY® (talquetamab-tgvs)

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TALVEY - MonumenTAL-2 (MMY1004) Study Cohort D

Last Updated: 12/12/2024

SUMMARY

Janssen does not recommend the use of TALVEY or DARZALEX FASPRO^® (daratumumab and hyaluronidase) in a manner that is inconsistent with the approved labeling.
MonumenTAL-2 (MMY1004) is an ongoing, phase 1b, multi-arm, open-label study evaluating TALVEY in combination with other anticancer therapies in patients with multiple myeloma (MM). Cohort D is evaluating the efficacy and safety of TALVEY in combination with DARZALEX FASPRO and lenalidomide in 34 patients with newly diagnosed multiple myeloma (NDMM).¹^,²
- Nooka et al (2024)² presented the initial efficacy and safety results of TALVEY in combination with DARZALEX FASPRO and lenalidomide. Following step-up dosing, patients received TALVEY 0.6 mg/kg every other week (Q2W) + DARZALEX FASPRO + lenalidomide at a median follow-up of 13.2 months (range, 10.0-14.6) or TALVEY 0.8 mg/kg every 4 weeks (Q4W) + DARZALEX FASPRO + lenalidomide at a median follow-up of 5.8 months (range, 1.7 [denotes patients who died]-12.0).

CLINICAL DATA - Monumental-2 study (Cohort D) - phase 1b

MonumenTAL-2 (MMY1004; clinicaltrials.gov identifier NCT05050097) is an ongoing, phase 1b, multi-arm, open-label study evaluating TALVEY in combination with other anticancer therapies in patients with MM.¹^,²

Cohort D of the MonumenTAL-2 study is evaluating the efficacy and safety of TALVEY in combination with DARZALEX FASPRO and lenalidomide in 34 patients with NDMM.¹^,²

Study Design/Methods

The study design is presented in Figure: MonumenTAL-2 Study (Cohort D): Study Design.

MonumenTAL-2 Study (Cohort D): Study Design²

Abbreviations: AE, adverse event; ASTCT, American Society for Transplantation and Cellular Therapy; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ICANS, immune effector cell-associated neurotoxicity syndrome; IMWG, International Myeloma Working Group; MM, multiple myeloma; ORR, overall response rate; PFS, progression-free survival; PO, by mouth; Q2W, every other week; Q4W, every 4 weeks; QW, weekly; SC, subcutaneous.
^aAEs assessed per CTCAE v5.0, except for CRS and ICANS, which were graded per ASTCT guidelines.
^bAssessed per IMWG 2016 criteria.
^cAdministered QW (on days 1, 8, 15, and 22) during cycles 1 and 2, Q2W (on days 1 and 15) during cycles 3 to 6, and once (on day 1) during each subsequent 28-day cycle.
^dFor 21 days of a 28-day cycle.

Nooka et al (2024)² presented the initial efficacy and safety results of the TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + lenalidomide and TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + lenalidomide cohorts at a median follow-up of 13.2 months (range, 10.0-14.6) and 5.8 months (range, 1.7 [denotes patients who died]-12.0), respectively, from the MonumenTAL-2 study.

Results

Patient Characteristics

Patient characteristics are presented in Table: MonumenTAL-2 Study (Cohort D): Patient Characteristics.

MonumenTAL-2 Study (Cohort D): Patient Characteristics²

Characteristic	TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + Lenalidomide (n=8)	TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + Lenalidomide (n=26)
Median age, years (range)	68.5 (45-84)	74.0 (45-89)
Male, n (%)	7 (87.5)	16 (61.5)
Race, n (%)
White	6 (75.0)	18 (69.2)
African American/Black	2 (25.0)	2 (7.7)
Asian	0	2 (7.7)
Native Hawaiian or other Pacific Islander	0	1 (3.8)
Not reported	0	3 (11.5)
Extramedullary plasmacytomas ≥1, n (%)	0	3 (11.5)
High-risk cytogenetics^a, n (%)	0	5 (27.8)
ISS stage^b, n (%)
I	5 (62.5)	9 (39.1)
II	2 (25.0)	10 (43.5)
III	1 (12.5)	4 (17.4)
ECOG PS^c, n (%)
0	4 (50.0)	9 (37.5)
1	4 (50.0)	16 (64.0)
Median time since diagnosis, months, (range)	1.2 (0.7-13.7)	1.4 (0.1-43.6)
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; FISH, fluorescence in situ hybridization; ISS, International Staging System; Q2W, every other week; Q4W, every 4 weeks. ^adel(17p), t(4;14), and/or t(14;16). Cytogenetic risk is based on FISH or karyotype testing. Percentages calculated from n=5 for the Q2W cohort and n=18 for the Q4W cohort. ^bPercentages calculated from n=8 for the Q2W cohort and n=23 for the Q4W cohort. ^cPercentages are calculated from n=8 for the Q2W cohort and n=25 for the Q4W cohort.

Efficacy

At data cutoff, the overall response rate was 100% and 96.2% in the TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + lenalidomide and TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + lenalidomide cohorts, respectively.
Treatment response and survival outcomes are summarized in Table: MonumenTAL-2 Study (Cohort D): Efficacy Outcomes.

MonumenTAL-2 Study (Cohort D): Efficacy Outcomes²

Parameter	TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + Lenalidomide (n=8)	TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + Lenalidomide (n=26)
Median follow-up, months (range)	13.2 (10.0-14.6)	5.8 (1.7^a-12.0)
ORR, n (%)	8 (100)	25 (96.2)
sCR, %	37.5	11.5
CR, %	25.0	11.5
VGPR, %	25.0	57.7
PR, %	12.5	15.4
≥VGPR, %	87.5	80.8
Median time to first response, months (range)	1.0 (0.9-2.3)	1.0 (0.9-1.9)
Median time to best response, months (range)	3.8 (1.0-11.6)	1.9 (0.9-9.2)
6-month PFS rate^b, % (95% CI)	100.0 (100.0-100.0)	95.8 (73.9-99.4)
6-month DOR rate^c, % (95% CI)	100.0 (100.0-100.0)	100.0 (100.0-100.0)
Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; ORR, overall response rate; PFS, progression-free survival; PR, partial response; Q2W, every other week; Q4W, every 4 weeks; sCR, stringent complete response; VGPR, very good partial response. Clinical data cutoff date of September 23, 2024. ^aDenotes patients who died. ^bMedian DOR was not reached in either cohort; data are still maturing. ^cMedian PFS was not reached in either cohort; data are still maturing.

Safety

Treatment-emergent adverse events (TEAEs) in both cohorts are summarized in Table: MonumenTAL-2 Study (Cohort D): Summary of Hematologic and Nonhematologic TEAEs (≥30%).
No patients discontinued any study treatments due to AEs in the evaluated cohorts.
- No treatment discontinuations were reported due to taste-, skin-, nail-, and rash-related G protein-coupled receptor class C group 5 member D (GPRC5D) AEs.
Dose modifications due to AEs in both cohorts are presented in Table: MonumenTAL-2 Study (Cohort D): Dose Modifications.
Hypogammaglobulinemia was reported in 63% and 54% of patients in the TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + lenalidomide and TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + lenalidomide cohorts, respectively; 50% and 19% of these patients received ≥1 intravenous immunoglobulin during treatment, respectively.
One death was reported in the TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + lenalidomide cohort caused by a large intestine perforation due to sigmoid mass, which was not drug related.

MonumenTAL-2 Study (Cohort D): Summary of Hematologic and Nonhematologic TEAEs (≥30%)²

TEAE, n (%)	TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + Lenalidomide (n=8)		TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + Lenalidomide (n=26)
TEAE, n (%)	Any Grade	Grade 3/4	Any Grade	Grade 3/4
Hematologic TEAEs
Neutropenia	6 (75.0)	6 (75.0)	12 (46.2)	11 (42.3)
Anemia	5 (62.5)	3 (37.5)	8 (30.8)	3 (11.5)
Thrombocytopenia	4 (50.0)	1 (12.5)	8 (30.8)	2 (7.7)
Nonhematologic TEAEs
Taste-related^a	8 (100.0)	0	24 (92.3)	1 (3.8)
CRS	7 (87.5)	0	20 (76.9)	0
ICANS	0	0	0	0
Skin-related^b	6 (75.0)	2 (25.0)	20 (76.9)	1 (3.8)
Infections^c	8 (100.0)	3 (37.5)	13 (50.0)	1 (3.8)
Rash-related^d	5 (62.5)	3 (37.5)	15 (57.7)	3 (11.5)
Diarrhea	7 (87.5)	0	11 (42.3)	1 (3.8)
Nail-related^e	5 (62.5)	0	13 (50.0)	0
Dry mouth	5 (62.5)	0	12 (46.2)	0
Constipation	3 (37.5)	0	13 (50.0)	0
Pyrexia	5 (62.5)	0	10 (38.5)	0
Cough	6 (75.0)	0	8 (30.8)	0
Fatigue	5 (62.5)	1 (12.5)	9 (34.6)	2 (7.7)
Nausea	5 (62.5)	0	9 (34.6)	2 (7.7)
Weight decreased	2 (25.0)	0	11 (42.3)	1 (3.8)
Abbreviations: COVID-19, coronavirus disease 2019; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; ICANS, immune effector cell-associated neurotoxicity syndrome; Q2W, every other week; Q4W, every 4 weeks; TEAE, treatment-emergent adverse event. Clinical data cutoff date of September 23, 2024. ^aIncludes dysgeusia, ageusia, taste disorder, and hypogeusia; per CTCAE v5.0, the maximum grade of dysgeusia was 2. ^bIncludes skin exfoliation, dry skin, pruritus, and palmar-plantar erythrodysesthesia syndrome. ^cGrade 3/4 infections included gastroenteritis, influenza, pneumonia, and COVID-19 pneumonia in the Q2W cohort and esophageal candidiasis in the Q4W cohort. ^dIncludes rash, maculopapular rash, erythematous rash, and erythema. ^eIncludes nail discoloration, nail disorder, nail toxicity, nail dystrophy, nail ridging, onychoclasis, onycholysis, and onychomadesis.

MonumenTAL-2 Study (Cohort D): Dose Modifications²

TALVEY Dose Modiﬁcation, %	TALVEY 0.6 mg/kg Q2W + DARZALEX FASPRO + Lenalidomide (n=8)	TALVEY 0.8 mg/kg Q4W + DARZALEX FASPRO + Lenalidomide (n=26)
Delayed dose	88	15
Skipped dose	75	31
Reduced dose	38	23
Abbreviations: Q2W, every other week; Q4W, every 4 weeks. Clinical data cutoff date of September 23, 2024.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 10 December 2024.

References

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1	Janssen Research & Development, LLC. A multi-arm phase 1b study of talquetamab with other anticancer therapies in participants with multiple myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 December 10]. Available from: https://clinicaltrials.gov/ct2/show/NCT05050097 NLM Identifier: NCT05050097.
2	Nooka AK, Cochrane T, D’Souza A, et al. Talquetamab, a GPRC5D×CD3 bispecific antibody, in combination with daratumumab and lenalidomide in patients with newly diagnosed multiple myeloma: safety and efficacy results from the phase 1b MonumenTAL-2 study. Poster presented at: 66th American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024; San Diego, CA.