TECVAYLI®
(teclistamab-cqyv)
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TECVAYLI® (teclistamab-cqyv)
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TECVAYLI - Less Frequent Dosing - Real-world Evidence
Last Updated: 09/05/2024
SUMMARY
Summarized below are real-world, observational, retrospective studies and registries that evaluated less frequent dosing of TECVAYLI in adult patients with relapsed or refractory multiple myeloma (RRMM).1
Real-world data
Study Design/Methods
This study included patients with RRMM who were treated with commercial TECVAYLI at MSK from November 29, 2022 (the date of the first patient treated) to March 1, 2024. - The data cutoff date for the analysis was April 17, 2024.
- Eligible patients included adults with RRMM who received ≥1 dose of commercial TECVAYLI.
- The index date was defined as the date of the first TECVAYLI dose.
- The baseline characteristics of patients were recorded at TECVAYLI initiation.
- Treatment responses, time to response, 6-month progression-free survival (PFS), duration of response (DOR), switch to less frequent dosing, reason for switching to less frequent dosing, and effectiveness after switching to less frequent dosing were recorded after TECVAYLI initiation.
- Treatment responses were evaluated based on the International Myeloma Working Group (IMWG) uniform response criteria.
- Results were reported for the overall population and 3 subgroups of interest:
- Early initiators: Patients treated within the first 4 months since commercial TECVAYLI was first used at MSK (November 29, 2022, to March 31, 2023; early initiators who were expected to have high disease burden).
- Recent initiators: Patients treated with TECVAYLI after March 31, 2023.
- Patients with less frequent TECVAYLI dosing: Patients who switched from weekly (QW) to once every other week (Q2W) or once every 4 weeks (Q4W) dosing.
Results
Treatment Disposition, Baseline Characteristics, and Disease Characteristics
- A total of 86 patients were included in this analysis. Baseline characteristics are provided in Table: Baseline Characteristics of Overall Population.
Early Initiators Compared With Recent Initiators
- Baseline characteristics for early initiators compared with recent initiators are provided in Table: Baseline Characteristics for Early Initiators and Recent Initiators.
Patients With Less Frequent Dosing
- Baseline characteristics of patients who switched to less frequent dosing are provided in Table: Baseline Characteristics for Patients With Less Frequent Dosing.
- At the analysis cutoff time point, 32 patients (37%) had transitioned to less frequent dosing; 30 patients transitioned from QW to Q2W dosing, and 2 patients transitioned from QW to Q4W dosing.
- Transition to less frequent dosing occurred after a median time of 3.3 months (95% confidence interval [CI], 1.9-4.3) from TECVAYLI initiation.
- The primary reasons for switching to less frequent dosing included achieving partial response or better (≥PR) (n=23) and/or safety management (n=14).
| Characteristics | N=86 |
|---|---|
| Median age, years (IQR) | 71 (64-78) |
| Age ≥75 years, n (%) | 31 (36) |
| Female, n (%) | 44 (51) |
| Race, n (%) | |
| White | 65 (76) |
| Black | 14 (16) |
| Other | 7 (8) |
| ECOG performance status, n/N (%) | |
| 0 | 10/50 (20) |
| 1 | 25/50 (50) |
| 2 | 5/50 (10) |
| CrCl <30 mL/min, n (%) | 9 (10) |
| ESRD on hemodialysis, n (%) | 2 (2) |
| Peripheral neuropathy, n (%) | 35 (41) |
| R-ISS stage, n/N (%) | |
| I | 13/51 (25) |
| II | 31/51 (61) |
| III | 7/51 (14) |
| Extramedullary plasmacytomas ≥1a | 30/79 (38) |
| High-risk cytogeneticsb | 56/79 (71) |
| Median time since diagnosis, years (range) | 6.2 (0.7-29.2) |
| Median prior LOTs, n (IQR) | 6 (4-8) |
| Prior autologous SCT, n (%) | 53 (62) |
| Prior allogeneic SCT, n (%) | 3 (3) |
| Prior BCMA exposurec | 32/86 (37) |
| Antibody-drug conjugate | 19/32 (60) |
| BCMA bispecific therapy | 3/32 (9) |
| CAR-T therapy | 21/32 (66) |
| Abbreviations: BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T cell; CrCl, creatinine clearance; ECOG, Eastern Cooperative Oncology Group; ESRD, end-stage renal disease; IQR, interquartile range; LOT, line of therapy; R-ISS, revised International Staging System; SCT, stem cell transplant. aIncluded soft-tissue plasmacytomas not associated with bone and extraosseous soft tissue. bdel(17p), t(4;14), t(14;16), t(14;20), and/or gain or amp 1q. cNine patients received ≥1 type of prior BCMA-directed therapy. | |
| Characteristics | Early Initiators Treated by March 31, 2023 (N=34) | Recent Initiators Treated After March 31, 2023 (N=52) |
|---|---|---|
| Median age, years (IQR) | 69 (63-77) | 71 (65-78) |
| Male, % | 50 | 48 |
| African American, % | 15 | 17 |
| HRCAsa, n/N (%) | 22/30 (73) | 34/49 (69) |
| Extramedullary disease, n/N (%) | 13/33 (39) | 17/46 (37) |
| Median prior LOT, n (IQR) | 8 (5-9)b | 5 (4-7)b |
| Prior BCMA therapy, n (%) | 21 (62)b | 11 (21)b |
| Abbreviations: BCMA, B-cell maturation antigen; HRCA, high-risk cytogenetic abnormality; IQR, interquartile range; LOT, line of therapy. aHRCAs include 1q+, t(4;14), t(14;16), t(14;20), and del(17p) or monosomy 17. bThe differences are statistically significant (P<0.05). | ||
| Characteristics | N=32 |
|---|---|
| Median age, years (IQR) | 70 (65-78) |
| Male, % | 38 |
| African American, % | 9 |
| HRCAsa, n/N (%) | 17/29 (59) |
| Extramedullary disease, n/N (%) | 10/29 (34) |
| Median prior LOT, n (IQR) | 6 (5-9) |
| Prior BCMA therapy, n (%) | 10 (31) |
| Abbreviations: BCMA, B-cell maturation antigen; HRCA, high-risk cytogenetic abnormality; IQR, interquartile range; LOT, line of therapy. aHRCAs include 1q+, t(4;14), t(14;16), t(14;20), and del(17p) or monosomy 17. | |
Efficacy
- Overall response rate (ORR) was 61% for 77 response-evaluable patients, including 43% with very good partial response or better (≥VGPR). ORR for patients with prior B-cell maturation antigen (BCMA)-directed therapy was 43%.
- The median time to first response was 1.3 months (interquartile range [IQR], 0.9-2.6).
- After a median follow-up of 9.5 months, the 6-month PFS rate was 52.4% (95% CI, 42.4-64.7).
- Median DOR was not reached.
Early Initiators Compared With Recent Initiators
- At a median follow-up of 10.9 months (95% CI, 9.8-11.7) for early initiators and 5.1 months (95% CI, 3.9-6.6) for recent initiators, ORR was 67% and 57%, respectively. Treatment response and survival outcomes for early initiators and recent initiators are detailed in Table: Efficacy Outcomes in Early Initiators and Recent Initiators.
Patients With Less Frequent Dosing
- At a median follow-up of 6.4 months (95% CI, 5.5-8.7) since transitioning to less frequent dosing, 28 of 32 patients were still in response and remained on treatment; 3 patients had progressed, and 1 patient died from infection with active multiple myeloma (MM). Treatment response and survival outcomes for patients with less frequent dosing are detailed in Table: Efficacy Outcomes in Patients With Less Frequent Dosing.
| Outcome | Early Initiators Treated by March 31, 2023 (N=34) | Recent Initiators Treated After March 31, 2023 (N=52) |
|---|---|---|
| Median follow-up, months (95% CI) | 10.9 (9.8-11.7) | 5.1 (3.9-6.6) |
| Best ORR, n/N (%) | 20/30 (67) | 27/47 (57) |
| 6-month PFS rate, % (95% CI) | 53.3 (38.5-73.7) | 52.3 (39.8-68.7) |
| 6-month DOR rate, % (95% CI) | 70.0 (52.5-93.3) | 82.1 (67.7-99.7) |
| Abbreviations: CI, confidence interval; DOR, duration of response; ORR, overall response rate; PFS, progression-free survival. | ||
| Outcome | N=32 |
|---|---|
| Median follow-up, months (95% CI) | 6.4a (5.5-8.7) |
| Best ORR, n/N (%) | 29/31 (94) |
| 6-month PFS rate, % (95% CI) | 90 (79.1-100) |
| Abbreviations: CI, confidence interval; ORR, overall response rate; PFS, progression-free survival. aLength of follow-up since switch to less frequent dosing. | |
Banerjee et al (2024)2
Study Design/Methods
- The analysis utilized data from the AcentrusMM EMRs structured data from 31 academic or community hospitals across 14 states in the United States (US). It included patients who were treated with TECVAYLI between October 26, 2022 (the day after Food and Drug Administration [FDA] approval of TECVAYLI), and November 30, 2023.
- The index date was defined as the date of the first TECVAYLI dose.
- Patients who met all of the following criteria were included in the analysis:
- Patients with ≥1 record for TECVAYLI on or after October 26, 2022.
- Patients with ≥1 MM diagnosis prior to or on the index date.
- Patients ≥18 years of age on the index date.
- Patients who did not receive TECVAYLI in a clinical trial and were not enrolled in a clinical trial on the index date.
- The treatment patterns were analyzed in a subgroup of patients who met the following additional criteria:
- Patients who completed the SUD confirmed by corresponding strengths per label.
- Patients who had received ≥1 cycle of TECVAYLI (≥28 days) post-index date.
- Switching to less frequent dosing schedule was defined as having ≥3 consecutive TECVAYLI records, starting the day after the first cycle of TECVAYLI use, with a dose interval ≥14 days (Q2W) or 28 days (Q4W) between each dose.
Results
Treatment Disposition, Baseline Characteristics, and Disease Characteristics
- As of data cutoff, 247 patients who met the analysis criteria were included. For select baseline characteristics of the study population, see Table: Baseline Patient Characteristics.
| Patient Demographics (on the Index Date) | N=247 |
|---|---|
| Age, years, mean (SD) | 68.3 (10.0) |
| Age, years, median (range) | 69 (41-89) |
| Age categories, n (%) | |
| <55 years | 26 (10.5) |
| ≥55 to <65 years | 57 (23.1) |
| ≥65 to <75 years | 92 (37.2) |
| ≥75 years | 72 (29.2) |
| Sex, n (%) | |
| Male | 134 (54.2) |
| Female | 111 (44.9) |
| Other | 2 (<1) |
| Race, n (%) of 182 patients with data available | |
| White | 138 (75.8) |
| Black or African American | 23 (12.6) |
| Asian | 21 (11.5) |
| Clinical characteristics | |
| Prevalent diagnosis and conditions of interest, n (%) | |
| Anemia | 126 (51.0) |
| Hypertension | 110 (44.5) |
| Renal impairment/failure | 100 (40.5) |
| Peripheral neuropathy | 89 (36.0) |
| Neutropenia | 55 (22.3) |
| Lytic bone lesions | 62 (25.1) |
| Hypogammaglobulinemia | 39 (15.8) |
| Extramedullary plasmacytomas | 14 (5.7) |
| Prior BCMA exposure, n (%) | |
| Any prior BCMA therapy | 48 (19.4) |
| CAR-T therapy (cilta-cel, ide-cel) | 27 (10.9) |
| ADC (belantamab) | 25 (10.1) |
| Elranatamab (from clinical trial) | 1 (<1) |
| Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T cell; SD, standard deviation. | |
- Of the 209 patients who completed SUD, 43.1% of patients had a 2-day interval (days 1-3-5) dosing schedule, and 13.9% had a 3-day interval (days 1-4-7) dosing schedule; 79.4% of patients (n=166) received their third dose within 7 days of starting TECVAYLI. See Table: TECVAYLI SUD Schedule Among Patients With Complete SUD for additional details.
- Acetaminophen (99.5%), antihistamines (98.6%), and steroids (86.1%) were administered to patients on the same day as the TECVAYLI SUD.
- During SUD, 3.3% of patients received tocilizumab on the same day as the TECVAYLI doses, and 23.9% of patients received tocilizumab ≥1 day after receiving TECVAYLI doses.
TECVAYLI SUD Schedule Among Patients With Complete SUD2
| SUD Pattern | N=209 |
|---|---|
| Exact 2-day interval (days 1-3-5), n (%) | 90 (43.1) |
| Exact 3-day interval (days 1-4-7), n (%) | 29 (13.9) |
| Exact 4-day interval (days 1-5-9), n (%) | 13 (6.2) |
| Othera, n (%) | 77 (36.8) |
| Time from the first to the third TECVAYLI dose, median (IQR), days | 5 (4-6) |
| Abbreviations: IQR, interquartile range; SUD, step-up dosing. aDosing schedule with different intervals between doses (eg, days 1-3-7, days 1-4-6) were included as other dosing pattern. | |
Treatment Effectiveness
- At the data cutoff, 61 patients either had initiated a subsequent line of therapy (LOT) after starting TECVAYLI or had died (as proxies for disease progression).
- The probability of initiating a subsequent LOT or death at 3 months was 16.7% (95% CI, 11.7-23.4); at 6 months, 35.7% (95% CI, 27.9-44.9); and at 9 months, 55.2% (95% CI, 44.8-66.3). The median TTNT or death was 8.6 months.
Less Frequent Dosing Schedule
- At the data cutoff, 190 patients completed ≥1 cycle of TECVAYLI use (≥28 days after the index date) with a mean (standard deviation [SD]) follow-up of 5.5 (3.3) months (median IQR, 5.1 [2.5-8.3] months).
- Thirty-nine patients switched from QW to less frequent dosing (Q2W or Q4W); 32 patients switched to the Q2W schedule, and switching to the Q4W schedule was rare at the time of data cutoff. The median time to switching to less frequent dosing was 8.5 months.
- The probability of switching to less frequent dosing at 3 months post-index was 15.5% (95% CI, 10.2%-23.2%); 6 months post-index, 38.3% (95% CI, 27.9%-50.9%); and 9 months post-index, 57.5% (95% CI, 39.4%-76.8%).
Study Design/Methods
- The study utilized data from the Komodo Healthcare MapTM, which includes health claims from more than 150 private insurers in the US. Patients included were treated with TECVAYLI between October 26, 2022 (after FDA approval of TECVAYLI in the US), and December 31, 2023.
- The index date was defined as the date of the first TECVAYLI claim.
- Patients who met all the following criteria were included in the analysis:
- Patients who had ≥1 TECVAYLI claim, with the first claim being on or after October 26, 2022.
- Patients who had ≥1 inpatient or outpatient claims for MM diagnosis prior to or on the index date.
- Patients ≥18 years of age on the index date.
- Patients who did not receive TECVAYLI in a clinical trial and were not enrolled in a clinical trial on the index date.
- Patients with a continuous health plan enrolment during the 6 months prior to the index date (baseline period).
Results
Treatment Disposition, Baseline Characteristics, and Disease Characteristics
- A total of 419 patients who met the analysis criteria were included. The baseline patient characteristics are presented in Table: Baseline Patient Characteristics.
| Patient demographics (on the index date) | N=419 |
| Age, years, median (IQR) | 65 (58-73) |
| Age categories, n (%) | |
| <65 years | 207 (49.4) |
| ≥65 to <75 years | 127 (30.3) |
| ≥75 years | 85 (20.3) |
| Sex, n (%) | |
| Female | 183 (43.7) |
| Male | 236 (56.3) |
| Race, n (%) of 292 patients with data available | |
| White | 185 (63.4) |
| Black or African American | 91 (31.2) |
| Asian or Pacific Islander | 16 (5.4) |
| Clinical characteristics (6-month baseline period) | |
| Prevalent comorbidities and conditions of interest | |
| Infection, n (%) | 222 (53.0) |
| Renal impairment/failure, n (%) | 206 (49.2) |
| Anemia, n (%) | 164 (39.1) |
| Lytic bone lesions, n (%) | 150 (35.8) |
| Lymphopenia, n (%) | 113 (30.0) |
| Hypogammaglobulinemia, n (%) | 125 (29.8) |
| Neutropenia, n (%) | 50 (11.9) |
| Frailty, n (%), n (%) | 61 (14.6)a |
| QCCI score excluding MM, mean (SD) | 4.2 (3.4) |
| Treatment history (any time prior to index)b | |
| Prior LOT, median (IQR) | 5 (3-6)c |
| Prior BCMA exposure, n (%) | 102 (24.3) |
| CAR-T therapy (cilta-cel, ide-cel) | 51 (12.2) |
| ADC (belantamab) | 71 (16.9) |
| Other bispecific antibodies | 0 |
| Abbreviations: ADC, antibody-drug conjugate; BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T cell; IQR, interquartile range; LOT, line of therapy; MM, multiple myeloma; QCCI, Quan-Charlson Comorbidity Index; SD, standard deviation. aBased on the International Myeloma Working Group algorithm. bBased on available data in the database, which may not reflect a patient’s complete treatment history. cDetermined based on a claims-based algorithm. | |
Less Frequent Dosing Schedule
- At a median follow-up of 4.2 months (IQR, 1.6-7.1), 78 patients switched to a less frequent dosing schedule, 58 patients switched to Q2W, and switching to Q4W was rare. At the data cutoff date, the median time to switching to less frequent dosing was not reached.
- According to the Kaplan-Meier survival analysis, the probability of switching to less frequent dosing at 3 months post-index was 19.0% (95% CI, 14.9%-24.2%); 6 months post-index, 38.6% (95% CI, 30.3%-48.3%); and 9 months post-index, 46% (95% CI, 35.7%-58.6%).
Time to the Next Treatment
- Forty-nine (11.7%) of the 419 patients initiated subsequent LOT after receiving TECVAYLI by the data cutoff date.
- The probability of starting the next LOT at 3 months post-index was 6.4% (95% CI, 4.1%-9.9%); 6 months post-index, 19.2% (95% CI, 14.6%-25.1%); and 9 months post-index, 23.6% (95% CI, 17.2%-32.0%). The median TTNT was not reached.
- Of the 78 patients who switched to a less frequent dosing schedule, 3 patients (3.8%) received a subsequent LOT at the data cutoff.
A literature search of MEDLINE®
References
| 1 | Tan CR, Derkach A, Maclachlan K, et al. Real-world less frequent dosing of teclistamab in patients with relapsed/refractory multiple myeloma. Oral Presentation presented at: The American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, IL. |
| 2 | |
| 3 |