For the best chance of achieving the progression-free survival seen in the MAIA trial:
Continue treatment with frontline DARZALEX® + Rd until disease progression or unacceptable toxicity1
Continuous treatment with frontline DRd studied in the MAIA trial
DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d).
You are now viewing a post hoc subset analysis by treatment duration of the MAIA trial. This information is not included in the current Prescribing Information and has not been evaluated by the US Food and Drug Administration. No conclusions should be drawn. These data should be understood in the context of the methodology.
Please see MAIA trial design & primary results.
In a post hoc subset analysis of patients treated for at least 18 months
Treatment duration and long-term outcomes with frontline DRd1,2
Methodology
- To explore the impact of treatment duration on long-term clinical outcomes, a post hoc analysis was conducted based on DRd treatment duration (<18 vs ≥18 months), excluding patients who discontinued therapy due to disease progression during the first 18 months1,2
- This post hoc subset analysis was based on patients who were treated for at least 18 months and excluded patients who discontinued therapy due to disease progression during the first 18 months1,2
- For the DRd arm, it included 283 patients who were treated for at least 18 months, out of 368 patients of the primary intent-to-treat (ITT) analysis of the MAIA trial. For the Rd arm, it included 204 patients who were treated for at least 18 months, out of 369 patients of the primary ITT analysis of the MAIA trial1-3
- Response data presented are cumulative deepest response rates achieved by 6, 9, and 18 months for patients who continued all study treatment for at least 18 months
DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d).
≥CR with DRd
More patients achieved a ≥CR by 18 months vs 6 months of DRd1,2
≥CR rates increased over 6, 9, and 18 months of continuous frontline DRd.1,2
~50% of patients achieved a ≥CR by 18 months of DRd treatment compared with ~9% by 6 months of treatment1,2
CR=complete response; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.
≥CR with Rd alone
≥CR by 18 months vs 6 months of Rd1,2
≥CR rates increased over 6, 9, and 18 months of continuous frontline Rd.1,2
~30% of patients achieved a ≥CR by 18 months of Rd treatment compared with ~4% by 6 months of treatment1,2
CR=complete response; ORR=overall response rate; PR=partial response; Rd=lenalidomide (R) + dexamethasone (d); sCR=stringent complete response; VGPR=very good partial response.
More patients achieved a ≥CR with DRd vs Rd among patients treated for at least 18 months (49.8% vs 30.4%, respectively)1,2
DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d).
Please see MAIA trial design & primary results.
When treated until disease progression or unacceptable toxicity
Patients achieved longer duration of response with continuous DRd vs continuous Rd1,2
You are now viewing the 28-month analysis of the MAIA study.
CI=confidence interval; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d).
*Responders were defined as patients who achieved a partial response or better.2
- Median duration of response was not reached with DRd vs 34.7 months (95% CI: 30.8-not estimable) for Rd alone†1
†Median follow-up was 28 months (range: 0.0-41.4 months).2
You are now viewing a follow-up analysis of the MAIA study. This information is not included in the current Prescribing Information and has not been evaluated by the US Food and Drug Administration.
CI=confidence interval; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); IQR=interquartile range; Rd=lenalidomide (R) + dexamethasone (d).
*Responders were defined as patients who achieved a partial response or better.3
- Patients achieved longer duration of response with continuous DRd (a triplet regimen) vs continuous Rd (a doublet regimen)†3,4
These analyses were not statistically adjusted for multiple comparisons. No conclusions should be drawn.
†Median follow-up was 56 months in the DRd group (IQR: 53.0-60.1) and in the Rd group (IQR: 52.5-59.4).1,3
You are now viewing a subset analysis by treatment duration of the MAIA trial. This information is not included in the current Prescribing Information and has not been evaluated by the FDA. No conclusions should be drawn. In the following analysis, treatment-emergent adverse events are presented as observed and should be understood in context with the specific methodology.
Please see MAIA trial design & primary results.
In patients who continued treatment:
An evaluation of frequently reported TEAEs over time from treatment initiation to ~30 months1
Methodology
- Most frequently reported treatment-emergent adverse events (TEAEs) that met the threshold of cumulative any grade TEAE >30% or Grade 3/4 TEAE >10% are presented1
- Combined TEAE rates are the sum of the percentages of the most frequently reported TEAEs, at each cycle period
- Percentages represent number of patients with >1 TEAE by treatment cycle divided by total number of patients treated within the treatment window
- Only TEAEs with onset date falling within the cycle intervals were calculated. Each patient was calculated once per preferred term for each cycle interval. The same patient could be calculated in multiple cycle intervals and for multiple preferred terms. TEAEs may not have resolved by the next cycle
- Decrease in adverse event (AE) rates over time from treatment initiation was observed for most AEs in both treatment arms. Cataract tended to increase over time in both treatment arms (see rates below)1
- 13% of intent-to-treat (ITT) patients discontinued treatment due to a TEAE with DRd (n=364) vs 22% with Rd alone (n=365)2
DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d).
TEAEs: DRd
In patients who continued treatment:
Most AE rates decreased over time from treatment initiation to ~30 months for DRd1
AEs for DRd across Cycles 1-301
Any TEAE ≥30% or Grade 3/4 ≥10%
Scroll to view data over time
| DARZALEX® once-monthly administration start | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Any Grade TEAE | Cycles 1-2 (n=364) | Cycles 3-6 (n=348) | Cycles 7-10 (n=330) | Cycles 11-14 (n=312) | Cycles 15-18 (n=299) | Cycles 19-22 (n=285) | Cycles 23-26 (n=271) | Cycles 27-30 (n=259) | |
| Hematologic | Neutropenia | 40.4% | 24.4% | 17.9% | 18.6% | 17.7% | 16.1% | 11.1% | 12.4% |
| Anemia | 17.3% | 10.9% | 8.2% | 6.7% | 4.0% | 6.0% | 5.5% | 7.3% | |
| Leukopenia | 14.0% | 5.7% | 4.2% | 3.8% | 3.0% | 3.5% | 4.1% | 2.3% | |
| Lymphopenia | 13.7% | 4.6% | 3.6% | 4.8% | 5.7% | 4.2% | 4.4% | 3.5% | |
| Nonhematologic | Constipation | 26.4% | 11.8% | 5.5% | 3.8% | 4.0% | 2.1% | 3.0% | 5.0% |
| Nausea | 21.4% | 6.6% | 4.2% | 3.8% | 5.0% | 1.8% | 2.6% | 1.9% | |
| Fatigue | 20.1% | 14.1% | 7.0% | 8.7% | 7.4% | 7.7% | 5.9% | 7.3% | |
| Diarrhea | 15.9% | 15.5% | 15.8% | 16.0% | 18.4% | 17.5% | 14.0% | 10.0% | |
| Dyspnea | 14.8% | 6.6% | 3.9% | 3.2% | 1.7% | 3.2% | 2.2% | 2.3% | |
| Edema peripheral | 14.3% | 12.6% | 7.3% | 7.7% | 6.4% | 6.3% | 4.1% | 4.2% | |
| Cough | 14.0% | 6.9% | 3.9% | 2.9% | 3.0% | 4.2% | 4.8% | 3.1% | |
| Asthenia | 13.5% | 8.9% | 7.3% | 6.7% | 6.0% | 6.0% | 3.7% | 2.7% | |
| Muscle spasms | 13.5% | 9.5% | 2.1% | 5.4% | 2.3% | 2.5% | 2.6% | 1.2% | |
| Back pain | 9.9% | 6.3% | 6.4% | 5.1% | 4.0% | 6.7% | 3.7% | 5.4% | |
| Insomnia | 9.9% | 7.2% | 5.2% | 7.4% | 3.0% | 4.2% | 3.0% | 3.1% | |
| Weight decreased | 9.1% | 12.4% | 4.5% | 3.8% | 1.3% | 2.5% | 1.1% | 1.9% | |
| Hypokalemia | 8.0% | 4.6% | 3.3% | 1.6% | 3.0% | 6.0% | 2.2% | 4.2% | |
| Peripheral neuropathy | 6.3% | 4.0% | 5.2% | 5.4% | 5.4% | 7.0% | 2.6% | 3.1% | |
| Bronchitis | 4.7% | 6.6% | 6.4% | 7.1% | 8.7% | 6.7% | 6.6% | 7.3% | |
| Pneumonia | 4.7% | 6.6% | 3.9% | 4.2% | 4.7% | 5.3% | 3.3% | 2.3% | |
| Cataract | 0.3% | 0.6% | 2.4% | 3.5% | 5.4% | 3.9% | 3.7% | 4.6% | |
| Combined TEAE rates (sum of the percentages) | 292% | 186% | 128% | 130% | 120% | 123% | 94% | 95% | |
AE=adverse event; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); TEAE=treatment-emergent adverse event.
Cycle=28 days.
In patients who continued treatment:
Combined rates of frequently reported TEAEs decreased over time from treatment initiation to ~30 months for DRd1
AE=adverse event; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); TEAE=treatment-emergent adverse event.
TEAEs: Rd alone
In patients who continued treatment:
AE rates over time from treatment initiation to ~30 months for Rd1
AEs for Rd across Cycles 1-301
Any TEAE ≥30% or Grade 3/4 ≥10%
Scroll to view data over time
| Any Grade TEAE | Cycles 1-2 (n=365) | Cycles 3-6 (n=335) | Cycles 7-10 (n=297) | Cycles 11-14 (n=263) | Cycles 15-18 (n=237) | Cycles 19-22 (n=210) | Cycles 23-26 (n=187) | Cycles 27-30 (n=169) | |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic | Neutropenia | 20.3% | 21.8% | 12.8% | 16.0% | 14.8% | 9.0% | 13.4% | 13.0% |
| Anemia | 19.5% | 16.1% | 8.1% | 8.0% | 10.1% | 5.7% | 3.7% | 5.3% | |
| Leukopenia | 4.4% | 2.4% | 1.3% | 3.0% | 3.0% | 2.4% | 2.7% | 4.1% | |
| Lymphopenia | 7.1% | 5.7% | 2.0% | 3.4% | 1.7% | 1.9% | 0.5% | 3.0% | |
| Nonhematologic | Constipation | 19.7% | 14.0% | 4.0% | 3.4% | 4.2% | 2.4% | 3.7% | 1.8% |
| Nausea | 15.6% | 6.0% | 4.0% | 2.3% | 2.1% | 3.8% | 2.1% | 0.0% | |
| Fatigue | 16.2% | 8.4% | 6.1% | 5.7% | 5.5% | 4.3% | 2.7% | 5.9% | |
| Diarrhea | 15.6% | 15.2% | 12.5% | 12.5% | 15.6% | 14.8% | 9.1% | 12.4% | |
| Dyspnea | 6.6% | 3.0% | 3.4% | 3.0% | 2.5% | 2.9% | 1.6% | 1.2% | |
| Edema peripheral | 11.8% | 12.5% | 6.4% | 3.8% | 5.5% | 6.7% | 4.8% | 4.7% | |
| Cough | 5.8% | 3.3% | 3.7% | 2.3% | 5.1% | 1.0% | 2.1% | 2.4% | |
| Asthenia | 9.6% | 5.7% | 6.4% | 4.2% | 5.1% | 3.3% | 2.7% | 5.9% | |
| Muscle spasms | 10.7% | 6.9% | 5.4% | 3.8% | 2.5% | 3.8% | 2.7% | 1.2% | |
| Back pain | 6.8% | 8.1% | 5.7% | 6.5% | 4.6% | 7.1% | 5.9% | 3.6% | |
| Insomnia | 12.6% | 9.3% | 6.7% | 5.7% | 5.1% | 2.9% | 2.1% | 4.1% | |
| Weight decreased | 7.1% | 6.6% | 2.7% | 1.5% | 4.2% | 2.9% | 1.6% | 1.2% | |
| Hypokalemia | 4.9% | 5.4% | 4.0% | 4.6% | 4.6% | 5.2% | 3.7% | 1.8% | |
| Peripheral neuropathy | 3.8% | 3.6% | 3.7% | 4.9% | 3.8% | 4.3% | 0.5% | 4.1% | |
| Bronchitis | 3.0% | 5.4% | 5.4% | 4.9% | 6.8% | 7.1% | 5.9% | 6.5% | |
| Pneumonia | 3.3% | 4.5% | 3.7% | 2.7% | 2.1% | 1.0% | 1.6% | 3.6% | |
| Cataract | 0.8% | 1.5% | 1.7% | 5.3% | 4.6% | 6.7% | 7.5% | 4.1% | |
| Combined TEAE rates (sum of the percentages) | 205% | 165% | 110% | 108% | 114% | 99% | 81% | 90% | |
AE=adverse event; Rd=lenalidomide (R) + dexamethasone (d); TEAE=treatment-emergent adverse event.
Cycle=28 days.
TEAEs: Combined
In patients who continued treatment:
Combined rates of frequently reported TEAEs decreased over time from treatment initiation to ~30 months for DRd and Rd1
AE=adverse event; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d); TEAE=treatment-emergent adverse event.
Keep your patients engaged throughout treatment by establishing clear treatment and personal goals
Help your patients understand the long-term safety profile and proven efficacy of continuous treatment with DRd with the EMMY approach
EXPECTATIONS
Set clear expectations at the start of treatment—and beyond—to prepare patients and caregivers for their journey ahead
MOTIVATION
Motivate patients through continued education to help them stay on track with DRd and reach their treatment goals
MILESTONES
Recognize milestones, including responses and dosing frequency, to encourage compliance with treatment
YOUR CARE TEAM
Establish strong collaboration between you, the care team, and the patient to provide guidance and resources for the duration of therapy
DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d).