RELEVANCE
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma
Phase 3N = 1,030NCT01476787NCT01650701
- Population
- Previously untreated follicular lymphoma (advanced stage; grade 1 to 3a in the 6-year report); 513 randomised to rituximab plus lenalidomide and 517 to rituximab plus chemotherapy.
- Design
- Multicentre, international phase 3 superiority trial in previously untreated follicular lymphoma. Rituximab plus lenalidomide: 18 cycles of the two drugs, then rituximab maintenance every 8 weeks for 12 cycles. Rituximab plus chemotherapy: investigator's choice of one of three rituximab-based regimens, then rituximab maintenance every 8 weeks for 12 cycles. Co-primary endpoints: complete response (confirmed or unconfirmed) at 120 weeks, and progression-free survival. 1030 patients were randomised.
- Primary endpoint
- CR rate, PFS
- Arms
- Rituximab plus chemotherapy (control, n = 517): Investigator's choice of one of three rituximab-based chemotherapy regimens, then rituximab maintenance every 8 weeks for 12 cycles
- Rituximab plus lenalidomide (R2) (experimental, n = 513): 18 cycles of rituximab plus lenalidomide, then rituximab maintenance every 8 weeks for 12 cycles
- People
- Morschhauser F
Δ CR rate−5 pointsΔ 36-month PFS−1 pointsPFSHR 1.03 (95% CI 0.84–1.27)Δ 72-month PFS+1 pointsΔ 72-month OS0 points
Show the numbers
| Endpoint | Analysis | Rituximab plus lenalidomide (R2) | Rituximab plus chemotherapy | Effect |
|---|---|---|---|---|
| CR rateRandomised patientsConfirmed or unconfirmed complete response at 120 weeks. | primaryMorschhauser 2018 | 48% (44–53%) | 53% (49–57%) | P=0.13 |
| PFSRandomised patients | interimMorschhauser 2018 | 77% at 3 y (72–80%) | 78% at 3 y (74–82%) | Interim 3-year rate; the abstract reports no hazard ratio or P value for this comparison. |
| PFSRandomised patients | interimmedian follow-up 72 monthsMorschhauser 2022 | 60% at 6 y | 59% at 6 y | HR 1.03 (95% CI 0.84–1.27)Second interim analysis after 6 years of follow-up; medians not reached in either group. |
| OSRandomised patients | interimmedian follow-up 72 monthsMorschhauser 2022 | 89% at 6 y | 89% at 6 y | Estimated 6-year overall survival was 89% in both groups; the abstract gives no hazard ratio. |
| Endpoint | Analysis | Rituximab plus lenalidomide (R2) | Rituximab plus chemotherapy | Effect |
|---|---|---|---|---|
| CR rateRandomised patientsConfirmed or unconfirmed complete response at 120 weeks. | primaryMorschhauser 2018 | 48% (44–53%) | 53% (49–57%) | P=0.13 |
| PFSRandomised patients | interimMorschhauser 2018 | 77% at 3 y (72–80%) | 78% at 3 y (74–82%) | Interim 3-year rate; the abstract reports no hazard ratio or P value for this comparison. |
| PFSRandomised patients | interimmedian follow-up 72 monthsMorschhauser 2022 | 60% at 6 y | 59% at 6 y | HR 1.03 (95% CI 0.84–1.27)Second interim analysis after 6 years of follow-up; medians not reached in either group. |
| OSRandomised patients | interimmedian follow-up 72 monthsMorschhauser 2022 | 89% at 6 y | 89% at 6 y | Estimated 6-year overall survival was 89% in both groups; the abstract gives no hazard ratio. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 1.03 | 0.84–1.27 |
Appears in
Sources
Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, et al. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018;379(10):934-947.
Morschhauser F, Nastoupil L, Feugier P, Schiano de Colella JM, Tilly H, Palomba ML, et al. Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R(2)) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma. J Clin Oncol. 2022;40(28):3239-3245.