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Dimopoulos MA et al. Proc ASCO 2011;Abstract 8009.

Lenalidomide and Dexamethasone (LEN plus DEX) Treatment in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (pts) and Risk of Second Primary Malignancies (SPM): Analysis of MM-009/010. Dimopoulos MA et al. Proc ASCO 2011;Abstract 8009. MM-009/010 Study Designs.

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Dimopoulos MA et al. Proc ASCO 2011;Abstract 8009.

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  1. Lenalidomide and Dexamethasone (LEN plus DEX) Treatment in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (pts) and Risk of Second Primary Malignancies (SPM): Analysis of MM-009/010 Dimopoulos MA et al. Proc ASCO 2011;Abstract 8009.

  2. MM-009/010 Study Designs • Analysis of pooled data from patients with relapsed/refractory multiple myeloma (RRMM) treated in 2 Phase III studies (MM-009) and (MM-010): N = 704 LEN 25 mg/d d1-21 Dex: 40 mg/d d1-4, 9-12, 17-20 1st 4 cycles; 40 mg/d d1-4 subsequent cycles Continue until disease progression R Placebo d1-28 Dex: 40 mg/d d1-4, 9-12, 17-20 1st 4 cycles; 40 mg/d d1-4 subsequent cycles Dimopoulos MA et al. Proc ASCO 2011;Abstract 8009.

  3. Incidence Rates for SPM During Active Treatment Phase (Safety Population) *Pts with >1 SPM counted once in the total Dimopoulos MA et al. Proc ASCO 2011;Abstract 8009.

  4. Incidence Rates of Invasive SPM* During Treatment and Follow-Up Double-blind phase Long-term follow-up only SPM = 0 SPM = 2 IR: 1.91(95% CI 0.23-3.66) 817 PYtotal PBO + Dex(n = 350) IR: 0 218 PY 599 PY SPM = 8 SPM = 0 Len + Dex(n = 353) IR: 1.71(95% CI 0.86-3.43) 886 PYtotal IR: 0 467 PY 419 PY Person-Years *Includes MDS and breast carcinoma in situ; excludes nonmelanoma skin cancers With permission fromDimopoulos MA et al. Proc ASCO 2011;Abstract 8009.

  5. SPM in RRMM: MM-009/010Time to Invasive SPM (Treatment Period) Len + Dex PBO + Dex Hazard ratio: 1.445 (95% CI 0.294 7.09) p = 0.649 Patients (%) Time (months) With permission fromDimopoulos MA et al. Proc ASCO 2011;Abstract 8009.

  6. LEN + DEX in RRMM: Overall Survival (Up to Unblinding) Hazard ratio: 0.607 (95% CI 0.459-0.803) Patients (%) Overall Survival (months) With permission fromDimopoulos MA et al. Proc ASCO 2011;Abstract 8009.

  7. LEN + DEX Overall Survival Including Data After Crossover Hazard ratio: 0.822 (95% CI 0.678-0.996) Patients (%) Overall Survival (months) With permission fromDimopoulos MA et al. Proc ASCO 2011;Abstract 8009.

  8. Conclusions • No difference in incidence rates of invasive SPMs in LEN + DEX arm versus PBO + DEX in MM-009/010 • SPM incidence rates were low and similar to the background incidence among persons similarly aged in the general population • OS was significantly longer for patients who received LEN + DEX • Confirmed with long-term follow-up despite ~50% of patients in the PBO + DEX arm crossing over to receive LEN-based therapy • The overall benefit-risk profile of LEN in RRMM remains strongly positive Dimopoulos MA et al. Proc ASCO 2011;Abstract 8009.

  9. Investigator Commentary: The Incidence of SPMs After Long-Term Follow-Up of MM-009/010 in RRMM Dr Niesvizky presented long-term follow-up of MM-009/010, which were the pivotal studies for approval of lenalidomide in relapsed/refractory multiple myeloma. The incidence of observed versus expected cancer was relatively similar, and many of these patients had already received high-dose melphalan and other treatments. So in this population there did not seem to be an increased risk of SPMs. Lenalidomide has stem cell activity, and it is plausible that it can affect stem cells to a point that there may be development of SPMs, but it doesn’t seem to be a common phenomenon. When SPMs develop after lenalidomide, it happens after prolonged alkylator therapy or after high-dose alkylating agent exposure, such as in the transplant setting. I initiate lenalidomide maintenance therapy for any patient who has not achieved a complete remission or in patients who have a high risk for relapse, even if they have achieved a CR. I delay lenalidomide maintenance for 5 to 6 months after transplant because I believe the “perfect storm” is to administer a drug that may be stem cell toxic at a time when the stem cells are beginning to proliferate and find their essential microenvironments. Sergio Giralt, MD

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