1 / 8

1 Lonial S et al. Proc ASCO 2013;Abstract 8542.

tamarr
Download Presentation

1 Lonial S et al. Proc ASCO 2013;Abstract 8542.

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Phase I/II Study of Elotuzumab plus Lenalidomide/Dexamethasone in Relapsed/Refractory Multiple Myeloma: Updated Phase II Results and Phase I/II Long Term Safety1Phase (Ph) I/II Study of Elotuzumab plus Lenalidomide/Dexamethasone (LEN/DEX) in Relapsed/Refractory Multiple Myeloma (RR MM): Updated Ph II Results and Ph I/II Long Term Safety2 1 Lonial S et al.Proc ASCO 2013;Abstract 8542. 2 Facon T et al. ProcEHA 2013;Abstract P764.

  2. Background • Elotuzumab (Elo) is a humanized monoclonal antibody that is currently under investigation for the treatment of multiple myeloma (MM). • It targets CS1, a protein that is highly expressed on the surface of MM cells, and enhances antibody-dependent cellular cytotoxicity in myeloma cells. • Previously, the Phase I part of this study showed that the combination of Elo with lenalidomide (Len) and low-dose dexamethasone (LoDex) was well tolerated with encouraging efficacy in relapsed or refractory MM (JCO 2012;30:1953). • Study objective: To report updated efficacy and safety results of the Phase I/II study of Elo/Len/LoDex for patients with relapsed or refractory MM. Lonial S et al. Proc ASCO 2013;Abstract 8542; Facon T et al. Proc EHA 2013;Abstract P764.

  3. Phase II Trial Design 10 mg/kg Elo (IV) + Len/LoDex (n = 36) R 20 mg/kg Elo (IV) + Len/LoDex (n = 37) Elotuzumab Dosing CYCLE 1 CYCLE 2 CYCLE 3 CYCLE 4 CYCLE N-1 CYCLE N Lenalidomide Cycle day Dexamethasone • Patients were stratified by prior lines of therapy (1 vs 2 or 3) and prior thalidomide or thalidomide analogs prior to randomization. Lonial S et al. Proc ASCO 2013;Abstract 8542; Facon T et al. Proc EHA 2013;Abstract P764.

  4. Phase II: Best Response • VGPR = very good PR; CR = complete response; sCR = stringent CR • Overall median time to first response: 1 month • Overall median time to best response: 2.6 months • Median duration of objective response: 17.8 months Lonial S et al. Proc ASCO 2013;Abstract 8542; Facon T et al. Proc EHA 2013;Abstract P764.

  5. Phase II: Progression-Free Survival Proportion of Progression-Free Patients Median Time to Progression/Death: 10 mg/kg (n = 36): 33 mos (95% CI: 14.883-NA) 20 mg/kg (n = 37): 18.6 mos (95% CI: 12.912-32.361) Total (n = 73): 25.8 mos (95% CI: 15.376-35.713) Months • Median follow-up: 10 mg/kg cohort = 20.8 mo, 20 mg/kg cohort = 17.1 mo • Patient follow-up is ongoing With permission from Lonial S et al. Proc ASCO 2013;Abstract 8542.

  6. Phase I/II: Select Grade 3/4 Adverse Events in ≥5% of Patients Lonial S et al. Proc ASCO 2013;Abstract 8542; Facon T et al. Proc EHA 2013;Abstract P764.

  7. Author Conclusions • The combination of Elo with Len/LoDex was well tolerated for all evaluated doses. • Adverse events occurring after 18 months of therapy were consistent with the safety profile observed with this combination. No new safety signals were identified. • Elo/Len/LoDex was effective in the treatment of relapsed/refractory MM. • ORR at 10 mg/kg of Elo was 92% and 84% in the total population. • Two Phase III trials of Elo at 10 mg/kg in combination with Len/LoDex are ongoing: • ELOQUENT-1 for previously untreated MM (NCT01335399) • ELOQUENT-2 for relapsed/refractory MM (NCT01239797) • Several trials of Elo in combination with other agents are ongoing in various settings for patients with MM. Lonial S et al. Proc ASCO 2013;Abstract 8542; Facon T et al. Proc EHA 2013;Abstract P764.

  8. Investigator Commentary: Updated Results of the Phase I/II Trial of Elo/Len/LoDex in Relapsed/Refractory MM Single-agent elotuzumab does not have any activity. It demonstrated activity when combined with lenalidomide. This study had relatively few patients, and the results may change with a larger population. If the Phase III study confirms the results of this Phase II trial, elotuzumab will be validated as a beneficial agent. It has a novel mechanism of action, and it belongs to a new class of agents. This is a major plus. The toxicity profile is similar to that of rituximab. It is a well-tolerated agent. It is not associated with any unusual toxicities. Strikingly, it demonstrated a progression-free survival (PFS) of more than 2 years in this patient population. If you consider that Len/Dexis approved in the same setting but is associated with a PFS of about 12 to 15 months, the PFS results observed with elotuzumab in this study are dramatic. Also, the objective response rate was >90% with 10 mg/kg of elotuzumab. These are impressive results. Hopefully, these data will be confirmedin a Phase III study. Interview with Antonio Palumbo, MD, August 12, 2013

More Related