A Decade of Progress in Multiple Myeloma

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1 A Decade of Progress in Multiple Myeloma Robert Z. Orlowski, Ph.D., M.D. Florence Maude Thomas Cancer Research Professor Departments of Lymphoma/Myeloma & Experimental Therapeutics Principal Investigator, MD Anderson SPORE in Multiple Myeloma Chair, SWOG Barlogie/Salmon Multiple Myeloma Committee Twitter

2 Newly Diagnosed Myeloma in 2004 Symptomatic multiple myeloma Not a candidate for autologous transplantation Candidate for autologous stem cell transplant Low disease burden and/or poor performance status Melphalan/prednisone High disease burden with good performance status Same options as for possible transplant candidates Clinical trial Dexamethasone Thalidomide/Dexamethasone Vincristine/Doxorubicin/ Dexamethasone Vincristine/Pegylated Liposomal Doxorubicin/Dexamethasone MD Anderson Color-Matrix Cancer Staging and Treatment Handbook

3 Myeloma Trialists Collaborative Group 6,633 patients from 27 trials comparing MP to combination chemotherapy Median survival: 29 months for both groups J Clin Oncol. 16:3832, 1998.

4 Current Landscape NCCN Guidelines Version

5 MPT vs. MP Meta-analysis Six randomized studies with 1,685 patients Median PFS 14.9 (MP) 20.3 mos. (MPT) OS 32.7 mos mos. Fayers, PM et al. Blood 118:1239, 2011.

6 MPV vs. MP PFS (MP) 16.6 mos. 24 mos. (MPV) OS (MP) 43.1 mos. (?impact of salvage) 56.4 mos. (MPV) San Miguel, JF et al. J Clin Oncol. 31:448, 2012.

7 Proportion of patients MPV vs. Vd by PFS Patients remaining, n VD (N=168, 51% PFS events (14.3 months)) VTD (N=167, 42% PFS events (14.9)) VMP (N=167, 49% PFS events (17.3)) Median follow-up 26 mos Time (months) VD VTD VMP Niesvizky, R et al. ASH Abstract 478, 2011.

8 Proportion of patients MPV vs. Vd by OS Patients remaining, n VD (N=168, 27% OS events) VTD (N=167, 27% OS events) VMP (N=167, 25% OS events) Median follow-up 26 mos Time (months) VD VTD VMP Niesvizky, R et al. ASH Abstract 478, 2011.

9 MPR-R vs. MPR vs. MP PFS MP 13 mos. vs. MPR 14 vs. MPR-R 31 mos. OS not yet different Palumbo, A et al. N Engl J Med. 366:1759, 2012.

10 E1A06 : MPT-T vs. MPR-R by PFS MPT-T (months) (95% CI) MPR-R (months) (95% CI) MPT-T / MPR-R HR (95% CI) 21 ( ) 18.7 ( ) 0.84 ( ) MPT-T similar to past studies with this regimen Why was MPR-R worse? Older patient age (median 75.7 vs. 71) More discontinuations (49% off induction vs. 42%)

11 E1A06 : MPT-T vs. MPR-R by OS MPT-T Median OS (95% CI) 52.6 m (40.4-n/a) MPR-R Median OS (95% CI) 47.7 m ( ) MPT-T / MPR-R Hazard Ratio (95% CI) 0.88 (0.63, 1.24) Why was MPT-T better vs. other studies? T maintenance Better salvage therapies

12 FIRST Trial by PFS Facon, T et al. ASH Abstract 2, 2013.

13 FIRST Trial by OS Facon, T et al. ASH Abstract 2, 2013.

14 Non-transplant Induction Which regimen is best? MPT > MP; MPV > MP; MPR-R > MP MPT-T (~MPT) ~ MPR-R; Rd > MPT; Vd ~ VMP Does that mean Rd > MPR-R? Rd, Vd, and MPV as standards with low SPMs PFS has improved (~14 ~24 mos) OS improved as well (~3 yrs ~4 yrs) Combination of induction & salvage

15 Relapsed/ Refractory in 2004 Consider repeating initial regimen (anticipate briefer second remission duration) or proceed as below Clinical trial Relapsed multiple myeloma Prior remission duration > 6-12 months Prior remission duration < 6-12 months Another regimen to which the patient s disease was not yet exposed If MP initially -> VAD, DVd, T±D, Dex If Dex -> VAD, DVd, MP, T±D, If TD -> VAD, DVd, MP If VAD/DVd -> MP, T±D In third line or later Bortezomib Multi-agent chemotherapy regimens DTPACE, Multi-alkylator Arsenic trioxide MD Anderson Color-Matrix Cancer Staging and Treatment Handbook

16 Current Landscape NCCN Guidelines Version

17 Len/Dex vs. Dex : PFS 4.7 mos mos. Weber, DM et al. N Engl J Med. 357:2133, 2007.

18 Bortezomib vs. Dex : PFS 3.49 mos mos. Richardson, PG et al. N Engl J Med. 352:2487, 2005.

19 Bortezomib/PLD vs. Bortezomib : PFS 6.9 mos. 9.3 mos. Orlowski, RZ et al. J Clin Oncol. 25:3892, 2007.

20 VTD vs. TD if PD Post-ASCT : PFS 19.5 mos mos. Garderet, L et al. J Clin Oncol. 30:2475, 2012.

21 Progression-free survival Probability (%) Bortezomib/Dex + Pan/Pbo PFS 100 Events Median PFS (95% CI) HR (95% CI) P value PAN-BTZ-Dex 207/387 Pbo-BTZ-Dex 260/ months (10.3, 12.9) months (7.6, 9.2) ( ) < PAN-BTZ-Dex (n/n = 207/387) Pbo-BTZ-Dex (n/n = 260/381) Number of patients at risk Months PAN-BTZ-Dex Pbo-BTZ-Dex

22 Are Data More or Less Impressive? More % had prior bortezomib But if they had to be sensitive, did this select patients more likely to respond Better HR in pts with prior bortez Activity in high risk pts seemed comparable Small number and not stratified Lower dose intensity given to Bor/Dex/Pan pts Pan had to work harder to overcome this Could lower dose/schedule have been better?

23 Are Data More or Less Impressive? Less More pts with only 1 prior line Lower frequency of prior SCT ISS stage seems to be generally lower Only ~25% had both bortez and either len or thal (likely most common induction in the US) More deaths seen in the Pan arm Greater toxicity lowers QOL/PRO, and increases healthcare resource utilization

24 Historical Comparisons Why is Bor/Dex/Pbo > past studies of Bor Dex was added Possible benefit of ~2 months in PFS Longer planned treatment (48 wks. vs. 39 wks.) Probably led to greater drug exposure PFS (and likely OS) in the relapsed & refractory setting improving despite use of novel drugs earlier in the disease

25 Future Directions Optimal sequencing of current agents Mechanisms of drug resistance to extend the utility of current drugs Novel drugs targeting prospectively identified myeloma vulnerabilities Biomarkers to identify which patients subgroups will benefit from which therapies

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