COMy Congress A New Era of Advances in Myeloma. S. Vincent Rajkumar Professor of Medicine Mayo Clinic
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1 A New Era of Advances in Myeloma S. Vincent Rajkumar Professor of Medicine Mayo Clinic Scottsdale, Arizona Rochester, Minnesota Jacksonville, Florida Mayo Clinic College of Medicine Mayo Clinic Comprehensive Cancer Center
2 No conflicts of interest to disclose
3
4 The Last Decade Diagnosis New Lab tests New Imaging New Criteria (MDE) Prognosis FISH GEP Molecular methods New Staging (RISS) Response PET MRD (NGF, NGS) New Response Criteria (MRD) Treatments Carfilzomib Pomalidomide Panobinostat Ixazomib Elotuzumab Daratumumab New Drugs (Abs) Rajkumar SV. 2017
5 The Last Decade Optimization Bortezomib Once weekly SQ Dexamethasone Once weekly Supportive Care Bisphosphonates Denosumab Vertebral Augmentation Plerixafor Pipeline Oprozomib Marizomib Isatuximab Filanesib LGH 447 Venetoclax Dinaciclib Understanding Pathogenesis Clonal heterogeneity Mechanisms of action Mechanisms of Resistance Rajkumar SV. 2017
6 VRd vs Rd (S0777): Overall Survival Durie et al. The Lancet , DOI: ( /S (16)31594-X)
7 Survival Probability Lenalidomide Maintenance: Overall Survival % N = 1209 LENALIDOMIDE CONTROL Median OS, (95% CI), mos HR (95% CI) P value NE (NE-NE) 0.74 ( ) ( ) 7-yr OS 62% 0.0 Patients at risk Attal M..McCarthy P, et al. ASCO Overall Survival, mos
8 Bortezomib Maintenance (HOVON): Overall Survival Sonneveld P et al. JCO 2012;30: by American Society of Clinical Oncology
9 Role of ASCT (IFM 2009): Overall survival Attal M et al. N Engl J Med 2017;376:
10 Myeloma: Frontline Treatment Newly Diagnosed MM* Not Transplant Candidate Transplant Candidate VRd x 3-4 cycles VRd Rd (if frail, age 75)* Auto SCT VRd x4 cycles Maintenance Maintenance (Len for std risk; Delayed Transplant Bortez for high risk) *Based on CALGB , S0777, IFM-DFCI, CTN 0702, HOVON VTd/VCd if VRd not available Rajkumar SV. 2016
11 A New Era of Advances
12 1. How do we address the genetic heterogeneity of this disease?
13 Primary Cytogenetic Abnormalities t(11;14) t(4;14) t(6;14) t(14;16) t(14;20) Trisomies Secondary Cytogenetic Abnormalities Myc translocations Del 17 1p del 6+ diseases that can each take multiple paths
14 Incidental Lessons Learnt Early ASCT and Bortezomib critical for t(4;14) and del(17p) Tandem ASCT may have a role in del(17p) Lenalidomide may work particularly well in trisomies Venetoclax has significant single agent-activity in t(11;14)
15 What needs to be done? Get real: We are not dealing with one disease RCTs Comparative Effectiveness Studies Pooling of resources
16 SWOG 1211 for high risk MM PHASE I PORTION RVD + Elotuzumab 8 cycles of Induction Therapy followed by Maintenance until progression or relapse n=6 RANDOMIZED PHASE II PORTION Induction Maintenance RVD x 8 Cycles 1,2 n=50 RVD-Elo x 8 Cycles 1,2 n=50 RVD Dose reduced RVD-Elo Dose reduced Off-Protocol at Progression/ Relapse
17 SWOG successor trial for high risk MM RANDOMIZED PHASE II PORTION Induction Maintenance KRD KRD-Dara KRD Dose reduced KRD-Dara Dose reduced Off-Protocol at Progression/ Relapse Saad Usmani, PI
18 2. Is Myeloma Curable?
19 ALL Pui et al. N Engl J Med 2006; 354:
20 APL Overall Survival by age Park J H et al. Blood 2011;118: by American Society of Hematology
21 Survival in Myeloma Kumar S. Blood 2008;111: ; Kumar S. Leukemia (2014) 28,
22 PFS in Heme Cancers in persons <50 years of age Rajkumar SV 2017
23 Where are we? Continuous therapy works; It is the dogma of the day We can keep many myeloma patients alive for 10 years plus
24 What needs to be done? Will we know cure when we see it? Design Appropriate Trials: Limited-Duration Therapy Our eventual GOAL for MM should be 6-12 months and done
25 3. What end points should we use?
26
27 Prognostic Value of MRD Status (IFM 2009): PFS MRD at post-maintenance N at risk (events) MRD neg (<10-6 ) MRD positive 0 Negative (<10-6) Positive P-value : p< (0) 86 (0) 86 (0) 86 (0) 86 (5) 77 (3) 61 (5) 36 (0) (0) 92 (0) 92 (0) 92 (7) 83 (17) 64 (11) 45 (13) 11 (1) 5 30 Months since randomization Avet-Loiseau H, et al. IMW 2015
28 Trials with: What needs to be done? MRD as validated surrogate endpoint for OS MRD as an integral biomarker to decide therapy
29 EAXXX MM: MRD Integral Biomarker PI: S. KUMAR R E G I S T E R Target Pop: MM pts 1 yr post-maintenance MRD Classification 75% 25% MRD + MRD - R E G I S T E R R A N D O M I Z E Arm A: Ixa-Len Ixa 4 mg days 1, 8, 15 Lenalidomide 15 mg PO days 1-21 every 4 weeks until PD Arm B: Len Lenalidomide 15 mg PO days 1-21 every 4 weeks until PD Arm C: Len Lenalidomide 15 mg PO days 1-21 every 4 weeks x 12 cycles
30 4. What can we do about access and cost?
31 Myeloma: Frontline Treatment Newly Diagnosed MM* Not Transplant Candidate Transplant Candidate VRd x 3-4 cycles VRd Rd (if frail, age 75)* Auto SCT VRd x4 cycles Maintenance Maintenance (Len for std risk; Delayed Transplant Bortez for high risk) *Based on CALGB , S0777, IFM-DFCI, CTN 0702, HOVON VTd/VCd if VRd not available Rajkumar SV. 2016
32 Myeloma: First Relapse First Relapse Not Refractory to Lenalidomide Refractory to Lenalidomide* DRd KRd Frail: IRd, ERd VCd DVd Frail: Pd, IPd *Relapse occurring while off all therapy, or while on small doses of single-agent lenalidomide, or on bortezomib maintenance Consider salvage auto transplant in eligible patients Rajkumar SV Rajkumar SV, Kyle RA. Progress in Myeloma: A Monoclonal Breakthrough. N Engl J Med 2016;375:
33
34
35 What needs to be done? Pharma should pay attention As leaders we need to use our influence Strict, evidence-based practice guidelines Clever sequencing
36 5. How do we move from tactics to strategy?
37 We do need tactical trials Recently Approved Drugs ( ) Carfilzomib Pomalidomide Panobinostat Ixazomib Daratumumab Elotuzumab Future Drugs Oprozomib Marizomib Isatuximab Filanesib LGH 447 Venetoclax Dinaciclib Rajkumar SV. 2016
38 What needs to be done? Cure versus Control Can we prevent Progression of MGUS and SMM? When should we intervene in relapse? (Paraprotein vs Symptomatic) Should we change therapy based on response? (Response-adapted therapy)
39
40 Contributions
41 The Hematologist: July-August 2015, Volume 12, Issue 4
42 Blood Aug 1;106(3): Epub 2005 Apr 26 Risk stratification and cost-savings in MGUS
43 Led to first approval of thalidomide in the US
44 Led to the Rd regimen: backbone of most myeloma treatments today
45 N Engl J Med 2007;356: Natural history and Risk-stratification of SMM
46 Paradigm shift in diagnosis of myeloma
47 Perseverance and Passion pays
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