Emerging treatments in Multiple myeloma. Josh Veatch Damian Green

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1 Emerging treatments in Multiple myeloma Josh Veatch Damian Green

2 Emerging treatments in multiple myeloma Introduction Daratumumab Elotuzumab PD 1 inhibitors HDAC inhibitors Other emerging therapies in early trials and development

3 Multiple myeloma Plasma cell neoplasm Disease manifestations Lytic bone lesions Hypercalcemia Marrow failure Paraprotein mediated effects renal failure Immunoparesis Outcomes have significantly improved with IMiDs and proteasome inhibitors, but no curative treatments Until recently no rituximab for myeloma

4 Ixazomib Chari, Ajai. "Novel Targets in Multiple Myeloma." American Journal of Hematology/Oncology 11.3 (2015).

5 Daratumumab Humanized antibody to CD38, a surface marker on multiple myeloma Induces cell killing through either complement or antibody dependent cellular toxicity. The Journal of Immunology February 1, 2011 vol. 186 no

6

7 Lokhorst HM et al. N Engl J Med 2015;373:

8 Daratumumab in combination therapy 498 patients with relapsed/refractory myleoma Bortezomib/dexamethasone for 8 cycles with half randomized to 16mg/kg Daratumumab followed by daratumumab maintenance PFS was primary endpoint, TTP, ORR and OS were secondary endpoints Median 2 prior lines of therapy, 76% with prior Imids, 48% with prior proteoasome inhibitor and IMiDs, 33% refractory to past therapy J Clin Oncol 34, 2016 (suppl; abstr LBA4)

9 journal/news/clinical/clinical pharmacology/therapeuticconsiderations managing multiple m

10 VD +/ Daratumumab ORR CR VGPR or better Daratumumab 83% 19% 59% Control 63% 9% 29% Thrombocytopenia Neuropathy Diarrhea anemia Daratumumab 59% 47% 32% 26% Control 44% 38% 22% 31% J Clin Oncol 34, 2016 (suppl; abstr LBA4)

11 Daratumumab +VD VD PFS Median, mo NE 7.16 HR (95% CI) 0.39 (0.28, 0.53) TTP P < Median, mo NE 7.29 HR (95% CI) 0.30 (0.21, 0.43) P < J Clin Oncol 34, 2016 (suppl; abstr LBA4)

12 Daratumumab FDA Approved as monotherapy With superior responses when combined with Bortezomib/Dex in relapsed/refractory disease Validation of CD38 as a target in multiple myeloma

13 Elotuzumab Monoclonal antibody directed at CS1 (SLAMF7) Surface marker on myeloma cells Also found on natural killer cells Limited/no activity as a single agent Much more activity when combined with lenalidomide Approved only as a combination therapy with lenalidomide

14 Characteristics of the Patients at Baseline (Intention-to-Treat Population). Lonial S et al. N Engl J Med 2015;373:

15 Lonial S et al. N Engl J Med 2015;373:

16 Lonial S et al. N Engl J Med 2015;373:

17 Lonial S et al. N Engl J Med 2015;373: Adverse Events

18 of action

19 Actual mechanism different from intended mechanism No drug to stupid to test Maybe we should just develop drugs at random hoping that they happen to activate natural killer cells

20 Chari, Ajai. "Novel Targets in Multiple Myeloma." American Journal of Hematology/Oncology 11.3 (2015).

21 Monoclonal antibody summary CD38 is a validated target in multiple myeloma Daratumumab SAR (Isatuximab) CS1/SLAMF7 is also a target, but possibly for different mechanisms Elotuzumab Other targets CD138 PD 1

22 PD 1 inhibition Leukemia (2016) 30, ; doi: /leu

23 Pembrolizumab with activity when combined with lenalidomide J Clin Oncol 34, 2016 (suppl; abstr 8010)

24 Pembrolizumab with activity when combined with lenalidomide Many responses ongoing with median follow up of 9 months Combination was tolerated with some immune adverse events Phase III trial enrolling now J Clin Oncol 34, 2016 (suppl; abstr 8010)

25 HDAC inhibitors Histone deacetylase inhibitors change marks on chromatin that modify gene expression, also modify acetylation of other proteins They have activity in many malignancies They are about as targeted as total body irradiation, digitalis Some thought that the important function in myeloma is due to the HDAC6 mediated induction of the aggresome, or of HDAC6 induction of oncogene expression

26 Chari, Ajai. "Novel Targets in Multiple Myeloma." American Journal of Hematology/Oncology 11.3 (2015).

27 HDAC inhibitors Nonspecific HDAC inhibitors have some modest efficacy in combinations, but at the cost of significant toxicity Diarrhea, fatigue, thrombocytopenia More targeted HDAC inhibitors (Ricolinostat) may be effective with less toxicity, but await randomized trials

28 Other targeted agents KSP1 mitotic spindle regulator AKT involved in mtor/growth signalling PIM kinase XPO1 nuclear exportin

29 Chari, Ajai. "Novel Targets in Multiple Myeloma." American Journal of Hematology/Oncology 11.3 (2015).

30 What s in preclinical development? CAR T cell targeted at CD19 Single response at UPENN resulted in a NEJM paper Subpopulation of cells expressing CD19? Or low threshold for CD19 level needed No responses among plasma cell neoplasm patients treated here with CD19 CAR BITE targeted at BCMA Currently in phase I trials CAR T cells targeted at BCMA 2 responses of marrow disease on highest dose level with typical cytokine release syndrome seen in CD19 CAR

31 Srivastava and Riddell, Trends in immunology (2016)

32 BCMA CAR T cell trial at the NCI with clinical responses 10 patients treated in a dose escalation 2 VGPR and 1CR 1 VGPR and 1CR of two patients treated at highest dose level Patients had cytokine release syndrome at highest dose level

33 A Human NSG mouse Xenograft model of Myeloma Anti-Tumor efficacy of BCMA-specific T-cells in RPMI 8226 ffluc tumor bearing NSG Day 0 T cell Injection 50:50 :: CD8:CD4 1.1E6 C113ST 2.3E6 C113ST 4.5E6 C113ST 10wk old NSG Males Day Rads Day 7 2 x 2.5E cells 4.3E6 tegfr Tyler Hill, Riddell Lab

34 1 million CARs 4 million CARs 4 million Control Day 0 Anti BCMA CAR T cells are effective against myeloma in a Xenograft model Day 9 Day 24 Day 44 Tyler Hill, Riddell Lab

35 Summary 2 new approved monoclonal antibodies A number of different new agents with modest single agent activity in refractory disease Emerging targeted immunotherapy coming soon to a clinical trial at our center

36 Thanks Fellowship/hematology Abbe Lynch Mark Albonizio Emerson Lynch Mike Linenberger Evan Yu Hannah Linden Bob Richard

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