Malignant pleural Mesothelioma: A Year In Review

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1 Malignant pleural Mesothelioma: A Year In Review Rabab Gaafar,MD Prof. Medical Oncology NCI Cairo University National Cancer Institute Conference 2015

2 ASCO news in Mesothelioma Introduction ASCO news second line (NGR-hTNF) ASCO news first line therapy (MAPS)

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4 Phase III Studies 1 th Line Treatment Important Studies Vogelzang phase III study JCO,2003 Van Meerbeeck phase III (EORTC 08983) JCO, 2005

5 Cisplatin-Pemetrexed vs Cisplatin in Frontline Treatment of Unresectable Mesothelioma Unresectable mesothelioma, chemo naive, Karnofsky PS > 70 (N = 456*) Stratified Center PS Pain/dyspnea on entry Histology Sex WBC Primary endpoint: OS Secondary endpoints: TTP, RR, QoL, toxicity Homocysteine level *8 pts did not receive treatment. Vogelzang NJ, et al. J Clin Oncol. 2003;21: R A N D O M I Z E Cisplatin 75 mg/m 2 + Pemetrexed 500 mg/m 2 IV every 3 wks (n = 226) Cisplatin 75 mg/m 2 IV every 3 wks (n = 222)

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7 EORTC Raltitrexed and Cisplatin in MPM : Phase III Study

8 Lack of effectiveness of EGFR and PDGFR Tki s when used as single agents Drug N RR SD PFS MST Gefitinib % 49% 40%-3 mo 6.8 mo Gefitinib % 50% NA 14.1 mo Erlotinib % 47% 28%-6 mo 39%-1 yr Imatinib 800 mg % 38% 2 mo Imatinib 600 mg % 29% 1.8 mo 14.3 mo Imatinib 400 mg % 12%>6 mo 2.1 mo 13 mo Imatinib 400 mg % 36% 1.8 mo 4.6 mo 1 Govindan 2005, 2 Lee ASCO 2008, 3 Garland ASCO 2004, 4 Millward ASCO 2003, 5 Villano ASCO 2004, 6 Mathy 2005, 7 Posta 2006, adapted from Kindler ASCO 2008

9 Targeting Angiogenesis Background Increased microvessel density poor outcome High serum VEGF Negative prognostic factor VEGF & VEGFC act as autocrine GFs for development of MM Anti VEGF Ab Bevacizumab Multikinase inhibitors (VEGFR, PDGFR) Thalidomide

10 Cis-gemcitabine ± bevacizumab placebo controlled phase II, 1 st line Overall survival both treatment arms combined X Karrison JCO 2007 Abstract 7526

11 PFS Probability OS Probability Lower Median Serum VEGF Levels Are Prognostic for Improved PFS and OS PFS by Baseline VEGF Level OS by Baseline VEGF Level VEGF median VEGF > median Log-rank P = VEGF median VEGF > median Log-rank P = Median 0.20 VEGF level: pg/ml Mos Mos Karrison T, et al. ASCO Abstract 7526.

12 Unsuccessful Combination trial: Pem/cis-platinum with anti VEGF TKI AXITINIB: Pan VEGFR (1,2,3)/PDGFR/c-Kit TKI Randomized Ph 2 Pem/Cis platinum +/- Axitinib (5 mg po bid) days 2-19 of a 21 d cycle followed by a palliative pleurectomy N=26 pts randomized, typical meso population Response Axitinib (N=20) Control (N=11) Total Group (N= 31) PR 35% 27% 32% SD 40% 55% 45% PD 25% 18% 23% PFS 8 months 8.3 months 8 months OS 17 months 18 months 18 months No difference between both groups, Axitinib does not seem to add to combination Van Buikhuisen 2013

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14 90 International centers 661 patients

15 ASCO news in Mesothelioma Introduction ASCO news second line (NGR-hTNF) ASCO news first line therapy (MAPS)

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32 ASCO news in Mesothelioma Introduction ASCO news second line (NGR-hTNF) ASCO news first line therapy (MAPS)

33 Slide 1 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

34 Slide 7 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

35 Slide 11 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

36 Slide 10 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

37 Slide 12 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

38 Slide 19 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

39 Slide 21 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

40 Slide 20 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

41 Slide 22 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

42 Slide 23 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

43 Slide 24 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

44 Slide 25 Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

45 MAPS trial conclusions Presented By Gerard Zalcman at 2015 ASCO Annual Meeting

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47 Immunotherapy: Tremelimumab Tremelimumab blocks the inhibitory effect of CTLA-4 and, therefore, enhances T-cell activation Most common AEs reported to date have been dermatologic (rash, pruritus), gastrointestinal (colitis, diarrhea), and fever

48 Phase II Trial of Tremelimumab in Pts With Unresectable Mesothelioma Randomized 2:1; stratified by EORTC (low vs high risk), previous lines of therapy (2 vs 3), and primary site (pleural vs peritoneal) Pleural or peritoneal mesothelioma with 1-2 previous therapy (which included first-line pemetrexed) No autoimmune disease (N = 564) Tremelimumab Placebo Primary objective: OS Secondary objectives: DCR, PFS, pt-reported outcomes, ORR, DoR, and safety 1. ClinicalTrials.gov. NCT Maio M, et al. ASCO Abstract TPS7609.

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51 Mesothelin Cell surface glycoprotein Overexpressed in > 90% of MM Involved in cell adhesion Elicits a humoral immune response in MM Hassan, Clin cancer Res, 20043

52 Mesothelin Targeting Agents Block cell adhesion Elicit Ab-dependent cytotoxicity response against mesothelin (+) tm cells Agent Mechanism of action Trials SS1P MORab- 009 CRS-207 Recom. immunotoxin (Antimesothelin FV fragment + Pseudomonas exotoxin) Humanized monoclonal Ab Attenuated Listeria vector that encodes human mesothelin Phase I, n:33 4 minor response, 19 SD Phase I All SD Phase I Hassan R et al. Clin Cancer res 2007 Armstrong et al. ASCO 2007

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