The Immunotherapy of Oncology
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1 The Immunotherapy of Oncology The 30-year Overnight Success Story M Avery, BIOtech Now 2014
2 Disclosures: Geoffrey R. Weiss, M.D. None
3 The History A. Chekov: It has long been noted that the growth of malignant tumors halts for a time when this disease [erysipelas] is present. Coley s Toxins: Strep pyogenes, Serr marcescens. BCG for superficial bladder cancer. Coley WB, AmJMedSci, 1893 Lamm DL, NEJM, 1991
4 Interleukin-2/LAK Cells NCI Surgery Branch # Patients Cancer Total Responses Melanoma 7 4 Colorectal 9 3 Sarcoma 4 0 Renal Cell 3 3 Lung 1 1 Esophagus 1 0 Total (44%) Rosenberg et al., NEJM, 1985
5 IL-2/LAK Clinical Protocol week L A K High-dose IL-2 600,000 IU/kg Q8hr x 14 doses Lymphocytapheresis Tumor measurements at Week 6 and 12 then every 12 weeks Repeat Q12 weeks Max 3 cycles
6 High-Dose Interleukin-2 in Renal Cell Carcinoma 255 metastatic RCC patients. 7 clinical trials of high-dose IL-2 alone. 15% overall response in metastatic RCC. Median duration of response: 54 months ( mos). Interleukin-2 FDA-approved for metastatic RCC in 1992.
7 High-Dose Interleukin-2 in Metastatic Malignant Melanoma 270 MM patients treated with high-dose interleukin-2 in 8 clinical trials 16% overall response rate in metastatic MM: 24 without progression at 1 year 10 CRs > 3-8 years Interleukin-2 FDA-approved 1998 for MMM
8 Sipuleucel-T for Advanced Prostate Cancer
9 Sipuleucel-T for Advanced Prostate Cancer 512 pts. Leukapheresis Wks 0, 2, 4 PMCs (APCs)+ PA2024 PMCs (APCs) Placebo Infusion 341 pts Infusion 171 pts PA2024=PAP/GMCSF Fusion Product Kantoff P et al ASCO GU Kantoff P et al. NEJM 2010
10 Sipuleucel-T for Advanced Prostate Cancer
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13 CTLA-4 BLOCKADE MELANOMA
14 Ipilimumab vs. Ipi/gp100 vs. gp100 In Metastatic Melanoma Phase III Trial 2 nd Line Therapy 676 patients: Stages III-IV Melanoma Category Med OS ORR 2-year Surv Ipilimumab 10.1 mos 10.9% Ipilimumab + gp100 Hodi FS et al, NEJM mos 5.7% 24% gp mos 1.5% 14% HR 0.68 P < 0.003
15 Hodi FS et al. N Engl J Med 2010; 363:
16 Ipilimumab plus Dacarbazine for Metastatic Melanoma Randomized phase III trial ipilimumab 10 mg/kg iv q3wks x 4 dacarbazine 850 mg/m 2 iv q3wks x 4 Untreated MMM Primary endpoint: OS placebo dacarbazine 850 mg/m 2 iv q3wks x 4 dacarbazine given alone weeks Robert C, NEJM 2011
17 Dacarbazine + Ipilimumab Overall Survival, Robert C et al. N Engl J Med 2011;364:
18 Dacarbazine + Ipilimumab Overall Survival study. Michele Maio et al. JCO 2015;33:
19 Tremilimumab in Metastatic Melanoma 655 Pts No prior Rx Tremilimumab, 15 mg/kg Chemo (Physician Choice) Endpoint Tremilimumab Chemo Med OS 12.6 mos 10.7 mos HR for Death 0.88 P=0.127 Ribas A et al. J Clin Oncol 2013
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21 Immune Checkpoint Inhibitors Nivolumab and Pembrolizumab Nivolumab: Fully human IgG4 antibody, blocks ligand activation of PD-1 receptor. Pembrolizumab: Humanized IgG4 antibody, blocks ligand activation of PD-1 receptor.
22 Nivolumab in Cancer Treatment Phase I trial. Advanced melanoma, NSCLC, renal cell cancer, CR prostate cancer, colorectal cancer. Nivolumab: 1 mg/kg; 3 mg/kg; 10 mg/kg; i.v, Q2wks. 5 expansion cohorts for each disease. IHC for tumor PDL-1 expression. Topalian SL et al. NEJM 2012.
23 Nivolumab in Cancer Treatment 296 patients. No maximum tolerated dose defined. 3 deaths from pulmonary toxicity. Responses NSCLC Melanoma Renal cell 18% (14/76) 28% (26/94) 27% (9/33) Topalian SL et al. NEJM 2012.
24 Nivolumab in Cancer Treatment 20/31 responses exceeded 1 year s duration. None of PDL-1 negative tumors had response. 9 of 25 PDL-1 positive tumors had response. Dominant toxicities: Diarrhea (11%), Rash (12%), Pruritis (9%). Topalian SL et al. NEJM 2012.
25 PD-1/PDL-1 BLOCKADE MELANOMA
26 Nivolumab vs. DTIC in Metastatic Melanoma Phase III as 1 st Line Therapy No prior Rx, BRAF negative 418 Pts Nivo, 3 mg/kg, iv, Q2wks + Placebo DTIC, 1000 mg/m 2, iv, Q3wks + Placebo Robert C et al. NEJM, 2014
27 Nivolumab vs. DTIC in Metastatic Melanoma Category Nivo DTIC OS 1 Yr 72.9% 42.1% Med PFS 5.1 mos 2.2 mos ORR 40% 13.9% HR for Death 0.42 P<0.001 Robert C et al. NEJM, 2014
28 Pembrolizumab in Melanoma KEYNOTE-001 Phase I-II trial with expansion cohort in melanoma. Objectives: assess safety and antitumor activity. 135 patients treated: 1) prior ipilimumab, or 2) < 2 prior regimens for advanced disease. Pembrolizumab administered i.v. over 30 minutes. Cohort 10 mg/kg Q2 wks 10 mg/kg Q3 wks 2 mg/kg Q 3 wks No prior Ipi Prior Ipi
29 Pembrolizumab in Melanoma KEYNOTE-001 Safety 135 patients at least 1 dose pembrolizumab. Common symptoms: fatigue, myalgia, headache, fever. 2% serious/life-threatening toxicity. Autoimmune reactions Vitiligo 9% Hypothyroidism 8% Pneumonitis 4% Hamid O, NEJM, 2013
30 Pembrolizumab in Melanoma KEYNOTE-001 % Response (# patients) Cohort 10 mg/kg Q 2 wks 10 mg/kg Q 3 wks 2 mg/kg Q 3 wks Total No prior ipi 49 % (19) 26% (5) 25% (5) 38% (44) Prior ipi 62% (8) 27% (7) -- Among 135 patients treated, median PFS = 36 weeks. Duration of response mos. One-year overall survival 81%. Hamid O, NEJM, 2013
31 KEYNOTE-006 Pembrolizumab vs. Ipilimumab Pembro, 10 mg/kg, iv Q 2 weeks 834 pts Pembro, 10 mg/kg, iv Q 3 weeks St III-IV Unresect. Ipilimumab, 3 mg/kg, iv Q 3 wks x 4 < 1 prior Rx
32 KEYNOTE-006 Pembrolizumab vs. Ipilimumab The study was closed early due to achievement of PFS and OS endpoints. Results to be presented at AACR Annual Meeting 2015 (April 18-22, 2015).
33 BMS Anti-PDL-1 in Metastatic Melanoma Phase I, > 2nd Line 55 Melanoma pts subset mg/kg, iv, Q2wks, up to 96 weeks. ORR (all doses): 17% Additional 27% SD > 24 weeks. Brahmer JR, NEJM, 2012.
34 BMS Anti-PDL-1 in Metastatic Melanoma Brahmer JR et al. NEJM, 2012
35 MPDL-3280A Anti-PDL-1 in Metastatic Melanoma Phase 1, no prior checkpoint-inhibitor 45 Melanoma pts subset mg/kg, Q3wks, iv. ORR, 26% for cohorts > 1 mg/kg. Responses observed in tumors and TIL expressing high levels PDL-1. Herbst RS et al. Nature, 2014
36 MPDL-3280A Anti-PDL-1 in Metastatic Melanoma
37 Predictive Biomarkers Ipilimumab activity Increased abs. lymphocyte count. Expression of inducible T-cell costimulator (ICOS). Tumor microenvironment inflammatory genes. Circulating immunosuppressive myeloid-derived suppressor cells. Maintenance of high clonotypes of TCRb chains.
38 Predictive Biomarkers PD-1/PDL-1 blockade activity Tumor PDL-1 expression: mixed results. Intrapatient tumor heterogeneity of IHC staining. Tumor vs. immune cell expression. High baseline CD8 cell densities at tumor margin.
39 LUNG CANCER
40 Nivolumab Phase II Trial in Metastatic Squamous Lung Cancer CHECKMATE patients with metastatic squamous NSCLC. Failed prior Pt-based regimen and > 1 additional regimen. Nivolumab, 3 mg/kg, i.v., Q2wks. Primary endpoint: Objective response rate. Rizvi NA, Lancet Oncol, March 2015
41 Nivolumab Phase II Trial in Metastatic Squamous Lung Cancer CHECKMATE- 063 ORR: 14.5% (17/117; 95% CI: %). CR/PR/SD: 40.5% 13/17 responses ongoing. Med Time to Resp: 3.3 mos Med Duration of Resp: not reached. 2 deaths: Pneumonia, Ischemic stroke. Rizvi NA, Lancet Oncol, March 2015
42 Nivolumab vs. Docetaxel in Advanced Squamous Lung Cancer: CHECKMATE patients 1 Pt doublet Nivolumab, 3 mg/kg, i.v Q2wks Docetaxel, 75 mg/m 2, i.v. Q3wks
43 Nivolumab vs. Docetaxel in Advanced Squamous Lung Cancer: CHECKMATE-017 Category Nivolumab (n=135) Docetaxel (n=137) Med OS (95% CI) 9.2 mos ( ) 6.0 mos ( ) P= HR 0.59 ( )
44 RENAL CELL CARCINOMA
45 Randomized Phase II Trial of Nivolumab in Renal Cell Carcinoma Blinded, randomized, multicenter trial. mrcc with clear cell component. Measurable disease At least 1 prior treatment with anti-angiogenic Rx No CNS metastases, autoimmune disease, prior immune checkpoint Rx, or >3 prior Rxs. 1 o endpoint: dose-related PFS Motzer RJ et al., JCO, Dec 2014.
46 Randomized Phase II Trial of Nivolumab in Renal Cell Carcinoma Nivolumab, 0.3 mg/kg, i.v., Q3weeks 168 pts Nivolumab, 2 mg/kg, i.v., Q3weeks Nivolumab, 10 mg/kg, i.v., Q3weeks
47 Randomized Phase II Trial of Nivolumab in Renal Cell Carcinoma Category 0.3 mg/kg 2 mg/kg 10 mg/kg mpfs (80% CI) 2.7 mos ( ) 4.0 mos ( ) 4.2 mos ( ) ORR 12 (20%) 12 (22%) 11 (20%) mos (80% CI) 18.2 mos (16-24) 25.5 mos (20-29) 24.7 mos (15-26)
48 (A) Progression-free and (B) overall survival by treatment arm (randomly assigned patients). Robert J. Motzer et al. JCO doi: /jco by American Society of Clinical Oncology
49 (A) Progression-free and (B) overall survival by treatment arm (randomly assigned patients). Robert J. Motzer et al. JCO doi: /jco by American Society of Clinical Oncology
50 Phase I nivolumab/ipilimumab in metastatic renal cell carcinoma Nivolumab, 3 mg/kg Ipilimumab, 1 mg/kg i.v. Q3wks x 4 44 mrcc patients untreated or prior Rx Nivolumab, 3 mg/kg Ipilimumab, 1 mg/kg i.v. Q3wks x 4 Both arms continue nivolumab Q2wks Hammers HJ, 2014 ASCO Annual Meeting Abstracts.
51 Phase I nivolumab/ipilimumab in metastatic renal cell carcinoma Category Arm N3 + I1 n=21 Arm N1 + I3 n=23 ORR, n (%) 6 (29) 9 (39) SD, n (%) [duration, wks] 7 (33) [6+ to 25+] 9 (39) [6+to 26.1] DOR, range (wks) PFS, range (wks)
52 LYMPHOMA
53 Immune Checkpoint Inhibition in Hodgkins Lymphoma chl has a small number of Reed Sternberg (RS) cells on background of extensive but ineffective inflammatory/immune response cells RS cells often have 9p24.1 structural mutations increased gene dosage of PD-1 ligands In EBV+ chl, viral infection also increases expression of PD-1 ligands
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57 PD-1 Blockade with Nivolumab in R/R HL Armand et al, abstract #289, ASH 2014; Ansell et al, NEJM Dec Phase I multicenter study R/R HL, prior Rx with brentuximab 78% s/p prior ASCT Dose: 3 mg/kg q2wk until CR, PD or toxicity Response: 20/23 (87%), CR in 17%, 3 SD 6 pts SCT PFS at 24 weeks = 86% 2 pts d/c Rx: MDS, pancreatitis Toxicity: rash 20%, thrombocytopenia 17%
58 Response in Tumor Burden of HL Patients Receiving Nivolumab Ansell SM et al. N Engl J Med 2014.
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60 Pembrolizumab in chl failing brentuximab C Moskowitz et al, abstract #290, ASH 2014 Phase Ib multicenter trial R/R chl, no prior autoimmune or interstitial lung disease Pembro 10 mg/kg IV q2wk Preliminary report of 15 pts evaluated at week 12
61 Pembrolizumab in chl Failing Brentuximab C Moskowitz et al, abstract #290, ASH 2014 Median 4 prior Rx s, 67% prior ASCT 1 pt d/c Rx due to toxicity (pneumonitis) Grade 1-2 resp events in 20%, thyroid disorders in 20% week 12 = 53%: 3 CR, 5 PR PD in 4 pts, toxicity or 2 years of therapy Conclusion: clinical benefit in pretreated chl
62 Nivolumab in lymphoid malignancies AM Lesokhin et al, abstract #291, ASH 2014 Phase I multicenter study, pre-planned interim analysis Heavily pretreated pts, including ASCT 3 mg/kg q2wks x 2 yrs, or PD/ toxicity Correlatives: anti-tumor activity and expression of immunomodulatory proteins
63 Nivolumab in lymphoid malignancies AM Lesokhin et al, abstract #291, ASH 2014 Tumor n CR PR SD % PFS 24 wks DLBCL FL MF MM PTCL/ other T Toxicity: pneumonitis 11%, 1 death Very few pts with 9p alteration or PD-L1 expression PD-L1 is expressed in FL microenvironment by stroma
64 The Immunotherapy Timeline Interferona2b 1995 BCG 1970 IL Ipilimumab 2011 Nivolumab 2015 Pembrolizumab 2014
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66 Ipilimumab plus Nivolumab Phase I trial in advanced melanoma. 2-Part study: Concurrent study-no prior ipilimumab. Sequential study- > 3 prior doses of ipilimumab. Endpoints: Safety and efficacy. Wolchok JD, NEJM, 2013
67 Concurrent Ipilimumab and Nivolumab Cohort Nivolumab (mg/kg) Ipilimumab (mg/kg) a Nivolumab/Ipilimumab i.v every 3 weeks x 4, then nivolumab alone, i.v., every 3 weeks up to 4 doses. Wolchok JD, NEJM, 2013
68 Concurrent Ipilimumab and Nivolumab Safety 53 patients treated. Cohort 3 (Niv 3/Ipi 3) exceeded acceptable toxicity. Cohort 2 (Niv 1/Ipi 3) = MTD. Serious/life-threatening toxicity in 49% of all patients. Hepatotoxicity 15% Diarrhea/colitis 9% Acute renal insufficiency 6% Wolchok JD, NEJM, 2013
69 Concurrent Ipilimumab and Nivolumab Niv/Ipi Dose (mg/kg) % Response Rate (#) % > 80 Reduction at 12 weeks (#) Responses ongoing in 19 of 21 patients at weeks. Wolchok JD, NEJM, 2013
70 Wolchok JD et al, NEJM, 2013
71 Sequential Nivolumab and Ipilimumab 33 patients, metastatic melanoma, > 3 prior doses ipilimumab. Cohorts 6 & 7 treated with nivolumab i.v. every 2 weeks up to 48 doses. Cohort Dose (mg/kg) Hodi FS et al. ASCO Annual Meeting Abstract 2013
72 Sequential Ipilimumab and Nivolumab Safety 33 patients treated. Serious/life-threatening toxicity in 18% of all patients. Lipase elevation 6% Endocrine events 6% Three patients discontinued treatment due to toxicity. Hodi FS et al. ASCO Annual Meeting Abstract 2013
73 Sequential Nivolumab and Ipilimumab Nivolumab dose (mg/kg) % Response Rate (#) % > 80 Reduction at 8 weeks (#) Some patients who did not respond to prior ipilimumab did respond to nivolumab. Hodi FS et al. ASCO Annual Meeting Abstract 2013
Out of 129 patients with NSCLC treated with Nivolumab in a phase I trial, the OS rate at 5-y was about 16 %, clearly higher than historical rates.
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