Monoclonal Antibodies in the Management of Non-Small Cell Lung Cancer (NSCLC): 2016 Update Angioinhibitors and EGFR MAbs

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1 Monoclonal Antibodies in the Management of Non-Small Cell Lung Cancer (NSCLC): 2016 Update Angioinhibitors and EGFR MAbs Corey J Langer, MD, FACP Director Thoracic Oncology Abramson Cancer Center Professor of Medicine University of Pennsylvania Philadelphia, PA 19104

2 Case Wild Type NSCLC

3 Clinical Details 56 yo African American man presents with SOB and L sided chest pain CXR shows a pathologic fx of the L 6th rib and a large L sided pleural effusion. CT confirms a 2 cm spiculated LUL mass with moderate L pleural effusion and multiple lytic mets involving the spine and ribs. Thoracentesis confirms NSCLC, p63 (+) with abundant keratin Patient receives local XRT to the rib fx with near complete relief of pain and is now being considered for systemic therapy 3

4 Subsequent Clinical Details Patient receives combination platinum, gemcitabine, and necitumumab along with zoledronic acid, and does very well with resolution of pleural effusion, shrinkage of the LUL mass to 8 mm and partial re-ossification of lytic lesions. Unfortunately, after six cycles of chemotherapy, the effusion recurs and the LUL lesion starts to grow (1.5 cm) with the appearance of satellite nodules. Patient undergoes pleurex drainage and is now being considered for 2nd line therapy. 4

5 Monoclonal Antibodies in the Management of Non-Small Cell Lung Cancer (NSCLC): 2016 Update Angioinhibitors and EGFR MAbs Corey J Langer, MD, FACP Director Thoracic Oncology Abramson Cancer Center Professor of Medicine University of Pennsylvania Philadelphia, PA 19104

6 Disclosures: Past 8 yrs Grant/Research Support: BMS, Pfizer, ImClone, Lilly, SPRI, Sanofi-Aventis, Amgen, CTI, Celgene, Vertex, Genentech (Roche), OSI, AstraZeneca, MedImmune, GSK, Merck, EMD Serono, ARIAD, Janssen, Inovio DSMC: Amgen, Synta, Lilly, Agennix, Peregrine, AbbVie, SWOG Scientific Advisor: BMS, ImClone, Sanofi-Aventis, Pfizer, GSK, AstraZeneca, Novartis, Genentech, OSI, Bayer/Onyx, Celgene, Clarient, Morphotek, Biodesix, Abbott Speakers Bureau: curtailed as of Dec, 2010 BMS, ImClone, Sanofi-Aventis, Lilly, Genentech, OSI 6

7 Bevacizumab in Nonsquamous NSCLC: Key Results E AVAiL 2,3 JO BEYOND Outcome PCB PC CGB (7.5) CGB (15) PC PCB PC PCB PC ORR, % P<0.001 P< P= HR for PFS 0.66 (P<0.001) 0.75 (P=0.003) 0.82 (P=0.03) 0.61 (P=0.009) 0.40 P < Median PFS, months HR for OS 0.79 (P=0.003) 0.93 (NS) 1.03 (NS) 0.99 (P=0.95) 0.68 P= Median OS, months PCB = paclitaxel, carboplatin, bevacizumab; PC = paclitaxel, carboplatin; CGB = cisplatin, gemcitabine; ORR = objective response rate. 1. Sandler A et al. N Engl J Med. 2006;355: Reck M et al. J Clin Oncol. 2009;27: Reck M et al. Ann Oncol. 2010;21: Ichinose Y et al. Eur J Cancer Suppl. 2009;7(2): abstract O Zhou C, et al. J Clin Onc. 2014;59:

8 Bevacizumab in Nonsquamous NSCLC: Key Results E AVAiL 2,3 JO BEYOND Outcome PCB PC CGB (7.5) CGB (15) PC PCB PC PCB PC ORR, % P<0.001 P< P= HR for PFS 0.66 (P<0.001) 0.75 (P=0.003) 0.82 (P=0.03) 0.61 (P=0.009) 0.40 P < Median PFS, months HR for OS 0.79 (P=0.003) 0.93 (NS) 1.03 (NS) 0.99 (P=0.95) 0.68 P= Median OS, months PCB = paclitaxel, carboplatin, bevacizumab; PC = paclitaxel, carboplatin; CGB = cisplatin, gemcitabine; ORR = objective response rate. 1. Sandler A et al. N Engl J Med. 2006;355: Reck M et al. J Clin Oncol. 2009;27: Reck M et al. Ann Oncol. 2010;21: Ichinose Y et al. Eur J Cancer Suppl. 2009;7(2): abstract O Zhou C, et al. J Clin Onc. 2014;59:

9 AvaALL: Trial Design Global trial conducted in ~20 countries Stage IIIB/IV non-squamous NSCLC treated with platinumdoublet (4-6 cycles) + bevacizumab PLUS > 2 cycles of bevacizumab maintenance N=600 PD 1 Enroll Randomize 1:1 Primary endpoint: OS SOC2* + bevacizumab PD 2 SOC3 + bevacizumab PD 3 SOC4 ± bevacizumab SOC2* SOC3 SOC4 * SOC2: Labelled agents for 2 nd -line treatment of NSCLC (erlotinib, pemetrexed and docetaxel) SOC3 and beyond: Choice of labelled agents in 3 rd -line and beyond is the Investigator s choice Bevacizumab dose must remain the same throughout the trial Beyond PD3, bevacizumab should be continued through subsequent lines of therapy at Investigator s discretion (in the absence of unacceptable toxicity or consent withdrawal) 9

10 Docetaxel and Ramucirumab vs. Docetaxel and Placebo in Second-Line Treatment of Stage IV NSCLC Study Design Key eligibility criteria N= 1253 Stage IV NSCLC or recurrent disease EGFR mutation hx ECOG PS 0 or 1 Measurable disease Adequate organ function R A N D O M I Z E D 1:1 n=628 Doc 75 mg/m 2 + RAM 10 mg/kg d1/21 n=625 DOC 75 mg/m 2 Placebo d1/21 Primary endpoint: OS Until disease progression, unacceptable toxicity or death Secondary endpoints: PFS, ORR 26.2% of patients (between Dec 10 and Feb 13) had squamous NSCLC Perol et al. ASCO Abstract LBA8006 (data from abstract only). clinicaltrials.gov/nct

11 REVEL Study: Docetaxel With or Without Ramucirumab in Second-Line Treatment Ramucirumab: fully human monoclonal antibody (IgG1) targeting VEGFR2. Successful in gastric cancer, but failed in phase 3 breast cancer study 1 REVEL: Randomized, double-blind Phase 3 study (N = 1253) 2nd-line Tx of stage IV NSCLC following PD post one prior platinum-based Tx Arm Docetaxel + RAM No Docetaxel + PLACEBO P-value HR (95% CI) ORR% <0.001 PFS (mos.) < ( ) OS (mos.) ( ) First study in second-line NSCLC to show a survival benefit vs. docetaxel alone First study to show a benefit for an angiogenesis inhibitor in SqCCa SCC = squamous cell carcinoma. Garon EB et al. Lancet. 2014;384:

12 Docetaxel and Ramucirumab vs. Docetaxel and Placebo in Second-Line Treatment of Stage IV NSCLC: Safety Adverse Event Grade 3 in > 5% of Patients, % RAM + DOC n=628 DOC n=625 Neutropenia Febrile neutropenia Fatigue Leukopenia Hypertension Pneumonia Grade 5 events Any grade pulmonary hemorrhage Any grade pulmonary hemorrhage occurred in 3.8% (RAM+DOC) vs 2.4% (DOC) of patients with squamous NSCLC Perol et al. ASCO Abstract LBA8006 (data from abstract only). 12

13 Angiogenesis in Advanced NSCLC Bevacizumab: first targeted agent to be approved for first-line use in advanced NSCLC: In combination with pac/carbo Non-squamous histology No antecedent hemoptysis or untreated brain mets BEYOND trial confirms E4599 Safe and effective up to age 75 Ramucirumab: First MAb targeting angiogenesis to show a survival benefit in the 2 nd -line setting (in combination with docetaxel) and the first to benefit squamous histology 13

14 FLEX: DDP-VNR+/-C225 - OS by Subgroups Ethnic Origin and Histology (ITT) Median OS (months) CT + Cetuximab CT HR [95% CI] p-value All (n=1125) [ ] Caucasian (n=946) [ ] Adenoca. (n=413) [ ] SCC (n=347) [ ] Asian (n=121) [ ] Pirker R, et al. ASCO Oral presentation and abstract 3.; Lancet

15 Background: SWOG Data Supports EGFR FISH as a Predictive Marker for Use of Cetuximab SWOG 0342 Concurrent or Sequential Chemotherapy + Cetuximab: Analysis by EGFR FISH * (p=0.02) FISH Status Events /N Median In Months 95% CI 1-4 Low 5-6 High FISH Status Events/ N Median In Months 95% CI 1-4 Low 5-6 High (A) Progression Free Survival and (B) Overall Survival according to FISH status for the entire study population. Hirsch R, et al. J Clin Onc. 2008;26:

16 SWOG 0819: Phase III Schema NSCLC Advanced Stage Tumor Tissue available Stratification Factors: 1)Appropriate for Bevacizumab treatment: yes vs. no 2)Smoking status: current or former vs. never 3)Stage: M1a vs M1b R A N D O M I Z E Co-Primary Objectives: OS (entire study), PFS (EGFR FISH) Paclitaxel Carboplatin *Bevacizumab Paclitaxel Carboplatin Cetuximab *Bevacizumab *Bevacizumab Cetuximab *Bevacizumab Correlative Science: Tumor: EGFR/HER pathways; KRAS Genomic DNA: EGFR polymorphisms Plasma: Proteomic predictor Prospective H Score Analysis Added Study accrual: 7/15/2009-6/1/2014 *In Bevacizumab Appropriate: as piloted in S0536 Herbst R. WCLC Abt

17 S0819 Results: Entire Study Population Overall Survival Progression Free Survival Cetuximab Arm N Events Median in Months 95% CI ( ) Cetuximab Arm N Events Median in Months 95% CI ( ) 100% Control Arm ( ) 100% Control Arm ( ) 80% P = 0.34 HR=0.94 ( ) 80% P = 0.68 HR=0.98 ( ) 60% 60% 40% 40% 20% 20% 0% Months After Registration Patients at Risk Patients at Risk Cetuximab Arm Cetuximab Arm Control Arm Control Arm Herbst R. WCLC Abt % Months After Registration

18 S0819 Results: Bevacizumab Inappropriate Overall Survival: Bevacizumab Inappropriate, FISH+ 100% N Events Median in Months 95% Conf. Int. Cetuximab ( ) 80% Control Arm ( ) 60% 40% P = HR=0.75 ( ) 20% 0% Months After Registration Patients at Risk Cetuximab Arm Control Arm Herbst R. WCLC Abt

19 S0819 Results: Squamous Cell Histology Overall Survival All SqCCA SqCCA, FISH+ 100% N Events Median in Months 95% CI 100% N Events Median in Months 95% CI 80% Cetuximab Arm ( ) Control Arm ( ) 80% Cetuximab Arm ( ) Control Arm ( ) 60% P = 0.18 HR=0.85 ( ) 60% P = HR=0.56 ( ) 40% 40% 20% 20% 0% Months After Registration % Months After Registration Patients at Risk Patients at Risk Cetuximab Arm Cetuximab Arm Control Arm Control Arm Herbst R. WCLC Abt

20 Thatcher N et al. Lancet Oncol 2015;16(7):

21 Thatcher N et al. Lancet Oncol 2015;16(7):

22 Thatcher N et al. Lancet Oncol 2015;16(7):

23 Thatcher N et al. Lancet Oncol 2015;16(7):

24 Thatcher N et al. Lancet Oncol 2015;16(7):

25 EGFR MAbs FLEX: Cetuximab in combination with Vnr/DDP yielded superior survival compared to chemo alone S0819: Cetuximab in combination with Pac/Carbo +/- Bev yielded no survival advantage overall, but proved (+) in FISH (+) subsets SQUIRE: Necitumumab in combination with Gem/ DDP yielded a statistically significant, but clinically modest, survival advantage compared to chemo alone, leading to FDA approval 25

26 Monoclonal Antibodies in the Management of Non-Small Cell Lung Cancer (NSCLC): 2016 Update Angioinhibitors and EGFR MAbs Corey J Langer, MD, FACP Director Thoracic Oncology Abramson Cancer Center Professor of Medicine University of Pennsylvania Philadelphia, PA 19104

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