Network Experience of TKI inhibitors as 1 st line use in advanced NSCLC Dr Jill Gardiner and Mr Steve Williamson April 2012.

Slides:

Advertisements

Similar presentations

FOLFOXIRI plus bevacizumab (bev) vs FOLFIRI plus bev

Advertisements

James R. Rigas Comprehensive Thoracic Oncology Program

Paz-Ares LG et al. Proc ASCO 2011;Abstract CRA7510.

Questions and answers about PARAMOUNT: phase III study of pemetrexed continuation maintenance therapy in advanced non-squamous NSCLC.

Facon T et al. Proc ASH 2013;Abstract 2.

Contemporary Treatment of Metastatic Non-Small Cell Lung Cancer

1 Sitemap Storyflow Title slideOverview slide13.6 months PFSSymptom controlQoL OS across 7 trials3 months OS > 12 month OS Summary slide.

Using Non-targeted Therapies in Targeted Lung Cancer Populations Nathan Pennell, M.D., Ph.D. September 6, 2014.

Lung Cancer: What’s New and What’s Old? Presented By Leora Horn at 2014 ASCO Annual Meeting.

Have the OPTIMOX-2, CAIRO-3, COIN, DREAM and other recent trials settled the question of maintenance versus observation in advanced CRC? Yes Deborah Schrag,

Cost of & Access to Molecularly Targeted Therapies as Barriers to Optimal Care H. Jack West, MD Swedish Cancer Institute Seattle, WA Global Resource for.

Tumour growth is angiogenesis dependent Judah Folkman 1971 VEGF gene identified and EGFR isolated 1980s Meta-analyses confirm survival benefit with chemotherapy.

Randomized Phase II Trial of Erlotinib (E) Alone or in Combination with Carboplatin/Paclitaxel (CP) in Never or Light Former Smokers with Advanced Lung.

Randomized Phase II trial of erlotinib (E) alone or in combination with carboplatin/paclitaxel (CP) in never or light former smokers with advanced lung.

©American Society of Clinical Oncology All rights reserved - American Society of Clinical Oncology Provisional.

First-Line TKI Use in EGFR Mutation-Positive NSCLC

Comparison of Nilotinib and Imatinib in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENESTnd Beyond One Year Larson.

Effect of Age on Efficacy and Safety Outcomes in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Receiving Lenalidomide and Low-Dose Dexamethasone.

Taxane-pretreated metastatic breast cancer (MBC): investigational agents TTP = median time to disease progression OS = median overall survival.

Phase II Presurgical Feasibility Study of Bevacizumab in Untreated Patients with Metastatic Renal Cell Carcinoma Jonasch E et al. Journal of Clinical Oncology.

ESMO 2011 Lung Cancer AVAPERL Study Authors: Dr. Sunil Verma Date posted: September 28 th, 2011.

Please note, these are the actual video-recorded proceedings from the live CME event and may include the use of trade names and other raw, unedited content.

Lung cancer perspectives. Targeted therapy : one for all or a few for one ? Miklos Pless, Winterthur

Result of Interim Analysis of Overall Survival in the GCIG ICON7 Phase III Randomized Trial of Bevacizumab in Women with Newly Diagnosed Ovarian Cancer.

1 SNDA Gemzar plus Carboplatin Treatment of Late Relapsing Ovarian Cancer.

O’Shaughnessy J et al. Proc ASCO 2011;Abstract 1007.

Randomized Phase III Trial Comparing FOLFIRINOX (F: 5FU/Leucovorin [LV], Irinotecan [I], and Oxaliplatin [O]) versus Gemcitabine (G) as First-Line Treatment.

Two Year Estimate of Overall Survival in COMBI-v, a Randomized, Open-Label, Phase 3 Study Comparing the Combination of Dabrafenib and Trametinib With Vemurafenib.

Gemcitabine + Cisplatin +/- Bevacizumab as 1st-line Treatment of Advanced NSCLC: AVAiL Study Manegold PASCO 25:#7514, 2007/Ann.

Final Analysis of Overall Survival for the Phase III CONFIRM Trial: Fulvestrant 500 mg versus 250 mg Di Leo A et al. Proc SABCS 2012;Abstract S1-4.

Professor Martin Schuler MD West German Cancer Center Essen, Germany

Treatment of advanced NSCLC:

A paradigm shift in the treatment of advanced lung cancer: survival and symptom benefits with Tarceva Tudor-Eliade Ciuleanu Cancer Institute Ion Chiricuta.

Final Efficacy Results from OAM4558g, a Randomized Phase II Study Evaluating MetMAb or Placebo in Combination with Erlotinib in Advanced NSCLC Spigel DR.

Rituximab plus Lenalidomide Improves the Complete Remission Rate in Comparison with Rituximab Monotherapy in Untreated Follicular Lymphoma Patients in.

SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy.

Results of a Randomized Phase 2 Study of PD , a Cyclin ‐ Dependent Kinase (CDK) 4/6 Inhibitor, in Combination with Letrozole vs Letrozole Alone.

Monoclonal Antibodies EGFR Inhibitors for Metastatic Colorectal Cancer: Where are we and What’s next Discussion of Abstracts Jeffrey Meyerhardt,

Time to Secondary Resistance (TSR) After Interruption of Imatinib: Updated Results of the Prospective French Sarcoma Group Randomized Phase III Trial on.

Anastrozole (‘Arimidex’): a new standard of care?

CV-1 Trial 709 The ISEL Study (IRESSA ® Survival Evaluation in Lung Cancer) Summary of Data as of December 16, 2004 Kevin Carroll, MSc Summary of Data.

A Phase 2 Study with a Daily Regimen of the Oral mTOR Inhibitor RAD001 (Everolimus) in Patients with Metastatic Clear Cell Renal Cell Cancer Amato RJ et.

until tumour progression until tumour progression

Impact of Bevacizumab (Bev) on Efficacy of Second-Line Chemotherapy (CT) for Triple- Negative Breast Cancer: Analysis of RIBBON-2 Brufsky A et al. Proc.

Who can benefit from chemotherapy holidays after first-line therapy for advanced colorectal cancer ? N. Perez-Staub, B. Chibaudel, A. Figer, A. Cervantes,

Lenalidomide Maintenance After Stem-Cell Transplantation for Multiple Myeloma: Follow-Up Analysis of the IFM Trial Attal M et al. Proc ASH 2013;Abstract.

HERA TRIAL: 2 Years versus 1 Year of Trastuzumab After Adjuvant Chemotherapy in Women with HER2-Positive Early Breast Cancer at 8 Years of Median Follow-Up.

Chemoimmunotherapy with Fludarabine (F), Cyclophosphamide (C), and Rituximab (R) (FCR) versus Bendamustine and Rituximab (BR) in Previously Untreated and.

A Phase III, Open-Label, Randomized, Multicenter Study of Eribulin Mesylate versus Capecitabine in Patients with Locally Advanced or Metastatic Breast.

Biomarker analyses from a phase III, randomized, open-label, first-line study of gefitinib (G) versus carboplatin/paclitaxel (C/P)

Personalized medicine in lung cancer R4 김승민. Personalized Medicine in Lung Cancer patients with specific types and stages of cancer should be treated.

Mok TS, Wu SL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361: Gefitinib Superior.

Lancet Oncol 2012; 13: 528–38 Vincent A Miller, Vera Hirsh, Jacques Cadranel, Yuh-Min Chen, Keunchil Park, Sang-We Kim, Caicun Zhou, Wu-Chou Su, Mengzhao.

J Thorac Oncol. 2012;7: 1653–1660) David P. Carbone, MD, PhD,* Keyue Ding, PhD,† Heinrich Roder, PhD,‡ Julia Grigorieva, PhD,‡ Joanna Roder, PhD,‡ Ming-Sound.

Weekly Paclitaxel Combined with Monthly Carboplatin versus Single-Agent Therapy in Patients Age 70 to 89: IFCT-0501 Randomized Phase III Study in Advanced.

Belani CP et al. ASCO 2009; Abstract CRA8000. (Oral Presentation)

N Engl J Med; Volume 373(17): ; October 22, 2015

Bayesian network meta-comparison of maintenance treatments for stage IIIb/IV non- small-cell lung cancer (NSCLC) patients with good performance status.

Nivolumab in Patients (Pts) with Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL): Clinical Outcomes from Extended Follow-up of a Phase 1 Study.

Rosell R et al. Proc ASCO 2011;Abstract 7503.

Meta-analysis of randomised phase III clinical trials comparing EGFR tyrosine kinase inhibitor (TKI) shows that male patients with non-small cell lung.

EGFR Inhibitors in Advanced NSCLC: Who, When, and Why?

Baselga J et al. SABCS 2009;Abstract 45.

University of British Columbia British Columbia Cancer Agency

Experience of Tyrosine-Kinase Inhibitors (TKI) for 1st line NSCLC

1 Verstovsek S et al. Proc ASH 2012;Abstract Cervantes F et al.

(A) Survival time. (A) Survival time. All patients. (a) PFS since the start of EGFR-TKI (groups A, B and C). (b) OS since the start of EGFR-TKI (groups.

Final Overall Survival Results from a Phase III, Randomized, Placebo-Controlled, Parallel-Group Study of Gefitinib Versus Placebo as Maintenance Therapy.

Third-Generation EGFR TKIs

Efficacy of BSI-201, a PARP Inhibitor, in Combination with Gemcitabine/Carboplatin (GC) in Triple Negative Metastatic Breast Cancer (mTNBC): Results.

Presentation transcript:

Network Experience of TKI inhibitors as 1 st line use in advanced NSCLC Dr Jill Gardiner and Mr Steve Williamson April 2012

Plans for Iressa Audit Preliminary data only from Astra Zeneca. No information on toxicity and QL. Numbers for each trust are small so all of the region needs to be included in the audit to produce meaningful data. Centralisation of Consent/Caldecott via the Network will allow much easier access of patient information across the region.

Iressa Audit Cover period 2010 and 2011 Response rates Duration of treatment Toxicity Response to 2 nd line treatment Overall survival

Tarceva

A standard second line treatment for Advanced NSCLC in the region. Data is now available in the first line setting for mutation positive advanced NSCLC. Tarceva has a licence as a first line treatment for mutation positive advanced NSCLC. It is at least comparable with the Iressa data. It has the advantage of Phase 3 data in the European population – the EURTAC study

Data Summary RR TKI v chemoPFS TKI v chemo Asian Iressa IPASS ( Mok et al NEJM 361 p ) 71.2% v 47.3%9.5m v 6.3m Asian Tarceva OPTIMAL ( Zhou et al Lancet Oncology 12 p ) 83% v 36%13.1m v 4.6m European Tarceva EURTAC ( Rossell et al ASCO 2011 #7503) 58% v 15%9.4m v 5.2m

Primary endpoint: PFS in ITT population (interim analysis 2 Aug 2010) PFS probability Erlotinib (n=77) Chemotherapy (n=76) HR=0.42 (0.27–0.64) Log-rank p< Time (months) Patients at risk Erlotinib Chemo IRC-assessed PFS confirmed these results

Best overall response in ITT population Erlotinib (n=77) n (%) Chemotherapy (n=76) n (%) Erlotinib (n=86) n (%) Chemotherapy (n=87) n (%) Complete response2 (3)0 (0)2 (2)0 (0) Partial response40 (52) 8 (11)48 (56) 13 (15) Objective response rate42 (55) 8 (11)50 (58) 13 (15) Stable disease18 (23)42 (55)18 (21)44 (51) Disease control rate60 (78)50 (66)68 (79)57 (66) Progressive disease6 (8)10 (13)6 (7)11 (13) No response assessment11 (14)16 (21)12 (14)19 (22) Interim analysis (Aug 2, 2010) Updated analysis (Jan 26, 2011)

Conclusions EURTAC is the first prospective study of an EGFR tyrosine-kinase inhibitor (TKI) versus chemotherapy for first-line treatment of EGFR mutation-positive NSCLC in Caucasian patients The study results confirms significant benefit in PFS of erlotinib over standard chemotherapy – 63% reduction in risk of progression (HR=0.37) OS data are immature, with high level of known crossover As expected, no new safety findings – tolerability of erlotinib was consistent with previous studies Erlotinib provides significant benefits over first-line chemotherapy in EGFR mutation-positive disease

Tarceva as first line treatment for Mutation positive NSCLC Approved by SMC Jan 2012 Approved by NECDAG Jan 2012 Due for NICE review June 2012

Tarceva Will everyone switch to Tarceva or will some continue to use Iressa? The plan is to audit the data we obtain. May allow us to do a comparison with the Iressa data.