Innovation: Present Meets Future
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- Noah Mosley
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1 Innovation: Present Meets Future SOCIAL INNOVATION Leading Innovation in the Cooperative Group Setting Craig Nichols, M.D. BEST OF SWOG Barlogie-Salmon Myeloma Committee Robert Z. Orlowski, M.D., Ph.D. Health Outcomes & Comparative Effectiveness Committee Scott D. Ramsey, M.D., Ph.D. Lung Cancer Committee David R. Gandara, M.D.
2 SWOG Lung Commieee: Innova>on meets the NCTN David R. Gandara, MD University of California Davis Comprehensive Cancer Center
3 SWOG Lung Commieee: Innova>on meets the NCTN TMSC Transi>on to NCTN TM Working Group Transforma>ve SWOG S1400 Lung Commieee S1403 Trans- Disciplinary Change in: - Biologic Concepts - Clinical Prac>ce - Standard of Care Transla>onal Bench to Bedside Genomics Epigenomics Modeling Imaging
4 Developing SWOG Lung Trials (Selected) 1. S1400: Master Protocol for Squamous Cell CA (SCCA)- NSCLC second line therapy PI: V. Papadimitrakopoulou 2. S1403: Afa>nib +/- Cetuximab in EGFR MT+ NSCLC PI: T. Lynch, S. Goldberg, K. Poli>
5 Unmet Needs in Clinical Trial Designs for NSCLC when viewed as a Mul>tude of Genomic Subsets Evolu>on of NSCLC à Histologic Subsets à Genomic Subsets Unmet Needs in Clinical Trials: How to develop drugs for uncommon- rare genotypes? How to apply broad- based screening (NGS)? How to achieve acceptable turn- around >mes for molecular tes>ng for therapy ini>a>on? (<2 weeks) How to expedite the new drug- biomarker FDA approval process? (companion diagnos>c) Li, Mack, Kung, Gandara: JCO 2013
6 Strategies for Integra>ng Biomarkers into Clinical Development of New Therapies for Lung Cancer A Joint NCI Thoracic Malignancies Steering Commieee- FDA Workshop Bethesda MD February 2-3, 2012 Trial Design Challenges in the Era of Biomarker- driven Trials Innova>ve Sta>s>cal Designs Challenges for Community Oncology Prac>ce par>cipa>on The Pa>ent Perspec>ve Drug & Biomarker Co- Development in Lung Cancer Need for Early Co- Development Need for Improved Pre- Clinical Models with clinical relevance Development of Future Lung Cancer Clinical Trials TMSC Master Protocol Task Force in NSCLC Biomarker- driven trial designs in both early stage adjuvant therapy & advanced stage NSCLC Account for inter- pa>ent tumor heterogeneity & genomic complexity of NSCLC
7 Master Lung- 1 (S1400): A Biomarker- driven Mul>- Arm Phase II/III Registra>on Protocol In Squamous Lung Cancer 2 nd Line Therapy
8 Ra>onale for Master Protocol Design Mul>- arm Master Protocol Homogeneous pa>ent popula>ons & consistent eligibility from arm to arm Each arm independent of the others Infrastructure facilitates opening new arms faster Phase II- III design allows rapid drug/biomarker tes>ng for detec>on of large effects Screening large numbers of pa>ents for mul>ple targets by a broad- based NGS plavorm reduces the screen failure rate Provides a sufficient hit rate to engage pa>ents & physicians Bring safe & effec>ve drugs to pa>ents faster Designed to faciliate FDA approval of new drugs
9 S1400: MASTER LUNG-1: Squamous Lung Cancer- 2 nd Line Therapy Biomarker A Biomarker Β Biomarker Profiling (NGS/CLIA) Biomarker C Biomarker Non- Match Mul>ple Phase II- III Arms with rolling Opening & Closure Biomarker D CT* Non- Match Drug TT A CT* TT B CT* TT C+CT CT* TT D+E E* Endpoint (Interim PFS) OS Endpoint (Interim PFS) OS Endpoint (Interim PFS) OS Endpoint (Interim PFS) OS TT=Targeted therapy, CT=chemotherapy (docetaxel or gemcitabine), E=erlo>nib PI: V. Papadimitrakopoulou (SWOG)
10 S1400: MASTER LUNG-1: Squamous Lung Cancer- 2 nd Line Therapy Biomarker Profiling (NGS/CLIA) Biomarker Non- Match CT* PD- L1i PiK3CA Mut Mul>ple Phase II- III Arms with rolling Opening & Closure CCND1 ampl or CDKN2 loss + RB WT FGFR ampl, Mut, Fusion MET Expr PI3Ki CT* CDK 4/6i CT* FGFRi+CT CT* HGFi+E E* Endpoint (Interim PFS) OS Endpoint (Interim PFS) OS Endpoint (Interim PFS) OS Endpoint (Interim PFS) OS TT=Targeted therapy, CT=chemotherapy (docetaxel or gemcitabine), E=erlo>nib PI: V. Papadimitrakopoulou (SWOG)
11 S1400 (MASTER LUNG-1) Squamous Lung Cancer- 2 nd Line Therapy Pa>ent Registra>o n Consent Tumor Collec>on Assign treatment Arm by marker Randomiza>on Genomic Screening <2 weeks Treatment Inves>ga>onal Targeted Therapy Interim Endpoint: PFS Primary Endpoint: OS Genomic Pre- screening In selected pa>ents NGS/IHC (Founda>on Medicine) Standard of Care Therapy Organizers: FOCR, NCI- TMSC, FDA, FNIH Par>cipants: En>re North American Lung Intergroup (SWOG, Alliance, ECOG- Acrin, NRG, NCI- Canada) Screening: up to 1,000 pa>ents/year With 6 arms open simultaneously, an>cipate a hit rate >60% in matching a pa>ent with a drug/biomarker arm
12 Governance Structure: S1400 Master Lung- 1 Project Friends of Cancer Research
13 Developing SWOG Lung Trials (Selected) 1. S1400: Master Protocol for Squamous Cell CA (SCCA)- NSCLC second line therapy PI: V. Papadimitrakopoulou 2. S1403: Afa>nib +/- Cetuximab in EGFR MT+ NSCLC PI: T. Lynch, S. Goldberg, K. Poli>
14 Clinical Trial Designs to address Circumven>on of Acquired Resistance in Oncogene- Driven NSCLC Advanced Stage NSCLC Biopsy Identification of Driver Oncogene Targeted TKI Monotherapy (1st generation agent) Targeted TKI Monotherapy (2 nd generation agent) EGFR Mutation Multi-drug Targeted Therapy from Gandara & Redman: ASCO Ed Session 2013; in press Clin Lung Cancer
15 Phase II/III trial of Afa7nib with or without Cetuximab in 1 st line therapy of EGFR- mutated NSCLC (S1403) Stage IIIB- IV NSCLC with EGFR muta>on 1 st Line EGFR TKI naive R A N D O M I Z A T I O N Afa>nib* Afa>nib + Cetuximab* *at PD: Biopsy for genomic study & PDX development (selected pa>ents) PD: Progressive Disease PDX: pa>ent- derived xenograv PIs: Lynch, Goldberg, PoliJ
16 Afa>nib + Cetuximab in EGFR- mutated NSCLC refractory to EGFR TKI Why is response T790M- independent? What is the mechanism of ac>on of this combina>on by comparison to Afa>nib alone? Response rate: 30% Clinical What are benefit the (DCR): mechanisms 75% of resistance to this combina>on? Janjigian, Pao et al. ESMO 2012
17 Phase II/III trial of Afa7nib with or without Cetuximab in 1 st line therapy of EGFR- mutated NSCLC (S1403) Stage IIIB- IV NSCLC with EGFR muta>on 1 st Line EGFR TKI naive R A N D O M I Z A T I O N Afa>nib* Afa>nib + Cetuximab* *at PD: Biopsy for genomic study & PDX development (selected pa>ents) - Pilot project for SWOG Trans Sci Ctr PIs: Lynch, Goldberg, PoliJ PD: Progressive Disease PDX: pa>ent- derived xenograv
18 SWOG Transla>onal Science Center: Pilot PDX Project in S1403 SWOG Sta>s>cal Center Jackson Lab (JAX) SWOG Cold Spring Harbor (CSHL) SWOG clinical trials
19 UCD- JAX PDX Plaiorm for Drug Tes7ng in NSG Models: (Fully Established: Clinically & Genomically Annotated) G C A T A C G T G A T G 14 models EGFR Mutant 12 models KRAS Mutant ALK Mutant 2 model Triple WT 14 models from Gandara et al: ECCO- ESMO 2013
20 SWOG Lung Commieee: Innova>on meets the NCTN Transi>on Transforma>ve SWOG S1400 Lung Commieee S1403 Trans- Disciplinary Transla>onal
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