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NCI’s Precision Medicine Initiative for Oncology – Operationalizing PublicPrivate Partnerships Jeffrey S. Abrams M.D. Associate Director, CTEP, DCTD Acting Director for Clinical Research, DCTD National Cancer Institute, NIH AACR Genomics In Clinical Medicine Think Tank July 13-14, 2016 NCTN as a Network in the Era of Precision Medicine LAPS Activated: • Lung-MAP (S1400) – led by SWOG • ALCHEMIST (A151216) – led by Alliance and ECOG-ACRIN • Exceptional Responders (9671) – open in NCTN and beyond • NCI MATCH –led by ECOG-ACRIN In development: • NCI Pediatric MATCH – led by COG … It takes a network … NCI National Clinical Trials Network 2 Key Aspects of NCI Precision Medicine Trials Single IND – multiple company partners working together within NCI IP agreement framework Public- private partnerships to extend the trials’ reach (FNIH, FOCR, Companies) Biopsies, NGS & other diagnostic tests paid for either by NCI or by company partners – trials are very expensive New educational issues for clinicians and patients – significance of diagnostic tests – somatic (variants, allelic fraction) and germline Correlative science: cfDNA, whole exome/genome, RNA seq NCI Precision Medicine Trials: Lessons Learned Multi-Lab Concordance for NGS testing is achievable Assay turnaround time is adequate Biopsies from sites nationwide are feasible Central IRB is a critical component Pre-screening is valuable Multiple arms can be difficult to manage when new data intrudes Adjuvant studies of rare variants are challenging NCI’s Early Therapeutics Clinical Trials Network (ETCTN) 5 NCI-Designated Cancer Centers (clinical) (Red= clinical centers gaining ETCTN opportunity under new program) 6 Recently developed NCI IND agents Agents that have achieved FDA approval based in part on early development in CTEP collaborative early phase programs Bortezomib- Mantle Cell Lymphoma Ipilumumab- Melanoma Lenalidomide and bortezomib- Multiple Myeloma Romidepsin- Peripheral T cell Lymphoma Sorafenib- Thyroid Cancer Ziv-aflibercept- Colorectal Cancer Dinutuximab (ch14.18)- Neuroblastoma Pending FDA approval Nivolumab – Anal and Nasopharyngeal Cancer Pembrolizumab – Merkel Cell, Mycosis Fungoides In pivotal trials based on development in CTEP program Cediranib and Oliparib- Ovarian Cancer Selumetinib- Uveal Melanoma 7 Molecularly Targeted Combinations: Accrual Data Active Studies 2011-2016: 263 97 Investigational/Investigational 127 Investigational/Commercial 39 Commercial New indication 29 Trials in review using investigational combinations Total Accrual: 11,432 across all histologies (phase 1, phase 2, and pilot studies only – ETCTN and Cooperative Group Network) NCI /Cancer Therapy Evaluation Program (CTEP) 8 NCI Drug Formulary Initiative: Industry-NCI/CTEP-Investigator Agreements Common Data Sharing and IP Option Agreement Language Funding Agreement/Protocol Language or MTA (for non-clinical studies) Simplified CRADA Agreement Institutions Collaborator A Investigational Agent A Collaborator B Investigational Agent B NCI/DCTD Network Groups Consortia • Agreements encompass multiple trials/studies of mutual interest • Framework accepted by Collaborators and Cancer Centers NCI /Cancer Therapy Evaluation Program (CTEP) 9 Recommendations What is the threshold (of rarity) that defines the need for national scale investigation (NCTN or private sector)? Nationwide screening effort is needed to find molecular subtype – new cost sharing structure seems necessary (gov’t, industry, philanthropy) Central IRBs are critical for multi-arm studies and for studies of rare diseases – system depends on volunteers Multiple agents are available for the target – Medical system needs a “bake-off” study to rationalize care NCI /Cancer Therapy Evaluation Program (CTEP) 10