NCCN News

NCCN Collaborates with Pfizer to Improve Provider Performance and Quality in Treatment of Metastatic Breast Cancer

The NCCN Oncology Research Program (ORP) is collaborating with Pfizer Independent Grants for Learning & Change (IGLC) to establish a peer-reviewed grant program to elicit proposals focused on health care provider performance and/or health care quality improvement and education projects. As part of this program, the NCCN ORP and Pfizer will jointly issue a Request for Proposals (RFP), focused on the development and adoption of evidence-based initiatives to improve patient care and outcomes in metastatic breast cancer.

The intent of the RFP is to encourage academic and community-based organizations to submit proposals describing concepts and ideas for design and implementation of programs that address clinical practice gaps and improve the care of patients through increased competence and performance of health care providers and health care systems. It is expected to fund approximately 6 to 8 projects.

“Through this collaboration, NCCN and Pfizer IGLC strive to improve the lives of people with cancer through the advancement of evidence-based treatment recommendations in tandem with enhanced clinician education and supportive care services,” said Robert W. Carlson, MD, Chief Executive Officer, NCCN. “NCCN is grateful for the opportunity to work with Pfizer on this important initiative.”

The NCCN ORP and Pfizer will announce an RFP seeking concepts for initiatives focusing on the following areas where gaps in care currently exist:

  • Provider education and provider/patient treatment shared decision-making
  • Adoption of evidence-based recommendations for management of metastatic breast cancer
  • Information related to patient assistance programs and other patient-centered resources
  • Comprehensive approaches to improving health care delivery systems

The NCCN ORP, organized to obtain funding to support scientifically meritorious research studies at NCCN Member Institutions, will be the lead organization for review and evaluation of applications. A review committee, led by NCCN and including a medical representative from Pfizer, will make decisions on which proposals will receive funding. Grant funding will be provided by Pfizer IGLC.

For more information about NCCN ORP and to view the RFP, visit NCCN.org. To view the RFP, visit http://www.nccn.org/clinical_trials/investigators/rfp/pfizer.aspx.

NCCN Receives $2 Million in Research Funding from Boehringer Ingelheim to Study Targeted Combination Approaches with Afatinib in Lung Cancer

The NCCN ORP has been awarded a $2-million grant from Boehringer Ingelheim Pharmaceuticals, Inc. to develop a program to evaluate scientifically targeted combination approaches with afatinib in the treatment of non–small cell lung cancer (NSCLC).

“Lung cancer accounts for more deaths than any other cancer in men and women in the United States,”1 said Diane E. Paul, MS, RN, Vice President, NCCN ORP. “The ongoing collaboration between NCCN and Boehringer Ingelheim indeed puts NCCN Member Institution investigators at the helm of oncology research with the potential to improve the lives of people with cancer.”

The first phase of the program will involve the establishment of an NCCN Afatinib Request for Proposals Development Team charged with evaluating existing data and defining the data and types of studies necessary to further characterize the safety and clinical effectiveness of afatinib in combination with other targeted agents in NSCLC.

Afatinib is FDA approved under the brand name Gilotrif for the first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. According to Boehringer Ingelheim, approval of afatinib in this indication was based on the primary end point of progression-free survival from the LUX-Lung 3 clinical trial, in which afatinib significantly delayed tumor growth when compared with standard chemotherapy. In addition, afatinib is the first treatment to show an overall survival (OS) benefit for patients with specific types of EGFR mutation–positive NSCLC compared with chemotherapy. A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared with chemotherapy.2,3

The NCCN ORP draws on the expertise of investigators at NCCN Member Institutions and the NCCN Affiliate Research Consortium to facilitate all phases of clinical research. This research is made possible by collaborations with pharmaceutical and biotechnology companies to advance therapeutic options for patients with cancer.

The NCCN ORP will use the grant from Boehringer Ingelheim, Inc. to support investigator-initiated clinical and correlative studies at NCCN Member Institutions and their affiliate community hospitals for afatinib. To date, this successful research model has received approximately $54 million in research grants and supported 125 studies that have produced a number of publications in peer-reviewed journals.

To learn more about NCCN ORP and ongoing clinical trials, visit NCCN.org.

NCCN Policy Summit Explores Challenges in Tissue Allocation

On Monday, June 8, 2015, as part of its Oncology Policy Program, NCCN hosted its Policy Summit: Emerging Issues in Tissue Allocation, at the National Press Club in Washington, DC.

The policy summit was held in response to growing issues of concern for many researchers due, in part, to expanding research interests in precision medicine. The increased demand by pharmaceutical and biotech companies for patient tissue specimens collected for clinical care and trials presents clinical, ethical, and legal issues.

The summit commenced with findings from the NCCN Tissue Allocation Work Group, convened in March 2015 to address areas of concern and establish best practices to address emerging issues around tissue allocation. Daniel Sullivan, MD, Moffitt Cancer Center, and Judith Carrithers, JD, MPA, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, presented the findings of the work group. Dr. Sullivan highlighted the shared goals of stakeholders, which include high-quality samples to serve both diagnostic and research purposes; consistent and standard practices for sample collection, processing, storage and release; and sufficient quantity of tumor sample for all planned uses. Ms. Carrithers emphasized the role of institutional review boards and institutional policies in deciding how tissue gets allocated to different stakeholders. The Tissue Allocation Work Group represented clinicians, pathologists, clinical and translational investigators, industry, patient advocacy groups, and institutional review boards.

Following presentation of the work group's findings, Kenneth Bloom, MD, GE Healthcare, further discussed the need to establish preanalytic standards. Dr. Bloom highlighted the impact biospecimen quality has on both clinical and research outcomes. He went on to describe the National Biomarker Development Alliance's efforts to establish pre-analytical standards and work with the College of American Pathologists (CAP) to implement these standards into CAP accreditation.

Tom Flotte, MD, Mayo Clinic Cancer Center, and Veronique Neumeister, MD, Yale School of Medicine, discussed the tissue practices at their respective academic cancer centers. Dr. Flotte focused on the unique features of Mayo Clinic Cancer Center's pathology department and the frozen section laboratory—every sample is frozen, and the well-designed work flow that allows for very high-quality pathology work to be completed in a controlled time frame. Dr. Neumeister described the organizational structure of the Yale Pathology Tissue Services and emphasized Yale's development of tissue microarrays.

Following the expert presentations, the summit featured 2 roundtable discussions, moderated by Clifford Goodman, PhD, The Lewin Group, the first of which facilitated deliberation about diagnostic, clinical, and research concerns. Panelists for the first roundtable included Carlos Arteaga, MD, American Association for Cancer Research; Phil Branton, MD, College of American Pathologists; Jeffrey W. Clark, MD, Massachusetts General Hospital Cancer Center; Marisa Dolled-Filhart, PhD, Merck; Dr. Flotte; and Roslyn Meyer, PhD, Yale University School of Medicine. Key takeaways from this discussion included the concept that poor quality of biospecimens can hinder innovation, preanalytic standards are highly desirable for all stakeholders, and cost will be the major hindrance to implementing preanalytic standards across both community and academic centers.

During the second and final panel discussion, Ms. Carrithers; Anitra Engebretson, Pancreatic Cancer Action Network; Hank Greely, JD, Stanford Law School; and Nadia Haque, PhD, Genentech, analyzed regulatory, policy, ethical, and patient concerns around tissue allocation. The group touched on the informed consent process and whether it is meeting the needs of patients, researchers, or industry partners. The overall consensus was that there is room for improvement. Specimen ownership, intellectual property ownership, and financial benefit of discoveries were all points of discussion for the group.

Recommendations for best practices and standards in tissue allocation, based on findings from the work group and policy summit, will be formulated and published as a White Paper in JNCCN in the fall of 2015. A full summary of the policy summit will be available in the summer of 2015 on NCCN.org.

References

  • 1.

    Cancer Facts & Figures 2015. American Cancer Society. Available at: http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2015/. Accessed June 29, 2015.

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  • 2.

    Yang JC, Wu YL, Schuler M. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol 2015;16:141151.

    • Search Google Scholar
    • Export Citation
  • 3.

    Boehringer Ingelheim Pharmaceuticals, Inc. Gilotrif prescribing information. Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Gilotrif/Gilotrif.pdf

    • Search Google Scholar
    • Export Citation

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  • 1.

    Cancer Facts & Figures 2015. American Cancer Society. Available at: http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2015/. Accessed June 29, 2015.

    • Search Google Scholar
    • Export Citation
  • 2.

    Yang JC, Wu YL, Schuler M. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol 2015;16:141151.

    • Search Google Scholar
    • Export Citation
  • 3.

    Boehringer Ingelheim Pharmaceuticals, Inc. Gilotrif prescribing information. Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Gilotrif/Gilotrif.pdf

    • Search Google Scholar
    • Export Citation

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