Researchers Receive Grants from NCCN Oncology Research Program Funded through Boehringer Ingelheim

The National Comprehensive Cancer Network^® (NCCN^®) Oncology Research Program (ORP) recently awarded five research grants to investigators following a review of proposals submitted in response to the NCCN Afatinib Request for Proposals. These grants were made possible through a $2-million research grant from Boehringer Ingelheim Pharmaceuticals, Inc. to scientifically evaluate and define the clinical effectiveness of its investigational compound, afatinib, in solid tumors, including breast, non-small cell lung (NSCLC), and head and neck cancers.

FORT WASHINGTON, Pa.--(BUSINESS WIRE)--The National Comprehensive Cancer Network^® (NCCN^®) Oncology Research Program (ORP) recently awarded five research grants to investigators following NCCN ORP Scientific Review Committee analysis of proposals submitted in response to the NCCN Afatinib Request for Proposals. These grants were made possible through a $2-million research grant from Boehringer Ingelheim Pharmaceuticals, Inc. to scientifically evaluate and define the clinical effectiveness of afatinib (BIBW 2992) in solid tumors, including breast, non-small cell lung (NSCLC), and head and neck cancers.

“Phase I Study of Induction Chemotherapy with Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage III/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC)”

“NCCN ORP is pleased to announce the funding of five new afatinib investigator-initiated clinical research studies to be conducted at NCCN Member Institutions,” said Diane Paul, MS, RN, Vice President, ORP at NCCN. “These five new studies add to the more than 60 studies that are currently enrolling through the NCCN Oncology Research Program. These studies, conducted by NCCN Member Institutions, not only create opportunities for patients to participate in important clinical research, but also make scientific discoveries more attainable. We are grateful for the support from Boehringer Ingelheim to make these research opportunities possible.”

Afatinib is an investigational oral, once-daily irreversible ErbB Family Blocker that specifically inhibits epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2) and ErbB4. It is currently in Phase III clinical development in NSCLC, head and neck and breast cancers. Afatinib (BIBW 2992) is not approved by the FDA; its safety and efficacy have not been established.

The following proposals for afatinib have been awarded funding:

• Matthew Fury, MD, PhD, Memorial Sloan-Kettering Cancer Center, “Phase I Study of Induction Chemotherapy with Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage III/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC)”
• Mark Kris, MD, Memorial Sloan-Kettering Cancer Center, “A Feasibility Trial of Afatinib + Chemoradiation (CRT) in Patients with EGFR-Mutated Locally Advanced, Unresectable Lung Cancers”
• Danielle Margalit, MD, MPH, Dana-Farber/Brigham and Women’s Cancer Center, “Phase I Study of Afatinib with Postoperative Radiation Therapy for Intermediate and High Risk Squamous Cancer of the Head and Neck (SCCHN)”
• Shanthi Marur, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, “Phase I/II Study of Afatinib/Carboplatin/Paclitaxel Induction Chemotherapy Followed by Standard Chemoradiation in HPV Negative Locally Advanced Stage III/Iva/IVb HNSCC”
• Lecia Sequist, MD, MPH, Massachusetts General Hospital Cancer Center, “A Randomized Phase II Study Comparing Concise versus Prolonged Afatinib as Adjuvant Therapy for Stage I-III NSCLC with EGFR Mutation”

The awardees responded to a Request for Proposals issued by the NCCN ORP to the 21 NCCN Member Institutions. Submissions were peer reviewed by the NCCN Afatinib Scientific Review Committee. The awardees were selected based on several key criteria, including scientific merit, existing data, and the types of studies necessary to further evaluate the activity of afatinib.

The NCCN ORP is organized to obtain funding to support scientifically meritorious research projects at NCCN Member Institutions. Policies and standards for the program were set by the NCCN Investigator Steering Committee, a group comprised of senior research physicians appointed by each NCCN Member Institution. The NCCN ORP has received more than $36 million in research grants from major pharmaceutical companies to support investigator-initiated trials. These trials explore new venues of clinical investigation that answer important scientific questions. Studies evaluate combinations and sequencing regimens of drugs, drug resistance, mechanisms of action of specific agents, or explore extended uses for scientific agents.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network^® (NCCN^®), a not-for-profit alliance of 21 of the world’s leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives.

The NCCN Member Institutions are: City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Memorial Sloan-Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children’s Research Hospital/University of Tennessee Cancer Institute, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; UNMC Eppley Cancer Center at The Nebraska Medical Center, Omaha, NE; The University of Texas MD Anderson Cancer Center, Houston, TX; and Vanderbilt-Ingram Cancer Center, Nashville, TN.

Clinicians, visit NCCN.org. Patients and caregivers, visit NCCN.com.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.

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