In 2016, the Breast Cancer Research Foundation (BCRF) launched the Drug Research Collaborative, a program the foundation developed to bridge the gap between academic investigators and their access to therapies under investigation and to encourage greater academia-driven research in breast cancer. The program was initially funded by a $15 million grant from Pfizer and included unique access to 16 of the pharmaceutical company’s portfolio of U.S. Food and Drug Administration–approved oncology drugs as well as therapies in development.
The nonprofit-academic-industry collaboration resulted in nine promising research projects investigating Pfizer oncology drugs in both early-stage and metastatic breast cancers. Three of the projects are multi-institution phase II trials testing novel combinations of drugs to combat therapy resistance, new immunotherapy combinations, and ways to optimize patient selection. The remaining six projects are laboratory studies.
Earlier this year, the Breast Cancer Research Foundation announced a new collaborative research effort funded by Pfizer and its development partner, Astellas Oncology, to investigate the role of the androgen receptor in metastatic breast cancer and the effectiveness of the androgen-receptor inhibitor enzalutamide (Xtandi) in men with castration-resistant prostate cancer.
I’m hoping this industry-academia-foundation partnership will become a new model for how academia‑driven research, both in the laboratory and in the clinic, is designed—not just in breast cancer, but in all cancers.— Larry Norton, MD
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“The goal of this partnership is to productively bring together leaders from industry and academia in a novel way. The intention is to augment innovation by leveraging the expertise and imagination of all involved: academic freedom meets industrial knowledge as well as products. Our hope is that this new model will not only lead to better treatments for breast cancer but will inform new approaches to biomedical clinical research in general,” said Larry Norton, MD, Senior Vice President, Office of the President; Medical Director of the Evelyn H. Lauder Breast Center; and Scientific Director of the Breast Cancer Research Foundation.
The ASCO Post talked with Dr. Norton about how collaborations among academia, the pharmaceutical industry, and nonprofit organizations have the potential to accelerate breast cancer research.
Returning Innovation to Researchers
How is the Drug Research Collaborative helping bridge the knowledge gap between academia and industry to spur new drug development for metastatic breast cancer?
The concept of pharmaceutical companies transferring the design of investigator-initiated clinical trials to foundations such as ours is a major advance in cancer research, because it returns a lot of the creative energy to the investigators. For most of the history of oncology research, the creative energy to develop clinical trial design came from academia, and industry would cooperate with those efforts by supplying funding and drugs for the trials. More recently, there has been a shift away from that paradigm to where it is more common to have clinical studies designed by industry, and the academic investigators are participants in those studies but not in how the trials are designed.
What we are doing is pioneering a research model that encourages a shared effort between industry and academia in a constructive way to design clinical studies that advance therapies for breast cancer, because imagination and creativity are extremely important parts of medical progress.
Determining the Role of the Androgen Receptor in Breast Cancer
The new collaboration between the Breast Cancer Research Foundation and Pfizer/Astellas will provide funding to research the androgen antagonist enzalutamide in androgen receptor–positive breast cancers. What role does the androgen receptor play in the development of breast cancer?
The majority of hormone receptor–positive breast cancers express the androgen receptor, as do many HER2-positive tumors and about one-third of triple-negative tumors, so it is common to find that estrogen-dependent tumors are also androgen-dependent. It makes sense that targeting the androgen receptor in breast cancer could have a significant benefit for patients. A number of clinical trials now underway are targeting the androgen receptor, as well as studies investigating androgen receptor biomarkers and androgen receptor–mutation analyses to help determine which patients might benefit most from androgen antagonists like enzalutamide.
This past year, the Breast Cancer Research Foundation convened a meeting of leading breast cancer experts from around the world to discuss how clinical investigation could improve our understanding of the role androgen-receptor inhibition plays in breast cancer. We are working out the details of the grant proposal review process, and we expect to select the final proposals from researchers by the end of this year.
I’m not going to presuppose what the proposals are going to be, because I want to see what we receive in terms of how imaginative they are, but, generally, our plan is to fund research in the biology of androgen-receptor breast cancers and how to target treatment optimally for each patient.
Developing a New Model for Cancer Research
Will the clinical trials be open to both men and women with androgen-receptor metastatic breast cancers?
It is possible we will get proposals that will include studies in men with breast cancer. We are throwing the door wide open to all ideas, and we will then go through the process of picking the best ones for research. I have my own ideas about what areas of research I’d like to see funded, but I don’t want to impose them on the process, because I want my community to have as much creative leeway in the development of these studies as possible.
I’m hoping this industry-academia-foundation partnership will become a new model for how academia-driven research, both in the laboratory and in the clinic, is designed—not just in breast cancer, but in all cancers. We have to harness the creativity, imagination, and innovation that are fostered in the academic setting and engage them in clinical and translational research in a way that augments the productivity and effectiveness of our current systems of trial design. ■
DISCLOSURE: Dr. Norton reported no conflicts of interest.