Introduction: The Unpredictable Nature of MBC
For Kelly Shanahan, M.D., the President of METAvivor, life with metastatic breast cancer (MBC) is a study in constant flux—much like the mercurial weather in her home of Tahoe, where 70-degree spring warmth can give way to a sudden winter snowstorm in a matter of hours. This inherent instability is not just a personal reality for those living with the disease; it is the driving force behind the global research agenda. As the medical community navigates a complex year of regulatory decisions, scientific breakthroughs, and the ever-present need for patient-centered advocacy, the mandate remains clear: to keep the momentum of metastasis research moving forward despite a challenging economic and political climate for federal research funding.
The State of Research: A Surge in Grant Interest
The most significant indicator of the current research climate is found in the numbers reported by the METAvivor Scientific Advisory Board (SAB). During the most recent grant cycle, the organization received 200 Letters of Intent (LOIs). This figure represents a doubling of the usual volume, a trend observed for the second consecutive year.
Dr. Stuart Martin, a long-time member of the SAB, notes that this surge reflects the increasing difficulty researchers face in securing federal dollars. "METAvivor is doing outstanding work to help metastasis research keep moving forward during this especially challenging time for research," says Dr. Martin.
The Review Process and the Need for Expertise
With the sheer volume of applications, the pressure to select the most impactful, transformative research is higher than ever. The selection process involves a two-tiered approach:
- Initial Filtering: The SAB reviews LOIs to identify the most promising, high-impact concepts.
- Full Application Review: The most exciting proposals are invited for a full application. These are then rigorously evaluated by both scientific experts and Patient Advocate Reviewers (PARs).
METAvivor is currently issuing a call to action for the medical and patient communities. The organization is actively seeking both scientists and patient advocates to serve as reviewers. As Dr. Shanahan emphasizes, the success of these research initiatives is inextricably linked to funding. With the cost of high-level oncology research skyrocketing, the organization continues to rely heavily on private donations to fill the gap left by fluctuating federal support.
Chronology of Upcoming Advocacy and Scientific Engagement
The calendar for the remainder of the first half of the year is packed with critical milestones, highlighting the intersection of patient experience and high-level medical strategy.
- May 31 (Chicago): Dr. Shanahan is scheduled to take the stage at the American Society of Clinical Oncology (ASCO) annual meeting—the preeminent oncology conference. Her presentation, "How to design trials that are meaningful to people with cancer," will focus on the necessity of integrating the patient voice into clinical trial design. Her approach, which jokingly references the Spice Girls’ "what I really, really want," underscores a serious point: trials are often designed with endpoints that are statistically significant but clinically irrelevant to the daily lives of patients.
- Mid-June (Minnesota): Following ASCO, the focus shifts to the Hormel Institute’s Global Cancer Consortium. Here, Dr. Shanahan will continue her advocacy for "building a bigger table," urging researchers to treat patients as the primary experts in living with the disease. Dr. Danny Welch, a seminal figure in metastasis research and an SAB member, will provide the keynote address on the hallmarks of metastasis, ensuring that the patient-centric message of METAvivor is underscored by foundational science.
Supporting Data: Regulatory Hurdles and Drug Approvals
The regulatory landscape remains a primary concern for the MBC community. A recent, highly publicized case involving the Oncologic Drugs Advisory Committee (ODAC) of the FDA highlights the friction between regulatory caution and the urgent need for new therapies.
The Camizestrant Debate
The ODAC recently voted not to recommend the approval of a switch strategy—moving from an AI + CDK4/6 inhibitor to an investigational drug, camizestrant + the same CDK4/6 inhibitor, upon the detection of an ESR1 mutation, even before imaging shows clinical progression.
The debate revolves around the incorporation of new technology into regulatory frameworks. While the European Medicines Agency (EMA) has recommended the approval of camizestrant based on the SERENA-6 trial, the FDA remains in a period of extended review. This disparity creates a "regulatory gap" that leaves patients questioning why evidence deemed sufficient in Europe is still undergoing intense scrutiny in the United States.
Recent FDA Wins
Despite the hurdles, May brought a wave of positive news that serves as a beacon of hope for patients:
- Veppanu (vepdegestrant): Approved for ER+, HER2- MBC with an ESR1 mutation, offering a targeted option for a specific, difficult-to-treat genetic profile.
- Datroway (datopotamab deruxtecan): Approved as a first-line treatment for patients with metastatic Triple-Negative Breast Cancer (TNBC) who are ineligible for immunotherapy.
- Enhertu (trastuzumab deruxtecan): The FDA expanded the indications for this drug into the early-stage HER2+ setting. By treating earlier, the clinical goal is to reduce the risk of progression to the metastatic stage, effectively "nipping the disease in the bud."
Implications for the Patient Community
The overarching theme of these developments is the necessity of "news for us, by us." Initiatives like the Live from Stage 4 podcast series have become essential lifelines. These episodes provide a space where board members—such as Janice Cowden and Lynda Weatherby—can break down complex regulatory decisions for the patient community, transforming dry FDA transcripts into understandable, actionable information.
The implication of this advocacy is profound: the patient is no longer a passive recipient of treatment, but an active stakeholder in the drug development process. When patients push for better-designed trials and more meaningful endpoints, they change the trajectory of oncology research.
Official Responses and Future Outlook
As the community looks toward the second half of the year, the atmosphere is one of cautious optimism. The research being presented at ASCO and other global forums suggests that while the metastatic environment is challenging, the pipeline is more robust than it has been in decades.
Dr. Shanahan’s personal journey—balancing the demands of national leadership with her own clinical trial participation—serves as a poignant reminder of what is at stake. As she prepares to fly from the intensity of the ASCO conference to Nashville for her own secondary scans, the message to the METAvivor community is twofold: keep pushing for access and innovation, and maintain the collective hope that the science is, at last, catching up to the urgency of the need.
The focus for the coming months will remain on:
- Expanding Access: Ensuring that new drugs like Veppanu and Datroway reach the patients who need them most without unnecessary administrative delays.
- Bridging the Gap: Continuing the dialogue between the FDA and the patient community regarding the use of circulating tumor DNA and other markers in clinical trials.
- Scientific Sustainability: Encouraging the philanthropic community to sustain the influx of research funding that has allowed METAvivor to double its grant review capacity.
In the words of those on the front lines, the table is getting bigger. The challenge for the rest of the year is ensuring that the seats at that table are occupied by those who are best equipped to turn research into survival.
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