Introduction: The Unpredictable Nature of the Fight
For Kelly Shanahan, M.D., President of METAvivor, the fight against metastatic breast cancer (MBC) is as volatile as the weather in her home in Lake Tahoe. "I’m watching snow fall outside my office window while only two days ago it was 70 degrees," she notes. "It’s a lot like life with MBC—things can change on a dime."
This metaphor underscores the broader landscape of metastatic cancer research: a field characterized by rapid shifts, the urgency of patient advocacy, and the constant, uphill battle to secure funding. As Dr. Shanahan outlines in her latest presidential update, the organization is currently navigating a period of unprecedented demand for research grants, high-stakes clinical conferences, and a complex regulatory environment.
The Research Landscape: A Surge in Demand
Unprecedented Grant Interest
The METAvivor Scientific Advisory Board (SAB) recently concluded its review of 200 letters of intent (LOIs) for the current grant cycle. This figure represents a doubling of submissions compared to previous years, a trend that reflects both the evolving science of metastasis and the growing uncertainty surrounding federal research funding.
Dr. Stuart Martin, a long-time member of the SAB, highlighted the critical nature of these efforts: "METAvivor is doing outstanding work to help metastasis research keep moving forward during this especially challenging time for research."
The Call for Reviewers and Funding
With the surge in LOIs, the next phase involves narrowing the field to the most impactful, innovative proposals. These submissions will undergo a rigorous dual-review process, involving both scientific experts and Patient Advocate Reviewers (PARs).
METAvivor is currently issuing an urgent call to action for:
- Subject Matter Experts: Scientists with experience in oncology and metastasis research.
- Patient Advocates: Individuals with personal or professional experience in MBC who can provide the patient-centric lens necessary to ensure research targets outcomes that matter most to those living with the disease.
- Financial Support: As federal funding remains precarious, the organization continues to rely heavily on private donations to ensure that no promising research project is sidelined due to a lack of resources.
Chronology of Advocacy: From ASCO to the Global Stage
The upcoming months are packed with high-level advocacy efforts designed to integrate the patient voice into the highest echelons of oncological research.
ASCO 2024: Elevating the Patient Voice
The American Society of Clinical Oncology (ASCO) conference in Chicago represents the "Super Bowl" of the cancer world—a space that Dr. Shanahan describes as "massive, overwhelming, exhausting, and exhilarating."
On May 31, Dr. Shanahan will take the main stage for a pivotal session titled "Elevating the Patient Voice: Choosing the Right Patient-Centered Endpoints in Modern Clinical Trials." Her 12-minute presentation, "How to design trials that are meaningful to people with cancer," will focus on the necessity of direct patient feedback in trial design. Referencing the iconic mantra of the Spice Girls—"Yo, I’ll tell you what I want, what I really, really want"—she plans to emphasize that clinical trial success should not be measured solely by tumor shrinkage, but by the tangible, meaningful improvements in the daily lives of patients.
Global Cancer Consortium: Building a Bigger Table
Following ASCO, Dr. Shanahan will travel to Minnesota in mid-June to address the Hormel Institute’s Global Cancer Consortium. The focus here remains on the same core message: "Building a bigger table."
Dr. Shanahan continues to urge researchers to pull up a seat for patients, positioning them as the ultimate experts in living with metastatic disease. She will be joined by METAvivor’s "OG" grant recipient and SAB member, Dr. Danny Welch, who is slated to deliver a keynote address on the biological hallmarks of metastasis, ensuring that METAvivor remains a prominent voice in the scientific discourse.
Supporting Data: Navigating the Regulatory Labyrinth
The ODAC Debate
A significant point of recent tension involves the FDA’s Oncologic Drugs Advisory Committee (ODAC) and the regulatory pathway for new breast cancer therapies. METAvivor recently weighed in on the committee’s decision regarding camizestrant.
In a recent episode of the Live from Stage 4 podcast—a platform dedicated to "news for us, by us"—Dr. Shanahan and board members Janice Cowden and Lynda Weatherby dissected the FDA’s decision not to recommend an investigational switch from an AI + CDK4/6 inhibitor to camizestrant in cases of ESR1 mutation before imaging shows disease progression.
The issue is nuanced. While the European Medicines Agency (EMA) has leaned toward approval based on the SERENA-6 trial, the FDA remains in a state of extended review. This disparity highlights the need for international alignment on how emerging technologies and diagnostic markers should influence regulatory approvals. METAvivor plans to host follow-up discussions featuring leading oncologists to explore how regulatory bodies can better incorporate real-time data into their decision-making processes.
Recent FDA Wins: A Landscape of Hope
Despite the regulatory hurdles, May 2024 brought significant momentum for the MBC community:
- Veppanu (vepdegestrant): Approved for ER+, HER2- MBC patients presenting with an ESR1 mutation.
- Datroway (datopotamab deruxtecan/dato-DXd): Received approval as a first-line treatment for metastatic Triple-Negative Breast Cancer (TNBC) patients who are ineligible for immunotherapy.
- Enhertu (trastuzumab deruxtecan): The FDA expanded its indications to the early-stage HER2+ setting, a move designed to lower the risk of these patients ever progressing to the metastatic stage.
These approvals represent more than just new drugs; they represent a fundamental shift toward precision medicine, where specific genetic mutations—like ESR1—are matched with targeted therapies rather than broad, one-size-fits-all chemotherapy regimens.
Implications: Why the Patient Voice Matters
The central implication of METAvivor’s current agenda is that the "patient voice" is no longer a peripheral sentiment—it is a functional requirement for modern oncology.
Meaningful Endpoints
By advocating for "patient-centered endpoints," METAvivor is challenging the status quo. For decades, trials were designed by researchers for researchers, often prioritizing Overall Survival (OS) or Progression-Free Survival (PFS) without adequately accounting for the quality-of-life trade-offs that come with aggressive treatments.
When a patient says, "I want to be able to walk my daughter down the aisle," or "I want to work without debilitating nausea," they are defining endpoints that clinical trials must respect. By insisting on these measures, METAvivor is forcing a rethink of what "success" looks like in the clinical laboratory.
The Power of Community-Led Media
The Live from Stage 4 podcast has emerged as an essential tool for patient empowerment. By translating complex FDA decisions and clinical trial data into accessible, "by us, for us" content, the organization is bridging the information gap. This ensures that the patient community is not just a passive recipient of medical decisions, but an active participant in the advocacy cycle.
Conclusion: The Road Ahead
As Dr. Shanahan heads from the ASCO stage to Nashville for her own clinical trial scans, the duality of her position is clear: she is both a leader of the movement and a patient in the thick of it.
The progress made in May serves as a reminder that while the road is long, the velocity of innovation is increasing. However, as the number of grant applications and the complexity of regulatory debates demonstrate, the need for sustained, informed, and aggressive advocacy has never been greater.
METAvivor’s mission remains anchored in the belief that through collaboration between scientists, regulators, and the individuals living with the disease, the "snowfall" of unpredictability can be managed. By building a bigger table, the organization ensures that the experts in living with cancer are the ones helping to steer the research that will ultimately save their lives.
As the year progresses, the focus will remain on these three pillars:
- Funding the most promising research through rigorous, patient-informed grant reviews.
- Influencing the regulatory process by ensuring the patient perspective is embedded in FDA and EMA decision-making.
- Empowering the community through high-quality education and advocacy.
The fight is, as ever, a marathon—but with every new drug approval and every seat pulled up to the table, the finish line comes into sharper focus.
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