Guest Column | November 21, 2023

How Pfizer Prioritizes Diversity When Implementing Multiple Myeloma Trials

By Dany Habr, MD, Oncology Chief Medical Affairs Officer, Pfizer

Cancer patient consulting with doctor-GettyImages-1217056000

“We only hear Black men’s stories when they’re dead or dying. But what about stories of living?”

These were the shattering words one patient shared with our multiple myeloma (MM) team at Pfizer when describing how overlooked he felt while coping with MM. Sadly, this man’s experience is far from rare.

Too many people living with MM experience the same feeling of being overlooked by our healthcare system, particularly within communities of color. Despite being disproportionately affected by the disease, many Black individuals in the U.S. struggle to gain access to the latest advancements in treatment and have fewer opportunities to participate in research, like joining a clinical trial.1-3 We cannot improve the standard of care in MM when so many patients’ needs and experiences aren’t taken into account.

Racial Disparities In Multiple Myeloma

Study after study has revealed a troubling pattern: MM disproportionately impacts Black individuals, with the impact magnified in older people.3-5 

To understand the extent of the problem, Pfizer’s Didem Aydin, MD, PhD, global medical director of multiple myeloma, recently co-authored a systemic review of global health disparities among MM patients.6 Multiple studies included in the review found that Black individuals are more likely than white individuals to be diagnosed with MM, and they are typically younger at disease onset, even though MM is usually most prevalent in patients ages 65 and up.7 This leads to further disparities, as Black patients — along with members of the Hispanic community — often face delayed diagnosis and tend to have decreased access to MM treatment compared to white individuals, especially as they age.8

We’ve also seen that these underserved yet disproportionately impacted populations are the least likely to be enrolled in MM clinical trials. There’s a clear need to demonstrate that treatments are safe and effective for people of color and provide them with rapid access to the latest innovations in care. The enrollment-incidence ratios for MM trials — meaning the number of people actually enrolled compared to those “expected” to be enrolled based on the demographics of the disease — are as low as 21% for Black and 4% for Hispanic patients.9 The enrollment-mortality disparity for these populations is equally high. Another analysis found that out of 2,896 newly diagnosed MM patients from nine national clinical trials, only 18% of participants were non-white.10 It’s especially troubling that such disparities appear to have increased over time and are more prominent in industry-sponsored trials.11

Diversifying MM Clinical Trials

Oncology researchers have a key role to play in addressing these systemic disparities8 and it starts with clinical trial design. Ensuring people of color are appropriately represented in clinical trials is the first step toward providing better medicines and innovative solutions that improve outcomes for all.

This responsibility was top-of-mind for my team when Pfizer set out to launch MagnetisMM, a series of inclusive-by-design clinical trials examining the efficacy of an investigational humanized B-cell maturation antigen (BCMA)-bispecific antibody as a potential treatment for MM. To ensure the trials were inclusive, we knew we needed to take a completely different approach to our clinical trial program, from design to recruitment. While we still have a lot of work ahead of us, I am sharing our approach and learnings in order to continue this important dialogue on how industry can better embed diversity, equity, and inclusion into clinical trials in MM and beyond.12

  • Trial Design: To build more geographically and culturally accessible trials, our initial step was bringing all the right voices to the table, including patients and investigators. We leveraged detailed demographic and epidemiological data that helped us determine investigators and sites, to help ensure representation of Black participants. Our clinical development team also worked closely with our field-based medical directors, who provided on-the-ground insights that informed site selection decisions.
  • Recruitment: Throughout the process, we collaborated closely with investigators at each site and held open forums with patient advocacy and community partners. We also enlisted the help of community navigators who could build trust with patients and assist them through enrollment logistics and ensuring there was sufficient understanding of the process. We also focused on meeting participants where they are, not just in their physical communities but also online as well. For example, we utilized social media to raise awareness of what people can expect when participating in a clinical trial, including patients’ experiences and safety protocols.
  • Community Education and Engagement: We knew we needed to build awareness and trust within the communities where we established trial sites, and improving health literacy was an important step.13 Ensuring that potential participants in the MagnetisMM clinical trial program were fully informed with accurate, culturally sensitive, and actionable information required both the right messengers and the right messaging. We partnered with community organizations and local healthcare providers who were closest with their communities’ cultural needs and backgrounds, who helped us reach potential patients with education on MM and information about participating in a clinical trial.  We also worked to share this information at a national level through collaborations with the Multiple Myeloma Research Foundation (MMRF) Black Community Education Program and the Leukemia and Lymphoma Society (LLS) Myeloma Link Program. We also worked hand-in-hand with MM patients as we developed and designed content for our clinical trials website, to ensure we were meeting patients’ needs.

The Path Forward For More Inclusive Research

To proactively address issues of clinical trial diversity, Pfizer refers to a framework for setting diversity enrollment goals across a number of therapeutic areas. It helps to ensure clinical trials represent the populations most affected by specific diseases, whether it’s due to genetics, barriers to care, or both — including people of color, older adults, rural communities, and individuals with lower socioeconomic status.14 We are applying the same community-based approach used in the MagnetisMM program to build strong relationships with participants and investigators. We are also investing in technologies, like telehealth, flexible sample collection, and remote trial monitoring, to further remove barriers to participation by making trials more decentralized.

Every patient deserves the chance to feel seen, heard, and prioritized in research and care — and for Black individuals with multiple myeloma, it’s a matter of urgency. We need more stories of survival, but in order to achieve that, patient communities need access to the best available treatment options and experience the best possible outcomes. It’s up to us — the medical research community — to work together throughout the healthcare ecosystem to make this possible by developing more innovative approaches to inclusive research and accessible care.

References:

  1. Harris Y, Gorelick PB, Samuels P, Bempong I. Why African Americans may not be participating in clinical trials. J Natl Med Assoc. 1996 Oct;88(10):630-4. PMID: 8918067; PMCID: PMC2608128.
  2. Sikander Ailawadhi, Kejal Parikh, Safiya Abouzaid, Zhou Zhou, Wenxi Tang, Zoe Clancy, Claudia Cheung, Zheng-Yi Zhou, Jipan Xie, Racial disparities in treatment patterns and outcomes among patients with multiple myeloma: a SEER-Medicare analysis, Blood Advances. Volume 3, Issue 20, 22 October 2019, Pages 2986-2994. https://doi.org/10.1182/bloodadvances.2019000308.
  3. Myeloma – Cancer Stat Facts. (n.d.). SEER. https://seer.cancer.gov/statfacts/html/mulmy.html
  4. Waxman, A. J., Mink, P. J., Devesa, S. S., Anderson, W. F., Weiss, B. M., Kristinsson, S. Y., McGlynn, K. A., & Landgren, O. (2010). Racial disparities in incidence and outcome in multiple myeloma: a population-based study. Blood, 116(25), 5501–5506. https://doi.org/10.1182/blood-2010-07-298760.  
  5. AACR Cancer Disparities Progress Report. American Association for Cancer Research. https://cancerprogressreport.aacr.org/disparities/cdpr22-contents/cdpr22-disparities-in-clinical-research-and-cancer-treatment/
  6. Mateos MV, Ailawadhi S, Costa, LJ, et al. Global disparities in patients with multiple myeloma: a rapid evidence assessment. Blood Cancer J. 13, 109 (2023). doi:10.1038/s41408-023-00877-9.
  7. Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j.seminoncol.2016.11.004
  8. Ailawadhi S, Parikh K, Abouzaid S, Zhou Z, Tang W, Clancy Z, Cheung C, Zhou ZY, Xie J. Racial disparities in treatment patterns and outcomes among patients with multiple myeloma: a SEER-Medicare analysis. Blood Adv. 2019 Oct 22;3(20):2986-2994. doi: 10.1182/bloodadvances.2019000308. PMID: 31648322; PMCID: PMC6849958.
  9. Loree JM, Anand S, Dasari A, et al. Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018. JAMA Oncol. 2019; 5(10):e191870. doi:0.1001/jamaoncol.2019.1870.
  10. Ailawadhi S, Jacobus S, Sexton R, et al. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018; 8(7):67. doi:10.1038/s41408-018-0102-7.
  11. Unger JM, Hershman DL, Osarogiagbon RU, et al. Representativeness of Black patients in cancer clinical trials sponsored by the National Cancer Institute compared with pharmaceutical companies. JNCI Cancer Spectr. 2020; 4:pkaa034. doi:10.1093/jncics/pkaa034.
  12. Habr D, Corsaro M. Reimagining diversity in multiple myeloma clinical trials. Hematol Oncol. 2022;40(4):689-694. doi:10.1002/hon.2997.
  13. Habr D, Wolf Gianares B, Schuler KW, Chari D. Patients at the Heart of the Scientific Dialogue: An Industry Perspective [published correction appears in Oncol Ther. 2023 Feb 7;:]. Oncol Ther. 2023;11(1):15-24. doi:10.1007/s40487-023-00220-z
  14. Habr D, McRoy L, Papadimitrakopoulou VA. Age Is Just a Number: Considerations for Older Adults in Cancer Clinical Trials. J Natl Cancer Inst. 2021;113(11):1460-1464. doi:10.1093/jnci/dja

About the Author:

Dany Habr is senior vice president and oncology chief medical affairs officer at Pfizer, overseeing the oncology portfolio and medical organization. He has co-authored over 44 manuscripts and more than 80 abstracts in the fields of hematology-oncology and health equity and has presented this work at major medical conferences around the world.