Broader Eligibility for Follicular Lymphoma Trials Would Boost Access, Authors Say

Authors of a recent editorial appearing in the Journal of the National Cancer Institute say opening clinical trials in follicular lymphoma (FL) to less than ideal candidates—and more like those seen in the clinic—would boost access and give physicians a better idea of how novel therapies work in typical patients.¹

Samuel Yamshon, MD, of the Division of Hematology and Medical Oncology, Weill Cornell Medicine, and John P. Leonard, MD, Perlmutter Cancer Center, NYU Langone Health, NYU Grossman School of Medicine, both in New York, made their case based on results from a study published earlier this summer in JNCI,² which found that 55% of patients in an Australian cohort would have been ineligible for at least 1 of 4 pivotal phase 3 studies in FL, with 40% ineligible for 2 or more. Notably, Yamshon and Leonard wrote, patients over age 60 were less likely to be eligible, even though most people who develop slow-growing FL are at least 60 years of age.³

Authors of the September 12, 2025, editorial noted that FDA has issued draft guidance calling for including more patients with poor performance status and customizing trials based on toxicities that can be expected in real-world care. This would be a departure from “stacking the deck” to get favorable results by finding the healthiest patients possible, which Yamshon and Leonard say is often seen in industry-sponsored trials.

Such an approach might be more impressive to payers, who increasingly want to know how expensive new therapies will fare with populations most likely to be treated, and where the prospect of adverse events could mean significant consequences.

Successes in FL have pushed 10-year overall survival past the 80% mark, the authors noted—a great story indeed, but one the authors note makes traditional end points problematic in drug development. Even median progression-free survival needs replacement with validated surrogate markers; the authors suggest complete remission 30 months after start of therapy is “increasingly important.”¹

But drug development is not the only agenda item for the authors. “Liberalizing clinical trial eligibility in follicular lymphoma would increase access to novel therapies for many patients,” they write. “Agents such as obinutuzumab and lenalidomide would not have been available on label for untreated patients and would have been completely inaccessible in certain regions outside the context of a trial, making study participation the sole means for patients to access these therapies at the time.”

They especially highlight how restrictions in the 4 pivotal trials cited in the previously published study “sidelined” older patients and those from socioeconomically disadvantaged groups, “potentially exacerbating existing disparities.”¹

With trial enrollment cited by many as an ongoing challenge, “From the trialist’s perspective, less stringent inclusion criteria would also allow for more rapid accrual to studies and readout of results, which could also increase access by facilitating quicker approval of effective therapies for the general population if the trial shows a positive result.”¹

References

1. Yamshon S, Leonard JP. Unstacking the deck in follicular lymphoma clinical trials. J Natl Cancer Inst. Published online September 12, 2025. doi: 10.1093/jnci/djaf231
2. Wong KS, Martynchyk A, Krisnadi Z, et al. Meeting trial eligibility in follicular lymphoma patients is associated with overall survival but not progression-free survival. JNCI: J Nat Cancer Inst. 2025;djaf174. https://doi.org/10.1093/jnci/djaf174
3. Follicular lymphoma. Mayo Clinic. Updated September 29, 2025. Accessed September 30, 2025. https://www.mayoclinic.org/diseases-conditions/follicular-lymphoma/symptoms-causes/syc-20584732