Nicholas Richardson, Vice President Clinical Development at Precision For Medicine, shared a post on LinkedIn:
“AbbVie and Genmab recently reported that the Phase III EPCORE DLBCL-1 trial of epcoritamab (Epkinly) in relapsed/refractory DLBCL missed its primary endpoint of overall survival.
Overall survival remains the gold standard endpoint in oncology, and rightly so. But this trial is also a reminder of how challenging OS has become to demonstrate in settings where patients have multiple effective subsequent therapies available.
In EPCORE DLBCL-1, epcoritamab did not show a statistically significant OS benefit compared with investigator’s choice chemo, despite improvements in secondary endpoints including PFS, CR, duration of response, and time to next treatment. The study enrolled heavily pretreated patients and was conducted during a period when treatment options and standards of care were rapidly evolving.
This reinforces the need to think carefully about when OS is the most appropriate primary endpoint, how post-progression therapies and crossover affect interpretability, and how we contextualize OS alongside other clinically meaningful measures of benefit.
As drug development continues to move into crowded therapeutic landscapes, especially in hematologic malignancies, endpoint selection and trial design become as critical as the drug itself. The epcoritamab data highlight why these conversations need to stay nuanced, data-driven, and patient-focused.”
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