iwCLL 2025 | Redefining endpoints in CLL clinical trials

So we have historical endpoints, such as progression-free survival and overall survival. So these endpoints are able to provide information about the efficacy, for instance, of the therapy, but probably they are not able to capture what is a change in the treatment in the landscape of therapy in CLL. For instance, moving from the chemoimmunotherapy to the targeted therapy era, there are new endpoints that could be better addressed. I think that… so we are moving towards surrogate endpoints. Surrogate endpoints, for instance, the most popular is the time to next treatment. Time to next treatment is able to assess how long the patient is able to remain on a given therapy before needing another therapy. And time to next treatment provides information not only on the efficacy, but also on the safety of medication because obviously also the interruption of the therapy is an event that is registered by time to next treatment. Another one is minimal residual disease. Minimal residual disease is a surrogate endpoint that provides information about the depth of response and is correlated with progression-free survival. However, all these endpoints are not able to identify really what are the needs of the patient because the need of patients is really the clinical benefit. 

So I think that there are an interesting study in the context of the GLOW trial, the GLOW trial is a trial comparing venetoclax plus ibrutinib versus obinutuzumab plus chlorambucil. In this study, it was assessed for the first time a combined endpoint, which includes the time the patient spent without progressing together with the time the patient spent without having major toxicities. And it was demonstrated that this endpoint was longer in terms of time, the patient treated with ibrutinib plus venetoclax versus chlorambucil plus venetoclax. But I think that at the end what we need is to implement more patient-reported outcomes because only by implementing this type of approach we can bring the voice of the patient into the management of CLL.

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