Dr. Pavel on the PFS With Lanreotide Autogel in the CLARINET FORTE Trial

Marianne Pavel, MD, senior physician and chair of Endocrinology at the Friedrich-Alexander University in Erlangen, Germany, as well as head of the NET Center, discusses the progression-free survival (PFS) of patients with pancreatic and midgut neuroendocrine tumors (NETs) who are treated with lanreotide (Somatuline) autogel in the phase 2 CLARINET FORTE trial.

The primary end point of the CLARINET FORTE trial was median PFS in patients with progressive disease, says Pavel. The 2 cohorts examined in the trial included patients with pancreatic and midgut NETs, and they experienced a median PFS of 5.6 months and 8.3 months, respectively.

According to Pavel, key questions that have been asked in this space include: Which patient should be selected for a somatostatin analog treatment? Should it be patients who have a lower Ki67? Who would be a good fit for this approach?

Many other aspects are under consideration and are not fully understood, adds Pavel. However, Ki67 is the most prominent prognostic factor in this space and also relates to duration of response, explains Pavel.

Looking at the Ki67 threshold, it is consistent with the CLARINET profile; the trial had a cut-off that excluded patients with a Ki67 of higher than 10%. It could be said that the median PFS is also 8 months, similar to the midgut cohort and pancreatic cohort. That is meaningful because most of these patients had been on the standard dose of lanreotide for a long time, adds Pavel.

Patients with pancreatic NETS had been treated for a median of 1.8 years on the standard dose of lanreotide and a median of 1.3 years in the midgut cohort. It's clinically meaningful to achieve a median PFS of 8 months or longer in the midgut cohort. If you look at the pancreatic cohort for those with a Ki67 threshold lower than 10%, no difference was found between a ≤2% and ≤5% Ki67 threshold, making the outcomes of median PFS similar, concludes Pavel.