CLL patients with 17P/TP53 frequently progress earlier to symptomatic disease and have shorter response durations with traditional chemoimmunotherapy. In 2013, two new targeted therapies, ibrutinib and idelalisib, were introduced into the CLL market. Both are indicated for patients tested positive for either 17P/TP53, or patients who have received at least one previous treatment. The objective of this study is to demonstrate the progression in 17P/TP53 testing in EU5 since 2012, and to evaluate how treatment choices have evolved in carriers of these chromosomal abnormalities.
IMS Oncology Advantage CLL, an anonymised patient database collected retrospectively through quarterly physician panel survey has been used, looking at 4 years of data from 2012 to 2015 for EU5 countries.
Out of 2800, 2693, 2657 and 2983 patients diagnosed in 2012, 2013, 2014 and 2015 respectively, 17P/TP53 testing was performed in 48% (2012) to 78% (2015) of patients in all lines of therapy. Within the tested population, the level of positivity for 17P/TP53 has remained stable with an average of 15%; among which, usage of ibrutinib and idelalisib grew from 0% in 2012 to 66% in 2015, bendamustine/rituximab combination therapy decreased from 18% to 10% and alemtuzumab monotherapy from 27% to 2%. Negativity for 17P/TP53 among 2nd+ Line patients remained stable with an average of 83%; among which usage of ibrutinib or idelalisib containing regimens increased from 0% in 2012 to 30% in 2015, bendamustine/rituximab remained stable at around 37% and FCR (fludarabine/cyclophosphamide/rituximab) decreased from 18% to 7%.
Over 2/3 of all CLL patients in EU5 are now tested for 17P/ TP53, which coincides with the increase in ibrutinib and idelalisib usage in 17P/TP53 positive patients and 17P/TP53 negative patients in 2nd+ line. Although bendamustine/rituximab still holds the lead among 17P/TP53 negative 2nd+ line patients, it is likely that ibrutinib and idelalisib based regimens will continue to take patient share in the coming year. The launch of venetoclax, indicated for the same population, could have an impact on the positive trend we have observed for these two molecules.
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All authors have declared no conflicts of interest.