Open-label, single-arm, phase II study of enzastaurin in patients with follicular lymphoma

Lee Schwartzberg, Robert Hermann, Ian Flinn, Douglas Flora, Eric D. Hsi, Oday Hamid, Peipei Shi, Boris K. Lin, Scott P. Myrand, Tuan S. Nguyen, Martin Dreyling

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

This open-label, phase II study investigated whether enzastaurin, a protein kinase C-beta (PKCβ) inhibitor, had activity in patients with grade 1 or 2 follicular lymphoma (FL). Adults with grade 1 or 2 FL who had no more than one prior treatment received oral enzastaurin continuously for up to 3 years. Of the 66 patients who received enzastaurin, 53 were evaluable for response. Overall response rate (ORR, primary efficacy endpoint) was 26·4% (3·8% complete response). Median (95% confidence interval) progression-free survival, time to response, and duration of response were 18·1 (11·5-28·3), 4·9 (2·8-8·1), and 22·3 (8·8-not applicable) months, respectively. In patients with tumour tissue available for biomarker analysis, ORRs in low versus high PKCβ2 expression groups were 41·7% and 8·3%, respectively (P = 0·041). The most common, mainly low-grade drug-related adverse events were fatigue (25·8%), diarrhoea (25·8%), nausea (18·2%), and chromaturia (18·2%). Four (6·1%) patients had Grade 3 toxicity and one (1·5%) patient had Grade 4 toxicity. Enzastaurin demonstrated limited clinical activity in grade 1 or 2 FL. Patients with low PKCβ2 expression in tumours had higher ORR than those with high PKCβ2 expression. Enzastaurin was well tolerated with mostly grade 1 or 2 toxicities. Further studies may be warranted in select patient populations.

Original languageEnglish (US)
Pages (from-to)91-97
Number of pages7
JournalBritish Journal of Haematology
Volume166
Issue number1
DOIs
StatePublished - Jan 1 2014

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Follicular Lymphoma
Protein Kinase C beta
enzastaurin
Drug-Related Side Effects and Adverse Reactions
Nausea
Disease-Free Survival
Fatigue
Diarrhea
Neoplasms
Biomarkers
Confidence Intervals
Population

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Open-label, single-arm, phase II study of enzastaurin in patients with follicular lymphoma. / Schwartzberg, Lee; Hermann, Robert; Flinn, Ian; Flora, Douglas; Hsi, Eric D.; Hamid, Oday; Shi, Peipei; Lin, Boris K.; Myrand, Scott P.; Nguyen, Tuan S.; Dreyling, Martin.

In: British Journal of Haematology, Vol. 166, No. 1, 01.01.2014, p. 91-97.

Research output: Contribution to journalArticle

Schwartzberg, L, Hermann, R, Flinn, I, Flora, D, Hsi, ED, Hamid, O, Shi, P, Lin, BK, Myrand, SP, Nguyen, TS & Dreyling, M 2014, 'Open-label, single-arm, phase II study of enzastaurin in patients with follicular lymphoma', British Journal of Haematology, vol. 166, no. 1, pp. 91-97. https://doi.org/10.1111/bjh.12853
Schwartzberg, Lee ; Hermann, Robert ; Flinn, Ian ; Flora, Douglas ; Hsi, Eric D. ; Hamid, Oday ; Shi, Peipei ; Lin, Boris K. ; Myrand, Scott P. ; Nguyen, Tuan S. ; Dreyling, Martin. / Open-label, single-arm, phase II study of enzastaurin in patients with follicular lymphoma. In: British Journal of Haematology. 2014 ; Vol. 166, No. 1. pp. 91-97.
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AU - Shi, Peipei

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