INTELLANCE 2/EORTC 1410 randomized phase II study of Depatux-M alone and with temozolomide vs temozolomide or lomustine in recurrent EGFRamplified glioblastoma.

van den Bent, Martin, Eoli, Marica, Sepulveda, Juan Manuel, Smits, Marion, Walenkamp, Annemiek, Frenel, Jean-Sebastian, Franceschi, Enrico, Clement, Paul M, Chinot, Olivier, de Vos, Filip, Whenham, Nicolas, Sanghera, Paul, Weller, Michael, Dubbink, H J, French, Pim, Looman, Jim, Dey, Jyotirmoy, Krause, Scott, Ansell, Pete, Nuyens, Sarah, Spruyt, Maarten, Brilhante, Joana, Coens, Corneel, Gorlia, Thierry and Golfinopoulos, Vassilis (2019) INTELLANCE 2/EORTC 1410 randomized phase II study of Depatux-M alone and with temozolomide vs temozolomide or lomustine in recurrent EGFRamplified glioblastoma. Neuro-oncology. ISSN 1523-5866.

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Abstract

BACKGROUND

Depatux-M is a tumor-specific antibody-drug-conjugate consisting of an antibody (ABT-806) directed against the activated Epithelial Growth Factor Receptor (EGFR) and the toxin monomethylauristatin-F. We investigated Depatux-M in combination with temozolomide or as single agent in a randomized controlled phase II trial in recurrent EGFR amplified glioblastoma.

PATIENTS AND METHODS

Eligible were patients with centrally confirmed EGFR amplified glioblastoma at first recurrence after chemo-irradiation with temozolomide. Patients were randomized to either Depatux-M 1.25 mg/kg every 2 weeks intravenously, or this treatment combined with temozolomide 150-200 mg/m2 day 1-5 every 4 weeks, or either lomustine or temozolomide. The primary endpoint of the study was overall survival.

RESULTS

260 patients were randomized. In the primary efficacy analysis with 199 events (median follow-up 15.0 months) the hazard ratio (HR) for the combination arm compared to the control arm was 0.71, 95% CI [0.50, 1.02]; p = 0.062. The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR =1.04, 95%CI [0.73, 1.48]; p = 0.83). The most frequent toxicity in Depatux-M treated patients was a reversible corneal epitheliopathy, occurring as grade 3-4 in 25-30% of patients. In the long-term follow-up analysis with median follow-up of 28,7 months the HR for the comparison of the combination arm versus the control arm was 0.66 (95%CI [0.48, 0.93].

CONCLUSION

This trial suggests a possible role for the use of Depatux-M in combination with temozolomide in EGFR amplified recurrent glioblastoma, especially in patients relapsing well after the end of first-line adjuvant temozolomide treatment. (NCT02343406).

Item Type:	Article
Subjects:	QZ Pathology. Oncology
Divisions:	Planned IP Care > Oncology and Clinical Haematology
Related URLs:	https://www.ncbi.nlm.nih.gov/pubmed/3174...
Depositing User:	Mrs Yolande Brookes
Date Deposited:	28 Nov 2019 11:38
Last Modified:	28 Nov 2019 11:38
URI:	http://www.repository.uhblibrary.co.uk/id/eprint/2632

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