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 and Eoli, Marica and Sepulveda, Juan Manuel and Smits, Marion and Walenkamp, Annemiek and Frenel, Jean-Sebastian and Franceschi, Enrico and Clement, Paul M and Chinot, Olivier and de Vos, Filip and Whenham, Nicolas and Sanghera, Paul and Weller, Michael and Dubbink, H J and French, Pim and Looman, Jim and Dey, Jyotirmoy and Krause, Scott and Ansell, Pete and Nuyens, Sarah and Spruyt, Maarten and Brilhante, Joana and Coens, Corneel and 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
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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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