A phase 1, first-in-child, multicenter study to evaluate the safety and efficacy of the oncolytic herpes virus talimogene laherparepvec in pediatric patients with advanced solid tumors.

Background

The survival rates for pediatric patients with relapsed and refractory tumors are poor. Successful treatment strategies are currently lacking and there remains an unmet need for novel therapies for these patients. We report here the results of a phase 1 study of talimogene laherparepvec (T-VEC) and explore the safety of this oncolytic immunotherapy for the treatment of pediatric patients with advanced non-central nervous system tumors.

Methods

T-VEC was delivered by intralesional injection at 10

Results

Fifteen patients were enrolled into two cohorts based on age: cohort A1 (

Conclusions

T-VEC was tolerable as assessed by the observation of no DLTs. The safety data were consistent with the patients' underlying cancer and the known safety profile of T-VEC from studies in the adult population. No objective responses were observed.

Trial Registration

ClinicalTrials.gov: NCT02756845. https://clinicaltrials.gov/ct2/show/NCT02756845.

Informations de copyright

© 2023 Moreno, Teira, Croop, Gerber, André, Aerts, Gros Subias, De Wilde, Bautista, Turpin, Kunduri, Hamidi, Lawrence and Streby.

Déclaration de conflit d'intérêts

•Lucas Moreno: Data monitoring committees for clinical trials sponsored by Novartis, Actuate Therapeutics, Shionogi, Incyte, the University of Southampton and the Royal Marsden NHS Foundation Trust; consulting for Novartis, EUSA Pharma, Norgine, Y mAbs Therapeutics, and Shionogi; travel expenses by EUSA Pharma; educational activities by Bayer and EUSA Pharma; drugs provided for academic trials by Roche Genentech and EUSA Pharma; member of the Executive Committee of SIOPEN (European neuroblastoma research cooperative group), which receives royalties for the sales of dinutuximab beta.•Pierre Teira: no disclosures.•James M. Croop: no disclosures.•Nicolas U. Gerber: no disclosures.•Nicolas André: advisory boards for BMS, Bayer, and Partner Therapeutics; travel grants from BMS; drugs provided for academic clinical trials by BMS and Pierre Fabre; grants for academic clinical trials from BMS.•Isabelle Aerts: advisory boards for AstraZeneca; travel grants from BMS, Novartis, and Roche.•Luis Gros Subias: no disclosures.•Bram De Wilde: advisory board member for Novartis, Bayer, and Roche.•Francisco Bautista: member of a data monitoring committee for a clinical trial sponsored by Sanofi; consultant or advisory role for Bayer, Amgen, Roche Genentech, and EUSA Pharma; honoraria from Roche Genentech for speaking at symposia.•Brian Turpin: no disclosures.•Srinivasa Kunduri: employee of Parexel and working for Amgen.•Ali Hamidi: employee and stockholder of Amgen.•Tatiana Lawrence: employee and stockholder of Amgen.•Keri A. Streby: consulting work with Amgen, Y-mAbs Therapeutics, and Illumina Radiopharmaceuticals LLC.