China-based Innovent Biologics (Innovent) announced on 3 June 2020 positive phase I results for its candidate ipilimumab copy biological, IBI310.
Ipilimumab is a monoclonal antibody that works to activate the immune system by targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), a protein receptor that down regulates the immune system.
The phase I study (NCT03545971) is an open-label, dose escalation, study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of single agent of IBI310 and in combination with TYVYT (sintilimab) in patients with advanced solid tumours (1a) and advanced melanoma (1b). In the phase 1a study, subjects with advanced solid tumours who have progressed from standard treatment were dosed with IBI310; while in the phase 1b study, subjects with advanced melanoma were treated with IBI310 in combination with sintilimab. The study is being carried out in China and is expected to be completed in July 2021.
Preliminary results of the study were presented at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. They showed, according to Innovent, that IBI310 has an ‘acceptable safety profile and preliminary efficacy’.
At the cut-off date of 12 November 2019, a total of 10 subjects were enrolled in the phase 1a study and 17 subjects were enrolled in the phase 1b study. There were no dose limiting toxicities (DLTs) in both phases, and the dose expansion in phase 1b is currently ongoing. The most common treatment related adverse event (TRAE) was pruritus (itching) in both the phase 1a and phase 1b studies, and no grade 3 or higher adverse events had occurred in the phase 1a study and only one subject in the phase 1b study experienced a grade 3 or higher TRAE (aspartate aminotransferase increased). There were no deaths.
With respect to efficacy, in the phase 1b study, three subjects in the 3 mg combination dose group had at least one tumour assessment and one of these subjects had an objective response*.
Innovent says that phase II/III clinical studies of IBI310 in combination with sintilimab are ongoing in multi-tumours. Dr Hui Zhou, Vice President of Medical Science and Strategic Oncology at Innovent goes on to say that Innovent hopes ‘to evaluate the clinical results of IBI310 in combination with sintilimab and bring this therapy to more patients in need as soon as possible’.
Innovent is also working on copy biologicals of adalimumab (IBI303) [1] and bevacizumab (IBI305) [2].
*The tumour objective response rate (ORR) is the assessment of the tumour burden (TB) after a given treatment in patients with solid tumours and has a long history. The ORR is undoubtedly an important parameter to demonstrate the efficacy of a treatment and it serves as a primary or secondary endpoint in clinical trials.
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that copy biologicals approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
It should be noted that data of the study presented in this article were published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
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Source: ASCO, ClinicalTrials.gov, Innovent
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