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Innovent starts phase II trial for ipilimumab copy biological Posted 19/02/2021

China-based Innovent Biologics (Innovent) announced on 11 December 2020 that the first patient had been successfully enrolled and dosed in the randomized, double-blind, phase II multicentre clinical trial (NCT04590599) evaluating its ipilimumab copy biological (IBI310) in combination with TYVYT (sintilimab) for the treatment of patients with second-line or above advanced cervical cancer.

The trial is a randomized, double-blind, controlled, parallel cohort, phase II clinical trial evaluating the efficacy and safety of IBI310 versus placebo, in combination with TYVYT, for advanced cervical cancer patients who have failed first and later line therapy or are intolerant to platinum-based chemotherapy. The trial is being carried out in China and plans to enrol 174 patients with advanced cervical cancer. The planned completion date is February 2024.

In July 2020, Innovent reported positive results from a phase I study of its ipilimumab copy biological both alone and in combination with TYVYT in patients with advanced solid tumours (1a) and advanced melanoma (1b). The preliminary results showed, according to Innovent, that IBI310 has an ‘acceptable safety profile and preliminary efficacy’ [1].

In September 2020, TYVYT in combination with candidate bevacizumab copy biological, Byvasda (IBI305) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the phase III ORIENT 32 study. Byvasda was approved by China’s National Medical Products Administration (NMPA) in June 2020 for use alone in the treatment of patients with advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer in China [2].

Innovent also announced on 12 January 2021 that its supplemental new drug application (sNDA) for sintilimab as second-line therapy for squamous NSCLC had been accepted by the NMPA. Then on 13 January 2021, the company announced that a sNDA for Byvasda (bevacizumab) in combination with sintilimab as first-line therapy in hepatocellular carcinoma had also been accepted by the NMPA.

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 outside of Europe might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Related articles
Positive phase III results for sintilimab plus copy biological Byvasda

Positive phase I results for Innovent’s ipilimumab copy biological

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References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Innovent’s ipilimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-Innovent-s-ipilimumab-copy-biological 
2. GaBI Online - Generics and Biosimilars Initiative. China approves bevacizumab copy biological Byvasda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: www.gabionline.net/Biosimilars/News/China-approves-bevacizumab-copy-biological-Byvasda 

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Source: ClinicalTrials.gov, Innovent

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