China-based Innovent Biologics (Innovent) announced on 1 June 2020 positive results for a phase I trial of its candidate bevacizumab copy biological, IBI305, in combination with TYVYT (sintilimab injection) in the treatment of advanced hepatocellular carcinoma, which is the most common form of liver cancer.
The aim of the study is to evaluate the safety, tolerability and efficacy of sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China.
Approximately 26‒38 subjects with locally advanced or metastatic hepatocellular carcinoma were planned to be enrolled in the study. The study was divided into two parts and included a dose escalation stage and a dose expansion stage.
The study was started in October 2018 and study treatment lasts up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. In the dose escalation phase, according to the enrolment sequence, subjects will receive either 7.5 mg/kg (low-dose group) or 15 mg/kg (high-dose group) of IBI305 in combination with a fixed dose of 200 mg of sintilimab, respectively, and then entered into the dose expansion phase after completing the dose escalation phase.
The planned completion date for the study is October 2020. However, clinical data for the study (with a cut-off date of 7 January 2020) was presented in a poster at the virtual 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO20 Virtual), which took place on 29‒31 May 2020.
As of 7 January 2020, a total of 50 subjects had been enrolled, including 29 subjects in the low-dose group and 21 subjects in the high-dose group. The 29 subjects in the low-dose group had at least two efficacy evaluations, of which 7 subjects had confirmed a partial response (PR), with objective response rate (ORR) of 24.1%. Of the 18 subjects in the high-dose group that had at least one efficacy evaluation, 6 subjects had a PR (1 unconfirmed, 5 confirmed), with an ORR of 33.3%.
Treatment-related adverse events (TRAEs) were mostly grade 1‒2, with the most common TRAEs including hypertension (28%) and pyrexia (26%); a total of 6 (12%) subjects experienced grade ≥3 TRAEs, with the most common grade ≥3 TRAE being hypertension (2 subjects).
Professor Zhou Aiping from Cancer Hospital Chinese Academy of Medical Sciences said that ‘this phase 1b study preliminarily showed positive efficacy and good safety in patients with advanced liver cancer’.
Innovent is also currently carrying out a phase III clinical trial of sintilimab in combination with IBI305 for first-line treatment of patients with advanced liver cancer.
Innovent presented positive phase III results for its bevacizumab copy biological IBI305 at the 55th Annual Meeting of the ASCO . The company has also had its adalimumab (IBI303) and rituximab (IBI301) copy biologicals accepted for review by China’s National Medical Products Administration, formerly the China Food and Drug Administration [2, 3].
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.
Biosimilars of bevacizumab
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for bevacizumab copy biological IBI305 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 19]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-bevacizumab-copy-biological-IBI305
2. GaBI Online - Generics and Biosimilars Initiative. Another adalimumab copy biological accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 19]. Available from: www.gabionline.net/Biosimilars/News/Another-adalimumab-copy-biological-accepted-for-review-in-China
3. GaBI Online - Generics and Biosimilars Initiative. Rituximab copy biological accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 19]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-copy-biological-accepted-for-review-in-China
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Source: ASCO, Clinicaltrials.gov, Innovent