Aibining (geptanolimab)

Groups were divided according to immunotherapy regimen: Group A (drug code: 609A), 16 patients were given 1 mg/kg of the drug for 21 days; Group B (drug code: HX008), 23 patients were treated with 200mg for 21 days; Group C (drug code: GB226), 28 patients were treated with 3mg/kg for 14 days; Group D (drug code: LP002), 26 patients were treated with 900mg for 14 days. The high sensitivity of early ECG changes induced by immune checkpoint inhibitors enables early prediction of related cardiotoxicity. The presence or absence of comorbid underlying disease and drug dosage are correlated with the occurrence of adverse cardiac events, and these early changes provide a evidence for clinical treatment and prevention.

Geptanolimab (GB226) demonstrated promising efficacy and a manageable safety profile in Chinese patients with r/r PMBCL.

Methods We enrolled 89 peripheral T cell lymphoma (PTCL) patients in phase II clinical trial of geptanolimab and performed targeted next-generation sequencing for 440 cancer-associated genes...Conclusions In this study we comprehensively depicted the pre-treatment mutation profiles of PTCL and identified genetic alterations with prognostic value for anti-PD-1 therapy. Notably, we found JAK3 mutations which are vital and prevalent in PTCL reduced PD-L1 levels in vivo and in vitro, which are of great clinical and biological sense.

P2, N=44, Not yet recruiting, Stephen Chan Lam

Clinical benefit was observed across most patient subgroups, with a trend of higher ORR in pts with squamous cell carcinoma, no previous bevacizumab use and higher CPS. GB226 demonstrated durable antitumor activity and manageable safety profile in pts with recurrent or metastatic cervical cancer. Clinical trial information: NCT03808857.

P1, N=30, Completed, Apollomics (Australia) Pty. Ltd. | Active, not recruiting --> Completed | Trial completion date: Jun 2022 --> Feb 2022

P1, N=72, Recruiting, Genor Biopharma Co., Ltd. | Trial primary completion date: Jun 2021 --> Jun 2022

P1, N=30, Active, not recruiting, Apollomics (Australia) Pty. Ltd. | Recruiting --> Active, not recruiting | N=45 --> 30 | Trial completion date: Dec 2021 --> Jun 2022 | Trial primary completion date: Jun 2021 --> Dec 2021

P1, N=72, Recruiting, Genor Biopharma Co., Ltd. | Trial completion date: Aug 2020 --> Aug 2022 | Trial primary completion date: Jun 2020 --> Jun 2021

P2, N=80, Recruiting, Genor Biopharma Co., Ltd. | Trial completion date: Jul 2021 --> Jul 2022 | Trial primary completion date: Dec 2020 --> Dec 2021

In this study, geptanolimab showed promising activity and manageable safety profile in patients with r/r PTCL. Anti-PD-1 antibody could be a new treatment approach for this patient population.

P2, N=80, Recruiting, Genor Biopharma Co., Ltd. | Trial completion date: Jul 2020 --> Jul 2021 | Trial primary completion date: Jun 2020 --> Dec 2020

P2, N=80, Recruiting, Genor Biopharma Co., Ltd. | Trial primary completion date: Mar 2020 --> Jun 2020

Patients could benefit from Geptanolimab after failure of Chidamide (an oral histone deacetylase [HDAC] inhibitor) treatment with an ORR of 33.3% (8/24). Geptanolimab (GB226), an anti-PD-1 antibody, can be an effective treatment for R/R PTCL, with an acceptable safety profile.

The ORR was 33.3% (95%CI: 7.5%-70.1%) in patients with prior anlotinib therapy (n=9). Geptanolimab shows promising efficacy and acceptable safety profile for recurrent/metastatic/unresectable ASPS.

P1, N=50, Not yet recruiting, CBT Pharmaceuticals, Inc.