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Poster Presentation 1:

Phase I results of gunagratinib (ICP-192), a highly selective irreversible FGFR 1-4 inhibitor in patients with head and neck cancer (HNC) harboring FGF/FGFR gene aberrations

Abstract Number: 6039

In the dose-escalation study, patients with advanced solid tumors (including HNC) with or without FGF/FGFR gene alterations were treated with escalating doses (range: 2mg-26mg) of gunagratinib once daily in 21-day cycles.

12 HNC patients were treated with escalating doses (range: 14mg-22mg) of gunagratinib. Among the 9 HNC patients with FGF/FGFR gene aberrations including FGF amplification and FGFR mutation, who have completed at least one tumor assessment, the overall response rate (ORR) was 33.3%, and the disease control rate (DCR) was 66.7%. The treatment-related adverse events (TRAEs) were manageable and gunagratinib was generally safe and well tolerated.

The most common treatment-related adverse events (TRAEs) included hyperphosphatemia, diarrhea, increased ALT or AST, etc. No serious TRAE were reported in HNC patients.

According to RECIST 1.1 criteria, among the 6 patients with NTRK fusion, the overall response rate (ORR) was 66.7% (4 patients with partial response (PR)), the disease control rate (DCR) was 100%. The ORR was 100% in dose groups of 4mg and above. All patients who achieved PR responded to ICP-723 at the first tumor assessment after 4-week treatment and maintained sustained responses to the date of data cutoff. One patient with lung adenocarcinoma and brain metastasis achieved PR with the target brain lesion shrunk from 10 mm to 3 mm.

Dr. Xiaoli Wei from Sun Yat-sen University Cancer Center said, “ICP-723 is safe and well-tolerated in patients with advanced solid tumors. Encouraging clinical efficacy including intracranial activity was demonstrated in patients with NTRK gene fusion in various tumor types.”
Online Publication:

Efficacy and safety of orelabrutinib in diffuse large B-cell lymphoma (DLBCL): a real-world analysis

Abstract Number: e19556

Fourteen patients with MCD DLBCL were included in the study. All patients received orelabrutinib 150 mg once daily. Among them, 8 were treated with R-CHOP or R-EPOCH as first-line therapy, and 6 with RICE, R-CHOP or R2 as second-line therapy. The complete response rate (CRR) for the first-line and second-line therapy were 75.00% and 66.67%, respectively.

The leading PI concluded that orelabrutinib-containing regimens demonstrated encouraging efficacy and well-tolerated safety profile among patients with MCD DLBCL. A large-scale prospective clinical study is on registration, which would offer a new potential therapeutic option for patients with MCD DLBCL

More information can be found at ASCO official website.

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