Jun. 7, 2022，Latest data of InnoCare’s robust oncology pipeline were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

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.

Professor Ye Guo from Shanghai East Hospital of Tongji University said, “This study showed the anti-tumor activity of gunagratinib in HNC patients carrying FGF/FGFR gene aberrations. Gunagratinib is safe and well-tolerated in patients with advanced solid tumors including HNC in this study.

Poster Presentation 2:

Safety, pharmacokinetics (PK) and clinical efficacy of ICP-723, a highly selective next-generation pan-TRK inhibitor, in patients with solid tumor

Abstract Number: 3106

As of 11 Feb 2022, a total of 17 patients in phase I dose escalation were treated with ICP-723 at doses of 1 mg QD, 2mg QD, 3mg QD, 4mg QD, 6mg QD and 8 mg QD. There is no DLT observed in the 6 dose groups. Six of 17 patients were confirmed as NTRK gene fusion positive tumors by either prior gene test reports or the central lab gene test.

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.

Reported AEs were generally manageable and resolved soon after supportive treatment.

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.