Hansoh Pharma Showcases Amivantinib and HS-20093 Clinical Data at ASCO 2024

The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting will be held in Chicago, USA, from May 31 to June 4 local time. As the world's largest, most academically advanced, and most authoritative clinical oncology conference, the meeting will showcase the latest research and development progress in the global field of cancer treatment and explore the future directions of cancer therapy.

Hansoh Pharma Presents 5 Innovative Studies at This Year's Conference, Covering Tumor Treatment Fields Such as Non-Small Cell Lung Cancer and Osteosarcoma. These Studies Include 2 Oral Presentations, 2 Research Data Papers, and 1 Study Design, Derived from the Marketed Product Aumolertinib and the Pipeline Candidate HS-20093.

Innovative Research 1

ARTEMIS-002 Study: Phase II Study of HS-20093 in Recurrent or Refractory Bone and Soft Tissue Sarcoma

Report Type:Oral Report

Report No.:11507

Reporter:Xie Lu, Peking University People's Hospital

[Research Introduction]

ARTEMIS-002 (NCT05830123) is a multicenter, open-label Phase II clinical study. The study is divided into two cohorts: Cohort 1 enrolls patients with advanced osteosarcoma who have progressed after standard treatment and are randomly assigned to receive HS-20093 at doses of 8.0 mg/kg or 12.0 mg/kg; Cohort 2 enrolls patients with other unresectable bone and soft tissue sarcomas who have no standard treatment options or have failed/intolerant to standard treatment, receiving HS-20093 at 12.0 mg/kg. The dosing regimen is intravenous infusion once every three weeks (Q3W). The primary endpoint of the study is the objective response rate (ORR) assessed by investigators according to RECIST 1.1.

【Research Results】

As of March 20, 2024, Cohort 1 enrolled a total of 42 patients with osteosarcoma, with a median of 3 prior treatment lines. Among them, 35 patients (83.3%) had lung metastases; 38 patients underwent at least one tumor assessment after baseline. The ORR in the 12.0mg/kg group was 17.4%, and the median progression-free survival (PFS) was not reached; the median PFS in the 8mg/kg group was 4.0 months. Cohort 2 enrolled a total of 20 patients with other bone and soft tissue sarcomas, with a median of 3 prior treatment lines. Among them, 18 patients (90%) had lung metastases; all 20 patients with other bone and soft tissue sarcomas were evaluable for efficacy, with an ORR of 25% and a median PFS of 7.1 months. In terms of safety, common ≥Grade 3 adverse events (incidence rate ≥10%) included decreased neutrophil count, decreased white blood cell count, decreased lymphocyte count, decreased platelet count, and anemia.

[Research Conclusion]

Preliminary data from the Phase II small-sample study showed that HS-20093 demonstrated strong anti-tumor activity in patients with recurrent or refractory bone and soft tissue sarcoma who had received extensive prior treatment, surpassing historical data of existing standard treatments, with good safety and tolerability. Clinical research data supports the continued development of HS-20093 for bone and soft tissue sarcoma.

Innovative Research 2

Evaluation of the Efficacy and Safety of High-Dose Aumolertinib in Patients with EGFR-Positive Brain Metastatic NSCLC

Report Type:Oral Report

Report No.:2007

Reporter:Fan Yun, Zhejiang Cancer Hospital

The ACHIEVE study is a prospective, open-label, single-arm, multi-center clinical study that enrolled a total of 63 patients with EGFR-mutant non-small cell lung cancer (NSCLC) and central nervous system metastases who received 165mg of Almonertinib orally once daily. The primary endpoint was progression-free survival (PFS). This study included a total of 63 patients. As of the data cutoff date of November 30, 2023, the median follow-up time was 538 days. The overall response rate (ORR) was 88.9% (56/63), with 42.9% (27/63) of patients experiencing disease progression, and the median PFS was 17.71 months (95% CI: 11.96-NE). Additionally, 88.9% (56/63) of patients had significant intracranial lesion responses, with 21 patients (33.3%) achieving complete response (CR) and 35 patients (55.6%) achieving partial response (PR).

Studies show that Aumetinib as a first-line treatment for EGFR-mutant NSCLC with central nervous system metastases demonstrates good efficacy and maintains tolerable safety.

Innovative Research 3

Ameitinib as First-Line Treatment for Adenosquamous Carcinoma: A Multicenter, Single-Arm, Prospective Study (ARISE Study)

Report No.:e20541

Reporter:Fujian Provincial Cancer Hospital, Lin Gen

The ARISE study enrolled a total of 18 patients with stage IIIB/IV EGFR-mutant adenosquamous carcinoma, who were administered oral doses of 110mg Almonertinib daily. Among them, 12 patients were evaluated for efficacy and safety. The median follow-up time was 13.3 months, with a median PFS of 6.2 months (95% CI: 5.0-8.2), and the median OS has not yet been reached. Of the 12 patients, 7 (58.3%) achieved partial response (PR), 3 (25.0%) achieved stable disease (SD), while 2 (16.7%) experienced disease progression (PD). The ORR and DCR were 58.3% (95% CI: 62.6%-74.6%) and 83.3% (95% CI: 89.6%-96.2%), respectively. Nine patients (75%) experienced at least one treatment-related adverse event (TRAE). The most common TRAEs were anemia (27.3%) and elevated transaminases (18.2%). No treatment-related deaths occurred.

The ARISE study is a prospective study that demonstrates amivantamab has good antitumor activity and manageable toxicity in patients with EGFR-mutant adenosquamous carcinoma.

Innovative Research 4

Aumetinib Late-Line Treatment for EGFR-Positive NSCLC

Report No.:e20619

Reporter:Shandong University Qilu Hospital Li Jisheng

This study collected information from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 and QLQ-LC13 in patients with advanced non-small cell lung cancer who received Aumetinib as initial treatment. Efficacy was evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0. The pre-specified primary symptoms were cough, hemoptysis, dyspnea, oral and tongue pain, dysphagia, alopecia, chest pain, arm or shoulder pain, and pain in other areas. A total of 33 patients were enrolled, with efficacy information available for 23 patients. The median follow-up time was 264 days (range: 36-491 days). The objective response rate (ORR) was 65.2%, and the disease control rate (DCR) was 91.3%. The EORTC QLQ-C30 showed an increase in general health status and functional scales and a decrease in symptom scales during Aumetinib treatment. The EORTC QLQ-LC13 symptom scale showed that cough, oral and tongue pain, chest pain, arm or shoulder pain, and pain in other areas were significantly improved after Aumetinib treatment (P < 0.05).

The study confirmed that advanced non-small cell lung cancer patients receiving Aumolertinib as first-line treatment showed significant improvement in overall health status, functional state, and major symptoms compared to baseline. The ORR and DCR in the study are comparable to those in the AENEAS trial.

Innovative Research 5

Efficacy and Safety of Aumolertinib with or without Chemotherapy as Adjuvant Therapy for Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer: The First Phase III Clinical Study Comparing a Third-Generation EGFR-TKI to Chemotherapy (APEX)

Report Type:Poster

Report No.:TPS8117

Reporter:Cancer Hospital, Chinese Academy of Medical Sciences: Tan Fengwei, Wang Jie, Gao Shugeng

APEX Study is a multicenter, randomized, open-label Phase III study. Enrollment criteria include histologically confirmed EGFR-mutated Stage II-III non-squamous non-small cell lung cancer, R0 resectable, and no prior treatment with EGFR-TKI. Patients must have an ECOG score of 0 or 1. The study is expected to enroll 606 patients, who will be randomized in a 3:2:1 ratio to receive either Aumolertinib monotherapy (110mg, orally, once daily) or Aumolertinib (110mg, orally, once daily) combined with Pemetrexed (500mg/m², intravenous infusion) and Cisplatin (75 mg/m², intravenous infusion), or Pemetrexed (500mg/m², intravenous infusion) combined with Cisplatin (75 mg/m², intravenous infusion). The first patient was enrolled on August 2, 2021. The primary endpoint is disease-free survival (DFS), and secondary endpoints include 2-, 3-, 4-, and 5-year DFS rates, 5-year overall survival (OS), OS, safety, and quality of life. Adverse events are graded according to CTCAE v.4.0 criteria.

Editor: Muyan

Disclaimer: This article is a reprint from Pharmcube. The images and text are the property of the original author, and the purpose of the reprint is to convey more information. It does not represent the views of this platform. If there are any issues regarding content, copyright, or other problems, please leave a message on this platform, and we will address it promptly.