The 2024 ASCO Annual Meeting was held in Chicago from 31st May to 4th June local time. As the world's most prominent, advanced, and influential clinical oncology meeting, global state-of-the-art research in oncology treatments were presented and potential game-changing highlights were discussed.
Hansoh Pharma presented five innovative studies at the grand conference, including two oral presentations, two abstracts of study data and one study design on almonertinib and the company’s pipeline product HS-20093, in the areas of non-small cell lung cancer and osteosarcoma.
Innovative study 1
ARTEMIS-002: Phase 2 study on HS-20093 in patients with relapsed or refractory osteosarcoma and other sarcomas
Type: Oral
No.: 11507
Presented by: Lu Xie, Peking University People's Hospital
[Background]
ARTEMIS-002 Study (NCT05830123) is a multicenter, open-label phase II trial. The study was divided into two cohorts: patients with osteosarcoma who progressed with standard systemic treatment were enrolled into cohort 1 and were randomized to receive either 8.0 mg/kg or 12.0 mg/kg of HS-20093; patients with other osteosarcoma that cannot be resected/treated with standard regimens or were irresponsive/intolerable to standard treatment were enrolled into cohort 2 and were treated with 12.0 mg/kg of HS-20093. The drug was administered via IV once every 3 weeks (Q3W). The primary endpoint of the study was ORR as assessed by investigators according to RECIST 1.1.
[Results]
As of 20 March 2024, cohort 1 enrolled a total of 42 patients with osteosarcoma with a median prior treatment line of 3. Among them, 35 patients (83.3%) had lung metastases; 38 patients underwent at least one post-baseline tumor assessment; in the 12.0 mg/kg group, the ORR was 17.4%, and the median progression-free survival (PFS) was not met; in the 8 mg/kg group, the median PFS was 4.0 months. Cohort 2 enrolled a total of 20 patients with other osteosarcomas with a median prior treatment line of 3. Among them, 18 patients (90%) had lung metastases; all 20 patients with other osteosarcomas were evaluable for efficacy, with an ORR of 25% and a median PFS of 7.1 months. In term of safety, common grade ≥3 adverse events (incidence ≥10%) were decreased neutrophil count, decreased white blood cell count, decreased lymphocyte count, decreased platelet count, and anemia.
[Conclusion]
Preliminary data from a small sample of this phase II study showed HS-20093 exhibited promising antitumor activity in patients with heavily-pretreated R/R osteosarcoma. The data was superior to historical data of standard treatments clinically available, and showed good tolerability. The clinical study data supports further investigation of HS-20093 for the treatment of osteosarcoma.
Innovative study 2
High-dose almonertinib in EGFR-mutated NSCLC with CNS metastases: Efficacy and safety
Type: Oral
No.: 2007
Presented by: Yun Fan, Zhejiang Cancer Hospital
ACHIEVE is a prospective, open-label, single-arm clinical trial across multiple centers. A total of 63 patients were selected and enrolled. The participants, all diagnosed with EGFR-mutated NSCLC with CNS metastases, received almonertinib through once-daily oral administration, with each dose being 165 mg. The median follow-up time, until November 30, 2023, was 538 days. The confirmed overall response rate (ORR) was 88.9% (56/63), while 42.9% (27/63) of patients progressed, with a median PFS of 17.71 months (95%Cl: 11.96-NE). Moreover, a notable 88.9% (56/63) of intracranial lesions achieved either a complete response (CR) in 21 cases (33.3%) or a partial response (PR) in 35 cases (55.6%).
Conclusions: Almonertinib exhibited promising efficacy and maintained tolerable safety as a first-line therapy in EGFR-mutated NSCLC with CNS metastases.
Innovative study 3
First-line treatment of EGFR mutation adenosquamous carcinoma of the lung with aumolertinib: A multicenter, single-arm, prospective study (ARISE Study)
No.: e20541
Presented by: Gen Lin, Fujian Cancer Hospital
18 eligible participants of stage IIIB/IV ASC with EGFR mutations received aumolertinib 110mg orally once daily. Of the 18 patients recruited, 12 were evaluated for efficacy and safety. The median follow-up was 13.3 months. The median PFS was 6.2 months (95% CI 5.0-8.2), while the median OS has not been reached. Of the 12 patients, seven (58.3%) achieved PR, three (25.0%) achieved SD, and two (16.7%) were PD. The ORR and DCR were 58.3% (95% CI: 62.6%-74.6%) and 83.3% (95% CI: 89.6%-96.2%), respectively. A total of nine patients (75%) experienced at least one treatment-related adverse events (TRAEs). The most common TRAEs were anemia (27.3%) and elevated aminotransferase (18.2%). No treatment-related deaths occurred.
Conclusion: As a prospective clinical study, ARISE Study shows that aumolertinib is an effective and well-tolerated drug for ASC with EGFR mutations.
Innovative study 4
The patient outcomes for EGFR-mutated advanced non-small-cell lung cancer with aumolertinib as the first-line treatment
No.: e20619
Presented by: Jisheng Li, Qilu Hospital, Shandong University
The study involved collecting the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) and EORTC Quality of Life lung cancer-specific module (QLQ-LC13) information on advanced NSCLC patients treated with aumolertinib as the first-line treatment. Efficacy was evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Prespecified key symptoms were cough, hemoptysis, dyspnea, sore mouth or tongue, dysphagia, hair loss, chest pain, arm or shoulder pain and pain of other sites. Totally, 33 patients were included and 23 patients had efficacy information. The median follow-up time was 264 days (interval: 36-491 days). The objective response rate (ORR) and disease control rate (DCR) was 65.2% and 91.3%, respectively. EORTC QLQ-LC30 showed general health status scale and functional scales increased and symptom scales decreased during aumolertinib treatment. Symptom scales assessed by EORTC QLQ-LC13 showed cough, sore mouth or tongue, chest pain, arm or shoulder pain and pain of other sites, were improved significantly after aumolertinib treatment (P < 0.05).
Conclusions: General health status, functional status and key symptoms improved from baseline in patients with advanced NSCLC receiving aumolertinib as first-line treatment. The ORR and DCR in the study were comparable to those shown the AENEAS trial.
Innovative study 5
Efficacy and safety of aumolertinib combined with or without chemotherapy as an adjuvant treatment for stage II-IIIA non-small cell lung cancer following complete tumor resection: The first third-generation EGFR-TKI versus chemotherapy phase III clinical study (APEX)
Type: Poster
No.: TPS8117
Presented by: Fengwei Tan, Jie Wang, Shugeng Gao, Cancer Hospital Chinese Academy of Medical Sciences
APEX is a multicenter, randomized, open label, phase III study. Patients with histologically confirmed stage II-III a non-squamous NSCLC harboring EGFR mutations without prior EGFR TKI treatment and R0 resection are eligible for this study. The performance status (Eastern Cooperative Oncology Group) is 0 or 1. This trial prepared to enroll approximately 606 patients, will be randomized (3:2:1) to receive either aumolertinib alone (110mg, po, once daily) or aumolertinib (110mg, po, once daily) plus pemetrexed (500mg/m2, iv) and cisplatin (75mg/m2, iv) or pemetrexed (500mg/m2, iv) plus cisplatin (75mg/m2, iv). The first patient was enrolled on August 2, 2021. The primary end point is DFS. The secondary endpoints include 2, 3, 4, 5-year DFS rates, 5-year overall survival (OS), OS, safety and quality of life. Adverse effects were graded per CTCAE v.4.0.
