Antengene to Present Clinical Results of ATG-008 (Onatasertib) at the 2022 American Society of Clinical Oncology Annual Meeting

Poster will report data from the Phase I/II TORCH-2 Study that evaluates ATG-008 (onataseritb) and toripalimab in patients with advanced solid tumors

TORCH-2 is the world's first clinical study evaluating the combination of a dual mTORC1/2 inhibitor and an anti-PD-1 monoclonal antibody

SHANGHAI and HONG KONG, June 1, 2022 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that an abstract titled "A phase I/II study of onatasertib, a dual TORC1/2 inhibitor, combined with the PD-1 antibody toripalimab in patients with advanced solid tumors (TORCH-2)" will be presented as a poster during the 2022 American Society of Clinical Oncology (ASCO 2022), taking place from June 3rd to 7th in Chicago, Illinois via in person or virtual attendance.

"Antengene is very pleased to share the clinical data from the TORCH-2 study with the oncology community. Based on the data outlined in the abstract, we are very enthusiastic to further explore the combination of ATG-008 and the PD-1 inhibitor, toripalimab, in the treatment of patients with advanced solid tumors, including cervical cancer. We hope to validate these encouraging early data and thereby help guide the next steps in our clinical development program with ATG-008." said Dr. Kevin Lynch, Antengene's Chief Medical Officer.

As of the data cut-off on December 20, 2021, the overall response rate (ORR) was 28.6% (based on 6 patients with 5 confirmed responses) and the disease control rate (DCR) was 71.4%. These data are based on 21 efficacy evaluable patients of 28 patients with advanced solid tumors enrolled in the dose-escalation and dose-expansion phases of the Phase I/II TORCH-2 study (median of 2 prior lines of therapy). No dose-limiting toxicities were reported in the dose escalation phase. Most common adverse events (grade 3 or greater) included lymphocyte count decrease, rash and hyperglycemia etc.

Toripalimab was developed by Junshi Biosciences.

Presentation Details:

Title: A phase I/II study of onatasertib, a dual TORC1/2 inhibitor, combined with the PD-1 antibody toripalimab in patients with advanced solid tumors (TORCH-2)

Abstract: 2610

Date: June 5, 2022

Time: 8:00 AM-11:00 AM CDT
          9:00 PM-12:00 midnight (Beijing Time, GMT+8)

The abstract provided several observations regarding cohorts in the efficacy evaluable patients:

• Efficacy Evaluable Cervical Cancer Cohort: Among the 5 efficacy evaluable patients in the cervical cancer cohort, 1 patient with negative PD-L1 expression experienced a complete response (CR) and 3 patients experienced a partial response (PR); all responses were confirmed.
• Additional Responses in the Efficacy Evaluable Patients: the study reported two additional PRs (one nasopharyngeal carcinoma and one ovarian cancer).
• Progression Free Survival (PFS) and Duration of Response: The median PFS for all  28 efficacy evaluable patients was 3.52 months and the 18-month PFS rate was 31.2% (as of December 20, 2021).  Note that the patient who achieved CR in the cervical cancer cohort had remained on treatment for 580 days.
• The Recommended Phase II Dose was determined.

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders".

Since 2017, Antengene has a built broad and expanding pipeline of 15 clinical and preclinical assets, of which 10 are global rights assets, and 5 came with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 23 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO^® (selinexor) already approved in mainland China, South Korea, Singapore and Australia.

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SOURCE Antengene Corporation Limited