#China #Shanghai #Antengene #ATG-022 #CDE Approval

Antengene's Pivotal Phase III Study Approved to Treat Advanced Cancer

Antengene Corporation Limited, an innovative biotech firm listed on the SEHK, has achieved a significant milestone with the recent endorsement from China’s Center for Drug Evaluation (CDE). This endorsement is for the initiation of their pivotal Phase III CLINCH-3 study focusing on ATG-022, an antibody-drug conjugate targeting Claudin 18.2 (CLDN18.2) for patients battling CLDN18.2 positive advanced gastric or gastroesophageal junction adenocarcinoma.

Overview of the Clinical Study

The study aims to enroll patients within the Chinese healthcare system as part of a multi-regional clinical trial (MRCT). Dr. Jay Mei, the founder and CEO of Antengene, emphasized that this endorsement highlights the company's integrated R&D capabilities, ranging from novel molecule discovery to clinical studies aimed at regulatory approval.

The design of the CLINCH-3 study is randomized, open-label, and multicenter, assessing the effectiveness and safety of ATG-022 against the current standard treatment options available to investigators. As a pivotal registrational study, it seeks to pave the way for future marketingauthorizations for ATG-022 in treating this specific type of advanced gastric cancer.

Importance of the Breakthrough Therapy Designation

Previously awarded Breakthrough Therapy Designation by the CDE, this status played a crucial role in discussions with regulatory bodies, streamlining feedback mechanisms and ensuring expedited clinical development pathways for ATG-022. This could potentially address significant unmet medical needs in this patient population, as many current treatment options offer limited efficacy.

Key Study Highlights

The primary endpoints of the CLINCH-3 trial include progression-free survival (PFS) and overall survival (OS) as assessed by independent review committees. Secondary endpoints will monitor the objective response rate (ORR), duration of response (DOR), disease control rate (DCR), safety assessments, and additional relevant metrics. Encouraging initial results from the earlier Phase I/II CLINCH study suggested a promising efficacy and safety profile for ATG-022 in patients with the specified cancer type.

The findings indicated that for patients with CLDN18.2 expression levels at IHC 2+ >20%, ATG-022 achieved an ORR of 46.7% at a dosing of 1.8 mg/kg and 40.0% at 2.4 mg/kg, with respective DCRs displaying robustness at 86.7% and 90.0%. Furthermore, median PFS reported was 6.97 months and 5.09 months for the respective dosing cohorts, while median OS in the 2.4 mg/kg group was tracked at 14.72 months, underscoring ATG-022's competitive position in the treatment arsenal.

Challenges in Treating Advanced Gastric Cancer

Professor Lin Shen from Peking University Cancer Hospital will be spearheading the CLINCH-3 study as the principal investigator. He elaborated on the persistent challenges associated with treating advanced gastric and gastroesophageal cancers, especially in third-line settings, where available treatment modalities fall short due to low response rates and minimal survival benefits. Moreover, the favorable safety profile, evidenced by only a 19.4% incidence of Grade 3 or higher treatment-related adverse events (TRAEs), stands in contrast to many conventional cancer treatment options, heralding ATG-022 as a promising candidate for these hard-to-treat tumors.

Future Directions and Continued Development

Antengene has articulated a comprehensive clinical development strategy for ATG-022 aiming for multi-faceted therapeutic applications. This includes not only pivotal studies in advanced gastric cancer settings but also combination studies with anti-PD-1 therapies and chemotherapy in initial treatment phases. The potential extension of ATG-022’s efficacy beyond gastric cancer to other CLDN18.2-positive tumors exemplifies the company’s commitment to broadening the treatment spectrum available to impacted patients across various demographics.

Through diligent efforts, Antengene aims to maximize ATG-022's clinical impact while contributing meaningful innovations in the global fight against cancer, particularly in regions with high unmet needs. As the CLINCH-3 study gears up for its launch, the wave of hope is palpable, with Antengene determined to adjust the landscape of treatment for advanced gastric cancers profoundly.

About Antengene

Antengene Corporation is a commercial-stage global biotech entity actively engaged in creating first-in-class and best-in-class therapeutic solutions for serious illnesses. It remains committed to addressing the pressing healthcare challenges and enhancing treatment outcomes through innovative drug development.