Akeso, Inc. (9926.HK) has announced the completion of patient enrollment in its global Phase III clinical trial (HARMONi-6/AK112-306) evaluating ivonescimab, a novel PD-1/VEGF bispecific antibody, for first-line treatment of squamous non-small cell lung cancer (sq-NSCLC). The study, conducted in China, compares ivonescimab combined with platinum-based chemotherapy against tislelizumab with chemotherapy.
Expanding Clinical Program
The HARMONi-6 trial represents one of six ongoing Phase III studies worldwide investigating ivonescimab in lung cancer. Summit Therapeutics, Akeso's global partner, is leading the HARMONi-3 trial, which evaluates ivonescimab plus chemotherapy versus pembrolizumab plus chemotherapy in both squamous and non-squamous NSCLC patients.
Ivonescimab has already achieved significant milestones in China, where it has received approval in combination with chemotherapy for EGFR-TKI-resistant, non-squamous NSCLC. Additionally, a supplemental New Drug Application (sNDA) for ivonescimab monotherapy in first-line PD-L1-positive NSCLC is under priority review.
Broader Oncology Applications
Beyond lung cancer, ivonescimab's clinical development program encompasses multiple Phase III trials across various cancer types, including:
- PD-L1-positive head and neck squamous carcinoma
- First-line biliary tract cancer
- First-line pancreatic cancer
- Triple-negative breast cancer
- Colorectal cancer
- Hepatocellular carcinoma
- Ovarian cancer
- Gastric cancer
Addressing Critical Unmet Needs
The development of ivonescimab addresses a significant therapeutic gap in sq-NSCLC treatment. With over 520,000 new cases of advanced, driver gene-negative sq-NSCLC annually, many patients cannot receive current anti-angiogenesis treatments like bevacizumab due to bleeding risks. While PD-1/L1 inhibitors with chemotherapy represent the current standard of care, patient outcomes remain suboptimal.
Therapeutic Advantages
Ivonescimab's dual targeting of PD-1 and VEGF pathways offers several potential advantages:
- Synergistic anti-tumor effects
- Favorable safety profile
- Suitable alternative for patients ineligible for bevacizumab
- Potential to improve outcomes in locally advanced or metastatic sq-NSCLC
The completion of enrollment in the HARMONi-6 trial marks a significant step toward potentially establishing ivonescimab as a new standard in immuno-oncology, particularly for patients with limited treatment options.
