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Akeso Completes Patient Enrollment in Phase III Trial Comparing Ivonescimab for First-Line Squamous NSCLC Treatment

5 months ago2 min read

Key Insights

  • Akeso has completed enrollment for the HARMONi-6 Phase III trial comparing ivonescimab plus chemotherapy to tislelizumab plus chemotherapy for first-line squamous non-small cell lung cancer treatment.

  • Ivonescimab, a novel PD-1/VEGF bispecific antibody, is currently being evaluated in six Phase III lung cancer trials globally, with potential applications across multiple cancer types.

  • The drug addresses a significant unmet need among 520,000 annual cases of advanced sq-NSCLC patients, offering a promising alternative for those ineligible for current anti-angiogenesis treatments.

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.
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