Akeso advances cancer immunotherapy as Ivonescimab reaches Phase III milestone in lung cancer treatment

Akeso, Inc. (9926.HK) has completed patient enrollment for its pivotal Phase III trial (HARMONi-6), marking a significant step in its mission to redefine first-line treatment options for lung cancer. The trial evaluates ivonescimab, a bispecific PD-1/VEGF antibody developed independently by Akeso, comparing its efficacy to tislelizumab (a PD-1 inhibitor), both in combination with platinum-based chemotherapy, for the treatment of squamous non-small cell lung cancer (sq-NSCLC).

This milestone underscores Akeso’s rapid progress in cancer immunotherapy, positioning ivonescimab as a potential alternative to existing PD-1/L1 inhibitors. The trial is part of an extensive global development program, with multiple Phase III trials underway to assess ivonescimab’s therapeutic benefits across different cancer types.

How Could Ivonescimab Change the Standard of Care for Lung Cancer?

Sq-NSCLC remains one of the most aggressive forms of lung cancer, with a poor prognosis and limited treatment options. Many patients are ineligible for anti-angiogenesis therapies, such as bevacizumab, due to bleeding risks, further complicating their treatment pathways.

Current first-line treatment strategies typically involve PD-1/L1 inhibitors combined with chemotherapy, a standard protocol in the U.S. and China. However, the need for more effective and safer treatment alternatives persists. Ivonescimab’s dual-action mechanism, which targets both PD-1 and VEGF pathways, offers a promising approach, potentially enhancing tumor suppression while maintaining a favorable safety profile.

According to clinical data, ivonescimab has demonstrated a synergistic anti-tumor effect that could surpass existing treatment options. If proven successful in its Phase III trial, it may establish a new global benchmark for first-line treatment in cancer immunotherapy.

What Other Clinical Trials Are Evaluating Ivonescimab?

Akeso is actively expanding ivonescimab’s clinical footprint with multiple Phase III trials, including HARMONi-3, which assesses its efficacy against pembrolizumab in both sq-NSCLC and non-squamous NSCLC. This study, led by Akeso’s global partner Summit Therapeutics, reflects the growing interest in ivonescimab’s potential beyond China’s domestic market.

The company is also investigating ivonescimab across a broad spectrum of cancers, including head and neck squamous carcinoma, where it is being compared to pembrolizumab in PD-L1-positive patients. It is also undergoing trials for biliary tract cancer, assessing its efficacy in combination with chemotherapy against durvalumab plus chemotherapy. Akeso is further exploring ivonescimab’s impact as a first-line treatment for pancreatic cancer.

Additional Phase III trials are in progress to evaluate ivonescimab for the treatment of triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, ovarian cancer, and gastric cancer. The drug’s versatility and its unique bispecific approach reinforce its potential as a game-changing cancer immunotherapy that could reshape treatment paradigms globally.

What Regulatory Approvals Has Ivonescimab Already Achieved?

Ivonescimab has already received regulatory approval in China for use in combination with chemotherapy for treating EGFR-TKI-resistant, non-squamous NSCLC. This approval establishes its clinical value and sets the stage for broader applications in lung cancer treatment.

Furthermore, the New Drug Application (sNDA) for ivonescimab monotherapy as a first-line treatment for PD-L1-positive NSCLC is currently under priority review in China. If approved, this could further accelerate the drug’s adoption and commercial success.

How Does This Fit Into Akeso’s Broader Drug Development Strategy?

While ivonescimab remains the centerpiece of Akeso’s cancer immunotherapy portfolio, the company is also making strides in autoimmune diseases. Recently, Akeso announced that its IL-17-targeting monoclonal antibody, gumokimab (AK111), has had its New Drug Application accepted by China’s National Medical Products Administration (NMPA) for treating moderate to severe plaque psoriasis.

Gumokimab has demonstrated rapid efficacy, with significant improvement observed within two weeks of treatment. Clinical data from its pivotal Phase III trial (AK111-301) reported that over 80% of patients achieved a PASI 90 response at 12 weeks, with nearly 50% achieving complete skin clearance (PASI 100). The drug’s long-term efficacy was sustained for 52 weeks, with nearly 90% of patients maintaining a PASI 90 response.

These results highlight gumokimab’s potential as a best-in-class treatment for psoriasis, reinforcing Akeso’s strategic focus on both oncology and immunology.

What Does This Mean for Akeso’s Market Position?

Akeso’s commitment to innovation in cancer immunotherapy and autoimmune diseases places it among the emerging leaders in global biopharmaceutical development. The company’s strategic expansion of ivonescimab’s clinical trials and its pursuit of regulatory approvals signal a strong growth trajectory.

With lung cancer incidence rates continuing to rise and an increasing demand for next-generation therapies, ivonescimab’s success could position Akeso as a major player in the oncology market. If the drug secures regulatory approvals beyond China, it may become a formidable competitor to existing PD-1/L1 inhibitors on a global scale.

As Akeso continues advancing its Phase III trials, investors and industry stakeholders will closely watch the outcomes, particularly the HARMONi-6 study. A positive result could mark a turning point in the treatment of lung cancer, offering new hope to patients worldwide.