Akeso secures another Phase 3 success with PD-1xVEGF in lung cancer

In a significant development, Akeso has announced that its innovative PD-1xVEGF bispecific antibody, ivonescimab, has outperformed BeiGene’s PD-1 inhibitor Tevimbra in a Phase 3 clinical trial targeting lung cancer patients in China. This marks the third successful late-stage trial for ivonescimab in the treatment of lung cancer, as highlighted in a release late on Tuesday. Akeso's partner, Summit Therapeutics, witnessed a notable 15% increase in its share price in premarket trading on Wednesday, reflecting investor confidence. Summit holds the rights to market the drug across the United States, Europe, and several other regions.

The Phase 3 trial, known as HARMONi-6, involved 532 participants with first-line advanced squamous non-small cell lung cancer (NSCLC) across 66 sites in China. The trial's primary endpoint was progression-free survival, where ivonescimab, when combined with chemotherapy, demonstrated a significant advantage over Tevimbra plus chemotherapy. Tevimbra is currently approved for NSCLC treatment in Europe but has not yet received approval in the United States.

According to Akeso, the ivonescimab regimen showed a clear superiority in the trial's intent-to-treat population for progression-free survival. Additionally, ivonescimab provided clinically significant benefits in patients regardless of their PD-L1 status, with both PD-L1-positive and PD-L1-negative groups experiencing improvements. Regarding safety, serious side effects and grade 3 or higher bleeding events were reported to be similar between the two treatment arms.

Akeso intends to present detailed findings from the HARMONi-6 study at an upcoming medical conference. Despite some variations in trial design, analysts from Jefferies suggest that the positive outcome of this study could positively impact Summit’s global HARMONi-3 trial. This ongoing trial is comparing ivonescimab and chemotherapy against Merck’s Keytruda combined with chemotherapy in patients with first-line metastatic squamous NSCLC, with overall survival being the primary focus.

Earlier in May 2024, ivonescimab had already demonstrated superiority over Keytruda in a different Phase 3 trial, named HARMONi-2, for patients with non-squamous NSCLC in China. Detailed results released in September indicated a 49% reduction in the risk of disease progression or death in the ivonescimab arm. These promising results have sparked a series of deals and funding opportunities for companies developing PD-1xVEGF bispecific treatments.

In February, Pfizer entered into a collaboration with Summit to explore the combination of ivonescimab with Pfizer’s vedotin-based antibody-drug conjugates (ADCs). The financial specifics of this agreement were not disclosed.

This recent correction clarifies that the Phase 3 trial was conducted solely by Akeso, without the involvement of Summit.