On December 8, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that at the 2025 ESMO (Free ESMO Whitepaper) Asia Congress, updated results from the pivotal Phase III HARMONi-6 study (AK112-306) were shared in an oral presentation by Professor Shun Lu from Shanghai Chest Hospital. The study evaluates ivonescimab (a first-in-class PD-1/VEGF bispecific antibody) combined with chemotherapy versus tislelizumab combined with chemotherapy in first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC).

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Beyond the previously reported efficacy data presented at the ESMO (Free ESMO Whitepaper) 2025 Presidential Symposium and simultaneously published in The Lancet, this presentation further disclosed patient-reported quality of life outcomes based on the EORTC QLQ-C30 questionnaire.

Both prolonging survival and improving quality of life are core indicators for evaluating cancer treatments. The results published at 2025 ESMO (Free ESMO Whitepaper) Asia demonstrate that, compared to the tislelizumab-based regimen, treatment with ivonescimab plus chemotherapy not only significantly prolongs progression-free survival (PFS) but also offers better tolerability, enables higher treatment adherence, and provides patients to maintain better overall health status and quality of life over a longer period. These findings highlight the comprehensive clinical value of the ivonescimab regimen in delivering both survival and quality-of-life benefits for patients.

Quality of life (QoL) assessments from the HARMONi-6 study show that, compared with PD-1 inhibitor plus chemotherapy, ivonescimab plus chemotherapy not only significantly prolongs progression-free survival (PFS) but also helps patients maintain better overall health status. Time to deterioration in "Global Health Status/Quality of Life" was meaningfully delayed in the ivonescimab arm (HR = 0.94), indicating a trend toward reduced risk of QoL worsening versus the control group.
The ivonescimab-based regimen met the primary PFS endpoint versus the tislelizumab-based regimen, delivering a decisive, strongly positive outcome with both statistical significance and clear clinical benefit. PFS was substantially prolonged with ivonescimab plus chemotherapy compared with tislelizumab plus chemotherapy.
The hazard ratio for PFS between the ivonescimab and tislelizumab arms was 0.60 (P < 0.0001), corresponding to an absolute PFS improvement (ΔPFS) of 4.24 months (11.14 months vs. 6.90 months). This benefit was consistent across all PD-L1 expression subgroups.
The HARMONi-6 study enrolled 532 patients with well-balanced baseline characteristics. Among these patients, 92.3% had stage IV disease at enrollment. The squamous histology profile of the patients reflected real-world patterns, with approximately 63% of patients exhibiting the central squamous subtype (66.9% in the ivonescimab arm vs. 59.4% in the control arm). PD-L1 expression levels were also aligned with clinical expectations.

The results from the HARMONi-6 study further validate the breakthrough clinical value of the ivonescimab-plus-chemotherapy regimen compared to PD-1-plus chemotherapy regimen. The ivonescimab-plus chemotherapy regimen addresses a critical clinical gap when anti-angiogenic agents such as bevacizumab demonstrated severe safety considerations in the treatment of sq-NSCLC. Since ivonescimab’s initial approval in 2024, it has been evaluated in multiple clinical studies and used in real-world settings involving over 40,000 patients, where its transformative clinical benefits have been consistently demonstrated.

Across the immuno-oncology landscape, ivonescimab has shown clinical superiority to both PD-1 based treatments, which are currently the optimal standard of care for many cancers, and to also VEGF-targeted therapies in anti-angiogenesis based treatments.

In July 2025, based on the HARMONi-6 study results, the supplemental New Drug Application (sNDA) for ivonescimab in combination with chemotherapy as first-line treatment for sq-NSCLC was accepted for review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). Akeso’s partner, Summit Therapeutics, is currently carrying out a global multicenter Phase III HARMONi-3 study, evaluating ivonescimab plus chemotherapy versus pembrolizumab plus chemotherapy as first-line therapy for advanced NSCLC (both squamous and non-squamous subtypes).

(Press release, Akeso Biopharma, DEC 8, 2025, View Source [SID1234661288])