Tislelizumab

HONG KONG, Dec. 8, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that at the 2025 ESMO 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). Beyond the previously reported efficacy data presented at the ESMO 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 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). Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. 21% more press release views with Request a Demo

iStock, Chitraporn Nakorn With positive data from the Phase III HERIZON-GEA-01 study, Zymeworks and Jazz Pharmaceuticals will approval application for Ziihera in the first half of 2026 for the treatment of gastroesophageal adenocarcinoma. Jazz Pharmaceuticals and Zymeworks’ HER2 bispecific antibody Ziihera significantly improved progression-free survival in a Phase III study of patients with gastroesophageal adenocarcinoma, clearing the way for a regulatory filing. The partners plan to supplemental biologics license application in the first half of 2026, seeking approval for Ziihera as a first-line option for patients with HER2-positive, locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). China’s BeOne Medicines is also collaborating with Jazz and Zymeworks on the development of Ziihera. Analysts at Leerink Partners said that the Ziihera regimens could “be able to replace Herceptin in GEA across the spectrum of” PDL1-positive and PLD1-negative patients. “These results exceeded our base case assumption which only assumed usage in the PDL1 negative subset,” they added in a note to investors Monday, increasing their peak GEA revenue forecast for Ziihera to around $2.9 billion. Herceptin is marketed by Roche’s Genentech and has long been a stalwart in breast and gastric cancers. Jefferies was similarly effusive about the Ziihera data, writing on Monday that the HERIZON-GEA-01 results “are practice-changing and may elevate Ziihera as the preferred HER2-targeting backbone in 1L GEA.” Data released on Monday come from the Phase III HERIZON-GEA-01 study , which enrolled around 920 patients with unresectable locally advanced, recurrent or metastatic GEA positive for the HER2 marker. Ziihera was administered with either a doctor’s choice of chemotherapy or with BeOne’s Tevimbra plus chemo. Controls were given Roche’s Herceptin plus chemotherapy. Without revealing specific data, the companies claimed that patients given either Ziihera-based regimen saw “highly statistically significant and clinically meaningful improvements” in progression-free survival versus controls. The Ziihera combos also led to better overall survival and the drug met key secondary endpoints such as objective response rate and duration of response. The companies promised to present HERIZON-GEA-01 data at an upcoming medical meeting early next year. Administered intravenously, Ziihera is a bispecific antibody that binds to two sites on the HER2 protein, triggering the internalization of the receptor. This mechanism leads to an overall reduction of the number of HER2 receptors on the surface of cancer cells, which in turn suppresses their ability to grow and divide uncontrollably. Ziihera also induces the immune system’s cancer-killing activity. Ziihera was originally developed by Zymeworks, which entered into a pact with BeOne (known as BeiGene at the time) in November 2018. Zymeworks then signed a licensing deal with Jazz in October 2022.