Tislelizumab

iStock, beast01 With ivonescimab’s data coming solely from China, its prospects in the U.S., where Summit owns the rights, remain up in the air. Summit Therapeutics’ and Akeso’s closely watched PD-1/VEGF immunotherapy ivonescimab was given clearance by China’s National Medical Products Administration on Friday for the first-line treatment of certain patients with non-small cell lung cancer. The Chinese approval could be a sign of ivonescimab’s regulatory prospects in the U.S., though analysts seem to be split on the matter, particularly given interim findings Friday from the HARMONi-2 trial, in which the PD-1/VEGF therapy failed to significantly boost overall survival (OS) in patients with PD-L1-positive non-small cell lung cancer (NSCLC) compared to Keytruda. Data maturity for this readout was 39%. “King Keytruda still reigns,” BMO Capital Markets analysts wrote in reaction to the data drop. The issue of ivonescimab’s failure to improve OS “adds questions to ivonescimab’s ability to challenge [Keytruda] in NSCLC,” they added, calling OS the “gold standard in oncology.” These findings, according to BMO, could “incrementally benefit” Merck, which has been facing share pressure from the emerging class of PD-1/VEGF inhibitors. On the other hand, Truist Securities skewed more in favor of Summit and Akeso, writing on Friday that they expect final OS in HARMONi-2 to be statistically significant. Truist argued that ivonescimab’s Chinese label and HARMONi-2 readout provide a “much earlier look” at its Phase III performance, “and so it is unsurprising” that the OS outcome fell short of significance. Still, Truist is “encouraged that even at this early look, the OS curves are separating.” The analysts contend that ivonescimab could demonstrate significantly better OS by the study’s final analysis, “if not potentially earlier.” A more mature readout is expected by year-end, according to Truist. The approval is a win for Akeso, which developed the drug and controls ivonescimab’s rights in China but the lingering questions regarding the molecule’s OS numbers remain a challenge for Summit, which secured the rights for the molecule in the U.S., Canada, Europe and Japan in 2022 for $500 million and up to $5 billion in downstream payments. Following the news of the approval in China, Summit’s stock immediately shed about one-third of its value, where it continues to sit Monday morning. Ivonescimab is a bispecific antibody that targets both the PD-1 and VEGF pathways, an emerging approach to cancer that captured the industry’s attention in September 2024 after Summit and Akeso declared triumph over Keytruda, touting PFS in HARMONi-2. The partners continue to build their case for ivonescimab, with another Phase III readout last week claiming its PFS superiority over BeiGene’s Tevimbra in NSCLC. Many analysts remain skeptical , however, noting the need for more data and flagging the fact that ivonescimab has thus far only been trialed in China, which presents a formidable barrier to U.S. approval. In an interview with BioSpace last September, Christiana Bardon, co-managing partner at MPM BioImpact, said ivonescimab still needs to prove itself in terms of OS, an important metric that many doctors consider when making prescribing decisions. Bardon and other experts also emphasized the need for more diverse data, noting that using Chinese-only populations could potentially skew the findings due to factors such as genetics and cultural differences in reporting side effects. Safety, in particular, stood out to Bardon as a possible point of contention for the FDA, given that there were very few grade 3 side effects in HARMONi-2. “[Adverse events] are probably underestimated compared to what we would see in a Western-based population,” she said. To address these concerns, Summit is running the Phase III HARMONi-3 trial, a global study that could pave the way for a U.S. approval application. That study is currently enrolling patients.

HONG KONG, April 25, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that its globally first-in-class PD-1/VEGF bispecific antibody, ivonescimab, has received approval from the National Medical Products Administration (NMPA) for its supplementary New Drug Application (sNDA) for use as a monotherapy for the first-line treatment of PD-L1-positive (TPS ≥ 1%) non-small cell lung cancer (NSCLC) in patients who are negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK) gene mutations. This indication marks Ivonescimab's second major approval. The sNDA approval is based on the breakthrough results of the AK112-303/HARMONi-2 Phase III study, which is a randomized, double-blind, controlled study that directly compared ivonescimab with pembrolizumab in first line PD-L1 positive NSCLC. Ivonescimab demonstrated a statistically significant improvement in the trial's primary end point, median progression-free survival (PFS) when compared to pembrolizumab, with a median PFS of 11.14 months, achieving a hazard ratio (HR) of 0.51 reducing the risk of disease progression or death by 49%. An interim analysis of OS conducted at 39% data maturity (α=0.0001), indicated a clinically meaningful improvement in OS with ivonescimab compared to pembrolizumab, with a hazard ratio (HR) of 0.777, reflecting a 22.3% reduction in the risk of death. Ivonescimab is the first therapy to achieve statistically significant positive results in a Phase III trial compared with pembrolizumab in a head-to-head setting. Ivonescimab represents a new, more effective, and safer "chemotherapy-free" option for the first-line treatment of NSCLC. Ivonescimab is the first bispecific antibody approved globally with a dual "cancer immunotherapy + anti-angiogenesis" mechanism. It has already shown significant positive results in three Phase III trials for lung cancer, including 1) treatment for EGFR-TKI-resistant NSCLC, 2) comparison with pembrolizumab in PD-L1-positive NSCLC, and 3) treatment in combination with chemotherapy versus tislelizumab in combination with chemotherapy in squamous NSCLC. Professor Zhou Caicun, principal investigator of the HARMONi-2 trial, director of the Department of Oncology at the Shanghai East Hospital, Tongji University, commented: "The Phase III HARMONi-2 study demonstrated that ivonescimab offers significant improvements in progression-free survival (PFS) and overall survival (OS) compared to pembrolizumab. This breakthrough provides a safer and more effective first-line treatment option for NSCLC, particularly beneficial for patients who need better efficacy or quality of life, or those who are not suitable for chemotherapy due to its side effects. Ivonescimab has also gained widespread recognition in treating EGFR-TKI-resistant NSCLC. The recent Phase III trial combining ivonescimab with chemotherapy, compared to tislelizumab for squamous NSCLC, showed promising positive results. Ivonescimab is now positioned as a new standard of care for both first- and second-line treatment in lung cancer. We are optimistic about its continued success in global Phase III trials and its potential to redefine cancer treatment standards worldwide." Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso, commented: "We are thrilled to announce the approval of ivonescimab as a first-line treatment for PD-L1-positive NSCLC, a major breakthrough in cancer immunotherapy. This milestone is a result of the dedication of investigators, participants, and patients, and we sincerely thank all of them. We also appreciate the regulatory authorities for their efficient and diligent review, which enables us to offer this new treatment to patients in China. Ivonescimab has shown superior efficacy over pembrolizumab in the HARMONi-2 Phase III trial, becoming the first therapy to achieve this globally. Positive results so far from three pivotal Phase III lung cancer trials further establish ivonescimab as a next-gen IO treatment with strong global potential. The clinical data highlights ivonescimab's exceptional efficacy and safety benefits for patients across various cancer types. Beyond lung, ivonescimab has demonstrated promising potential as first-line treatment for other key cancers, including breast, head and neck, biliary tract, and colorectal cancer, supported by, over 12 ongoing Phase III trials. Akeso, along with our partner Summit, are committed to advancing ivonescimab as a cornerstone of global cancer immunotherapy, aiming to provide safer, more effective treatment options for patients worldwide." 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, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 4 new drugs with 4 new indications are under regulatory review for approval. 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. For more information, please visit and follow us on Linkedin. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED