Tislelizumab

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. 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The PD-1 inhibitor Anniko marks Akeso’s first innovative medicine to receive FDA approval. Akeso is on a winning streak.Following a positive readout for its closely watched PD-1xVEGF bispecific ivonescimab, Akeso has won the FDA’s go-ahead for its PD-1 inhibitor penpulimab co-developed with Sino Biopharmaceutical’s Chia Tai-Tianqing Pharmaceutical.To be marked as Anniko, penpulimab is approved alongside chemotherapy for the first-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma, or as a single agent in patients who have tried platinum-based chemo and at least one other prior line of therapy.As Akeso noted Thursday, Anniko marks the company’s first innovative medicine to receive FDA approval. Previously, the drug has been approved in China for nasopharyngeal carcinoma, a rare cancer that develops in the nasopharynx, the upper part of the throat at the back of the nose. A separate application for Anniko in combination with Sino Biopharm’s VEGFR2 inhibitor anlotinib in first-line liver cancer is under review with Chinese authorities.About 10 PD-1/L1 inhibitors have reached the U.S. market before Akeso. The FDA nod puts Anniko in direct competition with Coherus BioSciences and Junshi Biosciences’ fellow China-made PD-1 Loqtorzi, which became the first FDA-approved therapy for nasopharyngeal carcinoma in 2023.The two Anniko indications are based on the international phase 3 AK105-304 trial and the pivotal AK105-202 study.In the phase 3 trial, Anniko’s chemo combination reduced the risk of progression or death by 55% versus chemo alone in the first-line setting, according to the FDA. Patients in the Anniko arm lived without progression for a median 9.6 months, which is significantly longer than the 7 months recorded by the control arm.Overall survival, a key secondary endpoint, was immature at the time of analysis, with 70% of prespecified deaths for the final analysis reported. According to the FDA, there was no sign of detriment to patients’ lives at this point. The full data from AK105-304 will be presented at the 2025 American Association for Cancer Research annual meeting in the following days. Previously, Loqtorzi got its first-line nod after showing its cocktail with chemo could significantly reduce the risk of death by 37% versus chemo alone in a phase 3 trial.As to the single-arm, China-only AK105-202 trial, Anniko triggered a 28% objective response rate in pretreated patients, and the median duration of response was not reached at the time of the analysis.Recurrent or metastatic nasopharyngeal carcinoma is not a large business opportunity. Citing a WHO 2020 analysis, Akeso noted that 133,000 new nasopharyngeal cancer cases are diagnosed annually worldwide, with 70% at a locally advanced stage. After an official rollout in the U.S. at the beginning of 2024, Coherus recorded $19.1 million Loqtorzi sales last year.According to the American Cancer Society, there is fewer than one case for every 100,000 people each year in the U.S., though it has higher rates in certain other countries, notably in South Asia. But the approval “highlights the quality of our innovation” and “underscores Akeso’s focus on delivering treatments for difficult-to-treat cancers for patients around the world,” Akeso CEO Michelle Xia, Ph.D., said in a statement. Despite Anniko’s breakthrough for Akeso on the international market, investors’ focus remains on the company’s Summit Therapeutics-partnered PD-1xVEGF bispecific ivonescimab, which has shown potential to replace Merck & Co.’s PD-1 blockbuster Keytruda as the new immunotherapy king in non-small cell lung cancer.Earlier this week, Akeso said the phase 3 HARMONi-6 trial in China found that ivonescimab and chemo did significantly better than BeiGene’s PD-1 inhibitor Tevimbra and chemo on progression-free survival for the first-line treatment of squamous NSCLC.That latest positive trial proves that ivonescimab’s head-to-head win against Keytruda as NSCLC monotherapies in the HARMONi-2 study was not a “one hit wonder,” Citi analyst Yigal Nochomovitz, Ph.D., said in a note.