Blog

  • Christian McCaffrey’s 201 scrimmage yards power 49ers past Falcons

    Christian McCaffrey’s 201 scrimmage yards power 49ers past Falcons

    Continue Reading

  • Sweet but smart? Scientists find surprising link between mangoes and lower diabetes risk

    Sweet but smart? Scientists find surprising link between mangoes and lower diabetes risk

    Image credits: Getty Images

    If there’s a ‘forbidden’ fruit diabetics fear, then mangoes top the list. According to the U.S. Department of Agriculture, a cup of fresh mango has 22.6 grams of sugar making it popular and loved for its natural…

    Continue Reading

  • Barinthus Biotherapeutics’s reverse takeover of Clywedog Therapeutics

    Barinthus Biotherapeutics’s reverse takeover of Clywedog Therapeutics

    The combined firm is expected to develop a portfolio of clinical-stage candidates targeting Types 1 and 2 diabetes and coeliac disease. 

    US-based clinical-stage biopharmaceutical company Barinthus Biotherapeutics has performed a reverse…

    Continue Reading

  • Bangladesh airport inferno estimated to cost $1bn in damages

    Bangladesh airport inferno estimated to cost $1bn in damages

    Osmond ChiaBusiness reporter

    Watch: Bangladesh’s Hazrat Shahjalal International Airport engulfed in flames

    Business leaders in Bangladesh fear losses of more than $1bn (£750m) after a devastating fire broke out in the logistics section of the…

    Continue Reading

  • Israeli forces martyr 97 Palestinians across Gaza – RADIO PAKISTAN

    1. Israeli forces martyr 97 Palestinians across Gaza  RADIO PAKISTAN
    2. Live: Israel kills 97 Palestinians in Gaza since start of ceasefire  Al Jazeera
    3. Truce resumes after Israeli airstrikes on Gaza amid scramble to shore up ceasefire – Middle East…

    Continue Reading

  • Kelun-Biotech Presents Positive Phase 3 Data for Trastuzumab Botidotin Compared to T-DM1 at 2025 ESMO

    Kelun-Biotech Presents Positive Phase 3 Data for Trastuzumab Botidotin Compared to T-DM1 at 2025 ESMO





    Kelun-Biotech Presents Positive Phase 3 Data for Trastuzumab Botidotin Compared to T-DM1 at 2025 ESMO


















    Accessibility Statement
    Skip Navigation




























    Trastuzumab botidotin is a HER2-targeted ADC composed of a cytotoxic drug (Duostatin-5, anti-microtubule agent) with site-specific conjugation to trastuzumab via a stable protease-cleavable valine-citrulline linker. The unique linker is stable in plasma and selectively cleaved by lysosomal cathepsin B that is up-regulated in cancer cells.

    In this study, a total of 365 patients with HER2+ unresectable or metastatic BC who had received at least one prior anti-HER2 therapy were randomized (1:1) to receive trastuzumab botidotin or T-DM1. 53% of patients had received ≥2 lines of anti-HER2 therapy, 61% of patients had HER2 Immunohistochemistry (IHC) 3+, and 60% of patients had been treated with TKIs, particularly pyrotinib (56%). As of April 26, 2025, median follow-up was 14.9 months.

    Median PFS was significantly longer in trastuzumab botidotin than in T-DM1 (11.1 months vs 4.4 months; HR: 0.39, 95% CI, 0.30-0.51, p<0.0001). PFS benefit with trastuzumab botidotin was consistently observed regardless of prior lines of anti-HER2 therapy (HR 0.36, 95% CI, 0.25-0.53, for 1 prior line; HR 0.39, 95% CI, 0.28-0.56, for ≥2 prior lines).

    ORR by blinded independent central review (BICR) was 76.9% vs 53.0%.

    A trend toward benefit in OS was observed in trastuzumab botidotin (HR 0.62; 95% CI, 0.38-1.03).

    Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 69.8% of patients in trastuzumab botidotin and 63.7% in T-DM1. The most common TEAEs associated with dose reduction were ocular AEs for trastuzumab botidotin, and were platelet count decreased for trastuzumab emtansine. Only two patients permanently discontinued trastuzumab botidotin due to TEAE. No on-treatment deaths were observed in trastuzumab botidotin, compared with 1.6% in T-DM1, all of which were considered unrelated to treatment.

    As a conclusion, this second head-to-head trial comparing T-DM1 with other anti-HER2 regimens demonstrated that trastuzumab botidotin statistically improved PFS with an ORR of 76.9% vs 53.0%. PFS benefit with trastuzumab botidotin was consistently observed regardless of prior lines of anti-HER2 therapy. Ocular AEs were also manageable.

    “Professor Xichun Hu, National Lead Principal Investigator from Fudan University Shanghai Cancer Center:”Trastuzumab botidotin effectively balances safety and efficacy through its unique molecular design, reducing the incidence of interstitial lung disease and hematologic toxicity. According to research data, trastuzumab botidotin demonstrated significant survival benefits in the pivotal Phase III trial, with an overall manageable safety profile, providing a new important treatment option for pretreated HER2+ BC patients. These positive results also offer robust evidence-based support for personalized treatment and updates to clinical practice guidelines.”

    About  Trastuzumab botidotin

    Trastuzumab botidotin is a differentiated HER2 ADC to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, monomethyl auristatin F (MMAF) derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a DAR of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

    Based on the results of a multi-center, randomized, open-label, controlled, Phase 3 KL166-III-06 study, trastuzumab botidotin was approved for marketing by the NMPA in for adult patients with unresectable or metastatic HER2 positive BC who have received one or more prior anti-HER2 therapy. At a pre-specified interim analysis, trastuzumab botidotin demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS as assessed by the BICR compared with T-DM1[; the beneficial trend for OS of trastuzumab botidotin was also observed.

    Currently, the Company has initiated an open, multi-center Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC.

    About Kelun-Biotech

    Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 projects are in the NDA stage and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC and novel DC platforms, OptiDC™, and has 1 ADC project approved for marketing and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.

    SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    WANT YOUR COMPANY’S NEWS FEATURED ON PRNEWSWIRE.COM?

    icon3

    440k+
    Newsrooms &
    Influencers

    icon1

    9k+
    Digital Media
    Outlets

    icon2

    270k+
    Journalists
    Opted In

    Also from this source

    Positive Results from Phase 3 OptiTROP-Lung04 Trial of Sacituzumab Tirumotecan Presented at ESMO Presidential Symposium and Simultaneously Published in NEJM

    Kelun-Biotech Presents Positive Results of Phase 3 Clinical Study OptiTROP-Breast02 for Sacituzumab Tirumotecan in Advanced HR+/HER2- Breast Cancer at 2025 ESMO

















    Continue Reading

  • Canva Hits the Road for a Global Creativity Tour

    Canva Hits the Road for a Global Creativity Tour

    All aboard the “brandwagon.” On Oct. 1, Canva hit the road—literally—with the launch of the Canva World Tour (CWT), a whirlwind, more than 40-city global adventure powered by the brand’s ambitious mission to train 1 million people on the…

    Continue Reading

  • Stalled offshore wind giant back in the race – Recharge News

    1. Stalled offshore wind giant back in the race  Recharge News
    2. Goldwind: ‘Rejecting our turbines will be costly for the West’  Recharge News
    3. Major US utility still bleeding red ink from Revolution Wind offshore project  Recharge News
    4. Here’s what Mingyang must do to sell turbines from planned UK factory to EU  Recharge News
    5. The case for concrete on pioneering French floating wind project  Recharge News

    Continue Reading

  • Bake Off’s Prue Leith visit ‘inspiration’ to cookery pupils

    Bake Off’s Prue Leith visit ‘inspiration’ to cookery pupils

    A head teacher said a visit from Great British Bake Off judge Dame Prue Leith was “a huge inspiration” to pupils.

    Dame Prue opened a new teaching kitchen at Bruern Abbey in Buckinghamshire, an independent school with a particular focus on…

    Continue Reading

  • Harvard-trained doctor recommends 10 healthy breakfast drinks to prevent bloating

    Harvard-trained doctor recommends 10 healthy breakfast drinks to prevent bloating

    Mornings can be rough—especially when bloating makes your stomach feel like a balloon before breakfast. Harvard-trained doctor Dr Saurabh Sethi recently shared a simple, doctor-approved guide to breakfast drinks that keep bloating at bay. From…

    Continue Reading