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Clinical readouts

Phase III and pivotal trial results — positive and negative, treated alike.

Latest picks

381–383 of 383
Aug 5Wed
  1. WeChat78

    Hengrui Pharma GLP-1/GIP Dual Agonist Reupaglutide Injection Meets Noninferiority Endpoint in China T2DM Pivotal Trial

    Hengrui Pharmaceuticals' GLP-1/GIP dual receptor agonist reupaglutide injection showed positive topline results in a pivotal trial in Chinese patients with inadequately controlled T2DM on oral drugs, with both dose groups meeting the noninferiority primary endpoint. The 4 mg group achieved a mean HbA1c reduction of 2.78% at week 36, an additional 0.49% mean reduction versus semaglutide injection 1 mg, with good overall tolerability and a safety profile similar to other GLP-1 agents.

    Why it matters: The brief gives the HbA1c difference of reupaglutide 4 mg versus semaglutide 1 mg and safety data for comparison with existing GLP-1 drugs.

  2. WeChat68

    PICC-2: Neoadjuvant Toripalimab Plus Celecoxib Achieves 89% pCR Rate in dMMR/MSI-H Locally Advanced Colorectal Cancer

    A team led by Professor Yanhong Deng at the Sixth Affiliated Hospital of Sun Yat-sen University published the PICC-2 randomized controlled trial in The Lancet Oncology. In patients with dMMR/MSI-H locally advanced colorectal cancer, adding the COX-2 inhibitor celecoxib to neoadjuvant toripalimab raised the pCR rate from 69% with monotherapy to 89% in the combination group, an absolute difference of 20 percentage points, with manageable safety.

    Why it matters: The article reports pCR rates for both the combination and monotherapy groups, letting readers judge the incremental benefit of a COX-2 inhibitor in neoadjuvant immunotherapy for dMMR/MSI-H colorectal cancer.

Jun 13Sat
  1. Danny M. Cohn Padmalal Gurugama Hilary J. Longhurst Emel Aygören-Pürsün Timothy J. Craig Henriette Farkas Joshua Jacobs William R. Lumry Markus Magerl Jonny Peter Marc A. Riedl David Maag Adele Golden Mrinal Y. Shah Andrea Sutherland Catherine R. Miller Ahmed M. Abdelhady Yuanxin Xu James S. Butler David Lebwohl John Leonard and Aleena Banerjithe HAELO Investigators*76

    Lonvoguran Ziclumeran — In Vivo CRISPR Gene Editing in Hereditary Angioedema

    The HAELO study, published in NEJM, reports clinical results of lonvoguran ziclumeran in hereditary angioedema using an in vivo CRISPR gene editing approach. DOI 10.1056/NEJMoa2600931.

    Why it matters: The clinical readout in NEJM offers a reference for efficacy and durability of similar in vivo CRISPR gene editing strategies in related indications.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org