Newsflash
Prodotti competitors / Area Oncology, Area Onco-Ema

Lung (NSCLC & SCLC), Solid Tumors, TIGIT, GYN, Bladder, Upper GI - COMPETITIVE LANDSCAPE

  • 13 gennaio 2025
Immagine News
Attenzione! Il presente contenuto è disponibile solo in lingua originale.
  • NSCLC:
    • Pfizer listed a new P3 BE6A LUNG-02 trial that will evaluate sigvotatug vedotin (integrin beta 6 ADC) + pembrolizumab (PD-1) vs pembro mono in 1L PD-L1 ≥ 50% mNSCLC
    • AstraZeneca and Daiichi Sankyo announced the voluntary withdrawal of their MAA in the EU for Dato-DXd (TROP2 ADC) in 2L+ Nsq mNSCLC
    • Summit amended the P3 HARMONi-3 trial of ivonescimab (PD-1/VEGF bsAb) + chemo vs pembro (PD-1) + chemo in 1L PD-L1 ≥ 1% mNSCLC to include non-squamous patients in addition to the already enrolling squamous population
    • Summit listed a P3 HARMONi-7 trial of ivonescimab (PD-1/VEGF bsAb) vs pembro (PD-1) in 1L PD-L1 high mNSCLC
  • SCLC:
    • PharmaMar announced the completion of enrollment in the P3 LAGOON trial of lurbinectedin (alkylating agent) +/- irinotecan vs irinotecan or topotecan in 2L SCLC
    • The EMA granted GSK’s GSK5764227 (B7-H3 ADC) PRIME designation for relapsed ES-SCLC based on data from the ongoing China P1 ARTEMIS-001 trial
  • TIGIT:
    • Merck announced the discontinuation of the vibostolimab (TIGIT) clinical development program after both P3 KEYVIBE-003 (vibo/pembro coform vs pembro in 1L PD-L1-high NSCLC) and P3 KEYVIBE-007 (vibo/pembro coform + chemo vs pembro + chemo in 1L PD-L1+ NSCLC) met futility criteria for OS and showed more irAEs in a pre-planned analysis
  • Upper GI:
    • BeiGene announced the FDA approval for tislelizumab (Tevimbra, anti-PD-1) combined with platinum-based chemotherapy in 1L HER2- G/GEJ for tumors that express PD-L1 (≥1%)
    • Vyloy (zolbetuximab, anti-CLDN18.2) has been added to Gastric Cancer and Esophageal and Esophageal Junction Cancers NCCN Guidelines Version 5.2024 as preferred regimen for 1L HER2-, CLDN18.2+ GC/GEJC
    • Zolbetuximab approved by China’s NMPA and Health Canada for 1L HER2-, CLDN18.2+ locally advanced unresectable or metastatic GC/GEJC
  • Endometrial
    • No major updates reported
  • UC:
    • Astellas announced China approval for enfortumab vedotin (EV/Padcev; nectin-4 ADC) + pembrolizumab (PD-1) for the treatment of 1L la/mUC
    • Bicycle Therapeutics shared updated data from P1/2 Duravelo-1 of BT8009 (Nectin-4 Bicycle Toxin Conjugate) in 2L+ mUC, and guided dose selection and topline data from P2/3 Duravelo-2 (BT8009 + pembro in 1L la/mUC or BT8009 +/- pembro in 2L la/mUC) in H2 2025
Tags:
Grazie per il tuo feedback!