September 9, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Ivonescimab vs Pembrolizumab, Novocure's TTFields, Natera's Signatera™


  1. Ivonescimab monotherapy reduces risk of disease progression in advanced NSCLC
    • Phase III HARMONi-2 trial shows ivonescimab monotherapy significantly improves progression-free survival (PFS) compared to pembrolizumab in PD-L1 positive advanced NSCLC.
    • Ivonescimab demonstrated a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death.
    • Higher overall response rate (ORR) and disease control rate (DCR) observed with ivonescimab compared to pembrolizumab.
    • Ivonescimab showed a manageable safety profile with fewer treatment-related adverse events (TRAEs) leading to drug discontinuation compared to pembrolizumab.
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  2. Novel computational pathology-based TROP2 biomarker for datopotamab deruxtecan predictive in NSCLC
    • TROPION-Lung01 phase 3 trial showed TROP2-QCS biomarker was predictive of clinical outcomes in NSCLC patients treated with datopotamab deruxtecan.
    • Datopotamab deruxtecan demonstrated greater efficacy in TROP2-QCS biomarker positive tumors compared to docetaxel.
    • In TROP2-QCS positive patients, datopotamab deruxtecan reduced the risk of disease progression or death by 43% versus docetaxel.
    • No new safety concerns were identified, and rates of grade 3 or higher treatment-related adverse events were similar regardless of TROP2 status.
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  3. Akeso's ivonescimab head-to-head phase III data against pembrolizumab unveiled at WCLC 2024
    • Ivonescimab demonstrated a median progression-free survival (mPFS) of 11.15 months vs. 5.82 months with pembrolizumab in 1L PD-L1 positive advanced NSCLC.
    • Ivonescimab significantly reduced the risk of disease progression or death by 49% compared to pembrolizumab, with a PFS HR of 0.51 (P<0.0001).
    • The objective response rate (ORR) for ivonescimab was 50.0% vs. 38.5% for pembrolizumab, and the disease control rate (DCR) was 89.9% vs. 70.5%.
    • Ivonescimab showed significant clinical benefits in refractory patient populations, including those with liver and brain metastases.
    • Summit will initiate HARMONi-7, a phase III trial in 1L PD-L1 high advanced NSCLC, in early 2025.
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  4. Novocure to present real-world data at ESMO 2024 demonstrating improved survival outcomes for newly diagnosed glioblastoma patients with increased use of tumor treating fields therapy
    • Novocure will present a real-world analysis of TTFields therapy usage and survival outcomes in newly diagnosed glioblastoma (ndGBM) patients at ESMO 2024.
    • The analysis suggests higher TTFields therapy device usage is significantly associated with improved survival outcomes in ndGBM patients.
    • Presentation details: Poster #459, titled 'Association of Tumor Treating Fields Device Usage with Survival in Newly Diagnosed GBM: A Real-World Analysis of Patients in the US'.
    • Novocure has also sponsored an ESMO Colloquium on the role of alternating electric fields in treating advanced non-small cell lung cancer.
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  5. PureTech founded entity Vor Bio announces new clinical data validating approach of using shielded transplants to deliver targeted therapies
    • Vor Bio announced new clinical data from its ongoing Phase 1/2 VBP101 study of patients with relapsed/refractory AML receiving trem-cel followed by Mylotarg.
    • The data demonstrated reliable engraftment, shielding from Mylotarg on-target toxicity, a broadened Mylotarg therapeutic window, and early evidence of patient benefit.
    • Vor Bio plans to approach the U.S. FDA to discuss a pivotal trial design for trem-cel + Mylotarg by year-end.
    • Vor Bio also announced a new preclinical asset, VADC45, with potential opportunities in oncology, gene therapy, and autoimmune disorders.
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  6. Natera to present new Signatera colorectal cancer data at ESMO showing 10X advantage in overall survival
    • Natera will present new data on its Signatera MRD test at the 2024 ESMO Congress in Barcelona.
    • The GALAXY observational arm of the CIRCULATE-Japan trial includes over 2,100 patients with stage I-IV CRC.
    • Signatera-positive patients had significantly shorter overall survival (OS) compared to Signatera-negative patients, with a hazard ratio of ~10.
    • Additional presentations will cover new Signatera data in breast cancer and squamous cell carcinoma of the head and neck.
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  7. BeiGene highlights Tevimbra data in lung and gastrointestinal cancers at ESMO 2024
    • BeiGene will present new data for Tevimbra (tislelizumab) at ESMO 2024 in Barcelona, Spain.
    • Interim results from the RATIONALE-315 study show significant event-free survival (EFS) and overall survival (OS) benefits for neoadjuvant tislelizumab plus chemotherapy in resectable NSCLC.
    • Three-year overall survival data from RATIONALE-305 demonstrate long-term efficacy and safety of tislelizumab plus chemotherapy in advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC).
    • BeiGene recently launched Tevimbra in Germany, Austria, and Norway following EU marketing authorizations for ESCC and NSCLC.
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  8. Monalizumab data from NeoCOAST-2 phase 2 study in early-stage NSCLC presented at WCLC 2024
    • AstraZeneca presented interim results from the NeoCOAST-2 Phase 2 study at the 2024 World Conference on Lung Cancer.
    • The study assesses the safety and efficacy of neoadjuvant durvalumab alone or combined with novel agents and chemotherapy in resectable, early-stage NSCLC.
    • Preliminary data from Arm 2 showed monalizumab added to durvalumab and platinum-based chemotherapy induced a pathological complete response rate of 26.7% and a major pathological response rate of 53.3%.
    • Treatment in Arm 2 demonstrated a manageable safety profile with no impact on surgical rate.
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  9. Bristol Myers Squibb to present data at ESMO demonstrating ongoing leadership in immuno-oncology
    • Bristol Myers Squibb will present nearly 60 abstracts at the ESMO Congress 2024 in Barcelona, Spain.
    • Key data includes ten-year follow-up from the Phase 3 CheckMate –067 trial showing long-term survival benefits of Opdivo plus Yervoy in advanced melanoma.
    • Updates from Phase 3 trials like CheckMate -77T, -9DW, and -8HW will be presented, covering various cancers including NSCLC, uHCC, and mCRC.
    • New data from the Phase 2 RELATIVITY-104 trial and the initiation of the Phase 3 RELATIVITY-1093 trial will be discussed, focusing on NSCLC treatments.
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  10. C4 Therapeutics to present preliminary CFT1946 monotherapy phase 1 clinical data at ESMO Congress 2024
    • C4 Therapeutics will present preliminary data from its Phase 1 trial of CFT1946 at the ESMO Congress 2024.
    • The trial focuses on CFT1946, a BiDAC degrader targeting mutant BRAF V600 solid tumors.
    • Data from 36 patients will be shared, covering safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity.
    • The presentation is scheduled for September 13, 2024, at 4:10 pm CEST in Barcelona, Spain.
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