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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
