Articles

  • Jan 25, 2025 | nature.com | Scott Kopetz |Takayuki Yoshino |Eric Van Cutsem |Cathy Eng |Harpreet Wasan |Jayesh Desai | +9 more

    Encorafenib + cetuximab (EC) is approved for previously treated BRAF V600E-mutant metastatic colorectal cancer (mCRC) based on the BEACON phase 3 study. Historically, first-line treatment of BRAF V600E-mutant mCRC with chemotherapy regimens has had limited efficacy. The phase 3 BREAKWATER study investigated EC+mFOLFOX6 versus standard of care (SOC) in patients with previously untreated BRAF V600E mCRC. The dual primary endpoint of progression-free survival is event driven; data were not mature at data cutoff. BREAKWATER met the other dual primary endpoint of objective response rate, demonstrating significant and clinically relevant improvement in objective response rate (EC+mFOLFOX6: 60.9%; SOC: 40.0%; odds ratio, 2.443; 95% confidence interval (CI): 1.403–4.253; 99.8% CI: 1.019–5.855; one-sided P = 0.0008). Median duration of response was 13.9 versus 11.1 months. At this first interim analysis of overall survival, the hazard ratio was 0.47 (95% CI: 0.318–0.691; repeated CI: 0.166–1.322). Serious adverse event rates were 37.7% versus 34.6%. The safety profiles were consistent with those known for each agent. BREAKWATER demonstrated a significantly improved response rate that was durable for first-line EC+mFOLFOX6 versus SOC in patients with BRAF V600E mCRC. ClinicalTrials.gov identifier: NCT04607421 . As presented at the 2025 ASCO GI Cancers Symposium: in the phase 3 BREAKWATER trial, patients with previously untreated BRAF V600E metastatic colorectal cancer received the BRAF inhibitor encorafenib, the anti-EGFR monoclonal antibody cetuximab and chemotherapy mFOLFOX6 versus investigator’s choice of chemotherapy with or without bevacizumab, leading to an improved objective response rate, with the dual primary endpoint of progression free survival still maturing.

  • Nov 13, 2024 | acsjournals.onlinelibrary.wiley.com | Jayesh Desai |Andrew Wagner |Irene García |Marilena Cesari

    INTRODUCTION Tenosynovial giant cell tumor (TGCT) is a rare, nonmalignant mesenchymal tumor of the synovium, bursae, or tendon sheaths that is driven by overexpression of colony-stimulating factor-1 (CSF-1).1-3 Surgery is the primary treatment for patients with TGCT when complete tumor resection is feasible; however, given the high frequency of disease recurrence, particularly in the diffuse subtype, patients may benefit from systemic therapy when surgical options are limited.2, 4...

  • Sep 23, 2024 | nature.com | Scott Kopetz |Fortunato Ciardiello |Jayesh Desai |Takayuki Yoshino |Tao Xie |Rona Yaeger

    AbstractThe BEACON CRC study demonstrated that encorafenib (Enco)+cetuximab (Cetux)±binimetinib (Bini) significantly improved overall survival (OS) versus Cetux + chemotherapy in previously treated patients with BRAF-V600E-mutant mCRC, providing the basis for the approval of the Enco+Cetux regimen in the United States and the European Union. A greater understanding of biomarkers predictive of response to Enco+Cetux±Bini treatment is of clinical relevance.

  • Jan 23, 2024 | mdpi.com | Eden C. Andrew |Jeremy Lewin |Jayesh Desai |Lisa Orme

    All articles published by MDPI are made immediately available worldwide under an open access license. No specialpermission is required to reuse all or part of the article published by MDPI, including figures and tables. Forarticles published under an open access Creative Common CC BY license, any part of the article may be reused withoutpermission provided that the original article is clearly cited. For more information, please refer tohttps://www.mdpi.com/openaccess.

  • Jul 19, 2023 | onclive.com | Jayesh Desai

    Jayesh Desai, MBBS, FRACP, medical oncologist, associate professor, head, Phase I/Early Drug Development Program, associate director, Clinical Research, Peter MacCallum Cancer Centre, chair, the Sir Peter MacCallum Department of Oncology, the University of Melbourne, discusses the evolution of divarasib (formerly GDC-6036), highlighting the rationale for combining the KRAS G12C inhibitor with cetuximab (Erbitux) in patients with advanced colorectal cancer (CRC) harboring KRAS G12C mutations...

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