August 2021: Pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy has been approved by the Food and Drug Administration for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) carcinoma (tumours with epicentre 1 to 5 centimetres above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chlamy
Efficacy was assessed in the multicenter, randomised, placebo-controlled trial KEYNOTE-590 (NCT03189719), which involved 749 patients with metastatic or locally advanced esophageal or gastroesophageal junction cancer who were not candidates for surgical resection or final chemoradiation. The PD-L1 IHC 22C3 pharmDx kit was used to assess PD-L1 status in tumour specimens from all patients. Until intolerable toxicity or disease progression, patients were randomised (1:1) to pembrolizumab in combination with cisplatin and fluorouracil or placebo with cisplatin and fluorouracil.
Overall survival (OS) and progression-free survival (PFS) were the primary efficacy end measures, as determined by the investigator using RECIST 1.1. (modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ). Patients who were randomised to pembrolizumab with chemotherapy had a statistically significant improvement in OS and PFS. The median OS for the pembrolizumab group was 12.4 months (95 percent confidence interval: 10.5, 14.0), compared to 9.8 months (95 percent confidence interval: 8.8, 10.8) for the chemotherapy arm (HR 0.73; 95 percent confidence interval: 0.62, 0.86; p0.0001). PFS was 6.3 months (95 percent confidence interval: 6.2, 6.9) and 5.8 months (95 percent confidence interval: 5.0, 6.0), respectively (HR 0.65; 95 percent confidence interval: 0.55, 0.76; p0.0001).
Nausea, constipation, diarrhoea, vomiting, stomatitis, fatigue/asthenia, decreased appetite, and weight loss were the most prevalent side effects observed in approximately 20% of patients who received the pembrolizumab combination in KEYNOTE-590.
For esophageal cancer, a dose of 200 mg every three weeks or 400 mg every six weeks is indicated.
Reference : https://www.fda.gov/
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Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.
Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.
Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.
Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.
These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.
Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.
