The Swiss Roche Group announced yesterday that TECENTRIQ® (atezolizumab) in combination with Avastin® (bevacizumab) has been approved by the US Food and Drug Administration (FDA) for breakthrough therapy for initial (first-line) treatment of advanced or metastatic liver Patients with cell carcinoma (HCC).
HCC is the most common type of primary liver cancer . This breakthrough therapy is based on the results of a Phase Ib study on the safety and clinical activity of TECENTRIQ combined with Avastin.
Dr. Sandra Horning, Roche’s chief medical officer and head of global product development, said: Hepatocellular carcinoma, as a malignant tumor, has limited treatment options and is the leading cause of death worldwide. Preliminary data on the treatment of this disease with TECENTRIQ and Avastin is promising. We look forward to cooperating with the health department to bring this highly promising treatment plan to patients with hepatocellular carcinoma as soon as possible.
Breakthrough Therapy Designation (BTD) aims to accelerate the development and review of new drugs for the treatment of serious or life-threatening diseases to ensure that these drugs are approved by FDA as soon as possible to benefit patients. This is not only the 22nd BTD obtained by Roche’s pharmaceutical product line, but also the 3rd BTD obtained by TECENTRIQ.
The Roche Group published data from the Phase Ib study of hepatocellular carcinoma at the American Society of Clinical Oncology (ASCO) annual meeting in June 2018. The results of the study showed that after a median follow-up of 10.3 months, remission was observed in 15 (65%) of 23 evaluable patients.
After a median follow-up of 10.3 months, the median progression-free survival (PFS), duration of remission (DOR), disease progression time (TTP), and overall survival (OS) were not reached. Of the safety-evaluable patients (n = 43), 28% (n = 12) experienced grade 3-4 treatment-related adverse events, and no treatment-related grade 5 adverse events were observed.
Roche has provided additional data in accordance with FDA requirements, and has been granted a breakthrough therapy qualification. After obtaining updated data from follow-up trials, Roche will publish the research results at a future medical conference.
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.
