Lawsuit Update Center
Roche recently unveiled results from a Phase 3 trial of Tecentriq for early-stage liver cancer. The study looked at the use of Tecentriq and Avastin. These two drugs work together to target and destroy cancer cells in the body. Tecentriq strengthens the immune system to fight cancer cells, while Avastin prevents the growth of new blood vessels that supply the tumor with nutrients to grow. The manufacturer of both drugs, Genentech, has indicated that the combination appears to reduce the risk of liver cancer recurrence.
The Tecentriq and Avastin combination reduced the risk of disease recurrence or death by 28% when compared to active surveillance after surgery. These results were presented at the American Association for Cancer Research’s 2023 annual meeting are wildly encouraging and wildly concerning – all at the same time.
Early Stage Liver Cancer
Early-stage liver cancer is the growth of malignant cells in the liver that have not spread beyond the liver or nearby lymph nodes. The causes of early-stage liver cancer are not fully understood, but risk factors include chronic hepatitis B or C infection, alcohol abuse, fatty liver disease, diabetes, obesity, exposure to certain chemicals, and a family history of liver cancer.
In its early stages, liver cancer may not cause noticeable symptoms. However, as cancer progresses, symptoms may include abdominal pain, loss of appetite, unintentional weight loss, fatigue, jaundice, swelling of the abdomen, nausea and vomiting, and an enlarged liver.
Early-stage liver cancer is often diagnosed during routine imaging tests, such as an ultrasound, CT scan, or MRI, that are performed for other reasons. If liver cancer is suspected, your doctor may order further tests, such as a liver biopsy, to confirm the diagnosis.
The treatment options for early-stage liver cancer depend on several factors, including the size and location of the tumor, as well as the overall health of the patient. Surgery is often the preferred treatment for early-stage liver cancer. During surgery, the tumor and a portion of the liver surrounding the tumor are removed. In some cases, a liver transplant may be recommended. Ablation therapy, embolization therapy, and radiation therapy may also be used.
The prognosis for early-stage liver cancer is generally good, with a five-year survival rate of up to 70%. However, the prognosis depends on several factors, including the size and location of the tumor, as well as the overall health of the patient. Early detection and treatment of liver cancer can improve the chances of successful treatment and improve outcomes.
What Is a Phase III Trial?
A Phase III clinical trial is the final stage of testing in the development of a new drug or treatment before it can be submitted to regulatory agencies for approval. These trials are typically randomized and double-blinded, meaning that participants are assigned randomly to either the experimental treatment or a control group (such as a placebo or standard treatment), and neither the participants nor the researchers know who is receiving which treatment.
Phase III trials involve larger groups of participants than Phase I or Phase II trials and can last several years. The goal of Phase III trials is to evaluate the effectiveness and safety of the treatment on a larger scale and to confirm the results of earlier trials. The data collected in these trials are then submitted to regulatory agencies for review and, if approved, the treatment can be made available to the public.
Increased Risk of Death in Early Evaluation
Many were wildly encouraged by these findings. The IMbrave050 study was praised as a landmark trial, as it was the first to demonstrate any efficacy for adjuvant treatment in liver cancer. The results have established a benchmark in adjuvant therapy for HCC and have the potential to change clinical practice because no other Phase III study has showm a cancer immunotherapy combo reduced risk of disease recurrence for early-stage hepatocellular carcinoma. This is a big deal and it may harbinger a new path to save lives from liver cancer.
But early evaluation of patients’ life expectancy associated the Tecentriq-Avastin combination with a 42% increased risk of death. The overall survival analysis was deemed immature, as “only” 7% of the trial population had died at that point.
Comparison to Other Immuno-Oncology Drugs
Checkpoint inhibitors, like Tecentriq, have shown impressive efficacy in treating various cancer types. Other drugs in this category, such as Opdivo and Keytruda, have demonstrated success in treating non-small cell lung cancer, melanoma, and kidney cancer. However, these drugs have their own problems and have been linked to immune-related adverse events, including colitis, hepatitis, and pneumonitis.
Safety Profile of Tecentriq-Avastin Combination
The safety profile of the Tecentriq-Avastin combination in the phase 3 IMbrave050 trial appeared to be on par with, or even better than, its performance in the earlier IMbrave150 trial. In the IMbrave150 trial, six treatment-related deaths (1.8%) occurred, and the study tracked a 38% rate of serious side effects from the combination, with 17% related to treatment. So there is a lot of promise. Still, these deaths are concerning and Roche will likely to need to set forth longer-term safety and efficacy data before attempting to get FDA approval.
