Pivotal Phase III IMbrave050 study investigating Tecentriq plus Avastin in people with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence following surgery met primary endpoint of recurrence-free survival
New adjuvant treatments are urgently needed as an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery
Data will be discussed with health authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency, to inform the next regulatory steps and presented at an upcoming medical meeting
SOUTH SAN FRANCISCO, CA, USA I January 18, 2023 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMbrave050 study met its primary endpoint of recurrence-free survival (RFS) at the prespecified interim analysis. The study is evaluating Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as adjuvant treatment following surgery for people with early-stage hepatocellular carcinoma (HCC) at high risk of disease recurrence. The Tecentriq combination showed a statistically significant improvement in RFS in the intention-to-treat population of HCC patients who have an increased risk of recurrence following resection or ablation with curative intent, compared with active surveillance.
Overall survival data were immature at the time of interim analysis and follow-up will continue to the next analysis. Safety for Tecentriq and Avastin was consistent with the known safety profile of each therapeutic agent and with the underlying disease. Results from the IMbrave050 study will be discussed with health authorities, including the U.S. Food and Drug Administration and the European Medicines Agency, and presented at an upcoming medical meeting.
“Today, more than 70% of people with early-stage HCC may have their cancer return after surgery, which is associated with poorer prognosis and shorter survival. IMbrave050 is the first Phase III study to show that a cancer immunotherapy combination reduced the risk of disease returning in people with this type of HCC,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are excited by the clinical benefit that this adjuvant Tecentriq combination may bring to people with early liver cancer and look forward to seeing more mature data to further confirm the benefit.”
With liver cancer incidence increasing and mortality rates rising globally, effective treatments are urgently required. Genentech is working in partnership with the community and leveraging its diagnostic and pharmaceutical expertise to develop solutions for patients that address unmet needs at each stage of liver cancer. IMbrave050 is part of Genentech’s overall commitment to drive fundamental treatment change and improve outcomes for people living with liver cancer. In unresectable HCC (uHCC), for example, Tecentriq plus Avastin was the first treatment in over a decade to significantly improve overall survival over the existing standard of care, based on data from the IMbrave150 study. The Tecentriq combination quickly became a standard of care in uHCC and is clearly defined as a preferred front-line treatment in multiple international clinical guidelines.
Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumor types.
About the IMbrave050 study
IMbrave050 is a Phase III global, multicenter, open-label, randomized study evaluating the efficacy and safety of adjuvant Tecentriq plus Avastin, compared with active surveillance, in people with HCC at high risk of recurrence (determined by the size and number of cancerous lesions and the histopathology results, if available) after surgical resection or ablation with curative intent.
The study randomized 662 people with a ratio of 1:1 to receive either Tecentriq (1,200 mg every three weeks) plus Avastin (15 mg/kg every three weeks) for a maximum of 12 months, or no intervention with active surveillance. The primary endpoint is independent review facility-assessed RFS. Key secondary endpoints include overall survival, RFS as determined by the investigator and RFS in patients with PD-L1-positive disease.
About hepatocellular carcinoma
According to the American Cancer Society, it is estimated that nearly 42,000 Americans were diagnosed with liver cancer in 2022. Liver cancer incidence has more than tripled since 1980. Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these conditions.
If diagnosed in the early stage, surgery may be prescribed to remove the primary tumor, however an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery. Early recurrence is associated with poorer prognosis and shorter survival. Tumor size, number of tumors, and portal vein invasion are associated with an increased risk of recurrence.
About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
About Avastin® (bevacizumab)
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor’s ability to grow and spread in the body (metastasize).
Tecentriq U.S. Indications
Tecentriq is a prescription medicine used to treat:
Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
- Tecentriq may be used alone as a treatment for their lung cancer:
- to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and
- they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and
- their cancer tests positive for “PD-L1.”
- Tecentriq may be used alone as their first treatment when their lung cancer:
- has spread or grown, and
- their cancer tests positive for “high PD-L1,” and
- their tumor does not have an abnormal “EGFR” or “ALK” gene.
- Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer:
- has spread or grown, and
- is a type called “non-squamous NSCLC,” and
- their tumor does not have an abnormal “EGFR” or “ALK” gene.
- Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer:
- has spread or grown, and
- is a type called “non-squamous NSCLC,” and
- their tumor does not have an abnormal “EGFR” or “ALK” gene.
- Tecentriq may be used alone when their lung cancer:
- has spread or grown, and
- if they have tried chemotherapy that contains platinum, and it did not work or is no longer working.
- if their tumor has an abnormal “EGFR” or “ALK” gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
Adults with a type of lung cancer called small cell lung cancer (SCLC). Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as their first treatment when their lung cancer:
- is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown.
Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq may be used with the medicine bevacizumab when their liver cancer:
- has spread or cannot be removed by surgery, and
- they have not received other medicines by mouth or injection through their vein (IV) to treat their cancer.
Adults with a type of skin cancer called melanoma. Tecentriq may be used with the medicines cobimetinib and vemurafenib in patients with melanoma when their skin cancer:
- has spread to other parts of the body or cannot be removed by surgery, and
- has a certain type of abnormal “BRAF” gene. Healthcare providers will perform a test to make sure this Tecentriq combination is right for the patient.
Adults and children 2 years of age and older with a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). Tecentriq may be used when your sarcoma:
- has spread to other parts of the body or cannot be removed by surgery.
It is not known if Tecentriq is safe and effective when used:
- in children younger than 2 years of age for the treatment of ASPS.
- in children for the treatment of NSCLC, SCLC, HCC or melanoma.
Please see http://www.Tecentriq.com for full Prescribing Information and additional Important Safety Information.
Avastin is approved for:
Avastin, in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.
About Genentech in cancer immunotherapy
Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.
In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit http://www.gene.com/cancer-immunotherapy.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech
