Roche RHHBY announced that the FDA has approved its cancer immunotherapy regimen, Tecentriq plus Avastin for the treatment of patients with unresectable hepatocellular carcinoma (“HCC”) who have not received prior systemic therapy. The application was based on the results of the phase III IMbrave150 study.
Data from the study had shown that treatment of patients with Tecentriq combo regimen in the IMbrave150 study reduced the risk of death and risk of disease worsening or death by 42% and 41%, respectively, compared to patients treated with Bayer’s BAYRY liver cancer drug, Nexavar.
Hepatocellular carcinoma, the most common form of liver cancer, is an aggressive disease as more than 750,000 people worldwide are diagnosed with it every year. The label expansion in the promising HCC space will boost sales of the drug.
Tecentriq is approved in the United States and the EU either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and PD-L1-positive metastatic triple-negative breast cancer. Roche has an extensive development program for Tecentriq, including multiple ongoing and planned phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.The program includes studies evaluating the drug as monotherapy as well as in combination with other drugs.
Roche’s shares have increased 7.7% in the past year against the industry's 1.7% decline.
While the uptake of Tecentriq has been strong, it is currently facing stiff competition from immuno-oncology therapies like Merck’s MRK Keytruda and Bristol-Myers’ BMY Opdivo in various indications. These two drugs are already approved for liver cancer.
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