Roche RHHBY announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion to the combination of immuno-oncology drug, Tecentriq (atezolizumab), and Avastin (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) or liver cancer.
The CHMP has recommended the approval of the combination for HCC patients who have not received prior systemic therapy.
While the European Commission (EC) is not bound by the CHMP recommendation, it generally takes the same into account.
The recommendation from the CHMP was based on positive results from the phase III IMbrave150 study, which showed that Tecentriq in combination with Avastin reduced the risk of death by 42% and the risk of disease worsening or death by 41% compared with Bayer’s BAYRY Nexavar in patients with unresectable HCC.
We note that the combination is already approved in the United States for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.
A potential approval in Europe will augment the sales potential of the combination.
We remind investors that Exelixis’ EXEL Cabometyx and Bristol Myers Squibb Company’s BMY Opdivo in combination with Yervoy are also approved for the treatment for patients with HCC who have been previously treated with Nexavar.
Tecentriq is already 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 lung cancer, small cell lung cancer, certain types of metastatic urothelial cancer and in PD-L1-positive metastatic triple-negative breast cancer (TNBC).
Moreover, Roche is currently evaluating Tecentriq in multiple ongoing phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.
Separately, Roche presented results from three phase III studies on Tecentriq in TNBC. Data from the phase III IMpassion031 study demonstrated that Tecentriq in combination with chemotherapy improved pathological complete response for patients with early TNBC when compared to placebo plus chemotherapy.
The final overall survival data from the phase III IMpassion130 study were consistent with prior interim analyses in patients with metastatic TNBC.
However, results from the phase III IMpassion131 study, evaluating Tecentriq in combination with paclitaxel for the treatment of people with metastatic TNBC and whose tumors expressed PD-L1, did not meet its primary endpoint of progression-free survival.
Roche’s stock has gained 15.2% in the year so far compared with the industry’s growth of 1.8%.
The company is a leader in the oncology space and approval of new drugs will further strengthen its portfolio. Last month, the FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children aged two months and above. The FDA also approved the company’s pipeline drug, satralizumab-mwge, as the first and the only subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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