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Roche's Tecentriq Gets Breakthrough Therapy Status for HCC
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Roche Holding AG (RHHBY - Free Report) announced that the FDA has granted breakthrough therapy designation to its immuno-oncology drug, Tecentriq, in combination with Avastin for the first-line treatment of advanced hepatocellular carcinoma (HCC).
The breakthrough status was based on positive data from a phase Ib study, which evaluated the safety and clinical activity of the Tecentriq and Avastin combination.
We note that the breakthrough therapy designation from the FDA is expected to speed up the development and review of drugs, intended to treat serious or life-threatening diseases.
This data was produced at the American Society of Clinical Oncology (ASCO) Annual Meeting, in June 2018. The data showed that after a median follow up of 10.3 months, responses (independent review facility (IRF) per RECIST v1.1) were seen in 15 (65 percent) of 23 efficacy-evaluable patients.
However, median progression free survival (PFS), duration of response (DOR), time to progression (TTP) and overall survival (OS) were not met after a median follow up of 10.3 months. Of the total number of patients (n=43) enrolled in the study, 28% experienced grade 3-4 treatment-related adverse events. No treatment-related grade 5 adverse events were observed in any of the patients. Per the FDA’s request, Roche provided additional safety data to gain this breakthrough therapy designation.
This is the 22nd breakthrough therapy designation for Roche’s portfolio of medicines and the third for Tecentriq.
Earlier this year, Roche initiated IMbrave150 (NCT03434379), an open-label, multicentre, phase III study, investigating the combination of Tecentriq and Avastin versus Nexavar (sorafenib) in patients who previously did not receive treatment for first-line unresectable or metastatic HCC. The study is currently under evaluation.
Tecentriq is also being studied for advanced triple negative breast cancer (TNBC) in combination with chemotherapy drug, Abraxane, as an initial (first-line) treatment. In a separate study, it is also being evaluated for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with chemotherapy (carboplatin and etoposide).
We note that Exelixis, Inc. (EXEL - Free Report) is also evaluating cabozantinib for the treatment of advanced HCC.
Notably, in October 2016, Tecentriq became the first and only anti-PDL1 cancer immunotherapy to be approved by the FDA for the treatment of metastatic non-small cell lung cancer (NSCLC).
Shares of Roche have decreased 8% over a year compared with the industry's decline of 1.7%.
Vanda Pharmaceuticals’ earnings estimates have been revised 11.1% upward for 2018 and 3.9% for 2019 over the past 60 days. The stock has surged 33.9% so far this year.
Illumina’s earnings estimates have been revised 0.8% upward for 2018 and 0.7% for 2019 over the past 60 days. The stock has surged 39.8% so far this year.
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Roche's Tecentriq Gets Breakthrough Therapy Status for HCC
Roche Holding AG (RHHBY - Free Report) announced that the FDA has granted breakthrough therapy designation to its immuno-oncology drug, Tecentriq, in combination with Avastin for the first-line treatment of advanced hepatocellular carcinoma (HCC).
The breakthrough status was based on positive data from a phase Ib study, which evaluated the safety and clinical activity of the Tecentriq and Avastin combination.
We note that the breakthrough therapy designation from the FDA is expected to speed up the development and review of drugs, intended to treat serious or life-threatening diseases.
This data was produced at the American Society of Clinical Oncology (ASCO) Annual Meeting, in June 2018. The data showed that after a median follow up of 10.3 months, responses (independent review facility (IRF) per RECIST v1.1) were seen in 15 (65 percent) of 23 efficacy-evaluable patients.
However, median progression free survival (PFS), duration of response (DOR), time to progression (TTP) and overall survival (OS) were not met after a median follow up of 10.3 months. Of the total number of patients (n=43) enrolled in the study, 28% experienced grade 3-4 treatment-related adverse events. No treatment-related grade 5 adverse events were observed in any of the patients. Per the FDA’s request, Roche provided additional safety data to gain this breakthrough therapy designation.
This is the 22nd breakthrough therapy designation for Roche’s portfolio of medicines and the third for Tecentriq.
Earlier this year, Roche initiated IMbrave150 (NCT03434379), an open-label, multicentre, phase III study, investigating the combination of Tecentriq and Avastin versus Nexavar (sorafenib) in patients who previously did not receive treatment for first-line unresectable or metastatic HCC. The study is currently under evaluation.
Tecentriq is also being studied for advanced triple negative breast cancer (TNBC) in combination with chemotherapy drug, Abraxane, as an initial (first-line) treatment. In a separate study, it is also being evaluated for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with chemotherapy (carboplatin and etoposide).
We note that Exelixis, Inc. (EXEL - Free Report) is also evaluating cabozantinib for the treatment of advanced HCC.
Notably, in October 2016, Tecentriq became the first and only anti-PDL1 cancer immunotherapy to be approved by the FDA for the treatment of metastatic non-small cell lung cancer (NSCLC).
Shares of Roche have decreased 8% over a year compared with the industry's decline of 1.7%.
Roche currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the pharma sector include Vanda Pharmaceuticals Inc. (VNDA - Free Report) and Illumina, Inc. (ILMN - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda Pharmaceuticals’ earnings estimates have been revised 11.1% upward for 2018 and 3.9% for 2019 over the past 60 days. The stock has surged 33.9% so far this year.
Illumina’s earnings estimates have been revised 0.8% upward for 2018 and 0.7% for 2019 over the past 60 days. The stock has surged 39.8% so far this year.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>