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Roche Presents Encouraging Data on Actemra and Tecentriq
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Roche Holding AG (RHHBY - Free Report) announced positive results from the phase III study, GiACTA, on arthritis drug, Actemra/RoActemra.
The study met its primary and key secondary endpoints as data showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, was more effective in sustaining remission through one year as compared to a 6- or 12-month steroid-only regimen in people with newly diagnosed and relapsing giant cell arteritis (GCA).
Given that high-dose steroids are the mainstay treatment for GCA despite being associated with serious adverse effects, an approval for Actemra would provide much needed alternative to patients with GCA.
We note that Actemra is currently approved for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA) in both intravenous and subcutaneous formulations.
Roche’s immunology portfolio currently comprises drugs like MabThera/Rituxan and Actemra for RA, Xolair for asthma, Pulmozyme for cystic fibrosis and Esbriet for idiopathic pulmonary fibrosis (IPF), along with a promising pipeline that includes etrolizumab for inflammatory bowel disease, and lebrikizumab for severe asthma, atopic dermatitis and IPF.
Roche also announced that its immune-oncology, Tecentriq (atezolizumab), was effective in shrinking tumors in patients with previously untreated advanced bladder cancer, as observed in a phase II study, IMvigor210.
Last month, the drug was granted accelerated approval by the FDA for the treatment of locally advanced or metastatic urothelial carcinoma.
Roche presented additional data on Tecentriq at the 52nd Annual Meeting of the American Society of Clinical Oncology. Initial data on Tecentriq, in combination with Exelixis’ (EXEL - Free Report) Cotellic, showed that the drug was well tolerated, with responses observed regardless of the Programmed Death Ligand-1 (PD-L1) expression in patients suffering from advanced colorectal cancer in a phase Ib study.
A phase Ib study among patients with triple-negative breast cancer (mTNBC) showed that Tecentriq in combination with Abraxane chemotherapy showed durable responses occurring across all lines of therapy. The safety profile was similar to that previously seen with Tecentriq or Abraxane chemotherapy alone. A dose finding study of Tecentriq in combination with anti-OX40 treatment (MOXR0916) showed a favorable safety profile and evidence of immune activation in an ongoing phase Ib study.
Roche also presented updated survival data from the phase II study POPLAR on Tecentriq in patients with previously treated advanced non-small cell lung cancer (NSCLC), wherein the drug showed an increasing overall survival benefit in patients.
We remind investors that the FDA has accepted the company’s Biologics License Application (BLA) and granted priority review to Tecentriq for the treatment of patients with locally advanced or metastatic NSCLC, whose disease expresses the protein PD-L1 as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy. A decision by the FDA is expected by Oct 19, 2016.
We expect investors to focus on new drug approvals at Roche, as the company’s top line could be marred by the entry of biosimilars for its key drugs (expected in the second half of 2017 in Europe) like MabThera and Herceptin.
Roche currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Pfizer Inc. (PFE - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
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Roche Presents Encouraging Data on Actemra and Tecentriq
Roche Holding AG (RHHBY - Free Report) announced positive results from the phase III study, GiACTA, on arthritis drug, Actemra/RoActemra.
The study met its primary and key secondary endpoints as data showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, was more effective in sustaining remission through one year as compared to a 6- or 12-month steroid-only regimen in people with newly diagnosed and relapsing giant cell arteritis (GCA).
Given that high-dose steroids are the mainstay treatment for GCA despite being associated with serious adverse effects, an approval for Actemra would provide much needed alternative to patients with GCA.
We note that Actemra is currently approved for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA) in both intravenous and subcutaneous formulations.
Roche’s immunology portfolio currently comprises drugs like MabThera/Rituxan and Actemra for RA, Xolair for asthma, Pulmozyme for cystic fibrosis and Esbriet for idiopathic pulmonary fibrosis (IPF), along with a promising pipeline that includes etrolizumab for inflammatory bowel disease, and lebrikizumab for severe asthma, atopic dermatitis and IPF.
Roche also announced that its immune-oncology, Tecentriq (atezolizumab), was effective in shrinking tumors in patients with previously untreated advanced bladder cancer, as observed in a phase II study, IMvigor210.
Last month, the drug was granted accelerated approval by the FDA for the treatment of locally advanced or metastatic urothelial carcinoma.
Roche presented additional data on Tecentriq at the 52nd Annual Meeting of the American Society of Clinical Oncology. Initial data on Tecentriq, in combination with Exelixis’ (EXEL - Free Report) Cotellic, showed that the drug was well tolerated, with responses observed regardless of the Programmed Death Ligand-1 (PD-L1) expression in patients suffering from advanced colorectal cancer in a phase Ib study.
A phase Ib study among patients with triple-negative breast cancer (mTNBC) showed that Tecentriq in combination with Abraxane chemotherapy showed durable responses occurring across all lines of therapy. The safety profile was similar to that previously seen with Tecentriq or Abraxane chemotherapy alone. A dose finding study of Tecentriq in combination with anti-OX40 treatment (MOXR0916) showed a favorable safety profile and evidence of immune activation in an ongoing phase Ib study.
Roche also presented updated survival data from the phase II study POPLAR on Tecentriq in patients with previously treated advanced non-small cell lung cancer (NSCLC), wherein the drug showed an increasing overall survival benefit in patients.
We remind investors that the FDA has accepted the company’s Biologics License Application (BLA) and granted priority review to Tecentriq for the treatment of patients with locally advanced or metastatic NSCLC, whose disease expresses the protein PD-L1 as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy. A decision by the FDA is expected by Oct 19, 2016.
We expect investors to focus on new drug approvals at Roche, as the company’s top line could be marred by the entry of biosimilars for its key drugs (expected in the second half of 2017 in Europe) like MabThera and Herceptin.
Roche currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Pfizer Inc. (PFE - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>