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Roche's Breast Cancer Study Meets Co-Primary Endpoint

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Roche (RHHBY - Free Report) announced that the phase III study, IMpassion130, evaluating combination of Tecentriq (atezolizumab)  and chemotherapy (Abraxane/nab-paclitaxel) compared with placebo in combination with nab-paclitaxel in patients with locally advanced or metastatic triple negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC) met its co-primary endpoint of progression-free survival (PFS).

The results demonstrated that combination of Tecentriq plus chemotherapy significantly reduced the risk of disease worsening or death (PFS) in PD-L1 positive population with metastatic or unresectable locally advanced TNBC. Overall survival (OS) is encouraging in the PD-L1 positive population at this interim analysis.

Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.

IMpassion130 is the first positive Phase III immunotherapy study in TNBC. Currently, Roche is conducting seven phase III studies investigating Tecentriq in TNBC. The company plans to present the results at an upcoming medical meeting and also submit these results to the FDA and the European Medicines Agency (EMA).

Year to date, shares of Roche have declined 12.7% compared with the industry’s decline of 5.1%.

We note that, Tecentriq is an important contributor to Roche’s revenues. IT is an immune oncology drug and The FDA granted accelerated approval to Tecentriq in May 2016 for the treatment of patients suffering from locally advanced or metastatic urothelial carcinoma. Initial uptake of the drug has been encouraging. In Oct 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). The drug has also been approved in Europe.

 

Zacks Rank & Stocks to Consider

Roche has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same space are Illumina, Inc. (ILMN - Free Report) , Aeglea BioTherapeutics, Inc. (AGLE - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All of them carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Illumina’s earnings per share estimates have moved up from $4.83 to $4.86 for 2018 and from $5.57 to $5.61 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 23.17%. The stock has rallied 28.2% so far this year.

Aeglea’s loss per share estimates have narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 103.7% so far this year.

ANI Pharmaceuticals’earnings per share estimates have moved up from $5.54 to $5.70 for 2018 and from $5.72 to $6.15 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 8.69%. The stock has rallied 4.6% so far this year.

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