Roche Announces Data On Perjeta, Alecensa And Tecentriq
Zacks Investment Research | Jun 06, 2017 06:11AM ET
Roche Holdings AG (OTC:RHHBY) announced data from the phase III study, APHINITY, on breast cancer drug Perjeta. The data from the study showed that the combination of Perjeta, Herceptin and chemotherapy (the Perjeta-based regimen) significantly reduced the risk of breast cancer recurrence or death (invasive disease-free survival; iDFS) by 19% in patients suffering from HER2-positive early breast cancer (eBC) compared with Herceptin and chemotherapy alone.
94.1% of people treated with the Perjeta-based regimen did not experience the recurrence of cancer compared with 93.2% treated with Herceptin and chemotherapy at the end of three years. The results will be presented in an oral session today at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO).
We remind investors that Roche has a strong presence in the oncology market. The company dominates the breast cancer space with strong demand for HER2 franchise drugs like Herceptin, Perjeta and Kadcyla.
However, competition is becoming stiff in the breast cancer market with companies like Novartis (NYSE:NVS) getting a boost with approval of new drugs like Kisqali.
Pfizer Inc. (NYSE:PFE) also announced data from its phase II study, ABRAZO, which is evaluating talazoparib in advanced breast cancer patients with germline BRCA 1/2 positive (gBRCA+) mutations, showing anti-tumor activity at the ASCO.
Roche’s share price shows that the company has outperformed the Zacks classified industry year to date. The stock is up 14.6% compared with the Large Cap Pharmaceuticals industry’s gain of 10.8%.
Coming back to the ASCO meet, Roche also announced positive data from the phase III study, ALEX, on lung cancer drug Alecensa. The data from the study showed that Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by more than half (53%) compared with crizotinib when given as initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The primary endpoint of the study was not reached.
Alecensa lowered the risk of tumour spread or growth in the brain or central nervous system. We note that Alecensa is approved as a monotherapy for patients suffering from ALK-positive NSCLC who have progressed on or are intolerant to crizotinib in Europe and the U.S.
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Alecensa was granted conditional marketing authorisation in Feb 2017 in the EU as a monotherapy for patients suffering from ALK-positive advanced NSCLC previously treated with crizotinib. Hence, Roche is submitting the data from the ALEX study as the specific obligation to obtain full approval of Alecensa as an initial treatment for ALK-positive advanced NSCLC.
New drug launches, such as Tecentriq, Cotellic and Alecensa boosted sales and are expected to continue to do so in the upcoming quarters.
Earlier, Roche also presented new encouraging data on immunotherapy drug Tecentriq along with updates from its cancer immunotherapy development program at ASCO 2017.
Data from a study on Tecentriq plus Avastin in metastatic Renal Cell Carcinoma (mRCC) highlight the combination’s potential to increase infiltration (trafficking) of T-cells into tumors and other immune-modulatory properties.
Alongside, two phase Ib studies in melanoma combining Tecentriq plus Cotelic and Tecentriq plus Cotellic plus Zelboraf showed that the addition of Zelboraf and/or Cotellic may alter the tumor micro environment, enhancing the anti-tumor activity of Tecentriq.
Immuno-oncology is a key focus area for Roche, with the company currently having multiple candidates under development. The FDA granted accelerated approval to immuno-oncology drug, 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.
Zacks Rank & Key Pick
Roche currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the health care sector is VIVUS, Inc. (NASDAQ:VVUS) . The stock currently sports a Zacks Rank #1 (Strong Buy). You can see .
VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company posted positive earnings surprises in each of the trailing four quarters, with an average beat of 233.69%.
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