Roche Holding AG RHHBY has entered into collaboration with Amgen AMGN. The companies will jointly evaluate the safety and efficacy of Amgen's investigational oncolytic immunotherapy candidate talimogene laherparepvec in a phase I study in combination with Roche's investigational anti-PDL1 therapy, atezolizumab (also known as MPDL3280A), in patients with triple-negative breast cancer and colorectal cancer with liver metastases.
The companies expect the combination to activate an anti-tumor immune response with talimogene laherparepvec and to block inhibitory T-cell checkpoints with atezolizumab. Consequently, anti-tumor activity relative to each agent alone should increase. We note that Amgen is looking forward to build a position in the immuno-oncology sphere with this collaboration. Atezolizumab, on the other hand, is Roche’s most advanced cancer immunotherapy candidate, which is being studied in as many as 10 ongoing phase III trials in lung, bladder, breast and kidney cancers.
Earlier, Roche had announced a series of data from various studies. The company announced new results from a phase II study, NeoSphere, on breast cancer drugs at the 51st Annual Meeting of the American Society of Clinical Oncology held in Chicago. The study indicated that Perjeta in combination with Herceptin and docetaxel chemotherapy given prior to surgery reduced the risk of the disease deteriorating and increased the time patients lived without their cancer relapsing as compared to a Herceptin-chemotherapy combination in women suffering from HER2-positive early breast cancer (eBC).
Patients were randomized to one of four study arms in the NeoSphere trial and received four cycles (12 weeks) of neoadjuvant treatment followed by surgery and a year of adjuvant treatment with Herceptin plus chemotherapy. We note that the FDA granted accelerated approval of the Perjeta regimen for the neoadjuvant treatment in patients with high-risk, HER2-positive eBC in 2013. A full approval is expected after complete review of data from the ongoing phase III study, APHINITY, which compares Perjeta, Herceptin and chemotherapy with Herceptin and chemotherapy for adjuvant (post-surgery) treatment in patients with HER2-positive eBC. Data from the trial is expected in 2016.
Roche also announced results from the phase III study, GALODIN. Results showed that Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone provided significant benefit to patients suffering from indolent non-Hodgkin’s lymphoma that is refractory to a Rituxan (rituximab)-based treatment.
Roche announced follow-up data from two studies on its MEK inhibitor, cobimetinib, in combination with Zelboraf. Data from the phase III study, coBRIM, showed that the combination helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma to live a median of one year (12.3 months) without their disease worsening or death compared to the median of 7.2 months with Zelboraf alone.
Roche’s oncology portfolio looks solid as ever and we expect further traction in 2015 from the HER2 franchise. We expect investor focus to remain on updates from the cancer immunotherapy program and other pipeline updates – cobimetinib in combination with Zelboraf, and others.
Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Valeant Pharmaceuticals International, Inc. VRX and Gilead Sciences Inc. GILD. Both carry a Zacks Rank #1 (Strong Buy).
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