Roche Holdings Ltd. (RHHBY) recently announced its intension to present results from thirteen studies conducted with pipeline candidates as well as approved products at the upcoming European Society for Medical Oncology (ESMO) Congress.
Roche will be presenting additional data, including overall survival (OS) data, from its phase III EMILIA study. The study compared trastuzumab emtansine (T-DM1) to Xeloda along with lapatinib in HER2-positive unresectable locally advanced or metastatic breast cancer patients who were previously treated with Herceptin and taxane chemotherapy. We note that the study met both the co-primary endpoints of longer progression free survival (PFS) and OS.
The company will also present data from the phase III HERA (HERceptin Adjuvant) study. The study evaluated Herceptin’s impact on disease free survival in women suffering from HER2-positive early breast cancer after completing standard chemotherapy.
Apart from HER2-positive breast cancer treatments, Roche is looking to present data on skin cancer candidates. Data presentation will include results from a pilot study conducted with 24 patients suffering from BRAF V600 mutation-positive metastatic melanoma and symptomatic brain metastases treated with Zelboraf. We note that Zelboraf is already approved in the US and Switzerland to treat patients suffering from inoperable or metastatic melanoma.
Earlier this moth, Roche provided an update on its research and development (R&D) programs and its strategy on innovation for unmet medical needs. The company is expected to present results from 19 late-stage clinical trials in the next 18 months.
Of these, 12 studies are investigating new molecular entities (NMEs). Moreover, Roche expects three additional NMEs to reach the Lifecycle Investment Point (LIP) and move to late-stage development by year end. Roche allotted half of its R&D budget to its oncology segment.
Moreover, Roche implemented rigorous portfolio prioritisation, new development designs, and cost-saving initiatives to keep its R&D budget stable despite its significant pipeline progress.
Our Recommendation
Roche, headquartered in Basel, Switzerland, carries a Zacks #3 Rank (Hold rating) in the short run.
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