Roche Holding AG RHHBY announced that its new investigational fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab) has met the primary endpoint of non-inferiority in the phase III FeDeriCa study.
In the study, the new FDC, which is administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, demonstrated non-inferior levels of Perjeta in the blood compared to the standard IV infusion of Perjeta + Herceptin and chemotherapy in patients with HER2-positive early breast cancer (eBC).
This new FDC of Perjeta + Herceptin in combination with chemotherapy is administered under the skin, thus providing a faster treatment option for the given patient population. The FDC of Perjeta and Herceptin is a new SC formulation, which uses Halozyme Therapeutics’ HALO Enhanze drug delivery technology.
Per the company, the SC administration of the new FDC takes around eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. This is a significant reduction in administration time compared to the infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations that takes approximately 150 minutes and almost 60-150 minutes for the subsequent maintenance dose.
Roche plans to present full data from the above study at an upcoming medical conference. The company also plans to submit the results to the FDA and the EMA for regulatory approvals.
Perjeta in combination with Herceptin and chemotherapy (the Perjeta-based regimen) is already approved by the FDA as an adjuvant (after surgery) treatment of HER2-positive eBC patients, who are at a high risk of recurrence.
We would like to remind investors that Roche has a strong presence in the oncology market. Particularly, it dominates the breast cancer space with solid demand for its HER2 franchise drugs, namely Herceptin, Perjeta and Kadcyla.
However, competition looms large on the HER2-positive breast cancer space. Puma Biotech’s PBYI Nerlynx (neratinib) is also approved for use as an extended adjuvant treatment of HER2-positive early stage breast cancer in adult patients, who were previously treated with Roche’s Herceptin-based adjuvant therapy.
Shares of Roche have increased 9.1% so far this year versus the industry’s decrease of 1.2%.
In a separate press release, Roche announced new six-year data from the phase III study on its multiple sclerosis (MS) drug Ocrevus (ocrelizumab). The longer-term data from the OPERA I, OPERA II and ORATORIO extension studies showed that an early and continuous treatment with Ocrevus for six or more years led to a reduced risk of disability progression in patients with relapsing MS (RMS) and primary progressive MS (PPMS).
The results were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis held in Sweden.
Zacks Rank & Another Key Pick
Roche currently carries a Zacks Rank #2 (Buy). Another stock worth considering in the large cap pharma sector is Merck & Co., Inc. MRK, which carries the same Zacks Rank as Roche. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merck’s earnings estimates have been revised 3.2% upward for 2019 and 1.3% for 2020 over the past 60 days. The stock has rallied 9% year to date.
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