Roche Announces Positive Data on Breast Cancer Drug Kadcyla
Roche RHHBY announced encouraging results from a phase III study, KATHERINE, on breast cancer drug, Kadcyla.
The international, multi-centre, two-arm, randomized, open-label, phase III study evaluated the efficacy and safety of Kadcyla compared to Herceptin as an adjuvant therapy in patients suffering from HER2-positive early breast cancer (eBC), who have pathological residual disease in the breast and/or axillary lymph nodes, following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy.
The trial evaluated a population of patients suffering from HER2-positive eBC who did not achieve a pathological complete response to neoadjuvant treatment and is generally associated with a worse prognosis.
The study met its primary endpoint as the results showed that Kadcyla, as a single agent, significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to Herceptin, as an adjuvant (after surgery) treatment, in patients.
We remind investors that Kadcyla, an antibody-drug conjugate, is already approved in the United States and EU for the treatment of HER2-positive metastatic breast cancer who have previously received Herceptin and taxane chemotherapy, separately or in combination.
Roche has licensed technology for Kadcyla under an agreement with ImmunoGen, Inc IMGN.
Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise drugs. The HER2 franchise includes Herceptin, Perjeta and Kadcyla. Growth in Herceptin is being driven by increasing demand in both the United States and Europe due to longer treatment duration. Moreover, the subcutaneous (SC) formulation of Herceptin is being increasingly adopted. The FDA approved Perjeta in combination with Herceptin and chemotherapy (the Perjeta-based regimen) for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence. In addition, the FDA granted full approval to use the same regimen for neoadjuvant treatment of HER-2-positive, locally advanced, inflammatory or early-stage breast cancer. Until now, the neoadjuvant indication had been allowed under accelerated approval. The European Commission approved Perjeta in combination with Herceptin and chemotherapy for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast cancer (eBC) at high risk of recurrence. These approvals further boosted sales.
Shares of Roche have lost 3.1% so far this year, against the industry’s increase of 6.1%.
Approval of new drugs and a potential label expansion of existing drugs bode well for Roche as its legacy drugs like Avastin, Herceptin and MabThera are facing competition from biosimilars. Novartis NVS has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen AMGN too has got its biosimilar of Avastin.
Roche currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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