- The latest results from Roche's Phase 3 APHINITY combo study show that adding Perjeta (pertuzumab) to Herceptin (trastuzumab) and chemotherapy significantly reduced the risk of recurrence or death (invasive disease-free survival (iDFS) for people with HER2-positive early-stage breast cancer after surgery compared to Herceptin and chemotherapy alone.
- Few details have been given about the results of the trial, but further study data will be presented at medical meetings later in 2017.
- The Perjeta/Herceptin cocktail is already approved to treat metastatic breast cancer and early stage breast cancer before surgery in both the U.S. and EU. The results could mean that Roche is close to another approval in the after-surgery indication.
"These results from the positive APHINITY study represent an important addition to the body of data for Perjeta in the treatment of people with HER2-positive early breast cancer," said Sandra Horning, CMO and head of Global Product Development at Roche. "We look forward to discussing these adjuvant results with global regulatory authorities."
As well as providing extra data to support the use of Perjeta in breast cancer, these results will help bolster the use for best-seller Herceptin, which is likely to face biosimilar competition from companies such as Mylan, Amgen, Daiichi Sankyo and others.
Until the full results are presented, its unclear how much the APHINITY results could change protocols in the breast cancer space and if they will have the desired boost for the Roche products that investors are hoping for.
The positive results pushed the stock of competitor Puma Biotechnology down 14% to trade near $30 per share. Puma's stock has swung around wildly – it climbed over 275% on positive Phase 3 results for its drug neratinib to $227 a share in 2014, then fell on news of a change in indication and NDA delays due to severe side effects.
Neratinib is in a neck-to-neck race with Perjeta, with a validated submission as an extended adjuvant treatment for HER2-positive early stage breast cancer in the E.U. However, neratinib faces the challenge that its approval is dependent on positive results in a subgroup of patients with hormone receptor-positive disease. Yet, the occurrence of severe diarrhea of grade three or higher is 40% in this group of patients -- a severe side effect that could stall approval of the drug.
Following a meeting earlier this week with the European Medicines Agency (EMA), it has also restricted its label to hormone receptor-positive and -negative patients initiating neratinib treatment within one year after completion of adjuvant trastuzumab therapy. The EMA is continuing to review the MAA, and no timeline has been given. Neratinib is also pending approval in the U.S.