Perjeta Under Priority Review for use Before Surgery in HER2-Positive Breast Cancer

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Genentech announced that FDA has granted its supplemental Biologics License Application (sBLA) Priority Review for the use of Perjeta (pertuzumab) regimen before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer. Perjeta is a personalized medicine that targets the HER2 receptor, a protein found in high quantities on the outside of cancer cells in HER2-positive cancers.

The sBLA submission for Perjeta is based on results from NEOSPHERE and TRYPHAENA, two Phase 2 studies of Perjeta in HER2-positive early stage breast cancer, and longer-term safety data from the Phase 3 CLEOPATRA study of Perjeta in HER2-positive metastatic breast cancer.

The NEOSPHERE study (Neoadjuvant Study of Pertuzumab and Herceptin in an Early Regimen Evaluation) was a randomized, multicenter study conducted in 417 people with newly diagnosed HER2-positive, locally advanced, inflammatory or early stage breast cancer. Participants were randomized to four study arms and received four cycles (12 weeks) of neoadjuvant treatment. The primary endpoint was pathologic complete response (pCR). Study data demonstrated that treatment with Perjeta, Herceptin and docetaxel chemotherapy significantly improved the rate of pCR by 58% compared to Herceptin and docetaxel alone (45.8% vs. 29%, P=0.014).

  • pCR of 29.0% for Herceptin and docetaxel
  • pCR of 45.8% for Perjeta, Herceptin and docetaxel
  • pCR of 16.8% for Perjeta and Herceptin
  • pCR of 24.0% for Perjeta and docetaxel

The TRYPHAENA study (ToleRabilitY of Pertuzumab, Herceptin and AnthracyclinEs in NeoAdjuvant breast cancer) was a randomized, multicenter study conducted in 225 people with HER2-positive, locally advanced, inflammatory or early stage breast cancer. Participants were randomized to one of three neoadjuvant Perjeta regimens. The primary endpoint was cardiac safety. The results below show the rate of pCR in the three arms:

  • pCR of 61.6% for Perjeta, Herceptin and anthracycline-based chemotherapy, followed by Perjeta, Herceptin and docetaxel
  • pCR of 57.3% for anthracycline-based chemotherapy, followed by Perjeta, Herceptin and docetaxel
  • pCR of 66.2% for the anthracycline-free arm (Perjeta, Herceptin, docetaxel and carboplatin chemotherapy)

Perjeta is already approved in combination with Herceptin (trastuzumab) and docetaxel to treat patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

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