Hengrui’s asset Pyrotinib demonstrated prolonged PFS benefit from dual HER2 inhibition in the 1L treatment of HER2-positive metastatic breast cancer

Breast cancer is the most common type of cancer worldwide in 2020. According to the GLOBOCAN 2020 report, there were approximately 2.26 million new breast cancer cases (including 253,465 cases in the United States and 531,086 cases in Europe) and approximately 685,000 breast cancer deaths worldwide. HER2-positive breast cancer, which accounts for approximately 15-20% of breast cancers, tends to grow and spread faster than other types. The neoadjuvant approach has become a standard therapy option for early-stage HER2-positive breast cancer to improve disease-free survival and overall survival. In September 2021, Jiangsu Hengrui Pharmaceuticals announced that the China National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for pyrotinib in combination with trastuzumab and docetaxel as a new neoadjuvant therapy regimen in early-stage or locally advanced HER2-positive breast cancer patients. Moreover, in July 2020, Pyrotinib received marketing approval in China for the 2L treatment of relapsed or metastatic HER2-positive breast cancer in combination with capecitabine.

With the data cutoff date of May 25, 2022, the median PFS of pyrotinib in the top executive group as per investigator (INV) was 24.3 months, while in the placebo group, the median PFS was 10.4 months. As per the independent review committee (IRC), the median PFS was found to be 33 months, while in the placebo group, the median PFS was 10.4 months. Talking about the overall response rate (ORR), it was found to be 88.2% as per IRC. In terms of safety, the drug demonstrated a manageable safety profile. The most common grade ≥3 TRAEs were decreased neutrophil count (62.6% vs. 65.2%), decreased WBC count (53.2% vs. 50.9%), and diarrhea (46.5% vs. 3.1%). Moreover, this was the second Phase III trial that demonstrated PFS benefit from dual HER2 inhibition in the first line treatment for this patient pool. The other Phase III trial of Pertuzumab in combination with trastuzumab and docetaxel was the standard first-line dual anti-HER2 therapy approved for HER2-positive metastatic breast cancer. The approval was based on the CLEOPATRA study, where the median PFS of the trial was 18.5 months with overall survival of 57.1 months. 

Expert Opinion: “To our knowledge, this is the second phase III trial to demonstrate PFS benefit from dual HER2 inhibition in 1L treatment of HER2-positive mBC”

“Patients with metastatic HER2-positive breast cancer are typically treated with the HER2-targeted therapies trastuzumab (Herceptin) and pertuzumab (Perjeta) in combination with a taxane, but resistance to this regimen inevitably develops”

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