On July 23, two new drugs for breast cancer, Piqray and Enhertu, were delivered to Hainan Hospital of Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine (Hainan Boao Research Hospital) (hereinafter referred to as "Ruijin Hainan Hospital") in Lecheng pilot area. An expert team composed of Qu Qing, Deputy Chief Physician of the Oncology Department of Shanghai Ruijin Hospital, Huang Jiahui, Physician of the Breast Center, and Shen Lili, Research Nurse of the Breast Center, went to the site to provide medication guidance. The patient was in good condition after receiving new drug treatment. This is also the first time that Ruijin Hainan Hospital has launched two new drug projects for a single disease within a day.

Data from the 2020 Global Cancer Burden Report shows that the number of new cases of breast cancer has replaced lung cancer as the world's largest cancer. In 2020, there will be 4.57 million new cancer cases in China, including 420000 cases of breast cancer, ranking first in the world in absolute number of cases. Experts pointed out that at present, the growth rate of breast cancer incidence rate in China has exceeded the global average, and is also higher than that in European and American countries.

Piqray, an innovative drug for breast cancer

Treatment challenge of breast cancer with PI3KCA mutation

In China, breast cancer is the tumor with the highest incidence rate among women. 50% - 70% of patients are HR+/HER2 - breast cancer, and PIK3CA is one of the most common mutation genes.Numerous clinical studies have shown that PIK3CA mutations can activate the carcinogenic pathway PI3K/AKT/mTOR, thereby stimulating tumor growth, leading to poor treatment response and poor prognosis. Treatment of breast cancer with PI3KCA mutation is a challenge. HR+/HER2 - patients with advanced breast cancer urgently need a treatment to change PIK3CA mutation.

HR+HER2 - New hope for breast cancer patients

Piqray, as the first drug for advanced breast cancer with HR+/HER2 - and PIK3CA mutations, is an inhibitor of phosphatidylinositol-3-kinase (PI3K). Inhibiting tumor growth by inhibiting the PI3K/AKT/mTOR signaling pathway.

Piqray, a new drug for breast cancer

The SOLAR-1 study results demonstrate that compared to the use of fluvastatin alone, the combination of Piqray and fluvastatin significantly prolongs the patient's progression free survival (PFS) and reduces the risk of disease progression by 35%. And regardless of whether there is lung/liver metastasis, the therapeutic effect of Piqray is consistent.All major international and domestic guidelines recommend that patients with PIK3CA mutation in HR+HER2 advanced breast cancer should use the new drug Piqray. Recommended for Level 1 in the ABC6 and NCCN guidelines. It has high safety and effectiveness, and patients can benefit from using this drug for treatment.

Enhertu, an innovative drug for breast cancer

HER2 positive breast cancer has treatment challenges

In China, 2-3 of every 10 breast cancer patients are classified as human epidermal growth factor receptor 2 (HER2) positive breast cancer patients. HER2 positivity indicates a higher degree of malignancy in tumor cells, faster disease progression, greater susceptibility to metastasis and recurrence, and poor prognosis.

Although there are many targeted drugs for HER2 positive breast cancer, such as Herceptin, Partuzumab, T-DM1, Pyrrolitinib, Neratinib, etc., advanced patients are still incurable, and most of them will relapse and metastasize. After first-line treatment, disease control is poor, which poses certain challenges.

New hope for HER2 positive breast cancer patients

Enhertu is a new antibody drug conjugate targeting HER2, which is formed by coupling human anti HER2 antibody and type I topoisomerase inhibitor.

Enhertu, a new drug for breast cancer

The clinical research results confirmed that among 184 HER2 positive patients with advanced breast cancer, the objective response rate after Enhertu treatment was 61.4%. In December 2019, DS-8201 was approved by the US Food and Drug Administration (FDA) for use in advanced breast cancer patients who had previously used two or more anti HER2 drugs. In October 2021, the FDA granted Enhertu breakthrough therapy recognition. In May 2022, Enhertu was approved by FDA to treat adult patients with HER2 positive unresectable or metastatic breast cancer who had previously received an anti HER2 treatment scheme. At present, the drug has been approved for marketing in the United States, Japan, the European Union, and other countries.