AZ leads breast cancer treatment market with expanded portfolio

AstraZeneca is rapidly expanding its breast cancer treatment pipelines by genetic subtype, beginning with the release of antibody-drug conjugate (ADC) developed jointly with Daiichi Sankyo.

Enhertu (trastuzumab deruxetecan), AZ and Daiichi Sankyo’s ADC treatment for breast cancer, expanded its domestic indication to treating metastatic HER+ breast cancer patients from the Ministry of Food and Drug Safety in December. In January, it won European approval for unresectable or metastatic HER2 low-expression breast cancer patients.

That means the U.K. drugmaker provides treatment options for various patients, ranging from HER+ breast cancer to HER2 low-expression breast cancer, on a U.S. approval basis with Enhertu alone, according to market analysts.

AstraZeneca did not stop there, stepping up to develop the pipeline of datopotamab deruxetecan (Dato-DXd) as the next-generation ADC drug.

Dato-DXd is an ADC anticancer treatment targeting trophoblast cell surface antigen 2 (TROP2). AZ is preparing to use it for treating HR+ (hormone receptor-positive) and HER2- (human epidermal growth sector receptor-negative) breast cancer patients and triple-negative breast cancer (TNBC).

Aside from ADC anticancer drug, AstraZeneca is also conducting phase 3 clinical trials of capivasertib, an AK-strain transforming (AKT) inhibitor, on HR+, HER2-, and TNBC patients. In the previous phase 3 trial, the CAPItello-291 study, capivasertib also confirmed improved progression-free survival (PFS) and overall survival (OS) in HR+, HRT2- breast cancer patients.

The company is also conducting clinical trials for Camizestrant, a selective estrogen receptor down-regulator, on HR+ breast cancer patients. In October, it demonstrated the treatment could reduce disease progression and death risks by 22 percent and 24 percent compared to the control group in phase 2 clinical trial of the SERENA-2 study.

Before the market release of these new drugs, Lynparza (olaparib) is now being used as a treatment option. Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor that demonstrated notable treatment effects in treating metastatic breast cancer patients represents AZ’s breast cancer treatment portfolio.

AstraZeneca seeks to lead the next-generation breast cancer treatment market by establishing pipelines.

Meanwhile, Roche, which has led the existing HER2+ breast cancer treatment market, is conducting clinical trials for inavolisib, a PIK3CA (a gene that makes one of the proteins in an enzyme called PI3K) cancer inhibitor, on HER+ and HER2- breast cancer patients.

Pfizer, Novartis, and Lilly have provided options with HR+ breast cancer treatments and are also preparing clinical trials to expand indications and create grounds.

Pfizer’s Ibrance (palbociclib), an oral treatment that selectively inhibits cyclin-dependent kinase (CDK) 4 and 6, reaffirmed its clinical data with a retrospective study in Asia on HR+/HER- metastatic breast cancer patients in 2020. Likewise, Novartis’ CDK4/6 inhibitor Kisqali (ribociclib) showed consistent OS data with previous clinical trials in post-menopausal women.

Lilly’s CDK4/6 inhibitor Verzenio (abemaciclib) expanded its treatment area by obtaining indications for treating early breast cancer at high risk of recurrence for the first time as a CDK4/6 inhibitor.

The expansion of early breast cancer indications was based on monarchE clinical trials. As a result, in terms of invasive disease-free survival rate (IDFS), Verzenio + endocrine therapy reduced recurrence and death risks by 25 percent in the second year, 30 percent in the third year, and 34 percent in the fourth year compared to endocrine therapy alone. Also, in terms of remote recurrence-free survival rate (DRFS), Verzenio + endocrine therapy, reduced remote recurrence and death risks by 28 percent in the second year, 31 percent in the third year, and about 34 percent in the fourth year, compared to endocrine therapy alone.

Gilead has also jumped into the completion for breast cancer treatment by winning approval from the U.S. Food and Drug Administration for Trodelvy (sacituzumab govitecan), a TROP-2 targeted ADC anticancer treatment, to treat metastatic breast cancer patients.