Enhertu gets expanded indications for NSCLC·breast cancer

Approved for HER2-positive NSCLC and HER2-low breast cancer treatments

Improved primary endpoints…reduced mortality risk than the control group

Enhertu (trastuzumab deruxtecan)

Daiichi-Sankyo Korea and AstraZeneca Korea announced that Enhertu (trastuzumab deruxtecan) received expanded indication for HER2-low metastatic breat cancer and metastatic non-small cell lung cancer (NSCLC) on May 20.

 

Enhertu is now approved for treating ▲patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have previously undergone systemic therapy in the metastatic setting or relapsed within 6 months of completing adjuvant chemotherapy and hormone receptor-positive (HR+) patients who have received or are unsuitable for endocrine therapy ▲patients with unresectable or metastatic NSCLC with activated HER2 (ERBB2) mutations who have previously received systemic therapy, including platinum-based chemotherapy.

 

The basis for this Enhertu’s expanded indication is DESTINY-Breast04 and DESTINY-Lung02 clinical trials DESTINY-Breast04 clinical trial compared the efficacy and safety of Enhertu and chemotherapy (capecitabine, Gemcitabine Paclitaxel, Nab-paclitaxel) chosen by physicians in 557 patients with unresectable or metastatic HER2-low breast cancer who had previously undergone 1-2 chemotherapy sessions.

 

The trial also demonstarted that the Enhertu treatment group of HR+ cohort had a significant improvement in median progression-free survival (mPFS), with 10.1 months compared to 5.4 months in the control group.

 

Enhertu also reduced the mortality risk by 50% in all patient cohort, including HR+ and HR- patients, compared to the control group.

 

Furthermore, Enhertu demonstrated an anti-tumor response for the second-line treatment of HER2-mutant metastatic NSCLC through the DESTINY-Lung02 study.

 

This study evaluated the efficacy and safety in patients with advanced, unresectable, or metastatic NSCLC who have previously been treated with systemic therapy, including platinum-based chemotherapy, more than once.

 

The clinical results demonstrated that Enhertu had Blinded Independent Central Review (BICR)-assessed confirmed ORR of 49%, complete response (CR) of 1%, and partial response (PR) of 48%.

 

"Enhertu’s expanded indication will provide an opportunity for patients with HER2-mutant lung cancer who had limited treatments options.

 

It also provides HER2-targeting treatment options for over 60% of all breast cancer patients.

 

Enhertu will be a meaningful treatment option for many patients from now," Daiichi Sankyo Korea’s Oncology Business Franchise Head Lee Hyun-ju said.

 

"We are pleased to provide the new treatment option, Enhertu, to patients with HER-2 low metastatic breast cancer and HER2-mutant metastatic NSCLC.

 

We will continue our efforts to improve cancer treatment settings based on our various oncology portfolio," AstraZeneca Korea’s Oncology Business Unit Director Yang Mi-sun said.