Daiichi Sankyo Enhertu approved in Japan as first HER2 directed therapy for patients with HER2 mutant metastatic lung cancer

The approval of ENHERTU by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on results from the DESTINY-Lung02 phase 2 trial presented at the European Society for Medical Oncology (ESMO) 2022 Congress.

ENHERTU previously received an Orphan Drug Designation by the Japan MHLW for this tumor type, a designation that provided priority review of the application.

In DESTINY-Lung02, a pre-specified interim analysis of patients with previously-treated HER2 mutant NSCLC showed that ENHERTU (5.4 mg/kg) demonstrated a confirmed objective response rate (ORR) of 53.8% (n=52; 95% confidence interval [CI]: 39.5-67.8) in patients with unresectable advanced or recurrent NSCLC with activating HER2 (ERBB2) mutations after prior chemotherapy as assessed by blinded independent central review (BICR).

“HER2 mutant non-small cell lung cancer is a rare but serious disease and now patients and physicians in Japan have the potential to benefit from the first HER2 directed treatment option approved specifically for this type of lung cancer,” said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “This is the fourth indication secured for ENHERTU in Japan in just over three years and the second approval this year alone, underscoring the benefit of this medicine across a range of HER2 targetable cancers.” 

In DESTINY-Lung02, the safety profile of ENHERTU was consistent with previous clinical trials with no new safety concerns identified. 

In Japanese patients, interstitial lung disease (ILD) occurred in 2.7% of patients treated with 5.4 mg/kg of ENHERTU at interim analysis. ENHERTU is approved in Japan with a Warning for ILD. As cases of ILD, including fatal cases, have occurred in ENHERTU-treated patients, ENHERTU is to be used in close collaboration with a respiratory disease expert. Patients should be closely observed during therapy by monitoring for early signs or symptoms of ILD (such as dyspnea, cough or fever) and performing regular peripheral artery oxygen saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue administration of ENHERTU and take appropriate measures, such as corticosteroid administration. Prior to initiation of ENHERTU therapy, a chest CT scan should be performed and medical history taken to confirm the absence of any comorbidity or history of ILD with the patient and carefully consider the eligibility of the patient for ENHERTU therapy. The efficacy and safety of ENHERTU as a neoadjuvant, adjuvant or first-line metastatic therapy for the treatment of patients with HER2 (ERBB2) mutant unresectable advanced or recurrent NSCLC has not been established. ENHERTU should be administered only to patients with NSCLC with confirmed HER2 (ERBB2) mutations as detected by an approved test.

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