Benzinga | Dec 23, 2021 08:09AM EST

AstraZeneca Partner Daiichi Sankyo Reports First Patient Dosed In DESTINY-Lung04 Phase 3 Trial Evaluating ENHERTU

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the first patient was dosed in the global DESTINY-Lung04 phase 3 trial evaluating the efficacy and safety of ENHERTU(r) (trastuzumab deruxtecan), a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (NASDAQ:AZN), as a first-line treatment in patients with HER2 mutant unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

DESTINY-Lung04 is the first head-to-head trial in NSCLC evaluating ENHERTU as a first-line treatment compared to the standard of care (platinum-pemetrexed doublet chemotherapy in combination with pembrolizumab) in patients with unresectable, locally advanced or metastatic non-squamous NSCLC harboring a HER2 exon 19 or 20 mutation.

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths globally, with 80% to 85% classified as NSCLC.1,2,3 There are currently no medicines approved specifically for the treatment of HER2 mutant NSCLC, which affects approximately 2% to 4% of patients with non-squamous NSCLC.4,5 Current standard of care in the first-line metastatic setting of patients with HER2 mutant NSCLC is PD-1 or PD-L1 immunotherapy with or without platinum-based chemotherapy.6 While these treatment regimens can improve survival in NSCLC, approximately 40% to 60% of tumors do not respond to initial treatment and disease progression occurs, underscoring the need for additional treatment approaches.7,8,9,10,11

"The results seen in the DESTINY-Lung01 trial showed a robust and durable tumor response in previously-treated patients with HER2 mutant metastatic non-small cell lung cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "Based on these promising findings, we are conducting DESTINY-Lung04 to evaluate the potential of ENHERTU as an earlier line of therapy in this patient population."