WCLC23: Daiichi says HER3-DXd yields nearly 30% ORR in mid-stage lung cancer trial

2023-09-10

临床结果临床2期抗体药物偶联物ASCO会议

In Phase II results reported Sunday at the World Conference on Lung Cancer (WCLC), Daiichi Sankyo said its investigational drug patritumab deruxtecan (HER3-DXd) demonstrated "clinically meaningful and durable responses" in heavily pretreated patients with EGFR-mutated non-small-cell lung cancer (NSCLC). The company indicated plans to file the therapy with US regulators in the second half of fiscal year 2023.

Ken Takeshita, global head of R&D at Daiichi Sankyo, said the HERTHENA-Lung01 study data "coupled with early trial results…[illustrate] the potential of this HER3-directed antibody-drug conjugate to become a new standard-of-care for this patient population with high unmet medical need."

HERTHENA-Lung01 has an estimated enrolment of 420 patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression on previous treatment. Daiichi Sankyo noted that subjects had received a median of three prior lines of systemic therapy, including platinum-based chemotherapy, third-generation EFGR tyrosine kinase inhibitors (TKI) and immunotherapy, while just over half had a history of central nervous system (CNS) metastases.

Efficacy consistent across subgroups

The results, which were also published in the Journal of Clinical Oncology, showed a confirmed objective response rate (ORR) of 29.8%. These included one complete response (CR), 66 partial responses (PRs) and 99 cases of stable disease. The median duration of response (DoR) was 6.4 months, and a disease control rate of 73.8% was observed. Further, as of the May 18 data cut-off, Daiichi Sankyo said median progression-free survival was 5.5 months, while median overall survival was 11.9 months.

The Japanese drugmaker noted that efficacy outcomes were consistent across subgroups, including a subset of 209 patients previously treated with a third-generation EGFR TKI and platinum-based chemotherapy. Further, an intracranial ORR of 33.3% was seen in a cohort of 30 patients who had brain metastases at baseline and no prior radiotherapy treatment. These included nine intracranial CRs, one intracranial PR and 13 cases of stable disease. The company said a CNS DoR of 8.4 months was also observed.

Patient death due to ILD

From a safety standpoint, Daiichi Sankyo reported that Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 64.9% of patients. In addition, 12 patients, or 5.3%, had confirmed treatment-related interstitial lung disease (ILD), and while the majority of these were low-grade cases, there were two Grade 3 events and one patient death due to ILD.

Takeshita said the HERTHENA-Lung01 results "will support our ongoing discussions with health authorities including our planned submission in the US."

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