Daiichi Sankyo announced that updated phase 1 safety and efficacy data for [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), were presented for a subgroup of patients with heavily pretreated HER2 mutated or HER2 expressing non-small cell lung cancer (NSCLC).
An updated subgroup analysis of 11 patients with HER2 mutated NSCLC receiving a recommended expansion dose of 6.4 mg/kg showed that [fam-] trastuzumab deruxtecan demonstrated a confirmed overall response rate of 72.7 percent (8 of 11 patients) and disease control rate of 100 percent (11 of 11 patients). Preliminary estimate of median duration of response has reached 11.5 months (95 percent CI: 0.03+, 11.5) and median progression-free survival has reached 14.1 months (95 percent CI: 4.0+, 14.1) for this subgroup of patients.
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"These preliminary results seen with [fam-] trastuzumab deruxtecan are encouraging, particularly given the existing unmet medical need for patients with metastatic NSCLC with HER2 alterations that have progressed on several prior therapies," said Junji Tsurutani, MD, PhD, Advanced Cancer Translational Research Institute, Showa University, Tokyo, Japan, a study investigator. "These results also demonstrate that continued evaluation of treatments that target the HER2 receptor is warranted in patients with NSCLC."
The updated subgroup analysis of 17 patients with heavily pretreated HER2 mutated or HER2 expressing (defined as IHC ≥1+ or amplified) NSCLC showed that [fam-] trastuzumab deruxtecan demonstrated a confirmed overall response rate of 58.8 percent (10 of 17 patients) and a disease control rate of 88.2 percent (15 of 17 patients). Preliminary estimate of median duration of response has reached 9.9 months (95 percent CI: 0.0+, 11.5) and median progression-free survival has reached 14.1 months (95 percent CI: 0.9, 14.1).
"Patient enrollment is currently underway into our phase 2 study of [fam-] trastuzumab deruxtecan in patients with advanced HER2 mutated or HER2 overexpressing NSCLC," said Gilles Gallant, BPharm, PhD, Vice President, DS-8201 Global Team Leader, Oncology Research and Development, Daiichi Sankyo. "Since there are no therapies specifically approved to treat patients with HER2 altered NSCLC, continued study of [fam-] trastuzumab deruxtecan is needed to better understand the potential role of a HER2 targeting antibody drug conjugate in treating these patients."
Updated preliminary safety data for this subgroup of patients with heavily pretreated HER2 mutated or HER2 expressing NSCLC receiving [fam-] trastuzumab deruxtecan were also reported. The most common adverse events (>30 percent, any grade) included nausea (50.0 percent), decreased appetite (50.0 percent), alopecia (50.0 percent), fatigue (44.4 percent) and vomiting (38.9 percent). Grade 3 adverse events occurring in >10 percent of patients included decreased neutrophil count (11.1 percent). As previously reported, one (1) grade 5 event of pneumonitis was observed in this cohort, which was adjudicated as unrelated to [fam-] trastuzumab deruxtecan by an independent adjudication committee. Any reported cases of interstitial lung disease (ILD)/pneumonitis in the [fam-] trastuzumab deruxtecan clinical development program are evaluated by an independent adjudication committee.