Fam-trastuzumab deruxtecan-nxki shows promise in HER2-mutant NSCLC
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Fam-trastuzumab deruxtecan-nxki showed promising clinical activity among patients with HER2-mutant non-small cell lung cancer, according to interim results of the DESTINY-Lung01 trial presented during the ASCO20 Virtual Scientific Program.
The novel HER2-targeted antibody-drug conjugate also conferred high objective response rates and durable responses among this patient population, researchers noted.
“These data demonstrate the potential of fam-trastuzumab deruxtecan-nxki (Enhertu; AstraZeneca, Daiichi Sankyo) as a new treatment option for patients with HER2-mutated NSCLC,” Egbert F. Smit, MD, PhD, professor in the department of thoracic oncology at Netherlands Cancer Institute, said during a presentation.
The ongoing, multicenter, phase 2 DESTINY-Lung01 trial included 42 patients (median age, 63 years; range, 34-83; 64.3% women) with HER-mutated metastatic nonsquamous NSCLC. Overall, 45.2% of patients had central nervous system metastases, 23.8% had an ECOG performance status of 0, and 76.2% had an ECOG status of 1.
Patients received a median two (range, 1-6) prior lines of treatment, including platinum-based therapy (90.5%), anti-PD-1 or PD-L1 inhibitors (54.8%), and docetaxel (19%).
In the trial, patients received fam-trastuzumab deruxtecan-nxki dosed at 6.4 mg/kg IV once every 3 weeks. Confirmed ORR by independent review committee served as the primary endpoint. Secondary endpoints included disease control rate, duration of response, PFS and safety.
Median follow-up was 8 months (range, 1.4-14.2).
At median treatment duration of 7.76 months (range, 0.7-4.3), 45.2% of patients remained on treatment.
Results showed a confirmed ORR of 61.9% (95% CI, 45.6-76.4); however, median duration of response was not reached at data cutoff.
Researchers reported a disease control rate of 90.5% (95% CI, 77.4-97.3) and estimated median PFS of 14 months (95% CI, 6.4-14).
Researchers observed grade 3 or higher treatment-associated adverse events among 64.3% of patients, including decreased neutrophil count (19%) and anemia (7.1%).
Five patients experienced drug-related interstitial lung disease, with one case of grade 1 interstitial lung disease was pending adjudication.
Treatment-related adverse events led to dose interruptions for 25 patients, whereas 16 patients had a dose reduction and 10 patients discontinued treatment due to such events.
“Enrollment in this HER2-mutated cohort was expanded with an additional 50 patients to better characterize the risk-benefit ratio of fam-trastuzumab deruxtecan-nxki in patients with HER2-mutated NSCLC,” Smit said.
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