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A novel antibody-drug conjugate (ADC), iza-bren (BL-B01D1), demonstrates encouraging security and efficacy leads to beforehand handled sufferers with EGFR-mutated non-small cell lung most cancers (NSCLC), based on findings introduced on the Worldwide Affiliation for the Research of Lung Most cancers (IASLC) 2025 World Convention on Lung Most cancers (WCLC).
Iza-bren is a first-in-class EGFR x HER3 bispecific ADC linked to a novel topoisomerase I inhibitor payload (Ed-04). The drug was evaluated in two Section I/II research in sufferers with domestically superior or metastatic stable tumors, together with EGFR-mutated NSCLC.
Sufferers acquired a spread of doses on totally different schedules, together with day one and day eight each three-week cycle (D1D8 Q3W) and day one each three-week cycle (D1 Q3W).
Among the many 171 EGFR-mutated NSCLC sufferers, 50 sufferers who acquired prior TKI and chemo-naive had been handled at 2.5 mg/kg D1D8 Q3W. On this subgroup, the target response price (ORR) was 66.0%, the confirmed ORR (cORR) was 56.0%, the median progression-free survival (mPFS) was 12.5 months, the median length of response (mDOR) was 13.7 months, and the median total survival (mOS) was not reached with a 12-mo OS price of 80.3%.
In accordance with the lead investigator, Dr. Wenfeng Fang from Solar Yat-sen College Most cancers Middle, Guangzhou, China, the security profile was manageable.
Essentially the most frequent hematologic treatment-related adversarial occasions (TRAEs) had been anemia (90.6%), leukopenia (80.7%), neutropenia (78.4%), and thrombocytopenia (74.3%). Essentially the most frequent non-hematologic TRAEs included nausea, alopecia, and asthenia. Only one.2% of sufferers had been discontinued because of TRAEs, and no treatment-related loss of life was noticed.
“This early data suggests iza-bren may offer a promising treatment option for patients with EGFR-mutated NSCLC,” stated Dr. Fang.
“Phase III registrational study of iza-bren as monotherapy in EGFR-mutated NSCLC after progression on a third generation TKI is ongoing in China.”
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Worldwide Affiliation for the Research of Lung Most cancers
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New antibody-drug conjugate reveals promising efficacy in EGFR-mutated NSCLC sufferers (2025, September 6)
retrieved 6 September 2025
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