On 17 October 2025, Bristol‑Myers Squibb announced the first global Phase I results of its bispecific antibody‑drug conjugate Iza‑bren (BL‑B01D1) at the European Society for Medical Oncology (ESMO) Congress in Berlin. The announcement was made by BMY and its partner SystImmune and marked the first public disclosure of safety and efficacy data from the global US‑Lung‑101 study.
The study enrolled 107 patients with advanced solid tumors, including non‑small cell lung cancer (NSCLC) with and without EGFR mutations. At the data cut‑off of July 23 2025, 55% (11 of 20) of patients receiving the 2.5 mg/kg dosing schedule achieved confirmed objective responses, with a median progression‑free survival of 5.4 months. Confirmed responses were also observed in the EGFR‑mutated NSCLC subgroup (3 of 10 patients) and in the EGFR‑wild‑type subgroup (3 of 4 patients).
The safety profile was consistent with the known class, with neutropenia being the most common blood‑related adverse event; these events were generally manageable and rarely required dose reductions or led to serious complications. No new safety concerns or interstitial lung disease were reported. The data support the continued development of Iza‑bren across multiple tumor types, including registrational studies in breast, lung, and urothelial cancers.
The announcement underscores Bristol‑Myers Squibb’s commitment to expanding its oncology pipeline through innovative bispecific antibody‑drug conjugates. The positive early clinical data position Iza‑bren as a first‑in‑class therapy for EGFR‑mutated NSCLC and other solid tumors, aligning with BMY’s strategy to diversify its growth portfolio beyond legacy products.
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