SystImmune and Bristol Myers Squibb Announce Positive PANKU-Lung01 Trial Results

BOTHELL, Wash., AND PRINCETON, N.J. — October 26, 2026

PANKU-Lung01 Demonstrates Improved Disease Control

PANKU-Lung01 (NCT06382116) is a randomized, multicenter Phase 3 study comparing iza-bren with platinum-based chemotherapy in patients with EGFR-mutated non-squamous NSCLC previously treated with an EGFR TKI. The reported analysis included 216 patients in the iza-bren group and 206 in the chemotherapy group. PFS, assessed by blinded independent central review, was the primary endpoint. The median PFS of 11.1 months with iza-bren represented an improvement of 5.4 months over the 5.7 months reported with chemotherapy. The hazard ratio of 0.40 indicated a substantial reduction in the risk of progression or death during the analysis period. The confirmed response rate also favored iza-bren, at 60.2% compared with 34.5% for chemotherapy. Median duration of response was nearly twice as long, reaching 10.4 months versus 5.7 months. Together, these findings indicate improved tumor response and longer disease control in the studied population. The OS analysis had not matured sufficiently to establish a definitive survival outcome, although a favorable trend was observed. The results address a clinical setting in which tumors can develop resistance to EGFR-targeted treatment and patients may require subsequent systemic therapy. Iza-bren is designed to target both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), which are involved in signaling pathways associated with tumor cell growth and survival. Its dual-targeting design aims to deliver a cytotoxic payload to cancer cells expressing these targets while also interfering with their signaling. The trial is notable as the first Phase 3 study to evaluate a dual-targeting EGFRxHER3 bispecific ADC in this patient population, according to the companies. However, the findings apply to the trial’s defined population and do not establish that iza-bren will provide the same benefit across all NSCLC subtypes or treatment settings.

Safety Findings and Treatment-Related Adverse Events

Iza-bren demonstrated a safety profile described by the companies as manageable, with no new safety signals observed in PANKU-Lung01. Grade 3 or higher treatment-related adverse events (TRAEs) were predominantly hematologic, and the companies reported that these events could be managed with standard supportive care. Treatment discontinuation due to TRAEs occurred in 1.9% of patients receiving iza-bren. Interstitial lung disease (ILD), an important potential safety concern in lung cancer treatment, was uncommon in the iza-bren group. Adjudicated ILD was reported in two patients, or 0.9% of the group: one Grade 3 case and one Grade 1 case. The announcement did not provide a complete breakdown of all adverse events by severity or detailed comparative event rates across the treatment arms, so the full safety profile cannot be assessed from these topline figures alone. The low reported discontinuation rate due to TRAEs suggests that few patients stopped treatment for these events in the reported analysis, but this measure should be interpreted alongside the overall frequency and severity of adverse events. Iza-bren, also known as BL-B01D1, is an investigational bispecific ADC designed to bind EGFR and HER3 and deliver a topoisomerase I inhibitor payload following target binding and internalization. Its mechanism combines targeted payload delivery with inhibition of EGFR- and HER3-related signaling. The clinical findings will need to be assessed alongside longer-term follow-up, including mature OS data, to better characterize the treatment’s overall benefit-risk profile. Iza-bren has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for previously treated advanced EGFR-mutated NSCLC. This designation does not constitute marketing approval. Any future approval will depend on regulatory review of the complete clinical and safety evidence.

SystImmune and Bristol Myers Squibb Expand Iza-Bren Development

The PANKU-Lung01 findings form part of a broader development program for iza-bren across multiple tumor types. The companies reported clinical benefit across five Phase 3 programs involving previously treated EGFR-mutated NSCLC, nasopharyngeal carcinoma after prior treatment, previously treated esophageal squamous cell carcinoma, advanced triple-negative breast cancer, and previously treated hormone receptor-positive/HER2-negative breast cancer. These programs investigate the potential of a dual-targeting ADC in cancers with different biological characteristics and treatment histories. Results from each indication must be evaluated independently, as outcomes in one tumor type do not establish efficacy in another. Biokin sponsors PANKU-Lung01 in mainland China. Outside China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement. SystImmune is a clinical-stage biotechnology company focused on cancer treatments, including bispecific and multispecific antibodies and ADCs. Bristol Myers Squibb develops medicines across oncology and other therapeutic areas, with a focus on advancing treatments for serious diseases. The PANKU-Lung01 data support continued investigation of iza-bren after EGFR-TKI treatment failure, particularly given the improvement in PFS, response rate and duration of response relative to platinum-based chemotherapy. Further follow-up will be important to determine whether the observed PFS advantage translates into a clear OS benefit and to provide a more complete understanding of long-term safety. The candidate remains investigational, and its future availability will depend on additional clinical evidence and regulatory decisions in relevant markets.

Source:SystImmune ,Press release