SystImmune, Inc. (SystImmune), a clinical stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) announced that SystImmune’s parent company Sichuan Biokin Pharmaceutical, Ltd. (Biokin) reported positive results from a prespecified interim analysis in the randomized, multicenter Phase 3 PANKU-Lung01 (NCT06382116) study evaluating izalontamab brengitecan (iza-bren), an investigational, first-in-class, dual-targeting EGFRxHER3 bispecific antibody-drug conjugate (ADC), versus platinum-based chemotherapy (PBC) in patients with EGFR-mutated non-squamous non-small cell lung cancer (NSCLC) who were previously treated with an EGFR tyrosine kinase inhibitor (TKI). Results will be presented today in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) 2026 Annual Congress taking place October 23 – 27 in Madrid, Spain, and simultaneously published in The Lancet.

Median follow-up for progression-free survival (PFS) was 14.6 months. Results showed iza-bren (n=216) significantly improved PFS, the study’s primary endpoint, compared to PBC (n=206), with a median PFS by Blinded Independent Central Review (BICR) of 11.1 months for iza-bren vs. 5.7 months for PBC (HR: 0.40; 95% CI: 0.31-0.51; p<0.0001). For the secondary endpoint of overall survival (OS), data were immature, though a favorable trend toward improved OS was observed with iza-bren vs. PBC. The confirmed objective response rate (cORR) by BICR was 60.2% for iza-bren vs. 34.5% for PBC, and the median duration of response (mDOR) was 10.4 months vs. 5.7 months.

“When EGFR-mutated NSCLC progresses after an EGFR TKI therapy, patients and physicians have historically had few effective treatment options, with chemotherapy often serving as the default, though it offers limited survival benefit,” said Professor Li Zhang, Chief Lung Cancer Expert, Sun Yat-sen University Cancer Center. “The PANKU-Lung01 findings suggest that iza-bren could change the trajectory of the disease, offering patients more time before their disease worsens. These results could mark an important shift in how we approach acquired resistance in this disease to significantly improve patient outcomes.”

Iza-bren showed a manageable safety profile in this population, with no new safety signals observed. Grade ≥3 treatment-related adverse events (TRAEs) were predominantly hematologic in nature. TRAEs were manageable with standard supportive care, and only 1.9% of patients in the iza-bren group discontinued treatment due to TRAEs. Interstitial lung disease (ILD) was uncommon with iza-bren (adjudicated ILD, two [0.9%]; one Grade 3 and one Grade 1).

“Post-progression EGFR-mutated NSCLC represents one of oncology's challenging treatment scenarios. With iza-bren, we achieved a nearly two-fold improvement in median PFS, along with a well-understood safety profile and high response rate. This demonstrates that dual-targeting EGFR and HER3 may fundamentally shift outcomes for these patients,” said Dr. Jonathan Cheng, chief medical officer, SystImmune. “These data validate our conviction that iza-bren addresses a critical unmet need and provides much-needed innovation for patients who often have limited options after TKI failure.”

“The PANKU-Lung01 results mark an important inflection point for iza-bren and reinforce our belief that this potentially first-in-class EGFRxHER3 bispecific ADC could, if approved, improve outcomes across the cancer treatment landscape,” said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. “The breadth of clinical benefit now seen across five tumor types is highly encouraging and speaks to the potential of iza-bren to address significant unmet needs in oncology. We are committed to advancing iza-bren with urgency to deliver this innovative treatment option to patients.”

Iza-bren has demonstrated clinical benefit across five Phase 3 trials in five distinct indications, including previously-treated EGFR-mutated NSCLC, nasopharyngeal carcinoma after prior treatment, previously-treated esophageal squamous cell carcinoma, advanced triple-negative breast cancer and previously-treated HR+/HER2-negative breast cancer, underscoring iza-bren’s broad therapeutic potential in areas of critical unmet need. Iza-bren has also received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for previously-treated advanced EGFR-mutated NSCLC.

The PANKU-Lung01 study is sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), in Mainland China. Outside of China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement.