BOTHELL, Wash. & PRINCETON, N.J.--(BUSINESS WIRE)-- SystImmune, Inc. (SystImmune), a clinical stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) today 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.

About izalontamab brengitecan (iza-bren)

Izalontamab brengitecan (iza-bren, BL-B01D1) is a bispecific antibody-drug conjugate (ADC) that targets both EGFR and/or HER3, antigens that are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Upon target binding and internalization, iza-bren's therapeutic novel Topo1i payload is released, causing cytotoxic stress that leads to cancer cell death. Iza-bren's dual mechanism of action also blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Iza-bren is being developed under a license and collaboration agreement by and between SystImmune and Bristol Myers Squibb.

About SystImmune

SystImmune is a clinical-stage biotechnology company located in Bothell, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.

About Bristol Myers Squibb: Transforming Patients’ Lives Through Science

At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that izalontamab brengitecan (iza-bren) may not achieve its primary study endpoints or receive regulatory approvals for the indications described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such treatment for such indication will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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