Iza-bren shows promising results in advanced cancer patients

REDMOND/PRINCETON - SystImmune Inc. and Bristol Myers Squibb (NYSE:BMY), a pharmaceutical giant with $47.7 billion in revenue and an impressive 74% gross profit margin, presented the first global phase I trial results for iza-bren, an EGFR x HER3 bispecific antibody-drug conjugate, at the European Society for Medical Oncology Congress in Berlin. According to InvestingPro analysis, BMY maintains a GOOD financial health score, positioning it well for continued research investments.

The US-Lung-101 study evaluated iza-bren in 107 patients with heavily pre-treated metastatic or unresectable advanced non-small cell lung cancer (NSCLC) and other solid tumors. Data showed a 55% confirmed response rate among patients receiving the 2.5 mg/kg dose on days 1 and 8 every three weeks, with a median progression-free survival of 5.4 months.

Responses were observed in patients with EGFR-mutated NSCLC (3 of 10 patients) and those without the mutation (3 of 4 patients). The most common side effects were blood-related, such as neutropenia, which were generally manageable with standard medical measures. No cases of interstitial lung disease were reported.

In August, the U.S. FDA granted iza-bren breakthrough therapy designation for previously treated EGFR-mutated NSCLC based on data from this global study and studies conducted in China.

"The first global presentation of iza-bren builds on the compelling data initially observed in Chinese patients, showing consistent efficacy in a heavily pre-treated global population," said Jonathan Cheng, Chief Medical Officer at SystImmune.

Global registrational studies are currently ongoing for iza-bren in first-line metastatic triple-negative breast cancer, second-line metastatic EGFR-mutated NSCLC, and second-line metastatic urothelial cancer.

SystImmune is developing iza-bren in collaboration with Bristol Myers Squibb for territories outside mainland China. The drug’s dual mechanism targets both EGFR and HER3 receptors, which are highly expressed in various epithelial cancers. Currently trading near its 52-week low, BMY offers investors a substantial 5.72% dividend yield. InvestingPro analysis indicates the stock is currently undervalued, with 10+ additional exclusive insights available to subscribers.

The information in this article is based on a press release statement from the companies. For comprehensive analysis of BMY and 1,400+ other stocks, including detailed Fair Value assessments and expert insights, explore InvestingPro’s extensive research reports and financial metrics.

In other recent news, Bristol Myers Squibb announced that its Phase 3 EXCALIBER-RRMM study of iberdomide, in combination with daratumumab and dexamethasone, showed a significant improvement in minimal residual disease negativity rates in patients with relapsed or refractory multiple myeloma. The trial will continue to assess progression-free survival and overall survival. The U.S. Food and Drug Administration granted Fast Track Designation to BMS-986446, an anti-MTBR-tau antibody for early Alzheimer’s disease, which is currently in Phase 2 clinical trials. SystImmune received a $250 million milestone payment from Bristol Myers Squibb after treating the first patient in its IZABRIGHT-Breast01 study, part of their collaboration on izalontamab brengitecan. Additionally, insitro and Bristol Myers Squibb are advancing their collaboration to develop ALS treatments, potentially providing up to $20 million in new funding. Bristol Myers Squibb also announced plans to offer significant discounts on Eliquis and Sotyktu for eligible cash-paying patients starting in 2026.

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