Onco-Summaries: Daily Oncology Updates at a Glance

26/02/2026

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• Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC

• Izalontamab brengitecan elicited significant PFS and OS benefit in TNBC

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Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC (Ref)

The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for an expanded indication for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutations, as detected by an FDA-authorized test.

• This application is part of the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program

• The approval is based on results from the Phase 1 Beamion LUNG-1 trial (NCT04886804)

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Izalontamab brengitecan elicited significant PFS and OS benefit in TNBC (Ref)

Positive topline results have been reported from a pre-specified interim analysis of a Phase 3 BL-B01D1-307 trial evaluating SystImmune and Bristol Myers Squibb's izalontamab brengitecan (EGFR × HER3 bispecific ADC) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose disease progressed following prior taxane therapy.

• In the pre-specified interim analysis, iza-bren demonstrated statistically significant and clinically meaningful improvement in both PFS and OS vs chemotherapy of physician’s choice, meeting both dual primary endpoints

• These data will be presented at an upcoming medical meeting

• The BL-B01D1-307 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 BMS under a collaboration and exclusive license agreement

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