On August 28, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that BL-B01D1 for injection is proposed to be included in the priority review process. It is intended for patients with recurrent or metastatic nasopharyngeal carcinoma who have previously been treated with PD-1/PD-L1 monoclonal antibodies and have failed at least two lines of chemotherapy (with at least one line containing platinum).
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
iza-bren is a first-in-class ADC comprised of an EGFR x HER3 bispecific antibody conjugated to a novel topo-I inhibitor payload (Ed-04) via a stable tetrapeptide-based cleavable linker. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic payload is released causing genotoxic stress that leads to cancer cell death.
The results of BL-B01D1 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring driver genomic alterations (GA) outside of classic EGFR mutations were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
Methods: Phase Ib part of this study included the expansion cohorts, each defined by a pre-specified GA, including EGFR exon 20 insertions, non-classical EGFR mutations, mutations in HER2, ALK, ROS1, BRAF (V600E and others), KRAS (G12C and others), SMARCA4, MET (Exon 14), RET, and NTRK. Pts with these GA who progressed on standard targeted therapies (if available) and no more than one prior line of chemotherapy were enrolled. iza-bren was given at 2.5 mg/kg D1D8 Q3W.
Results: As of Dec 5, 2024, a total of 73 NSCLC pts with listed GA were enrolled. Five pts were still on treatment, but were excluded from the analysis due to insufficient follow-up for the first post-baseline scan (see table below). Among 7 pts with EGFR exon 20 insertions, 85.7% (6 out of 7) achieved cPR. Among 8 pts with KRAS G12C mutations, 3 cPR and 1 PR pending confirmation were observed. Efficacy for subgroups will be presented. The most frequent hematologic TRAEs (all grades) were anemia (87.7%), leukopenia (74.0%), thrombocytopenia (74.0%), and neutropenia (72.6%); the most frequent non-hematologic TRAEs were asthenia (42.5%), nausea (41.1%), stomatitis (37.0%), diarrhea (32.9%), and alopecia (31.5%). Grade 3 and above TRAEs which were predominantly hematologic in nature, were able to be effectively managed with standard supportive measure including dose reductions, as demonstrated by the TRAE leading to discontinuation rate of 2.7%. Only 1 case of G2 ILD was observed. Notably, no iza-bren related death was reported. No new safety signals were observed.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Post time: Sep-05-2025