Onco-Summaries: Daily Oncology Updates at a Glance
12/10/2026
Opamtistomig (PD-L1 x 4-1BB BsAb) receives US FDA Fast Track Designation in First-Line Biliary Tract Cancer (Ref)
Leads Biolabs announced that opamtistomig (LBL-024), a PD-L1 x 4-1BB bispecific antibody, has been granted US FDA Fast Track Designation for the treatment of patients with first-line advanced or metastatic biliary tract cancer (BTC)
This is the second FDA Fast Track Designation received by opamtistomig, following a previous designation in extrapulmonary neuroendocrine carcinoma (EP-NEC)
Clinical development is ongoing, with a Phase II study evaluating opamtistomig plus chemotherapy in first-line BTC having advanced to the expansion stage following favorable preliminary safety and efficacy findings; enrollment has been completed
In Phase 3 ACTION-1 trial, RYZ101 met primary endpoint of PFS in patients with GEP-NETs (Ref)
Bristol Myers Squibb reported positive topline results from the interim analysis of the Phase 3 ACTION-1 trial evaluating RYZ101 in patients with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have progressed following Lutetium-177 (Lu177)-based therapy
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival versus investigator's choice of therapy
The safety profile was consistent with previous clinical experience with RYZ101
Overall survival follow-up is ongoing
The company plans to discuss the results with regulatory authorities and pursue potential submission pathways
Detailed data are expected to be presented at a future medical meeting
RYZ101 is an Actinium-225-based targeted radiopharmaceutical therapy acquired through Bristol Myers Squibb's acquisition of RayzeBio
HLB/Elevar Resubmits US FDA application for first-line Liver Cancer combination (Ref)
HLB along with its US subsidiary Elevar Therapeutics and China's Jiangsu Hengrui Medicine, have resubmitted their US FDA application for the rivoceranib (VEGFR TKI) plus camrelizumab (anti–PD-1) combination as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC), following remediation of manufacturing-related issues cited in prior FDA Complete Response Letters (CRLs)
This marks the fourth FDA submission since the initial filing in May 2023
The resubmission follows the FDA's most recent CRL, which was related to manufacturing deficiencies identified at Hengrui's active pharmaceutical ingredient (API) production facility
According to the companies, corrective actions have been completed, and both the API and finished drug manufacturing sites have undergone FDA inspections. The finished drug facility reportedly received a Voluntary Action Indicated (VAI) classification
The filing is supported by Phase 3 clinical data demonstrating a median overall survival of 23.8 months with rivoceranib plus camrelizumab versus 15.2 months with sorafenib, corresponding to a 36% reduction in the risk of death
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