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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Apr 29
- 3 min read
27/04/2026
Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDUFA date of Aug'26 set (Ref)
The US FDA has accepted the sBLA and granted priority review to Jazz, BeOne and Zymeworks' zanidatamab (bispecific HER2-directed antibody) + chemotherapy ± BeOne's tislelizumab (PD-1 inhibitor) for the first-line treatment of adult patients with HER2+ unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction, and esophagus. The US FDA has set a PDUFA target action date of August 25, 2026
The filing is based on results from the pivotal Phase 3 HERIZON-GEA-01/NCT05152147 trial of zanidatamab + chemotherapy ± tislelizumab vs trastuzumab + chemotherapy as a first-line Tx of HER2+, locally advanced or metastatic gastroesophageal adenocarcinoma. To note, both investigational arms, zanidatamab + chemo + tislelizumab (n=302) and zanidatamab + chemo (n=304), led to a significant PFS benefit vs trastuzumab + chemo (n=308). The triplet arm also achieved a significant OS benefit. While OS for the doublet was not significant at the first interim analysis, a strong trend favouring it vs the control arm was observed
Tovecimig + paclitaxel significantly improved PFS and ORR in biliary tract cancer; sBLA submission planned (Ref)
Compass Therapeutics announced that the Ph2/3 COMPANION-002 trial evaluating tovecimig + paclitaxel vs paclitaxel alone, in patients with unresectable advanced, metastatic or recurrent biliary tract cancer (BTC) treated in the second-line setting, met the key secondary endpoint of PFS
4.7 mos vs 2.6 mos, representing a 56% reduction in risk of progression (HR=0.44, p<0.0001)
Secondary endpoint of OS did not meet statistical significance due to high crossover (54% of control patients)
Crossover patients had median OS of 12.8 months vs. 6.1 months for non-crossover patients (HR=0.54, p=0.04)
Pooled median OS across all patients was 8.9 months, longer than typical chemotherapy benchmarks (~6 months)
As previously disclosed, primary endpoint of ORR was met (17.1% vs 5.3%; p=0.031)
Next Steps: Compass plans to meet with the FDA ahead of a Biologics License Application (BLA) submission
FDA Grants Breakthrough Therapy Designation to TERN-701 in Chronic Myeloid Leukemia (Ref)
Terns Pharmaceuticals' TERN-701, an oral allosteric BCR::ABL1 inhibitor, received Breakthrough Therapy Designation for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase, without the T315I mutation, who have been treated with two or more tyrosine kinase inhibitors (TKIs)
The designation is based on data from the ongoing Phase 1/2 CARDINAL trial, which showed promising activity including major and deep molecular responses at week 24, even in patients with high disease burden and prior multiple therapies
Relay Therapeutics Advances PI3Kα/CDK4 Triplet Toward Frontline Breast Cancer Phase 3 Trial (Ref)
Relay is advancing zovegalisib + atirmociclib + aromatase inhibitor (AI) as a frontline triplet regimen for HR+/HER2- metastatic breast cancer patients with PI3Kα mutations
In heavily pre-treated, CDK4/6-experienced patients (median third-line), the triplet showed a 44% overall response rate (ORR), consistent across kinase and non-kinase PIK3CA mutations
A frontline Phase 3 trial in endocrine-sensitive patients is expected to start in early 2027, pending regulatory feedback
Planned study design: Randomized Phase 3 study; zovegalisib + atirmociclib + aromatase inhibitor (AI) vs CDK4/6 inhibitor (investigator’s choice) + AI, in frontline endocrine sensitive patients with PIK3CA-mutated, HR+/HER2- advanced or metastatic breast cancer
Key endpoints: Median progression-free survival (primary) and overall survival (secondary)
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