Onco-Summaries: Daily Oncology Updates at a Glance
Updated: 2 days ago
08/10/2026
China NMPA approves Enhertu as adjuvant therapy for HER2-positive early breast cancer and Datroway for metastatic TNBC
US FDA approved atezolizumab + chemotherapy for adjuvant treatment of stage III dMMR Colon Cancer (Ref)
US FDA approved atezolizumab (Tecentriq; anti-PD-L1) in combination with fluoropyrimidine- and oxaliplatin-based chemotherapy for the adjuvant treatment of patients with Stage III mismatch repair-deficient (dMMR) colon cancer
The approval is based on results from the Phase 3 ATOMIC trial, which evaluated atezolizumab plus mFOLFOX6 versus mFOLFOX6 alone in patients with resected Stage III dMMR colon cancer
The study demonstrated a statistically significant improvement in disease-free survival (DFS), with a hazard ratio of 0.50 (95% CI: 0.35–0.73; p=0.0001), indicating a 50% reduction in the risk of disease recurrence or death compared with chemotherapy alone
Median DFS had not yet been reached in either treatment arm at the time of analysis
The approval covers both intravenous Tecentriq and subcutaneous Tecentriq Hybreza formulations for eligible patients
Perspective therapeutics receives US FDA Fast Track Designation for [212Pb]PSV359 in Solitary Fibrous Tumors (Ref)
Perspective Therapeutics announced that the US FDA has granted Fast Track Designation to [212Pb]PSV359, its investigational FAP-targeted alpha radiopharmaceutical, for the treatment of adult patients with locally advanced unresectable and/or metastatic FAP-positive solitary fibrous tumors (SFTs)
The therapy is currently being evaluated in an ongoing Phase 1/2a clinical trial in patients with advanced FAP-positive solid tumors
The designation was supported by evidence demonstrating FAP expression and uptake in solitary fibrous tumors, providing a scientific rationale for targeted treatment in this indication
The company highlighted the broader potential of targeting FAP-α, which is expressed across a range of solid tumors and within the tumor microenvironment, supporting future expansion opportunities beyond SFT
US FDA granted Fast Track Designation to VIR-5500 in mCRPC (Ref)
Vir Biotechnology announced that the US FDA has granted Fast Track designation to VIR-5500 (PSMA × CD3 bispecific T-cell engager), for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC)
VIR-5500 is being developed in collaboration with Astellas Pharma and is currently being evaluated in an ongoing Phase 1 clinical trial (NCT05997615)
The study is assessing VIR-5500 both as monotherapy and in combination with standard therapies, including enzalutamide, docetaxel, and darolutamide, across advanced prostate cancer settings
As per previously reported data, VIR-5500 was generally well tolerated and exhibited promising anti-tumor activity in patients with mCRPC
Phase 3 trials are anticipated to begin in 2027
China NMPA approves Enhertu as adjuvant therapy for HER2-positive early breast cancer and Datroway for metastatic TNBC (Ref; Ref)
Daiichi Sankyo and AstraZeneca announced two breast cancer approvals from China’s National Medical Products Administration (NMPA):
Trastuzumab deruxtecan (Enhertu; HER2-directed ADC) is approved as adjuvant treatment for adults with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based therapy
The approval is based on the Phase 3 DESTINY-Breast05 trial, which compared Enhertu with trastuzumab emtansine (T-DM1)
Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 (investigator-assessed IDFS: HR 0.47; 95% CI 0.34 to 0.66; p<0.0001)
The 3-year IDFS rate was 92.4% with Enhertu versus 83.7% with T-DM1
Disease-free survival was consistent with IDFS (HR 0.47; 3-year rate 92.3% vs 83.5%)
Datopotamab deruxtecan (Datroway; Trop-2-directed ADC) is approved for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy
The approval is based on the Phase 3 TROPION-Breast02 trial, which compared Datroway with investigator’s choice of chemotherapy in previously untreated patients
Datroway met both dual primary endpoints, assessed by blinded independent central review:
Median overall survival was 23.7 vs 18.7 months (HR 0.79; 95% CI 0.64 to 0.98; p=0.0291)
Median progression-free survival was 10.8 vs 5.6 months (HR 0.57; 95% CI 0.47 to 0.69; p<0.0001)
The objective response rate was 63% vs 29%
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