Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 4 days ago
- 2 min read
17/08/2026
Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC (Ref)
AstraZeneca and Daiichi Sankyo announced that trastuzumab deruxtecan (Enhertu; HER2-directed ADC) achieved a statistically significant and clinically meaningful improvement in progression-free survival (PFS) vs the current global standard of care (platinum-pemetrexed chemotherapy + pembrolizumab) in the Phase 3 DESTINY-Lung04 trial for first-line HER2-mutant advanced non-small cell lung cancer (NSCLC)
Safety profile was consistent with prior data; no new safety concerns reported
Secondary endpoints (overall survival, response rates, duration of response) are under evaluation
Data will be presented at upcoming medical meetings and submitted to regulators worldwide
AstraZeneca halts Phase 3 eVOLVE-Lung02 trial of volrustomig in mNSCLC (Ref)
AstraZeneca has discontinued the Phase 3 eVOLVE-Lung02 trial evaluating volrustomig (PD-1 x CTLA-4 BsAb) + chemotherapy in metastatic non-small cell lung cancer (mNSCLC) patients with PD-L1 <50%, following the recommendation of the Independent Data Monitoring Committee (IDMC)
The IDMC determined the volrustomig regimen was unlikely to meet dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in PD-L1-negative (<1%) patients compared with pembrolizumab + chemotherapy
No new safety concerns were observed; findings were consistent with known profiles of the individual agents
Phase 3 trials of volrustomig in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma remain ongoing
ORPATHYS + TAGRISSO deliver survival benefit in MET-driven EGFRm NSCLC (Ref)
HUTCHMED announced positive Phase 3 SAFFRON trial results showing that the combination of savolitinib (ORPATHYS; c-MET inhibitor) + osimertinib (TAGRISSO; EGFR TKI) significantly improved both progression-free survival (PFS) and overall survival (OS) compared to platinum-based chemotherapy in EGFR-mutated NSCLC patients with MET-driven resistance after progression on TAGRISSO
No new safety signals; consistent with known profiles of each drug
Regulatory Status: Already approved in China (SACHI trial) and temporarily authorized in Switzerland; global filings planned
US FDA fast track designation granted for PIKTOR + paclitaxel in biomarker-selected advanced Endometrial Cancer (Ref)
Faeth Therapeutics announced that the FDA has granted Fast Track designation for its investigational therapy PIKTOR (sapanisertib, dual mTORC1/mTORC2 inhibitor + serabelisib, PI3K-alpha inhibitor) + paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K/AKT/mTOR pathway alteration and who have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI)
Clinical Development:
Phase 2 trial (FTH-PIK-201) in advanced endometrial cancer; topline data expected by year-end 2026.
Phase 1b/2 trial (FTH-PIK-101) in HR+/HER2- breast cancer; first patient dosed April 2026, interim data anticipated in 2027
UroGen submits NDA for UGN-103 in recurrent LG-IR-NMIBC (Ref)
UroGen Pharma has submitted a New Drug Application (NDA) to the US FDA for UGN-103, an investigational mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
Clinical Data (UTOPIA Trial):
Phase 3 single-arm study showed 77.8% complete response at 3 months and 94.5% durability at 6 months, consistent with outcomes from ZUSDURI’s pivotal ENVISION trial
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