Oncology Updates - Key Oncology News
- Oncofocus Team
- 11 minutes ago
- 2 min read
August 3rd Week, 2026
Special Designations
⭐ The US FDA granted a Fast Track Designation to 858 Therapeutics' ETX-19477 (PARG inhibitor) for the Tx of adults with BRCA‑mutated, HR+/HER2‑ unresectable or metastatic breast cancer (Ref1)
❓ Who are the key competitors to ETX-19477 in the BRCA-m HR+/HER- BC?
⭐ The US FDA granted FTD to BlossomHill Therapeutics, Inc.’s BH-30643 (macrocyclic OMNI-EGFR™ inhibitor) for the Tx of adults with advanced or metastatic EGFR C797S-positive NSCLC following prior third-generation EGFR TKI therapy (Ref2)
❓ How is BH-30643 positioned in the EGFRm ≥2L NSCLC landscape?
⭐ The US FDA granted FTD to Faeth Therapeutics' PIKTOR (sapanisertib [dual mTORC1/mTORC2 inhibitor] + serabelisib [PI3K-alpha inhibitor]) + paclitaxel for the Tx of ≥2L advanced or recurrent endometrial cancer with a PI3K/AKT/mTOR pathway alteration (Ref3)
❓ What is the current SOC for pre-treated endometrial cancer?
🔬 The Ph3 INTerpath-001 trial of Merck & Co./MSD and Moderna's intismeran autogene (V940; mRNA-based individualized neoantigen therapy) + pembro as adjuvant Tx of completely resected stage IIB-IV melanoma met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival (Ref4)
❓ How is V940 positioned in the melanoma landscape?
🔬 In the Ph3 DESTINY-Lung04 trial, AstraZeneca and Daiichi Sankyo US' trastuzumab deruxtecan (Enhertu; anti-HER2 ADC) demonstrated a statistically significant and clinically meaningful PFS improvement vs pembro + platinum-pemetrexed doublet chemo in 1L unresectable LA/M HER2-mutant nsq-NSCLC pts (Ref5)
❓ Which are some key assets in the developmental landscape of 1L HER2-mutant NSCLC?
🔬 In the Ph3 SAFFRON study, AstraZeneca and HUTCHMED's savolitinib (ORPATHYS; c-MET inhibitor) + AstraZeneca's osimertinib (TAGRISSO; EGFR TKi) demonstrated a statistically significant and clinically meaningful improvement in both PFS and OS vs platinum doublet chemo in EGFRm NSCLC pts with high MET overexpression or amplification, and disease progression on prior osimertinib (Ref6)
❓ What is the expected launch timeline for savolitinib + osimertinib regimen in the US?
Setbacks
🛑 AstraZeneca has decided to discontinue the Ph3 eVOLVE-Lung02 trial evaluating volrustomig (PD-1 x CTLA-4 BsAb) + chemo vs pembro + chemo in 1L metastatic NSCLC pts with PD-L1 <50% (Ref7)
❓ Which are the key BsAb assets being developed in 1L NSCLC?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
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