Oncology Updates - Key Oncology News

June 4th Week,2025

Regulatory Events 

🎯 Daiichi Sankyo and AstraZeneca's Dato-DXd (Datroway; TROP2 ADC) has been granted an accelerated approval by the US FDA for the Tx of EGFR+ NSCLC patients previously treated with EGFR directed therapy and platinum-based chemotherapy. (Ref 1)

❓ Which other key regimens are expected to enter this setting in the near future?

Special Designations 

⭐ enGene's detalimogene voraplasmid (non-viral gene therapy) was granted a Regenerative Medicine Advanced Therapy (RMAT) designation by the US FDA for the Tx of BCG unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. (Ref 2)

❓ What are the current Tx options and benchmarks in this setting?

⭐ The US FDA granted a Priority Review to Syndax Pharmaceuticals’ supplemental NDA of revumenib (Revuforj; selective menin inhibitor) for the Tx of relapsed or refractory AML with NPM1 mutation. The PDUFA date has been set for Oct 25, 2025. (Ref 3)

❓ What is the projected revenue increase for Revuforj following the anticipated label extension?

⭐ The US FDA granted a Breakthrough Therapy Designation to Revolution Medicines’ daraxonrasib (RAS(ON) multi-selective inhibitor) for the Tx of previously treated metastatic PDAC in patients with KRAS G12 mutations. (Ref 4)

❓ Which other assets targeting these patients received special designations? How do they compare?

⭐ QBiotics Group Limited’s tigilanol tiglate (intratumoural oncolytic agent) elicited an ORR of 80.0% in advanced and/or metastatic soft tissue sarcoma patients in stage 1 part (n=10) of the Phase 2a, QB46C-H07 trial. (Ref 5)

❓ What are the current benchmarks in this setting?

Clinical Updates

🔬 The Ph3 STELLAR-303 trial of Exelixis' zanzalintinib (thrid generation multi-target TKI) + Roche’s atezolizumab (Tecentriq; anti-PD-L1) demonstrated a statistically significant improvement in OS vs Bayer’s regorafenib (Stivarga; multi-kinase inhibitor) in previously treated non-MSI-H CRC patients, regardless of liver metastases. (Ref 6)

❓ Can the zanzalintinib + atezolizumab combo be the next SoC for these patients?

Setbacks 

🛑 Philogen S.p.A. withdrew its EMA marketing authorisation application for Nidlegy (daromun; L19IL2 + L19TNF) as a neoadjuvant Tx for adults with locally advanced, fully resectable melanoma, due to unavailability of CMC and additional clinical data in the allowed time period. (Ref 7)

❓ What is the current SoC for the Tx of resectable Melanoma?

🌐 References: 

1) https://www.astrazeneca.com/media-centre/press-releases/2025/datroway-approved-in-us-for-egfrm-lung-cancer.html

2) https://engene.com/fda-grants-rmat-designation-for-engenes-detalimogene-enabling-potential-for-expedited-review-in-high-risk-non-muscle-invasive-bladder-cancer/

3) https://ir.syndax.com/news-releases/news-release-details/syndax-announces-fda-priority-review-snda-revuforjr-revumenib

4) https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-announces-fda-breakthrough-therapy

5) https://qbiotics.com/announcement/qbiotics-reports-80-objective-response-rate-in-injected-tumours-in-stage-1-of-phase-iia-clinical-trial-of-tigilanol-tiglate-for-soft-tissue-sarcoma

6) https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-zanzalintinib-combination-immune-checkpoint

7) https://www.philogen.com/philogen/wp-content/uploads/2025/06/Philogen-Press-Release-Nidlegy-MAA-withdrawal-FINAL.pdf