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Oncology Updates - Key Oncology News

June 4th Week



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: 


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