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Oncology Updates - Key Oncology News

3rd June, 2025



Regulatory Events 



🎯 The US FDA approved the updated labelling of Pfizer’s talazoparib (PARP inhibitor) + enzalutamide (androgen receptor inhibitor) for mCRPC to include the final OS data for the combo’s existing indication for the Tx of HRR gene-mutated mCRPC, but did not expand the indication to include non-HRR gene mutated patients. (Ref 1) 


❓ What were the key factors that influenced the FDA’s decision to not expand the indication? 



🎯 The US FDA approved Incyte’s tafasitamab (anti-CD19) + rituximab + lenalidomide for the Tx of adults with relapsed or refractory follicular lymphoma (Ref 2) 


❓ How is the combination positioned against the current SOC? 



Special Designations 



⭐ The US FDA granted the Orphan Drug Designation to Medicovestor, Inc.’s ADoBind MC001 (Frα ADC) for the Tx of pancreatic cancer. (Ref 3) 


❓ What are the other key ADCs in pancreatic cancer with an ODD? 



⭐ The US FDA granted the Orphan Drug Designation to Circle Pharma, Inc.’s CID-078 (Cyclin A/B RxL inhibitor) for the Tx of SCLC. (Ref 4) 


❓ What are the key unmet needs in the SCLC space? 



Deal & Collaborations 


 

🤝 Pierre Fabre Laboratories acquired the worldwide rights for PFL-721 (STX-721; EGFR/HER2 ex20 inhibitor) and PFL-241 (STX-241; EGFR inhibitor) from Antares Therapeutics, a spin-out of Scorpion Therapeutics. Both assets are currently being evaluated as a Tx for NSCLC. (Ref 5) 


❓ How are these assets positioned in the NSCLC pipeline landscape? 



🤝 Crescent Biopharma completed its merger with GlycoMimetics, with the combined company operating under the name Crescent Biopharma, Inc. The company’s pipeline includes bispecific antibodies such as the CR-001, a tetravalent PD-1 x VEGF BsAb, and CR-002 and CR-003, which are novel ADCs. (Ref 6) 


❓ How is this merger going to impact the BsAb and ADC space? 



🤝 NextCure, Inc. entered a strategic partnership with Simcere Zaiming for the development of SIM0505 (CDH6 ADC) in solid cancers. As a part of the agreement, NextCure gained global rights to SIM0505 excluding greater China, where Simcere Zaiming will retain rights. (Ref 7) 


❓ What is the development status of SIM0505 in solid tumor indications? 



Setbacks 



🛑 AbbVie’s Phase 3 VERONA trial of venetoclax (BCL-2 inhibitor) + azacitidine did not meet the primary endpoint of OS (HR 0.908; p=0.3772) vs azacitidine in newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). (Ref 8) 


❓ How is this failure going to impact AbbVie’s MDS program? 


 

To know answers to these questions and for additional insights, write to us at support@oncofocus.com. 



🌐 References: 


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