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Oncology Updates - Key Oncology News

October 1st Week, 2025



Regulatory Events



🎯 The US FDA approved Jazz Pharmaceuticals' lurbinectedin (DNA alkylating agent) + Roche's atezolizumab (anti-PD-L1) as a maintenance Tx for adults with ES-SCLC whose disease has not progressed after first-line induction Tx with atezolizumab, carboplatin and etoposide. (Ref 1)


❓ How is this approval expected to impact the Tx paradigm?



🎯 AstraZeneca and Daiichi Sankyo’s sBLA for trastuzumab deruxtecan (HER2 ADC) followed by paclitaxel, trastuzumab and pertuzumab has been accepted by the US FDA for the neoadjuvant Tx of adults with HER2+ve stage 2/3 breast cancer. (Ref 2)


❓ What are the currently approved Tx options in this indication?



🎯 AbbVie completed the submission of a BLA to the US FDA for the approval of pivekimab sunirine (CD123 ADC) for the Tx of Blastic Plasmacytoid Dendritic Cell Neoplasm. (Ref 3)


❓ What were the clinical outcomes that supported the submission?



Clinical Events



🔬 In the Phase 3 DESTINY-Breast05 trial, AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan (HER2 ADC) elicited a significant IDFS improvement vs trastuzumab emtansine in patients with HER2+ve early breast cancer with residual invasive disease in the breast or axillary lymph nodes after neoadjuvant Tx and high risk of disease recurrence. (Ref 4)


❓ What are the current benchmarks in this indication?



Special Designations



⭐The US FDA granted the fast track designation to GI INNOVATION's GI-102 (CD80-IL2v3 immunocytokine) for the Tx of advanced or metastatic Melanoma. (Ref 5)


❓ Which other promising assets are in pipeline for this indication?



⭐ The US FDA granted the fast track designation to Umoja Biopharma's UB-VV111 (in vivo CD19 CAR-T) for the Tx of R/R LBCL following two or more lines of prior Tx and R/R CLL following two or more lines of prior Tx. (Ref 6)


❓ What are the other CAR-T therapies being developed for these indications?



⭐ The US FDA granted the fast track designation to Ensem Therapeutics' ETX-636 (PI3Kα inhibitor and degrader) for the Tx of adults with PIK3CA-mutant, HR+/HER2- advanced breast cancer. (Ref 7)


❓ What are the key unmet medical needs of this indication?



Deals And Collaborations



🤝 Genmab and Merus N.V. announced a transaction agreement pursuant to which Genmab will acquire all the shares of Merus for $97.00 per share in an all-cash transaction representing a transaction value of ~$8.0 billion. (Ref 8)


❓ What are the key assets in Merus’ pipeline, and their competitive position?



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



🌐 References:


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