Oncology Updates - Key Oncology News

October 5th Week, 2025

Regulatory Events

🎯 The EC approved Merck & Co./ MSD's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT ± cisplatin after surgery, and then as a single agent for adults with resectable LA SCCHN with PD-L1 CPS ≥1. (Ref 1)

❓ How is this approval expected to impact the treatment algorithm of LA SCCHN?

Clinical Events

🔬 Merck & Co./MSD and Eisai US reported that the Phase 3 LITESPARK-011 trial of belzutifan (HIF-2α inhibitor) + lenvatinib (multiple-TKI) met one of its primary endpoints of PFS for the Tx of patients with advanced renal cell carcinoma whose disease progressed on or after Tx with anti-PD-(L)1. (Ref 2)

❓ What are the current SOC benchmarks for this indication?

Special Designations

⭐ The US FDA granted the rare pediatric drug designation (RPDD) to Cellectar Biosciences, Inc.'s iopofosine I131 in inoperable R/R pediatric high-grade glioma. (Ref 3)

❓ Which other assets have received the FDA RPDD?

⭐ The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting ADC) for the Tx of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC). (Ref 4)

❓ What are the clinical outcomes that support the FTD?

⭐ The US FDA granted the orphan drug designation to Exousia Pro's exosome-based therapy for Glioblastoma multiforme (Ref 5).

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

⭐ The US FDA granted the orphan drug designation to Revolution Medicines' daraxonrasib (RAS(ON) multi-selective inhibitor) for the Tx of pancreatic cancer. (Ref 6)

❓ Which are the key promising assets in the pipeline landscape of pancreatic cancer?

Deals And Collaborations

🤝 GSK and Syndivia announced an agreement granting GSK exclusive worldwide rights to develop and commercialize a preclinical ADC for metastatic castration-resistant prostate cancer. (Ref 7)

❓ Who are the other key players developing ADCs for prostate cancer?

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

🌐 References:

1) https://www.merck.com/news/european-commission-approves-keytruda-pembrolizumab-as-part-of-a-treatment-regimen-for-adults-with-resectable-locally-advanced-head-and-neck-squamous-cell-carcinoma-la-hnscc-expressing-pd-l1/

2) https://www.merck.com/news/merck-and-eisai-announce-welireg-belzutifan-plus-lenvima-lenvatinib-met-primary-endpoint-of-progression-free-survival-pfs-in-certain-previously-treated-patients-with-advanced-renal-c/

3) https://www.cellectar.com/news-media/press-releases/detail/379/cellectar-biosciences-receives-rare-pediatric-disease

4) https://www.prnewswire.com/apac/news-releases/alphamab-oncology-announces-biparatopic-her2-targeting-adc-jskn003-was-granted-fast-track-designation-by-fda-for-the-treatment-of-proc-302596008.html

5) https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/exousia-pro-is-excited-to-announce-that-it-has-received-orphan-drug-d-1092559

6) https://www.globenewswire.com/news-release/2025/10/27/3174539/0/en/Revolution-Medicines-RAS-ON-Multi-Selective-Inhibitor-Daraxonrasib-Granted-U-S-FDA-Orphan-Drug-Designation-in-Pancreatic-Cancer.html

7) https://www.gsk.com/en-gb/media/press-releases/gsk-acquires-exclusive-rights-from-syndivia-for-antibody-drug-conjugate/