Oncology Updates - Key Oncology News

October 2nd Week, 2025

Regulatory Events

🎯 The US FDA approved Regeneron's cemiplimab (PD-1 inhibitor) as an adjuvant Tx for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. (Ref 1)

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

🎯 The US FDA accepted for Priority Review Orca Bio's BLA seeking approval of Orca-T (allogeneic T-cell immunotherapy) as a Tx of hematological malignancies including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes. (Ref 2)

❓ What were the clinical outcomes that supported the BLA acceptance?

Clinical Events

🔬 The Phase 3 TROPION-Breast02 trial of AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (TROP2 ADC) elicited a statistically significant and clinically meaningful improvement in the dual primary endpoints of OS and PFS vs investigator's choice of chemotherapy as a first-line Tx for patients with locally recurrent, inoperable or metastatic, triple-negative breast cancer for whom immunotherapy was not an option. (Ref 3)

❓ What are the current survival benchmarks for this indication?

Special Designations

⭐ The US FDA granted the fast track designation to Vivace Therapeutics, Inc.'s VT3989 (TEAD autopalmitoylation inhibitor) as a Tx for patients with unresectable malignant nonpleural or pleural mesothelioma whose disease has progressed on prior immune checkpoint inhibitor therapy and platinum-based chemotherapy. (Ref 4)

❓ Which are the other key promising assets in the pipeline landscape of mesothelioma?

⭐ The US FDA granted the fast track designation to Werewolf Therapeutics' WTX-124 (conditionally activated IL-2 INDUKINE therapy) for the potential Tx of patients with locally advanced or metastatic cutaneous melanoma after standard of care immunotherapy. (Ref 5)

❓ Which other active assets have received the FTD for Melanoma?

⭐ The US FDA granted the fast track designation to Adcendo ApS’ ADCE-D01 (uPARAP-targeting ADC) for the Tx of soft tissue sarcoma. (Ref 6)

❓ What is the current Tx algorithm for STS?

⭐ The US FDA granted the orphan drug designation to Precision NeuroMed's cinetredekin besudotox (IL13PE38; cytotoxic protein) for the Tx of glioblastoma. (Ref 7)

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

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

🌐 References:

1) https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-rwlc-approved-us-first-and-only

2) https://orcabio.com/orca-bio-announces-fda-acceptance-and-priority-review-of-the-biologics-license-application-bla-for-orca-t-to-treat-hematological-malignancies/

3) https://www.astrazeneca.com/media-centre/press-releases/2025/datroway-improved-os-and-pfs-in-tropion-breast02.html

4) https://www.prnewswire.com/news-releases/vivace-therapeutics-vt3989-granted-fast-track-designation-by-the-us-food-and-drug-administration-for-the-treatment-of-mesothelioma-302577269.html

5) https://www.globenewswire.com/news-release/2025/10/08/3163279/0/en/Werewolf-Therapeutics-Receives-Fast-Track-Designation-from-the-U-S-FDA-for-WTX-124-an-Investigational-Therapy-for-the-Treatment-of-Cancer.html

6) https://www.prnewswire.com/news-releases/adcendo-aps-announces-fda-fast-track-designation-granted-to-adce-d01-for-the-treatment-of-soft-tissue-sarcoma-302578781.html

7) https://www.prnewswire.com/news-releases/precision-neuromed-granted-fda-orphan-drug-designation-by-us-fda-for-treatment-of-glioblastoma-multiforme-gbm-302575427.html