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Oncology Updates - Key Oncology News
- Oncofocus Team
- 4 days ago
- 2 min read
February 4th Week, 2025
📝 Merck & Co/ MSD's sBLA for neoadjuvant pembro followed by adjuvant pembro + RT ± cisplatin in resectable, LA SCCHN has been accepted by the US FDA for priority review (PDUFA date: Jun 23, 2025) (Ref 1)
❓ It is set to be the first approved Tx option for perioperative LA SCCHN. What are its challengers in the pipeline?
📝 BMS’ sBLA for nivo + ipi as a 1L Tx for adult and pediatric patients with unresectable or metastatic, MSI-H/dMMR colorectal cancer has been accepted by the US FDA for priority review (PDUFA date: Jun 23, 2025). The application was also granted the breakthrough therapy designation (Ref 2)
❓ What is the current SOC for metastatic, MSI-H/dMMR CRC in the 1L setting, and if approved, will nivo + ipi replace the current SOC?
📝 Regeneron’s linvoseltamab (BCMA x CD3 BsAb) received positive opinion recommending conditional marketing authorization from the EMA’s CHMP for the treatment of adults with R/R multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38, and have demonstrated disease progression on the last therapy (Ref 3)
❓ Will the current results allow linvoseltamab to become a SOC, and what is the status of the confirmatory trial for the regimen?
📝 Innovent’s NDA for neoadjuvant IBI310 (anti-CTLA-4) + sintilimab (anti-PD-1) for resectable, MSI-H/dMMR colon cancer has been accepted by the CDE of China’s NMPA for priority review (Ref 4)
❓ What will be the impact of these regulatory developments on the Tx paradigm?
📝 MAIA Bio plans to initiate the Ph3 THIO-104 trial of THIO (telomere-targeting agent) administered in sequence with a CPI in 3L NSCLC patients who are resistant to CPIs and CT in 2025 (Ref 5)
❓ What are the POC results that support the plans to initiate a Ph3 trial of THIO?
📝 Eleison and Bull Frog AI enter a collaboration to apply the proprietary BullFrog Data Networks™ solution to analyze clinical data from Eleison’s ongoing Ph3 trial and previous clinical studies of glufosfamide (alkylating agent) for pancreatic cancer (Ref 6)
❓ How is the AI platform expected to influence the analysis of glufosfamide trial data?
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