Oncology Updates - Key Oncology News

May 5th Week, 2025

Regulatory Events

🎯 The EC approved Bristol Myers Squibb’s subcutaneous nivolumab (Opdivo Quantig; anti-PD-1) co-formulated with Halozyme, Inc.’s recombinant human hyaluronidase (rHuPH20) for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab + ipilimumab IV, or in combination with chemotherapy or cabozantinib. (Ref 1)

❓ What is the development status of other key subcutaneous immune checkpoint inhibitors?

Special Designations

⭐ The US FDA granted the Priority Review status to Bayer’s sevabertinib (HER2 & EGFR TKi) for the Tx of HER2+ve NSCLC, who have received a prior systemic therapy. (Ref 2)

❓ What is the estimated launch timeline for sevabertinib?

⭐ Singapore's Experimental Drug Development Centre (EDDC) EBC-129 (CEACAM5 & CEACAM6 ADC) has been granted the Fast Track designation by the US FDA for the Tx of pancreatic ductal adenocarcinoma (PDAC). (Ref 3)

❓ What are the clinical outcomes that support the designation?

⭐ Shanghai Henlius’ AC101/HLX22 (anti-HER2) has been granted the Orphan Drug Designation by the EC for the Tx of gastric cancer. (Ref 4) HLX22 was originally developed through a discovery collaboration between Alligator Bioscience AB’s subsidiary, Atlas Therapeutics, and AbClon.

❓ What is the current development status of HLX22 in this indication?

Setbacks

🛑 Daiichi Sankyo US and Merck & Co./MSD voluntarily withdrew the BLA seeking accelerated approval of patritumab deruxtecan (HER3 ADC) in the US for EGFR mutated NSCLC patients previously treated with at least 2 systemic therapies due to the failure in meeting statistically significant OS in the Phase 2 HERTHENA-Lung01 trial. (Ref 5)

❓ How is this failure of patritumab deruxtecan going to impact its overall development status?

🛑 Adlai Nortye’s Phase 3 BURAN trial of buparlisib (PI3K inhibitor) + paclitaxel did not meet the primary endpoint of OS vs paclitaxel alone in recurrent and metastatic HNSCC patients that have progressed after anti-PD-(L)1-based treatment. (Ref 6)

❓ What are the possible reasons for failure of the regimen in this indication?

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

🌐 References:

1) https://news.bms.com/news/details/2025/Bristol-Myers-Squibb-Receives-European-Commission-Approval-for-the-Subcutaneous-Formulation-of-Opdivo-nivolumab-Across-Multiple-Solid-Tumor-Indications/default.aspx

2) https://www.bayer.com/media/en-us/sevabertinib-bay-2927088-granted-fda-priority-review-for-the-treatment-of-patients-with-her2-mutant-non-small-cell-lung-cancer/

3) https://www.eddc.sg/experimental-drug-development-centre-granted-u-s-fda-fast-track-designation-for-antibody-drug-conjugate-ebc-129-to-treat-pancreatic-ductal-adenocarcinoma/

4) https://alligatorbioscience.se/en/mfn_news/alligator-bioscience-announces-european-orphan-drug-designation-for-hlx22-in-gastric-cancer/

5) https://www.merck.com/news/patritumab-deruxtecan-biologics-license-application-for-patients-with-previously-treated-locally-advanced-or-metastatic-egfr-mutated-non-small-cell-lung-cancer-voluntarily-withdrawn/#:~:text=About%20EGFR%2DMutated%20Non%2DSmall%20Cell%20Lung%20Cancer&text=NSCLC%20accounts%20for%20about%2087,up%20to%2070%25%20of%20patients.

6) https://ir.adlainortye.com/news-releases/news-release-details/adlai-nortye-announces-topline-results-phase-iii-buran-trial