Oncology Updates - Key Oncology News

July 3rd Week, 2026

Regulatory Events 

🎯 The US FDA has accepted Bristol Myers Squibb’s NDA for MeziKd regimen consisting of mezigdomide (cereblon E3 ligase modulator) + carfilzomib (proteasome inhibitor) + dexamethasone (corticosteroid) for RRMM (Ref) 

❓ How is MeziKd positioned in the RRMM landscape? 

🎯 Eli Lilly and Company's selpercatinib (Retevmo; RET TKI) was granted a traditional full approval by the US FDA for the Tx of adult and pediatric pts aged ≥2 years with LA/M solid tumors with a RET gene fusion, that have progressed on or following prior systemic Tx or who have no satisfactory alternative Tx options (Ref) 

❓ What is the addressable market for RET+ solid tumors in the US? 

Special Designation 

⭐ Oncolytics Biotech Inc.'s pelareorep (dsRNA immunotherapy), in combination with a checkpoint inhibitor, received a US FDA Fast Track Designation for the ≥2L Tx of inoperable, LR/M SCAC (Ref)

❓ How is pelareorep positioned in the SCAC developmental landscape? 

⭐ The US FDA has granted Fast Track Designation to SOTIO Biotech's SOT109 (CDH17 ADC) for advanced unresectable or metastatic colorectal cancer pts who have exhausted standard Tx (Ref) 

❓ Which are the key assets being developed for late-line MSS CRC? 

Clinical Updates 

🔬 Ph3 KEYNOTE-C93 trial met its primary endpoint of PFS with Merck&Co/MSD's pembrolizumab (Keytruda; Anti-PD-1) significantly outperforming platinum doublet chemo in previously untreated pts with dMMR advanced or recurrent endometrial cancer (Ref) 

❓ What are the clinical benchmarks for 1L dMMR endometrial cancer? 

🔬 The global Ph3 study of HUYABIO International's HBI-8000 (HDAC inhibitor) + Bristol Myers Squibb' nivolumab met its primary endpoint, showing a clinically and statistically meaningful improvement in PFS vs nivolumab + placebo, as frontline Tx of advanced melanoma (Ref) 

❓ What were the POC outcomes for HBI-8000 in advanced melanoma? 

🔬 The registrational Ph2 AZUR-1 trial of GSK and AnaptysBio's dostarlimab (Jemperli; anti-PD-1) in untreated stage II/III LA dMMR/MSI-H rectal cancer has met primary endpoint, showing a meaningful and sustained clinical complete response rate at 12 months (cCR12) (Ref) 

❓ What is the current SOC for LA MSI-H rectal cancer? 

Deals & Collaborations 

🤝 AstraZeneca has entered into an exclusive license agreement with Dizal Pharmaceutical to acquire worldwide rights to develop and commercialize sunvozertinib (Zegfrovy; oral irreversible EGFR inhibitor) (Ref) 

❓ Which are the key lung cancer assets in AstraZeneca's portfolio? 

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

🌐 References: 

1) https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-New-Drug-Application-for-Mezigdomide-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx

2) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive

3) https://ir.oncolyticsbiotech.com/press_releases/oncolytics-biotech-receives-fast-track-designation-for-pelareorep-in-second-line-and-later-anal-cancer/

4) https://sotio.com/news-publications/news/fda-grants-fast-track-designation-to-sotio-s-sot109-a-cdh17-targeting-adc-for-colorectal-cancer

5) https://www.merck.com/news/keytruda-pembrolizumab-as-monotherapy-significantly-improved-progression-free-survival-pfs-in-certain-patients-with-advanced-or-recurrent-endometrial-cancer-with-mismatch-repair-deficient-d/

6) https://huyabio.com/huyabio-international-delivers-significant-landmark-phase-3-results-in-advanced-melanoma/

7) https://www.gsk.com/en-gb/media/press-releases/jemperli-dostarlimab-achieves-sustained-clinical-complete-responses-in-dmmrmsi-h-locally-advanced-rectal-cancer/

8) https://www.astrazeneca.com/media-centre/press-releases/2026/astrazeneca-licenses-novel-egfr-inhibitor.html