Oncology Updates - Key Oncology News

May 2nd Week, 2026

Regulatory Events 

🎯 AstraZeneca and Daiichi Sankyo US’ trastuzumab deruxtecan (HER2 ADC) was approved by the US FDA for both the neoadjuvant and adjuvant Tx of patients with HER2+ early breast cancer (Ref 1) 

❓ How does the efficacy and safety shown by the ADC compare to the benchmarks? 

Special Designations

⭐ The US FDA granted the Fast Track Designation to Alloplex Biotherapeutics Inc’s SUPLEXA (activated patient-derived immune cells) for the Tx of patients with MSI-H colorectal cancer (Ref 2)

❓ What is the current SOC for MSI-H CRC?

⭐ Servier’s emiltatug ledadotin (B7-H4 ADC) was granted the Breakthrough Therapy Designation by the US FDA for patients with LA/M or recurrent Adenoid Cystic Carcinoma with solid histology or high-grade transformation (Ref 3)

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

⭐ Zai Lab’s zocilurtatug pelitecan (DLL3 ADC) was granted the Fast Track Designation by the US FDA for extrapulmonary neuroendocrine carcinomas after progression on standard first‑line Tx (Ref 4)

❓ How is the ADC positioned in the pipeline landscape? 

Deals and Collaborations 

🤝 Rigel Pharmaceuticals Inc. entered an exclusive global licensing deal with Arvinas and Pfizer to develop, manufacture, and commercialize vepdegestrant, the first FDA-approved oral PROTAC for ER+/HER2-, ESR1-mutated A/M breast cancer (Ref 5)

❓ How is vepdegestrant positioned in the Breast cancer market landscape?

Clinical Events 

🔬 In the Ph3 VOLGA trial, AstraZeneca’s perioperative durvalumab (anti-PD-L1) ± tremelimumab (anti-CTLA-4) in combination with Pfizer and Astellas Pharma’s neoadjuvant enfortumab vedotin (Nectin-4 ADC) demonstrated a significant EFS benefit vs surgery with or without approved adjuvant Tx MIBC patients who were ineligible for or declined cisplatin chemotherapy (Ref 6) 

❓ Which are the key therapies in the competitive landscape for perioperative MIBC? 

Setbacks

🛑 The Ph3 R3767-ONC-2011 trial of Regeneron’s fianlimab (anti-LAG3) + cemiplimab (anti-PD-1) failed to meet the primary endpoint of PFS vs Merck & Co./MSD’s pembrolizumab (anti-PD-1) for the first-line Tx of unresectable or metastatic melanoma (Ref 7)

❓ What was the rationale behind the R3767-ONC-2011 study? 

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

🌐 References: 

1) https://www.astrazeneca-us.com/media/press-releases/2026/ENHERTU-fam-trastuzumab-deruxtecan-nxki-approved-in-the-US-for-two-new-indications-for-patients-with-HER2-positive-early-breast-cancer.html

2) https://alloplexbio.com/alloplex-biotherapeutics-receives-fda-fast-track-designation-for-suplexa-in-colorectal-cancer-indication/

3) https://www.prnewswire.com/news-releases/emiltatug-ledadotin-emi-le-granted-breakthrough-therapy-designation-by-the-us-fda-for-adenoid-cystic-carcinoma-acc-302769049.html

4) https://ir.zailaboratory.com/news-releases/news-release-details/zai-lab-receives-us-fda-fast-track-designation-zocilurtatug

5) https://www.rigel.com/investors/news-events/press-releases/detail/437/rigel-enters-exclusive-global-licensing-agreement-for

6) https://www.astrazeneca.com/media-centre/press-releases/2026/imfinzi-ev-improves-efs-os-in-bladder-cancer.html

7) https://investor.regeneron.com/news-releases/news-release-details/regeneron-provides-update-phase-3-trial-fianlimab-lag-3