Oncology Updates - Key Oncology News

August 3rd Week, 2025

Regulatory Events 

🎯 Health Canada granted approval to Merck & Co./MSD's pembrolizumab (anti-PD-1) mono as a neoadjuvant treatment, then continued as adjuvant treatment in combination with RT +/- cisplatin and then as monotherapy for adult patients with resectable locally advanced HNSCC with PD-L1 CPS ≥1. (Ref 1) 

❓ What were the clinical outcomes that supported the approval? 

Clinical Events 

🔬 The Phase 3 KEYNOTE-905/EV-303 trial of Merck & Co./MSD's pembrolizumab (anti-PD-1) + Astellas Pharma and Pfizer's enfortumab vedotin (anti-Nectin-4 ADC) given before and after radical cystectomy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of EFS, as well as key secondary endpoints of OS and pCR vs radical cystectomy alone in cisplatin-ineligible MIBC patients. (Ref 2) 

❓ How are these results going to impact the Tx paradigm of MIBC? 

🔬 CEL-SCI Corporation filed a Breakthrough Medicine Designation application with the Saudi Food and Drug Authority for Multikine (leukocyte interleukin injection) as a neoadjuvant treatment of HNSCC. (Ref 3) 

❓ What is the development status of Multikine in other key geographies? 

Special Designations 

⭐ The US FDA granted the Breakthrough Therapy Designation to Daiichi Sankyo and Merck & Co./MSD’s ifinatamab deruxtecan (anti-B7-H3 ADC) for the treatment of adult patients with extensive-stage SCLC with disease progression on or after platinum-based chemotherapy. (Ref 4) 

❓ How do the outcomes of the ADC compare against the current SOC? 

⭐ The US FDA granted the Fast Track designation to Halda Therapeutics' HLD-0915 (androgen receptor-targeting RIPTAC) for the treatment of patients with metastatic castration-resistant prostate cancer. (Ref 5) 

❓ Which are the other key assets with an FTD in this indication? 

Deal & Collaborations 

🤝 In a $1.3B deal, Bayer and Kumquat Biosciences Inc. entered an exclusive global license and collaboration to develop and commercialize Kumquat’s KRAS G12D inhibitor. (Ref 6) 

❓ Who are the other key players developing KRAS inhibitors? 

🤝 Pilatus Biosciences signed a clinical trial collaboration with Roche under which Roche will provide atezolizumab (anti-PD-L1) to support Pilatus’ upcoming first-in-human Phase 1 trial of PLT012 (anti-CD36) + atezolizumab in hepatocellular carcinoma. (Ref 7) 

❓ What are the key unmet needs in this indication? 

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

🌐 References: 

1) https://www.newswire.ca/news-releases/health-canada-approves-keytruda-r-for-patients-with-resectable-locally-advanced-head-amp-neck-squamous-cell-carcinoma-tumours-that-are-pd-l1-cps-positive-as-neoadjuvant-treatment-continued-as-adjuvant-treatment-combined-with-radiotherapy-wi-817696791.html

2) https://www.merck.com/news/keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-significantly-improved-event-free-and-overall-survival-and-pathologic-complete-response-rate-for-certain-patients-with-muscle/

3) https://feeds.issuerdirect.com/news-release.html?newsid=5377304342464475&symbol=CVM

4) https://www.merck.com/news/ifinatamab-deruxtecan-granted-breakthrough-therapy-designation-by-u-s-fda-for-patients-with-pretreated-extensive-stage-small-cell-lung-cancer/

5) https://haldatx.com/halda-therapeutics-receives-fda-fast-track-designation-for-hld-0915-for-the-treatment-of-metastatic-castration-resistant-prostate-cancer/

6) https://www.bayer.com/media/en-us/bayer-and-kumquat-biosciences-enter-global-exclusive-license-and-collaboration-in-precision-oncology

7) https://www.pilatusbio.com/latest-news/pilatus-biosciences-announces-clinical-trial-collaboration-with-roche-to-evaluate-plt012-in-first-in-human-study-in-hepatocellular-carcinoma