Oncology Updates - Key Oncology News

July 3rd Week, 2025

Regulatory Updates 

🎯 Corcept Therapeutics submitted an NDA to the US FDA for relacorilant (selective cortisol modulator) to treat patients with platinum-resistant ovarian cancer. (Ref 1) 

❓ What are the clinical outcomes that support the NDA submission? 

Special Designations 

⭐ The US FDA granted the Priority Review to Johnson & Johnson Innovative Medicine’s TAR-200 (intravesical gemcitabine releasing system) for the Tx of BCG unresponsive high-risk non-muscle invasive bladder cancer with CIS, with or without papillary tumors. (Ref 2) 

❓ What are the other key assets being developed for BCG unresponsive HR-NMIBC? 

⭐ The US FDA granted the Breakthrough Therapy Designation to Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan (HER2 ADC) + Roche’s pertuzumab (anti-HER2) for the first-line Tx of unresectable or metastatic HER2+ve breast cancer. (Ref 3) 

❓ How does the clinical efficacy of the combo compare against the SOC options for HER2+ve BC? 

⭐ The US FDA granted the Fast Track Designation to Zenith Epigenetics Ltd.’s ZEN-3694 (BET inhibitor) + abemaciclib for the Tx of metastatic or unresectable NUT carcinoma in patients who have received at least one line of prior chemotherapy. (Ref 4) 

❓ What are the key unmet needs for this indication? 

Clinical Updates 

🔬 The first patient has been successfully enrolled in the registrational Phase 3 AK112-312/HARMONi-GI6 trial of Akeso Biopharma and Summit Therapeutics, Inc.'s ivonescimab (PD-1 x VEGF BsAb) + FOLFOXIRI as a first-line Tx for advanced metastatic colorectal cancer. (Ref 5) 

❓ What are the other ongoing Phase 3 trials of ivonescimab? 

Deal and Collaborations 

🤝 I-Mab Biopharma entered into a definitive agreement to acquire 100% ownership of Bridge Health Biotech which will provide I-Mab with the rights to bispecific and multi-specific applications, based on the CLDN18.2 parental antibody used in givastomig (CLDN18.2 x 4-1BB BsAb). (Ref 6) 

❓ Who are the key players developing bispecifics with CLDN18.2 as one of the targets? 

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

🌐 References: 

1) https://ir.corcept.com/news-releases/news-release-details/corcept-submits-new-drug-application-relacorilant-treatment-0

2) https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-u-s-fda-priority-review-for-tar-200-nda-in-high-risk-non-muscle-invasive-bladder-cancer

3) https://www.daiichisankyo.com/files/news/pressrelease/pdf/202507/20250717_E.pdf

4) https://www.zenithepigenetics.com/newsroom/news-releases?article=63

5) https://www.prnewswire.com/news-releases/akeso-announces-first-patient-enrolled-in-the-phase-iii-trialak112-312harmoni-gi6of-ivonescimab-for-first-line-treatment-of-advanced-metastatic-colorectal-cancer-302506248.html

6) https://www.i-mabbiopharma.com/news-releases/news-release-details/i-mab-strengthens-givastomig-intellectual-property-portfolio