Onco-Summaries: Daily Oncology Updates at a Glance

17/11/2025

Dewpoint Therapeutics' DPTX3186 received the FDA fast track designation for gastric cancer (Ref)

The US FDA granted the fast track designation to Dewpoint Therapeutics' DPTX3186 (oral condensate modulator) for the treatment of gastric cancer.

• Isaac Klein, CSO and Head of R&D, Dewpoint Therapeutics: “We are honored that the FDA has recognized the urgency of gastric cancer and the promise of our condensate-based approach. DPTX3186 represents a new way of modulating disease relevant biology and has the potential to bring a meaningful option to patients with limited treatments available. Fast Track designation provides an important framework to advance this program with greater efficiency and speed.”

• Dewpoint is now initiating a Phase 1a/2a clinical trial across leading cancer centers in the United States

ITM Isotope Technologies Munich SE's ITM-94 received the FDA fast track designation for clear cell renal cell carcinoma (Ref)

The US FDA granted the fast track designation to ITM Isotope Technologies Munich SE's ITM-94 ([68Ga]Ga-DPI-4452) as a diagnostic agent for the detection of clear cell renal cell carcinoma (ccRCC).

• The designation was granted based on the potential of ITM-94 as a more effective, non-invasive diagnostic agent designed to improve outcomes for people living with ccRCC

  
  

• Dr. Celine Wilke, CMO, ITM: “The FDA’s Fast Track designation is a validation of ITM-94’s potential to aid in the non-invasive diagnosis of renal cell carcinoma. We have seen promising data in our ongoing clinical trial that suggest ITM-94 could change how clinicians diagnose and stage patients across the broader ccRCC disease landscape, with potential utility in supporting clinical decision-making for indeterminate renal masses as well. This news highlights the innovation within our pipeline and the important role an effective diagnostic can play in cancer treatment.”

The Phase 3 HERIZON-GEA-01 trial of zanidatamab + chemotherapy ± tislelizumab met the PFS endpoint in HER2+ve Gastroesophageal Adenocarcinoma (Ref)

Positive topline results were reported from the Phase 3 HERIZON-GEA-01 trial of Jazz Pharma & Zymeworks' zanidatamab (Ziihera; bispecific HER2-directed antibody) in combination with chemotherapy, with or without BeOne's tislelizumab (PD-1 inhibitor), as a first-line treatment for HER2+ve, locally advanced or metastatic gastroesophageal adenocarcinoma, including cancers of the stomach, gastroesophageal junction, and esophagus. 

• Both the doublet and triplet regimens demonstrated highly statistically significant and clinically meaningful improvements in PFS vs trastuzumab + chemotherapy

  
  

• The triplet also demonstrated clinically meaningful and statistically significant improvements in OS

  
  

• With the doublet, a clinically meaningful effect was seen with a strong trend toward statistical significance for OS vs control arm at the time of this first analysis. The trial is ongoing with an additional planned OS interim analysis in mid-2026

OBI Pharma's OBI-902 received the FDA orphan drug designation for Cholangiocarcinoma (Ref)

The US FDA granted the orphan drug designation to OBI Pharma's OBI-902 (TROP2 ADC) for the treatment of Cholangiocarcinoma.

• In August 2025, OBI launched a Phase I/II clinical trial in the United States and Taiwan, recruiting patients with advanced solid tumors

  
  

• Heidi Wang, CEO, OBI Pharma: "Based on our preclinical data, OBI-902 has several important advantages over other TROP2 ADCs either approved or in development; including high stability in blood circulation, excellent bystander effect that extends the killing to neighboring cancer cells lacking TROP2 expression, potential ability to overcome drug resistance, and outstanding activity in animal and organoid models of cancer. Importantly, this marks the first time an ADC that incorporates OBI's proprietary GlycOBI® ADC technology is being evaluated in patients, including those diagnosed with cholangiocarcinoma. We look forward to investigating this potential best-in-class TROP2 ADC in the clinic."