ASCO 2025 Breaking News

ImCheck Therapeutics will present new data at ASCO 2025 showing its lead candidate ICT01, combined with azacitidine and venetoclax, achieved a 96% remission rate in AML patients unfit for intensive chemotherapy. The 10 mg dose showed strong efficacy and a favorable safety profile.

This builds on earlier trials exploring ICT01 in solid tumors and combinations with Keytruda and Proleukin. In August 2024, ImCheck received €20.18 million ($22.35 million) in public funding under France’s 2030 plan to support further development of its oncology and infectious disease pipeline, including ICT41, aimed at bacterial and viral infections.--->Read the article

French biotech OSE Immunotherapeutics is sharing primary endpoint results from its Phase II TEDOPaM trial, assessing Tedopi combined with FOLFIRI versus FOLFIRI alone in advanced pancreatic ductal adenocarcinoma patients post-FOLFIRINOX induction. 

The study explores maintenance therapy efficacy, with findings suggesting that the addition of Tedopi may improve overall survival in this challenging patient population.

The conference this year includes joint sessions with the American Association for Cancer Research (AACR) and the European Society for Medical Oncology (ESMO), fostering international collaboration and discussion on advancements in cancer research and treatment. 

These sessions aim to explore the latest strategies for detection and treatment of minimal residual disease, among other topics, highlighting the importance of global partnerships in oncology.

Obsidian Therapeutics is presenting Phase I results from its Agni-01 study of OBX-115, an engineered tumor-infiltrating lymphocyte (TIL) therapy with membrane-bound IL15, in patients with immune checkpoint inhibitor-resistant advanced melanoma. 

The therapy aims to enhance persistence and antitumor activity, with early data suggesting that OBX-115 is well-tolerated and demonstrates encouraging clinical activity in this patient population.

UK-based Bicycle Therapeutics (Nasdaq: BCYC) is set to present preliminary Phase I/II data on zelenectide pevedotin (BT8009), a Nectin-4-targeting drug conjugate, in combination with pembrolizumab for cisplatin-ineligible urothelial cancer patients. 

The study aims to assess safety and efficacy in this patient population, with early results indicating promising anti-tumor activity and a differentiated safety profile.

ImPact Biotech is presenting interim results from its Phase III ENLIGHTED study evaluating padeliporfin vascular targeted photodynamic therapy (VTP) in patients with low-grade upper tract urothelial carcinoma (UTUC). 

The analysis, covering 50% of the targeted enrollment, indicates that padeliporfin VTP is well-tolerated and demonstrates clinical benefit in all evaluable patients. These findings suggest potential for padeliporfin VTP as a minimally invasive treatment option for patients underserved by current standards.

Genmab’s (Nasdaq: GMAB) data at the 2025 ASCO Annual Meeting will include the first disclosure of results from a Phase I/II trial of rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha-targeted, TOPO1-inhibor antibody-drug conjugate, in recurrent/advanced endometrial cancer.  

The Danish biotech company will also present results from an analysis of the Phase I/II EPCORE NHL-1 study of epcoritamab, a T-cell–engaging bispecific antibody administered subcutaneously, including long-term follow-up in adult patients with relapsed/refractory diffuse large B-cell lymphoma who remain in complete response at two years.

Judith Klimovsky, executive vice president and chief development officer of Genmab, said: “Our presence at ASCO reflects our commitment to advancing our antibody science for patients in need of alternative treatment options, including women with endometrial cancers that have progressed following treatment with existing available therapies.

“We’re particularly encouraged by Rina-S as a potential treatment option for endometrial cancer, one of the few cancers with rising mortality rates and few treatment options. Additionally, together with AbbVie (NYSE: ABBV), we are continuing our commitment to evaluating epcoritamab as a potential core therapy across B-cell malignancies.”

Among the companies displaying the strength of Chinese research in oncology at the 2025 ASCO Annual Meeting will be Hutchmed (Nasdaq/AIM:​HCM).

New data from several studies of compounds discovered by Hutchmed, including savolitinib, ranosidenib, fruquintinib and surufatinib will be presented at the meeting.

Results from the SACHI China Phase III study of savolitinib in combination with Osimertinib, in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET amplification after disease progression on EGFR inhibitor therapy, will be presented at a late-breaking oral presentation.

SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. SACHI data supports the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China.

Results will also be presented from the dose-escalation stage of the Phase I study of ranosidenib, a novel, small-molecule, highly selective oral dual-inhibitor of both Isocitrate dehydrogenase (IDH) 1 and IDH2 enzymes, being studied in patients with locally advanced or metastatic solid tumors with IDH mutations.

Data show that the compound was well tolerated, showing target inhibition and durable responses in patients. Efficacy signals were observed especially in the efficacy evaluated group of lower-grade glioma patients, with an objective response rate of 7.1% and a disease control rate of 100%.

There will also be data from the sub-group analyses of the FRUSICA-1 open-label, single-arm, pivotal Phase II study to evaluate the efficacy and safety of fruquintinib plus sintilimab in previously treated advanced endometrial cancer (EMC) patients with proficient mismatch repair status, and results from two subgroup analyses of a Phase IV study of fruquintinib involving 2,798 colorectal cancer patients in China, will be presented, too.

The clock is ticking, and there is just a week to go. This year’s theme is Driving Knowledge to Action: Building a Better Future, for which read: a deeper push into the era of precision oncology, more and more AI, and a lot more besides.

Expectations are of course high, with over 6,000 abstracts and hundreds of oral and poster presentations spanning virtually every tumor type. Plenary and late-breaking sessions this year are spotlighting practice-changing studies in early breast cancer as well as advanced renal and gastrointestinal malignancies--->What to look out for at ASCO 2025