K-Bios head to ASCO…anticancer drugs to AI predictions

Major companies set out to disclose clinical results and more

LG Chem’s US subsidiary AVEO will present the results of the Phase III trial on Fotivda+Opdivo

Tium Bio, Onconic Therapeutics, and ImmuneOncia plan to reveal the results of their new anticancer drugs

Lunit to present 12 findings, including AI-derived prediction of response to Enhertu for treating biliary tract cancer

Korean pharmaceutical and biotech companies set out to participate in the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which is just 5 days away.

 

At ASCO 2025, LG Chem's U.S.

 

subsidiary Aveo Oncology, along with Tium Bio, Onconic Therapeutics, and ImmuneOncia, will each present clinical trial results about their anticancer drugs.

 

Lunit plans to introduce a large number of results on the accuracy of AI-derived treatment response predictions for anticancer drugs.

 

ASCO 2025 will be held from the 30th of this month to the 3rd of next month in Chicago, U.S.

 

It is recognized as one of the world's three major cancer academic conferences, along with the American Association for Cancer Research (AACR) and the European Society for Medical Oncology (ESMO).

 

Every year, over 400 companies from 120 countries around the world participate to present the latest cancer data.

 

LG Chem subsidiary Aveo Oncology to announce Phase III trial results for kidney cancer drug Fotivda According to industry sources on the 26th, LG Chem, Tium Bio, Onconic Therapeutics, ImmuneOncia, and Lunit are among the domestic pharmaceutical and biotech companies that will present clinical results at this year's event.

 

LG Chem will present the latest data on its independently developed kidney cancer treatment ‘Fotivda (tivozanib)’ through its US subsidiary Aveo Oncology (AVEO).

 

Aveo Oncology received approval for Fotivda from the European Medicines Agency (EMA) in 2017 and the U.S.

 

Food and Drug Administration (FDA) in 2021.

 

LG Chem acquired Aveo Oncology in 2022 for USD 571 million (approximately KRW 700 billion).

 

The study being presented this time is the global Phase III TiNivo-2 trial.

 

It evaluates the efficacy of Fotivda in combination with Opdivo (nivolumab) or as monotherapy as a second-line treatment for patients with metastatic renal cell carcinoma who have previously received treatment with Opdivo (nivolumab)+Yervoy (ipilimumab) or VEGF TKI +immunotherapy.

 

Given that the previous Phase III clinical trial on the same Fotivda+Opdivo combination failed to meet the primary endpoint, attention is focused on whether the reattempt made by the company with a different clinical strategy succeeded.

 

Aveo Oncology stated that the results of the control group receiving Fotivda monotherapy in the clinical trial confirmed the drug’s potential as a second-line treatment.

 

The company explained that the PFS endpoint demonstrated clinical significance with Fotivda monotherapy.

 

Aveo Oncology will also announce the results of a Phase III trial for its head and neck cancer treatment candidate, ficlatuzumab.

 

Ficlatuzumab is a monoclonal antibody-based targeted anticancer drug that inhibits the action of hepatocyte growth factor (HGF), which promotes tumor growth.

 

LG Chem will present the results of a Phase III trial comparing the combination therapy of ficlatuzumab and Erbitux (cetuximab) with Erbitux monotherapy as a control group for the treatment of head and neck cancer.

 

In addition, the company will present a poster on the Phase Ib dose-escalation trial of AV-380, an anti-GDF15 antibody for the treatment of cancer cachexia.

 

Tium Bio, Onconic Therapeutics, and ImmuneOncia to present interim clinical results Tium Bio will present the interim results from a Phase II clinical trial of its candidate drug 'TU2218' that targets biliary tract cancer and head and neck cancer, in combination with the immunotherapy drug 'Keytruda (pembrolizumab)’ for the first time.

 

TU2218 is an oral dual inhibitor that simultaneously blocks the signaling pathways of 'transforming growth factor (TGF-β)' and 'vascular endothelial growth factor (VEGF),' which are involved in cancer cell growth and metastasis, thereby maximizing the response rate of immunotherapy agents like Keytruda.

 

The company explained that the dual-target mechanism that targets TGF-β and VEGF improves the tumor microenvironment (TME), thereby enhancing the sensitivity.

 

Tium Bio is conducting a Phase II clinical trial on TU2218 to enter the market as a first- and second-line treatment for head and neck cancer and biliary tract cancer.

 

Existing treatments for head and neck cancer and biliary tract cancer have a short overall survival (OS) of 6 months to 1 year.

 

The company explained, “TU2218 has secured significant OS extension data in an with high unmet need.”

Onconic Therapeutics will present two clinical data updates related to its next-generation dual-targeted anticancer drug candidate, nesuparib.

 

The first presentation will be about the Phase Ib/II and Phase Ib trials in progress for metastatic pancreatic cancer.

 

Pancreatic cancer is a representative intractable cancer with limited treatment options, and the company explained that the presentation is significant in that it explores the potential of nesuparib as a treatment option for this disease.

 

The second presentation will be about the PENELOPE study, a Phase 2 investigator-initiated clinical trial in progress for endometrial cancer patients.

 

This trial is exploring the combination of Nesuparib and the immune checkpoint inhibitor Keytruda as a new treatment option for endometrial cancer.

 

An Onconic Therapeutics representative said, “The presentations show that nesuparib is receiving attention as a new option in the fields of pancreatic cancer and endometrial cancer, where treatment options are limited.

 

We will accelerate development to benefit patients in need and demonstrate the value of nesuparib through the global oncology community.” ImmuneOncia has also announced plans to present clinical data at ASCO 2025.

 

The presentation is expected to highlight promising results from the Phase Ib clinical trial of IMC-002, a monoclonal antibody targeting the immune checkpoint protein CD47.

 

This drug works by blocking the CD47 and SIRPα signals, thereby enabling macrophages to eliminate cancer cells.

 

Lunit announces AI-derived “anticancer drug response prediction technology” results Lunit will showcase a range of AI-derived technologies for predicting the response to anticancer drugs.

 

Lunit announced that it will present 12 research findings utilizing its AI biomarker platform 'Lunit Scope' at ASCO 2025.

 

The most notable data is the results of a study predicting the efficacy of Enhertu (trastuzumab deruxtecan) in patients with HER2-positive biliary tract cancer.

 

Conducted in collaboration with Japan’s National Cancer Center East (NCCE), the study analyzed 288 immune histochemistry (IHC) slide images of HER2-positive bile duct cancer patients using Lunit Scope's 'uIHC' technology to quantitatively evaluate the intensity of HER2 expression and its distribution within cells (cell membrane, cytoplasm, etc.).

 

The results demonstrated that Lunit AI not only accurately assessed the intensity of HER2 expression but also that the cell membrane specificity of HER2 expression was a better predictor of treatment response in patients.

 

Among 29 patients treated with Enhertu, those with high HER2 cell membrane specificity had a median progression-free survival (mPFS) of 11.0 months, compared to 4.2 months in patients with low cell membrane specificity, indicating improved treatment outcomes.

 

Among the patients identified by AI, additional patients who were not detected by conventional HER2 expression intensity measurement methods were included, suggesting that the AI-derived cell membrane specificity analysis method can identify more patients responsive to Enhertu treatment compared to the conventional method.

 

Additionally, Lunit is presenting research results on AI-based prediction of claudin 18.2 (CLDN18.2) expression and immune phenotype in gastric cancer patients.

 

According to Lunit, claudin 18.2-targeted therapy has emerged as a new alternative for gastric cancer treatment, but practical limitations have arisen due to sample shortages and the additional costs and time required.

 

To address this, Lunit developed an AI model that predicts Claudin18.2 expression using only basic H&E slides.

 

The model demonstrated a high AUROC value of 0.751, indicating its ability to predict Claudin18.2-positive patients in a gastric cancer patient population.

 

Claudin 18.2 expression is also associated with the response to immune checkpoint inhibitors, and it has been confirmed that it significantly extends progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone.

 

Generally, early clinical or preclinical results are presented at AACR, and late-stage clinical results at ASCO, rendering more active technology transfer and partnership discussions at the ASCO event.

 

Given the commercial value of late-stage clinical data, the achievements of domestic pharmaceutical and biotech companies at the event are expected to serve as a stepping stone for their future global market entry.