K-Bio unveils new cancer drug outcomes at the ASCO meeting

K-bio presented the status of drugs under development, including bispecific antibodies·immunotherapy·targeted anticancer drugs

Confirmed the possibility of the use of drugs in combination with existing therapies, such as Keytruda and Lenvima

Daewha Pharmaceutical unveils its Phase 3 trial results of oral paclitaxel 'Liporaxel'

The Korean pharmaceutical and biotech industry has unveiled additional clinical outcomes of drug candidates, such as immunotherapy for cancer, targeted anticancer agents, and bispecific antibodies, under development.

 

Major Korean companies, including Daewha Pharmaceutical, LG Chem, Onconic Therapeutics, ImmuneOncia, and Tium Bio, unveiled their trial results of new anticancer drugs at the American Society of Clinical Oncology (ASCO 2025) annual meeting, which started on May 30 and lasted 4 days in Chicago, U.S.

 

'FOTIVDA' monotherapy is more effective than Optivo combination therapy LG Chem, through its U.S.-based subsidiary AVEO Oncology ("AVEO"), unveiled the results of the Phase 3 TiNivo-2 study evaluating 'FOTIVDA' monotherapy.

 

Anticancer drug FOTIVDA

AVEO 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 for $571 million (approximately KRW 700 billion) in 2022.

 

In the previous TiNivo-2 clinical trial, which assessed the clinical possibility of combination therapy, the FOTIVDA + Opdivo combination failed to show improved progression-free survival (PFS) compared to FOTIVDA monotherapy.

 

The latest analysis is a follow-up result from the second-line treatment setting.

 

It evaluated the potential of FOTIVDA monotherapy in 153 patients with renal cell carcinoma who had failed prior treatment with Opdivo+Yervoy or a VEGFR (vascular endothelial growth factor receptor) targeted therapy+immunotherapy combination.

 

Patients were randomly assigned in a 1:1 ratio to either the FOTIVDA monotherapy group or the FOTIVDA + Opdivo group.

 

Clinical results showed that in the Opdivo+Yervoy failure group, the PFS for FOTIVDA monotherapy was 9.2 months, which is similar to the 9.3 months observed for the FOTIVDA+Opdivo group.

 

The objective response rate (ORR) was higher for FOTIVDA monotherapy at 32.4%, compared to 24.2% for the FOTIVDA+Opdivo group.

 

Differences were more pronounced in the patient group that had failed prior VEGF targeted therapy+immunotherapy.

 

In this group, the PFS for FOTIVDA monotherapy was 7.4 months, which was 2.5 months longer than the 3.9 months for the combination group.

 

ORR was recorded at 22.0% for the monotherapy group and 9.5% for the combination therapy group.

 

The researchers stated, "Subgroup analysis of the TiNivo-2 study showed that FOTIVDA monotherapy demonstrated greater efficacy than FOTIVDA + Opdivo.

 

The addition of Opdivo to FOTIVDA did not show a significant benefit, consistent with previous clinical results." Daehwa Pharmaceutical unveils oral paclitaxel Phase 3 clinical trial results

Daewha Pharmaceutical

Daehwa Pharmaceutical has unveiled the results of a multinational Phase 3 clinical trial for Liporaxel, an improved oral formulation of the injectable anti-cancer drug paclitaxel.

 

Liporaxel is a modified new drug that converts injectable paclitaxel into an oral formulation through Daehwa's proprietary lipid-based DHLASED platform technology.

 

Liporaxel's strength is its convenience of administration.

 

Paclitaxel, an intravenous (IV) formulation and a first-generation cytotoxic anticancer drug, is known for its long administration time and various side effects, such as vomiting, nausea, and hair loss.

 

In clinical trials, Liporaxel demonstrated improvements in side effects, such as hair loss and peripheral neuropathy, compared to the paclitaxel IV formulation.

 

Being free from infusion-related side effects is also a key strength of Liporaxel.

 

The recently disclosed Phase 3 clinical study aimed to prove the non-inferiority of Liporaxel compared to injectable paclitaxel in 549 patients with metastatic breast cancer.

 

Clinical results showed that Liporaxel achieved a median PFS of 10.02 months, demonstrating non-inferiority compared to injectable paclitaxel's 8.45 months.

 

Overall survival (OS) was similar, with Liporaxel at 32.95 months and injectable paclitaxel at 32.46 months.

 

ORR and disease control rate (DCR) were higher in the Liporaxel group.

 

In terms of safety, Liporaxel showed a lower occurrence rate of peripheral neuropathy, hypersensitivity reactions, musculoskeletal and connective tissue disorders, and infusion-related reactions compared to injectable paclitaxel.

 

The researchers emphasized, "Liporaxel demonstrated equivalent efficacy to injectable paclitaxel, along with good tolerability and manageable toxicity.

 

These results indicate that Liporaxel is an effective and convenient alternative to injectable paclitaxel for patients with HER2-negative metastatic breast cancer." Major biotech companies unveil immunotherapy·targeted anticancer drug clinical outcomes

ASCO 2025 site (source=ASCO).

TiumBio presented the results of its Phase 2 clinical trial of combination therapy containing 'TU2218,' an immunotherapy candidate, in combination with MSD's immunotherapy Keytruda.

 

TU2218 simultaneously blocks the pathways of transforming growth factor-beta (TGF-ß) and vascular endothelial growth factor (VEGF), which are known to inhibit immunotherapy activity.

 

This mechanism aims to maximize the efficacy of immunotherapies.

 

The recently disclosed trial represents early cohort results from an ongoing study in patients with head and neck cancer and biliary tract cancer.

 

Clinical results showed that the TU2218+Keytruda combination therapy resulted in a partial response (PR) in 7 out of 11 patients with head and neck cancer, with stable disease (SD) observed in 1 patient.

 

In the biliary tract cancer cohort, 4 out of 23 patients achieved a PR and 7 showed SD.

 

Onconic Therapeutics shared updates on two ongoing clinical trials for 'Nesuparib,' a targeted anticancer drug under development, at this conference.

 

Nesuparib is a new drug candidate with a dual mechanism that simultaneously inhibits poly ADP-ribose polymerase (PARP) and Tankyrase.

 

Onconic Therapeutics unveiled progress from its Phase 1b clinical trial in metastatic pancreatic cancer.

 

This multicenter, open-label, Phase 1b dose-finding study is recruiting up to 48 patients with locally advanced or metastatic pancreatic cancer.

 

The trial is divided into Group A Nesuparib+FOLFIRI therapy (oxaliplatin, leucovorin, irinotecan, fluorouracil) and Group B Nesuparib+gemcitabine+albumin-bound paclitaxel.

 

The primary objectives of the trial are to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to identify the optimal combination therapy based on safety.

 

The Phase 1 trial is being conducted.

 

Additionally, Onconic Therapeutics is also confirming the potential of Nesuparib in recurrent endometrial cancer.

 

The clinical study, named PENELOPE, is being conducted to verify whether adding Nesuparib to Keytruda maintenance therapy improves PFS after treatment with paclitaxel+carboplatin+Keytruda.

 

Patient enrollment began in the fourth quarter of last year.

 

ImmuneOncia revealed clinical outcomes for its immunotherapy candidate IMC-002.

 

IMC-002 works by blocking the signals between CD47 on cancer cells and macrophages.

 

The results disclosed are preliminary findings from an ongoing Phase 1b clinical trial in patients with hepatocellular carcinoma.

 

The trial is evaluating the tolerability and safety of IMC-002 in combination with Lenvima, which is used to treat hepatocellular carcinoma.

 

Among 10 evaluable patients, the ORR was 30%, and the DCR was 70%.

 

The median time to progression (TTP) was 8.3 months.

 

The researchers said, "The efficacy and a safety profile were confirmed when IMC-002 20mg/kg in combination with Lenvima was administered every 3 weeks."