K-Pharma Bio ASCO launch table

Clinical presentation by Yuhan Leclaza et al.

Yuhan Lazertinib, Potential Effectiveness in Treatment of Brain Metastasis Lung Cancer

Cell therapy products of GC Cell and Artiva, ORR 27% in early clinical trials

Genexine, AbClone, and Abion announced the clinical results of their candidate materials

Pipeline clinical results of major domestic pharmaceutical bio companies such as Yuhan Corp.

 

were disclosed at ASCO.

 

According to the industry on the 31st, the abstract of a paper scheduled to be presented at ASCO, which will be held in Chicago, USA from June 2nd to 6th (local time), was recently released.

 

ASCO is a major international academic conference that celebrates its 59th this year.

 

About 400 biopharmaceutical companies from all over the world participate every year.

 

There are more than 2,900 paper abstracts published this year.

 

Most of the research results are made public in the form of posters.

 

At this ASCO, Yuhan Corp.

 

and GC Cell's US affiliates Artiva, Genexine, AbClon, and Abion disclosed research results of major pipelines under development.

 

Four studies related to Yuhan Corporation's third-generation lung cancer drug Lazertinib were announced.

 

Lazertinib is an oral third-generation EGFR tyrosine kinase inhibitor (TKI) drug with high selectivity for EGFR T790M-resistant mutations.

 

Some details of clinical trials using Amivantama and Lazertinib in combination with EGFR mutation advanced non-small cell lung cancer (NSCLC) with no treatment experience were disclosed.

 

These are the results of circulating tumor nucleic acid (ctNDA) liquid biopsy using plasma samples and long-term follow-up of 20 patients as of November 15 last year.

 

Median follow-up and treatment periods were 33.6 and 33.5 months, respectively.

 

In terms of efficacy, PFS and OS could not be estimated.

 

At 12 months, 85% (n = 17) of the patients showed the expected PFS.

 

At 24 months and 36 months, it was 65% (13 people) and 51% (10 people), respectively.

 

50% of patients are continuing treatment with PFS.

 

In phase 2 clinical trial for NSCLC patients with brain metastasis, Lazertinib showed an intracranial objective response (iORR) in 22 out of 38 patients.

 

Treatment-related side effects were identified in 85% (n = 27) of patients.

 

The most common side effects were skin rash and paresthesia.

 

Grade 3 or higher adverse events were reported in 10% (3 patients).

 

Grade 3 or higher side effects are side effects that could potentially endanger the patient's life if not treated.

 

Professor Min-hee Hong of Yonsei Cancer Center explained, "This study means that using Lazertinib instead of topical treatment can be a potential treatment strategy for NSCLC patients with brain metastases." The results of a study to identify biomarkers for the treatment of Amivantamab and Lazertinib in a tumor environment after administration of Osimertinib, a major third-generation lung cancer drug, were also disclosed.

 

"The MET mutation identified by tissue immunohistochemical analysis (IHC) can be a predictive biomarker for the response to Amivantamab/Lazertinib administration after Osimertinib administration," said Professor Benjamin Besse and others at the Gustave Roussy Cancer Center in France.

 

Analysis using tumor nucleic acid (ctDNA) did not identify some groups." Clinical results were also announced comparing the incidence of venous thromboembolism (VTE) side effects in EGFR mutant NSCLC patients with the combined administration of Amivantamab and Lasertinib and single administration of each drug.

 

VTE is one of the common side effects of lung cancer patients.

 

In a study of 540 patients, the incidence of VTE was higher with combination therapy than with each monotherapy.

 

Artiva, a US affiliate of GC Cell, announced the first human administration data for 'AB-101', a CAR-NK cell therapy.

 

These are the results of a phase 1/2 clinical trial of monotherapy of AB-101 and the combination of AB-101 and the anticancer drug 'Rituximab (product name: Rituxan)' in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma.

 

AB-101 responded in 3 out of 4 patients who had previously failed CD19-targeted CAR-T treatment.

 

In the AB-101 monotherapy group, ORR was 27% (3/11 patients).

 

Genexine disclosed the results of phase 2 clinical trial led by head and neck cancer researchers on the triple combination therapy of 'GX-188E', a DNA vaccine for the treatment of cervical cancer, 'GX-I7', and 'Keytruda', candidates for immuno-anticancer drugs for lymphopenia.

 

This clinical trial was led by Professor Kim Hye-ryeon of the Department of Oncology at Severance Hospital.

 

The study was conducted on 11 patients with head and neck cancer who were about to undergo surgery.

 

After surgery, 63.6% (7 patients) showed MPR and 36.3% (4 patients) showed pCR.

 

AbClon disclosed the efficacy and safety of the CAR-T treatment 'AT101' confirmed in phase 1 clinical trial.

 

In this phase 1 of 18 patients with relapsed or refractory B-cell non-Hodgkin's lymphoma, an ORR of 66.7% (4/6 patients) was confirmed in subject group 1.

 

AT101 showed an ORR of 100% (3/3 patients) in phase 1 clinical trial subject group 2.

 

There was no cytokine release syndrome of grade 3 or higher in each subject group.

 

Abion presented the results of the pilot expansion cohort analysis of NSCLC's new drug candidate 'ABN401'.

 

The pilot expansion cohort is a clinical trial designed to predict the direction of phase 2 clinical trial after the phase 1 clinical trial.

 

Patients with c-MET mutation NSCLC were selected and administered the same dose of ABN401 as in the ongoing phase 2 clinical trial.

 

Through data analysis, the efficacy, safety, and tolerability of ABN401 were confirmed.

 

No adverse events of grade 3 or higher were observed.