ESMO 2023

KRASG12D-LODER: brief review of its R&D progress and the clinical result in 2023 ESMO

15 November 2023
3 min read

Locally advanced pancreatic cancer (LAPC) accounts for 30% of pancreatic cancer (PC). LAPC incurs high mortality. On October 20, 2023, a novel extended-release siRNA targeting KRASG12D/V (G12D/V) mutations (Loder) in combination with standard chemotherapy was reported at the ESMO Congress.

KRASG12D-LODER's R&D Progress

The drug KRASG12D-LODER is a small interfering RNA (siRNA) that targets the KRAS G12D gene. It is being developed for the treatment of pancreatic cancer, a type of neoplasm that affects the digestive system. Additionally, it has potential therapeutic applications in the fields of endocrinology and metabolic diseases.

According to the Patsnap Synapse, KRASG12D-LODER is currently in Phase 2, which is the second highest phase in the drug development process. And the clinical trial areas for KRASG12D-LODER are primarily in the United States and Israel. The key indication is Pancreatic Ductal Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma.

Detailed Clinical Result of KRASG12D-LODER

The two-cohort, phase II multicenter, open-label trial (NCT01676259) was conducted in pancreatic cancer patients. 

In this study, cohort 1: Patients (pts) with LAPC randomized to: Loder + gemcitabine/nab-paclitaxel (GnP); or GnP. Cohort 2: pts with Borderline Resectable (BR) PC or LAPC single arm, Loder + (modified)FOLFIRINOX ((m)FFX) or GnP. The Loder was inserted into primary tumor via endoscopic ultrasound (EUS 19G needle) q3 mo. for 2-3 doses. mITT, all patients ≥ 1 treatment. Key study endpoints: overall survival (OS), safety.

The result showed that N= 49 pts in mITT (6 BRPC, 43 LAPC, Loder n=38, control n=11). KRAS known for n=35: G12V, n=12; G12D, n=11; G12R, n=7; Q61R, n=2; wild-type, n=1. For mITT: no difference in OS for Loder + chemo vs. chemo (OS=21.1 vs. 22.2 mo.). However, in pts with G12D/V a non-statistically significant numerical advantage was seen in Loder + (m)FFX or GnP arm (n=18, Cohorts 1,2) median OS = 19.4 mo. vs. 13.8 mo.

It can be concluded that loder with chemotherapy is feasible, safe, and shows a promising signal in KRASG12D/V BR, LAPC. Further evaluation is warranted.

How to Easily View the Clinical Results Using Synapse Database?

If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need. 

Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name. 

图形用户界面, 文本, 应用程序

描述已自动生成

A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more. 

图形用户界面, 文本, 应用程序

描述已自动生成

If you would like to view more information about this result, you can go to the result detail page by clicking on the title. 

Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc. 

In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data. 

Finally, if you need to download these results, you can conveniently check the check boxes on the left side of the list, or directly click the "Export" button to download the data for personalized analysis and file sharing.

Click on the image below to embark on a brand new journey of drug discovery!

Qualigen Therapeutics announces first dose of Phase 1a QN-302 Clinical Study for advanced solid tumors administered to initial patient
Latest Hotspot
3 min read
Qualigen Therapeutics announces first dose of Phase 1a QN-302 Clinical Study for advanced solid tumors administered to initial patient
15 November 2023
Qualigen Therapeutics reports the initial dosage in the Phase 1a QN-302 Clinical Study for Advanced or Metastatic Solid Tumors has been administered to the first patient.
Read →
What are BTK inhibitors and how do you quickly get the latest development progress?
What are BTK inhibitors and how do you quickly get the latest development progress?
15 November 2023
Bruton's Tyrosine Kinase (BTK) inhibitors present a promising treatment for B-cell malignancies. Over the past decade, numerous clinical trials involving BTK inhibitors with anticancer potential have commenced, signaling a bright future for BTK inhibitors.
Read →
Endostar: Brief Review of its R&D progress and the clinical result in 2023 ESMO
ESMO 2023
4 min read
Endostar: Brief Review of its R&D progress and the clinical result in 2023 ESMO
15 November 2023
On 23 Oct 2023, the results from a phase II trial of endostar in patients with locally advanced squamous cell carcinoma of esophagus were reported at the ESMO Congress.
Read →
The FDA approves Lilly's Zepbound™ (tirzepatide) - an effective new option for managing continual weight issues such as obesity or health-related overweight conditions
Latest Hotspot
3 min read
The FDA approves Lilly's Zepbound™ (tirzepatide) - an effective new option for managing continual weight issues such as obesity or health-related overweight conditions
15 November 2023
The FDA greenlights Lilly's Zepbound™ (tirzepatide) - a potent, new choice for managing persistent weight issues, including obesity or overweight cases with health issues connected to weight.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.