Novartis Submits Prospectus for JDQ443, a Novel KRAS G12C Inhibitor, in Advanced NSCLC

Mar 26, 2024 00:01 CST Updated 00:01

Novartis

Drug Development and Manufacturing

KRAS was the first oncogene discovered in the human body. In 1982, scientists cloned the first oncogene from a human bladder cancer cell line, and soon identified this oncogene as KRAS. KRAS mutation is an important driver gene in non-small cell lung cancer, with a mutation rate of 20-30% in Western populations and 7-10% in Asian populations.

The proportion of KRAS mutations in Chinese patients with lung adenocarcinoma is 8.3%. The predominant populations are males, those with a history of smoking, invasive mucinous adenocarcinoma, and solid-type adenocarcinoma. G12C is the most common mutation (33.6%), followed by G12D (23.9%) and G12V (22.1%).

KRAS Mutation Subtypes in Chinese Lung Adenocarcinoma DOI: 10.2147/OTT.S96834

JDQ443 is a highly selective and highly bioactive KRAS G12C inhibitor developed by Novartis. Initial data from the dose-escalation portion of the Ib/II KontRASt-01 (NCT04699188) trial, presented at the 2022 AACR Annual Meeting, showed early signs of efficacy and tolerable safety. The study results demonstrated an ORR of 45% in a subgroup of 20 NSCLC patients.For the 7 NSCLC patients receiving 200 mg BID, the ORR was as high as 57%.Researchers observed SD in 55% of patients, with no reports of disease progression. Among the 39 patients treated with four different doses of JDQ443, most TRAEs were grade 1-2, with no grade 4 or 5 TRAEs reported; for the 11 patients receiving JDQ443 200 mg BID, no grade 3 or higher TRAEs occurred.

Inclusion and Exclusion Criteria

JDQ443 Tablets

Suitable Population: Patients with advanced or metastatic solid tumors and non-small cell lung cancer harboring the KRAS G12C mutation.

Treatment Group: JDQ443 Tablets vs. Docetaxel(Progression on chemotherapy may cross over to targeted therapy)

Simple inclusion criteria: Patients with genetically confirmed KRAS (G12C) mutation, histologically or cytologically proven advanced solid tumors. Non-small cell lung cancer patients must have progressed after receiving platinum-based chemotherapy and immunotherapy but have not received more than three prior lines of treatment. Measurable lesions are required; patients must have adequate organ function.

Consultation on Each G12C Clinical Project

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