Innovent’s Dupert® Gains NMPA Approval as China's First KRAS G12C Inhibitor
Thursday, August 22, 2024
Innovent Biologics has announced that China's National Medical Products Administration (NMPA) has approved Dupert® (fulzerasib) for treating adult patients with advanced non-small cell lung cancer (NSCLC) who carry the KRAS G12C mutation and have undergone at least one prior systemic therapy.
The RAS protein family, which includes KRAS, HRAS, and NRAS, is implicated in various cancers. KRAS mutations are found in nearly 90% of pancreatic cancers, 30-40% of colon cancers, and 15-20% of lung cancers. The KRAS G12C mutation is more common than other mutations such as ALK, ROS1, RET, and NTRK.
Fulzerasib is an orally active KRAS G12C inhibitor that targets the GTP/GDP exchange process by binding to the cysteine residue of the KRAS G12C protein, thereby inhibiting its activity and leading to the death of cancer cells. Preclinical studies have shown that fulzerasib is highly selective for the G12C mutation.
Dupert® is the first KRAS G12C inhibitor to be approved in China and marks Innovent's eleventh commercial product, offering new hope for patients with this specific type of lung cancer.
Lung cancer is one of the most common and deadly cancers globally, with NSCLC accounting for approximately 85% of cases. KRAS mutations are frequently found in NSCLC but rarely occur alongside other mutations, such as EGFR and ALK. As a result, patients with advanced NSCLC and the KRAS G12C mutation often do not benefit from existing targeted therapies. For these patients, after initial treatment, the options for further therapy are limited and often less effective.
The approval of Dupert® is based on the results of a Phase 2 clinical trial (NCT05005234) conducted in China. The study evaluated the effectiveness and safety of fulzerasib as a monotherapy in patients with advanced NSCLC who had the KRAS G12C mutation and had not responded to or could not tolerate standard treatment. The full results of this study have been published in the Journal of Thoracic Oncology.
As of December 13, 2023, 116 patients with NSCLC were enrolled and evaluated in the study. Fulzerasib showed promising anti-tumor activity and was generally well-tolerated. The Independent Radiology Review Committee (IRRC) reported an objective response rate (ORR) of 49.1%, a disease control rate (DCR) of 90.5%, and a median progression-free survival (PFS) of 9.7 months. The median duration of response (DoR) and overall survival (OS) were not yet reached at the time of the data cutoff.
KRAS has long been a difficult target for treatment despite being a common driver of cancer. The development of KRAS G12C inhibitors has opened up new possibilities in precision medicine. We are proud to have contributed to the development of Dupert®, the first KRAS G12C inhibitor approved in China, and we hope it will benefit more patients with advanced lung cancer.
Patients with advanced NSCLC and KRAS G12C mutations have limited treatment options, and traditional chemotherapy offers little benefit. The approval of Dupert® as the first KRAS G12C inhibitor in China marks a significant milestone in targeted cancer therapy. As our eleventh product, Dupert® further strengthens Innovent's oncology portfolio. We remain committed to driving innovation in cancer treatment and serving more patients in need.
Innovent and GenFleet Therapeutics entered into an exclusive agreement in September 2021 for the development and commercialization of fulzerasib in China, including mainland China, Hong Kong, Macau, and Taiwan.
In January 2023, China's NMPA granted Breakthrough Therapy Designation (BTD) to fulzerasib for treating patients with advanced NSCLC and the KRAS G12C mutation who had received at least one systemic therapy. In May 2023, another BTD was granted for fulzerasib for treating advanced colorectal cancer patients with the KRAS G12C mutation who had undergone at least two systemic therapies.
In August 2024, fulzerasib received approval from the NMPA for treating adult patients with advanced NSCLC who have the KRAS G12C mutation and have undergone at least one prior systemic therapy.
Source:innoventbio.com
