Garsorasib (D-1553) New Indication Added to Breakthrough Therapy Designation Program

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Thu, 13 Jun 2024 06:55:30 +0000
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Recently, Garsorasib (D-1553), developed by InventisBio, has been once again included in the Breakthrough Therapy Designation (BTD) program by the National Medical Products Administration (NMPA). This time, two new indications for D-1553 have been added to the BTD program:

1. For the treatment of locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12C mutation, in patients who have failed first-line therapy.

2. In combination with cetuximab injection, for the treatment of KRAS G12C-mutant, locally advanced or metastatic colorectal cancer (CRC) that has progressed after second-line standard treatments (including oxaliplatin, irinotecan, 5-fluorouracil, and anti-VEGF monoclonal antibodies) and is not amenable to surgery.

These two new indications represent advancements in the fields of pancreatic ductal adenocarcinoma and colorectal cancer. Previously, the NMPA’s Center for Drug Evaluation (CDE) approved the initiation of a Phase II, single-arm, registration clinical trial for D-1553 in the treatment of second-line and beyond KRAS G12C-mutant, advanced pancreatic ductal adenocarcinoma after failure of standard treatments. This clinical trial is set to launch in China soon. The registration study for colorectal cancer is also in active communication with regulatory authorities.

Clinical Significance:

KRAS G12C mutations are associated with poor prognosis and represent a significant unmet medical need in several cancers. The inclusion of these two new indications in the Breakthrough Therapy Designation underscores the broader potential clinical value of Garsorasib. InventisBio remains committed to innovating for patient benefit, advancing its pipeline, and providing more therapeutic options for patients with unmet needs.

About Garsorasib:

Garsorasib is a novel, highly selective KRAS G12C inhibitor developed by InventisBio. It works by irreversibly binding to the KRAS G12C-mutant protein, locking it in an inactive state, which can be used to treat KRAS G12C-mutant non-small cell lung cancer (NSCLC), colorectal cancer, and other cancers.

In June 2022, Garsorasib was included in the Breakthrough Therapy Designation (BTD) program by the NMPA. In August 2023, InventisBio entered into a License and Collaboration Agreement with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. for the development, registration, production, and commercialization of Garsorasib in mainland China. In December 2023, the new drug application (NDA) for Garsorasib for the treatment of locally advanced or metastatic NSCLC with KRAS G12C mutations, following progression or intolerance to first-line therapy, was accepted by the NMPA.

Ongoing Global Clinical Trials:

Currently, Garsorasib is undergoing international, multi-center clinical trials for NSCLC in first-line therapy and other solid tumors, including colorectal cancer. Several studies have already reported favorable results at leading international academic conferences, demonstrating the drug’s good safety profile and anti-tumor efficacy.

InventisBio is committed to advancing Garsorasib and expanding its indications to provide more effective treatment options for patients facing challenging cancers.