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Association details:
| Biomarker: | KRAS G12C |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | fulzerasib (GFH925) (KRAS G12C inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
Excerpt:
...Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC....
Trial ID:
Source:
Title:
A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations
Excerpt:
...- Pathologically diagnosed, previously treated, advanced tumor with KRAS p.G12C mutation...
Trial ID:
Less C2 evidence
Title:
China’s First NDA for a KRAS G12C Inhibitor: Innovent Announces the National Medical Products Administration of China Has Accepted and Granted Priority Review Designation to the New Drug Application for IBI351
Published date:
11/24/2023
Excerpt:
Innovent Biologics...announces that the New Drug Application (NDA) for IBI351 (KRAS G12C inhibitor) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China and granted Priority Review designation, for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. It is China’s first NDA for a KRAS G12C inhibitor and is anticipated to benefit more lung cancer patients harbouring KRAS G12C mutation after approval....The NDA acceptance and Priority Review designation are based on the results from a single-arm registrational Phase 2 clinical study (NCT05005234) intended to evaluate the efficacy and safety of IBI351 monotherapy in advanced NSCLC patients harbouring KRAS G12C mutation who failed or were intolerant to the standard treatment in China.
Title:
Innovent Announces NMPA’s Breakthrough Therapy Designation for IBI351 (KRASG12C Inhibitor) as Monotherapy for Previous Treated Advanced Non-small Cell Lung Cancer
Published date:
01/05/2023
Excerpt:
Innovent Biologics...announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI351 (GFH925) for the treatment of advanced non-small cell lung cancer patients with KRASG12C mutation that have received at least one prior line of systemic therapy....The NMPA BTD for IBI351 was based on the results from a phase I/II trial (CDE Registration No. CTR20211933).
Title:
Innovent Presents Clinical Data of Phase Ia Study for IBI351 (KRASG12C Inhibitor) as Monotherapy for Solid Tumors at the 2022 Chinese Society of Clinical Oncology (CSCO) Annual Meeting
Published date:
11/15/2022
Excerpt:
Favorable safety and tolerability and promising antitumor activity of IBI351 monotherapy were observed in previously-treated advanced NSCLC, CRC and pancreatic cancer harboring KRASG12C mutation.
Trial ID:
