Evidence Level:Sensitive: C1 - Off-label
(Approved for Non Small Cell Lung Cancer)
New
Title:
Mirati Therapeutics Receives Approval from the MHRA for KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation
Excerpt:Mirati Therapeutics...announced the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for KRAZATI® (adagrasib) as a monotherapy indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRASG12C mutation and have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway
Excerpt:...MRTX0902 and adagrasib combination therapy: KRAS G12C mutation....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A study of adagrasib for patients with KRASG12C-mutant non-small cell lung cancer (NSCLC), who are elderly or who are unwell because of their lung cancer. Un estudio de adagrasib para pacientes con cáncer de pulmón de células no pequeñas (CPCNP) con mutación KRASG12C, que son ancianos o que no se encuentran bien debido a su cáncer de pulmón.
Excerpt:...- Histologically or cytologically confirmed stage IV NSCLC- KRASG12C-mutation by local testing (by tissue or ctDNA)- Prior treatment with at least one line of systemic therapy for NSCLC (e.g., platinum-based doublet chemotherapy and/or immune-checkpoint inhibition or both).- Life expectancy ≥12 weeks- Measurable disease according to RECIST v1.1- Age ≥18 years with ECOG PS 2 (cohort 1), or age ≥70 years with ECOG PS 0-1 (cohort 2)- Adequate haematological, renal and liver function- Negative pregnancy test for patients of childbearing potential- Ability to comply with the trial protocol, in the investigator's judgment.-Written informed consent for protocol treatment must be signed and dated by the patient and the investigator prior to any trial-related intervention, including the submission of mandatory biomaterial. ...
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Adagrasib in Combination With TNO155 in Patients With Cancer (KRYSTAL 2)
Excerpt:...- Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 must be either Non-Small Cell Lung Cancer or Colorectal Cancer)...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
Excerpt:...- Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Excerpt:...- Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
Excerpt:...- Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
Excerpt:...- KRASG12C-mutated solid malignancy determined by a sponsor-approved assay using either tumor tissue or ctDNA....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status
Excerpt:...KRASG12C-mutation by local testing (by tissue or ctDNA)....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
Excerpt:...Cohort A* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19)
Excerpt:...- Histologically confirmed diagnosis of solid tumor malignancy (Phase 1) or NSCLC (Phase 2) with KRAS G12C mutation...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Excerpt:...- Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
Excerpt:...- Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 1b must be either Non-Small Cell Lung Cancer or Colorectal Cancer)...
Less C2 evidence
Evidence Level:Sensitive: D – Preclinical
Title:
The ULK1 inhibitor ENV-201 impairs tumor growth in KRAS-driven flank xenografts as a single agent and in combination with the KRAS inhibitor adagrasib
Excerpt:We have demonstrated the added benefit of KRAS inhibition and autophagy inhibition in an animal model, using the NCI-H2122 cell line (homozygous for the activating KRASG12C mutation) as flank xenografts in NOD/SCID mice….Both ENV-201 and adagrasib treatments resulted in significant tumor growth inhibition when either drug was used as a single agent (32% or 55% TGI, respectively). Significant additive tumor growth inhibition (78%) was also observed when animals were treated with both drugs in combination.
