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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

Bristol Myers Squibb Announces U.S. FDA Accelerated Approval of KRAZATI® (adagrasib) in Combination with Cetuximab for Adult Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC)

Published date:
06/21/2024
Excerpt:
Bristol Myers Squibb...announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI ® (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C -mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Evidence Level:
Sensitive: B - Late Trials
Title:

Mirati announces Adagrasib (KRAZATI™) Receives Breakthrough Therapy Designation from FDA for Patients with Advanced, KRAS-Mutated Colorectal Cancer and NEJM Publishes Phase 1b/2 Data from Adagrasib With or Without Cetuximab in Colorectal Cancer

Published date:
12/21/2022
Excerpt:
Mirati Therapeutics, Inc. (NASDAQ: MRTX), announced today that the FDA has granted BTD to adagrasib in combination with cetuximab in patients with KRASG12C-mutated, advanced CRC whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy. This designation is supported by results from the Phase 1b cohort of the KRYSTAL-1 trial.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

Excerpt:
...- Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase I Trial of Adagrasib (MRTX849) in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer

Excerpt:
...- Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with KRASG12C mutation....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Adagrasib with or without Cetuximab in Colorectal Cancer with Mutated KRAS G12C

Published date:
12/21/2022
Excerpt:
In the combination-therapy group (28 evaluable patients), the response was 46% (95% CI, 28 to 66). The median response duration was 7.6 months (95% CI, 5.7 to not estimable), and the median progression-free survival was 6.9 months (95% CI, 5.4 to 8.1)....Adagrasib had antitumor activity in heavily pretreated patients with metastatic colorectal cancer with mutant KRAS G12C, both as oral monotherapy and in combination with cetuximab.
DOI:
10.1056/NEJMoa2212419
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

LBA24 - KRYSTAL-1: Updated efficacy and safety of adagrasib (MRTX849) with or without cetuximab in patients with advanced colorectal cancer (CRC) harboring a KRASG12C mutation

Published date:
09/05/2022
Excerpt:
In 28 pts evaluable for efficacy, ORR was 46% (13/28) and DCR was 100% (28/28). Median DOR was 7.6 mo (95% CI 5.7–NE) and median PFS was 6.9 mo (95% CI 5.4–8.1)...Adagrasib is well tolerated as monotherapy and with cetuximab. Both showed clinical activity in heavily pretreated pts with KRASG12C-mutated CRC, with more sustained responses with the combination.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

LBA6 - KRYSTAL-1: Adagrasib (MRTX849) as monotherapy or combined with cetuximab (Cetux) in patients (Pts) with colorectal cancer (CRC) harboring a KRASG12C mutation

Published date:
09/13/2021
Excerpt:
As of 9 July 2021, 32 pts with CRC (53% female; median age 60 years; 3 median prior lines of therapy) were treated with adagrasib + cetux (median follow-up 7 months)….Among the 28 pts evaluable for clinical activity, the response rate was 43% (12/28, including 2 unconfirmed PRs who remain on study) and DCR was 100%....Adagrasib is well tolerated as monotherapy and combined with cetux and demonstrates promising clinical activity in heavily pretreated pts with KRASG12C-mutant CRC.
Trial ID:
Evidence Level:
Sensitive: D – Preclinical
Title:

Abstract LB-098: The anti-tumor activity of the KRAS G12C inhibitor MRTX849 is augmented by cetuximab in CRC tumor models

Published date:
05/15/2020
Excerpt:
The combination of MRTX849 plus cetuximab demonstrated the best anti-tumor activity in multiple models . The combination of MRTX849 and cetuximab demonstrated increased KRASG12C modification and MAPK pathway inhibition suggesting these therapies converge to more fully inhibit KRASG12C.
DOI:
10.1158/1538-7445.AM2020-LB-098