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KRYSTAL-1

Adagrasib in advanced solid tumours harbouring a KRAS G12C mutation, excluding NSCLC and colorectal cancer (KRYSTAL-1, phase 2 cohort)

Phase 1/2N = 63NCT03785249

Population
KRAS G12C-mutated advanced solid tumours other than NSCLC and colorectal cancer (pancreatic and biliary tract among the tumour types)
Design
Single-arm phase 2 cohort of KRYSTAL-1 (plus phase 1b cohort): adagrasib 600 mg orally twice daily in KRAS G12C-mutated advanced solid tumours other than NSCLC and colorectal cancer; pancreatic cancer is one of the tumour types. Primary end point objective response rate. Single-arm; no comparison group.
Primary endpoint
ORR
Arms
  • Adagrasib (experimental, n = 63): Adagrasib 600 mg orally twice daily
People
Bekaii-Saab TS
Show the numbers
Results reported for KRYSTAL-1
EndpointAnalysisAdagrasibControlEffect
ORRPancreatic cancer patients with measurable disease at baseline (21)primaryBekaii-Saab 202333.3%—7 of 21 patients; a tumour-type subset of a mixed cohort, with no confidence interval in the abstract.
ORRPatients with measurable disease at baseline across all tumour types in the cohort (57)primaryBekaii-Saab 202335.1%—20 of 57 patients, all partial responses; data as of 1 October 2022.
Results reported for KRYSTAL-1
EndpointAnalysisAdagrasibControlEffect
ORRPancreatic cancer patients with measurable disease at baseline (21)primaryBekaii-Saab 202333.3%—7 of 21 patients; a tumour-type subset of a mixed cohort, with no confidence interval in the abstract.
ORRPatients with measurable disease at baseline across all tumour types in the cohort (57)primaryBekaii-Saab 202335.1%—20 of 57 patients, all partial responses; data as of 1 October 2022.
Primary publication: Bekaii-Saab TS, Yaeger R, Spira AI, Pelster MS, Sabari JK, Hafez N, et al. Adagrasib in Advanced Solid Tumors Harboring a KRAS(G12C) Mutation. J Clin Oncol. 2023;41(25):4097-4106. PubMedDOI

Appears in

Sources

  1. Bekaii-Saab TS, Yaeger R, Spira AI, Pelster MS, Sabari JK, Hafez N, et al. Adagrasib in Advanced Solid Tumors Harboring a KRAS(G12C) Mutation. J Clin Oncol. 2023;41(25):4097-4106.

    PubMedDOI