Fewer than or equal to three prior lines of therapy.
Patients with untreated active brain metastases were excluded.
Enrolled patients were followed for a median period of 12.2 months. An independent blinded central review of the patients found that 124 patients had at least one measurable lesion at baseline and were evaluated for efficacy. Of these, 46 patients experienced a confirmed response (three complete responses and 43 partial responses), resulting in an objective response rate of 37.1% (95% Cl: 28.6–46.2). The median time to objective response was 1.4 months, the median duration of response was 10 months (95% CI: 6.9-11.1), and 43% of responders remained on treatment without progression. The disease control rate was 80.6% (95% Cl: 72.6–87.2).
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(For Immediate Release Singapore January 28, 2021) In the phase II CodeBreak 100 trial, sotorasib provided durable clinical benefit with a favorable safety profile in patients with pretreated non-small cell lung cancer (NSCLC) and who harbor KRAS p.G12C mutations, validating CodeBreak 100 s phase I results, according to research presented today at the International Association for the Study of Lung Cancer World Conference on Lung Cancer.
Outcome in patients with advanced NSCLC on second- or third-line therapies is poor, with a response rate of less than 20% and median progression-free survival of fewer than four months. Approximately 13% of patients with lung adenocarcinomas harbor KRAS p.G12C mutations.
Sotorasib Provides Durable Clinical Benefit for Patients with NSCLC and KRAS Mutations
Exciting New Research to be Presented at International Association for the Study of Lung Cancer World Conference on Lung Cancer’s Presidential Symposium
SINGAPORE, Jan. 28, 2021 (GLOBE NEWSWIRE) In the phase II CodeBreak 100 trial, sotorasib provided durable clinical benefit with a favorable safety profile in patients with pretreated non-small cell lung cancer (NSCLC) and who harbor
KRAS p.G12C mutations, validating CodeBreak 100’s phase I results, according to research presented today at the International Association for the Study of Lung Cancer World Conference on Lung Cancer.
Outcome in patients with advanced NSCLC on second- or third-line therapies is poor, with a response rate of less than 20% and median progression-free survival of fewer than four months. Approximately 13% of patients with lung adenocarcinomas harbor
Amgen aims for first KRAS inhibitor approval in the US
Sotorasib is a potential treatment for advanced KRAS G12C-mutated NSCLC
Amgen is aiming for the first approval of a KRAS targeting drug after announcing that it has filed its investigational drug sotorasib with the US Food and Drug Administration (FDA).
The company has filed a new drug application (NDA) with the FDA for the investigational KRAS inhibitor, seeking approval for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy.
If approved, it would become the first therapy designed to target the KRAS pathway, an oncogene that is implicated in around a third of all human cancers.