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  • Results from phase II CodeBreaK 100 show Lumakras ...

Results from phase II CodeBreaK 100 show Lumakras is the first and only KRAS G12C inhibitor with overall survival data for NSCLC.-Amgen.

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Published:6th Jun 2021
Amgen has presented data on overall survival, a secondary endpoint, from the Phase II results of the CodeBreaK 100 clinical study for Lumakras (sotorasib) in previously treated patients with non-small cell lung cancer (NSCLC) during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

These data were also simultaneously published in the New England Journal of Medicine (NEJM). The publication includes mature overall survival and duration of response data, and results from subgroup and exploratory biomarker analyses. Lumakras shows a median overall survival (OS) of 12.5 months among 124 evaluable patients, the majority of which were previously treated with both platinum-based chemotherapy and immunotherapy (81%) (data cutoff of March 15, 2021). The results confirmed an objective response rate (ORR) of 37.1%, duration of response (DoR) of 11.1 months and disease control rate (DCR) of 80.6%, with an additional patient achieving complete response (bringing the total to four complete responses and 42 partial responses) compared to previously reported results. The data published in NEJM are updated from results presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) held in January 2021 and are based on a longer follow-up time of 15.3 months. In exploratory analyses, tumor response to Lumakras was consistently observed across a range of biomarker subgroups, including patient subgroups stratified by baseline PD-L1 expression levels and those with STK11 mutation. In the patient subsets separated by baseline PD-L1 expression (n=86), response and tumor shrinkage were observed across the range of baseline PD-L1 expression levels, with the response rate of 48% for the PD-L1 negative group (TPS <1%). improved efficacy with liumakras was seen in stk11-mutant group with concurrent wild-type keap1 (n="22)" with median progression free survival (pfs) of 11.0 months and median os of 15.3 months. "sotorasib is the first krasg12c inhibitor to show an overall survival benefit, and the data represent a major step forward for patients with kras g12c-mutated non-small cell lung cancer where standard of care options are suboptimal," said lead author ferdinandos skoulidis, m.d., ph.d., assistant professor of thoracic head and neck medical oncology at the university of texas md anderson cancer center. "kras has been one of the most challenging therapeutic targets in cancer research, and these practice-changing results give hope to patients with the kras g12c mutation who previously had no targeted treatment options." lumakras received approval from the fda on may 28, 2021, for the treatment of adult patients with kras g12c-mutated locally advanced or metastatic nsclc, as determined by an fda-approved test, who have received at least one prior systemic therapy. lumakras has received accelerated approval based on orr and dor. continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). see- "sotorasib for lung cancers with kras p.g12c mutation"- ferdinandos skoulidis, m.d., ph.d., bob t. li, m.d., ph.d., m.p.h., grace k. dy, m.d., timothy j. price, m.b., b.s.,, et al.-june 4, 2021 doi: 10.1056 nejmoa2103695.></1%).>

Condition: NSCLC/KRAS G12C
Type: drug

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