TEST:

cobas® EGFR Mutation Test v2

EXKIVITY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy...This indication is approved under accelerated approval based on overall response rate and duration of response.

TAGRISSO is a kinase inhibitor indicated for...the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.

TAGRISSO is a kinase inhibitor indicated...as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

TAGRISSO is a kinase inhibitor indicated...as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

In this randomized, international, open-label, phase 3 trial, we assigned 419 patients with T790M-positive advanced non-small-cell lung cancer, who had disease progression after first-line EGFR-TKI therapy, in a 2:1 ratio to receive either oral osimertinib...The median duration of progression-free survival was significantly longer with osimertinib than with platinum therapy plus pemetrexed (10.1 months vs. 4.4 months; hazard ratio; 0.30; 95% confidence interval [CI], 0.23 to 0.41; P<0.001). The objective response rate was significantly better with osimertinib (71%; 95% CI, 65 to 76) than with platinum therapy plus pemetrexed (31%; 95% CI, 24 to 40) (odds ratio for objective response, 5.39; 95% CI, 3.47 to 8.48; P<0.001).

Rezivertinib (BPI-7711) showed promising efficacy and a favorable safety profile for the treatment among the locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation in the first-line setting.

CONTRADICTING EVIDENCE: DNA was extracted from plasma and ctDNA was analyzed for the presence of mutations in the EGFR gene using the COBAS® EGFR v2 qPCR (Roche) test….The original EGFR mutation (OM) was identified in 35 (48%) of pts at the time of enrollment with significantly higher detection rates in TKI naïve pts compared to TKI-treated group, 70% vs 37% (p=0.012). Detection of original mutation at the study baseline was negative predictor of PFS and OS (table 1).

Patients with NSCLC who progressed after treatment with EGFR-TKI, and with EGFR T790 M detected by an approved companion diagnostic test (cobas® ), were treated with osimertinib….Among 147 patients tested, 57 patients received osimertinib, with an overall response rate (ORR) of 58%.

...16.7% (2/12) of the T790M positive patients with either TP53 R237C or KRAS G12V failed to benefit from the subsequent osimertinib treatment.

...16.7% (2/12) of the T790M positive patients with either TP53 R237C or KRAS G12V failed to benefit from the subsequent osimertinib treatment.

AZD9291 was associated with a higher objective response rate and longer progression-free survival in patients with T790M-mediated drug resistance than in those with non–T790M-mediated resistance….the current median progression-free survival in patients with detectable EGFR T790M (9.6 months) is encouraging.

Two patients showed EGFR A763_Y764insFQEA, which has been considered as sensitive to classical EGFR tyrosine kinase inhibitors (EGFR-TKIs). Two patients (EGFR A763_Y764insFQEA and EGFR T751_I759>S) had received erlotinib during their treatment course and both of them showed stable disease with a progression-free survival of 5.9 and 10.1 months, respectively.

Two patients showed EGFR A763_Y764insFQEA, which has been considered as sensitive to classical EGFR tyrosine kinase inhibitors (EGFR-TKIs). Two patients (EGFR A763_Y764insFQEA and EGFR T751_I759>S) had received erlotinib during their treatment course and both of them showed stable disease with a progression-free survival of 5.9 and 10.1 months, respectively.

Two patients showed EGFR A763_Y764insFQEA, which has been considered as sensitive to classical EGFR tyrosine kinase inhibitors (EGFR-TKIs). Two patients (EGFR A763_Y764insFQEA and EGFR T751_I759>S) had received erlotinib during their treatment course and both of them showed stable disease with a progression-free survival of 5.9 and 10.1 months, respectively.