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Association details:
| Biomarker: | EGFR T790M |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Semena (befotertinib) (EGFR inhibitor, Tyrosine kinase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer
Excerpt:
...- patients must also have confirmation of tumour T790M mutation status (confirmed positive) after disease progression on the prior EGFR TKI....
Source:
Title:
D-0316 First Time in Patients Ascending Dose Study
Excerpt:
...- Confirmation that the tumour harbours an EGFR T790M mutation....
Less C2 evidence
Source:
Title:
EP08.02-139 - A Phase 2 Study of Befotertinib in Patients with EGFR T790M Mutated NSCLC after Prior EGFR TKIs
Published date:
07/12/2022
Excerpt:
Befotertinib has shown favorable efficacy and manageable safety in pts with locally advanced or metastatic NSCLC harboring T790M mutation as a second-line option in the Chinese population.
Source:
Title:
Phase I Trial of a Third Generation EGFR Mutant-Selective Inhibitor (D-0316) in Patients with Advanced Non-Small Cell Lung Cancer
Published date:
02/26/2022
Excerpt:
This phase I, open-label, multicenter clinical trial evaluated daily oral D-0316 administration in dose-escalation (25 to 150 mg; 17 patients) and dose-expansion (50, 100 mg; 67 patients) cohorts for safety, tolerability, anti-tumor activity, and pharmacokinetics....the overall response rate (ORR) was 33.3% and 45.5%, the disease control rate (DCR) was 86.7% and 93.9%, and the median PFS was 8.3 and 9.6 months, respectively....D-0316 is safe, tolerable, and effective for patients with locally advanced/metastatic NSCLC with the EGFR T790M mutation who previously received EGFR-TKI.
DOI:
https://doi.org/10.1093/oncolo/oyab007
Trial ID:
Source:
Title:
CT170 - D-0316 in patients with advanced T790M-positive EGFR-mutant non-small cell lung cancer who progressed on prior EGFR-TKI therapy: results from a phase II study (NCT03861156)
Published date:
04/10/2021
Excerpt:
In this phase II, open-label, single-arm study, eligible pts were those who had confirmed locally advanced or metastatic NSCLC, and had disease progression after first-line EGFR-TKI and with T790M mutation….Pts were initially orally given D-0316 50 mg....The ORR was 64.8% (95% CI: 59.0-70.3) and the disease control rate (DCR) was 95.2% (95% CI: 92.0-97.3).
Trial ID:
