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Association details:
| Biomarker: | EGFR T790M |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Sanrisso (rilertinib) (EGFR inhibitor, Tyrosine kinase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Safety, Tolerability and Pharmacokinetics of SH-1028 in Patients With Advanced NSCLC
Excerpt:
...Patients must have confirmation of tumor T790M+ mutation status....
Source:
Title:
A Study to Evaluate the Safety and Efficacy of SH-1028 in Locally Advanced or Metastatic NSCLC
Excerpt:
...- Patients must have confirmation of T790M+ mutation status, which have experienced disease progression while on a previous continuous treatment with an EGFR-TKI or clinical benefit from EGFR-TKI according to the Jackman criteria while on continuous treatment with an EGFR-TKI (PR/CR, or SD continued ≥6 months); Patients can receive more than one line of systemic therapy....
More C2 evidence
Source:
Title:
Safety, efficacy, and pharmacokinetics of SH-1028 in EGFR T790M-positive advanced non–small cell lung cancer patients: A dose-escalation phase 1 study
Published date:
02/22/2023
Excerpt:
Patients with EGFR T790M mutation, locally advanced non-small cell lung cancer (NSCLC), or metastatic NSCLC who had progressed after previous EGFR TKI therapy were eligible....The ORR and DCR of the 200 mg cohort were 75% (95% confidence interval [CI], 19.41-99.37) and 75.0% (95% CI, 19.41-99.37), respectively. The overall ORR was 40% (95% CI, 19.12-63.95), and DCR was 70.0% (95% CI, 45.72-88.11)….SH-1028 showed a manageable safety and promising antitumor activity in patients with EGFR T790M mutation at the dose of 200 mg once daily.
DOI:
https://doi.org/10.1002/cncr.34697
Trial ID:
Source:
Title:
Efficacy and safety of SH-1028 in patients with EGFR T790M positive non-small-cell lung cancer: a multicenter, single-arm, open-label, phase 2 trial
Published date:
07/04/2022
Excerpt:
A total of 286 patients with EGFR T790M-positive advanced NSCLC were enrolled in this study...ORR was 55.9% (95% confidence interval [CI]: 42.4∼68.8) in Part A and 60.4% (95% CI: 53.7∼66.8) in Part B. The median PFS was 12.4 months (95% CI: 8.3∼20.8) in Part A and 12.6 months (95% CI: 9.7∼15.3) in Part B. The median OS was 26.0 months (95% CI: 23.3∼NR) in Part A, and OS was immature in Part B....SH-1028 is efficacious and tolerable in second-line treatment of advanced NSCLC patients with positive EGFR T790M.
DOI:
https://doi.org/10.1016/j.jtho.2022.06.013
Trial ID:
Source:
Title:
Oritinib (SH-1028) a third-generation EGFR tyrosine kinase inhibitor in locally advanced or metastatic NSCLC patients with positive EGFR T790M: Results of a single-arm phase II trial
Published date:
03/23/2022
Excerpt:
At data cutoff (September 17, 2021), 137 of 227 patients achieved confirmed partial responses with ORR of 60.4% (95% CI: 42.4%, 68.8%) by IRaC. The DCR was 92.5% (88.3%, 95.6%), the mPFS was 12.6 months (95% CI: 9.7, 15.3), the mDOR was 12.5 months (95% CI: 11.2, NA)....Oritinib demonstrated potential clinical benefit and tolerable in advanced NSCLC patients with EGFR T790M mutation.
DOI:
https://doi.org/10.1016/j.annonc.2022.02.016
Trial ID:
Source:
Title:
P51.03 - Oritinib (SH-1028), a Third-generation EGFR-TKI in Advanced NSCLC Patients with Positive EGFR T790M: Results of a Single-arm Phase Ib Trial
Published date:
08/18/2021
Excerpt:
From March 2019 to December 2019, 60 patients from 9 centers of China were enrolled in dose-extension cohort and 59 patients received at least one dose of oritinib and had at least one tumor assessment. Median age was 59 years old, 64.4% of patients were female and 49.2% received ≥ 2 prior systemic anticancer therapies. At the time of data cutoff (Mar 17, 2021), 36 of 59 patients achieved confirmed partial responses with ORR of 61.0% (95% CI:48.2%, 73.8%) per investigator. mPFS was 9.7 months (95% CI: 7.2, 13.8)...Oritinib demonstrated potential clinical benefit in advanced NSCLC patients with EGFR T790M mutation following prior therapy with EGFR TKIs.
Trial ID:
