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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 and Tolerability of SH-1028 in Patients With Advanced Solid Cancer
Excerpt:
...In addition, other lines of therapy may have been given; patients must have confirmation of T790M+ mutation status....
Source:
Title:
SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations
Excerpt:
...- Patients must harbor one of the two common sensitizing EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M, the mutations should be confirmed by the central laboratory....
Trial ID:
Less 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:
