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Association details:
| Biomarker: | TMB-H |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Imfinzi (durvalumab) (PD-L1 inhibitor) + Imjudo (tremelimumab) (CTLA4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
NEPTUNE: Phase III Study of First-Line Durvalumab Plus Tremelimumab in Patients With Metastatic NSCLC
Published date:
10/11/2022
Excerpt:
NON-SUPPORTIVE EVIDENCE: NEPTUNE did not meet its primary endpoint of improved OS with durvalumab plus tremelimumab versus chemotherapy in patients with mNSCLC and bTMB ≥20.
DOI:
https://doi.org/10.1016/j.jtho.2022.09.223
Trial ID:
Source:
Title:
A Blood-based Assay for Assessment of Tumor Mutational Burden in First-line Metastatic NSCLC Treatment: Results from the MYSTIC Study
Published date:
12/22/2020
Excerpt:
The dataset used for the clinical validation was from MYSTIC, which evaluated first-line durvalumab (anti-PD-L1 antibody) ± tremelimumab (anticytotoxic T-lymphocyte-associated antigen-4 antibody) or chemotherapy for metastatic NSCLC....Using the new bTMB algorithm and an optimal bTMB cutoff of ≥20 mut/Mb, high bTMB was predictive of clinical benefit with durvalumab + tremelimumab versus chemotherapy.
DOI:
10.1158/1078-0432.CCR-20-3771
Trial ID:
Source:
Title:
Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non–Small Cell Lung Cancer The MYSTIC Phase 3 Randomized Clinical Trial
Published date:
04/09/2020
Excerpt:
Among 809 patients with evaluable bTMB, those with a bTMB ≥20 mutations per megabase showed improved OS for durvalumab plus tremelimumab vs chemotherapy (median OS, 21.9 months [95% CI, 11.4-32.8] vs 10.0 months [95% CI, 8.1-11.7]; HR, 0.49; 95% CI, 0.32-0.74).
Trial ID:
Source:
Title:
Tremelimumab plus durvalumab retreatment and 4-year outcomes in patients with mesothelioma: a follow-up of the open label, non-randomised, phase 2 NIBIT-MESO-1 study
Published date:
04/09/2021
Excerpt:
NIBIT-MESO-1 was an open-label, non-randomised, phase 2 trial of patients with unresectable pleural or peritoneal mesothelioma who received intravenous tremelimumab (1 mg/kg bodyweight) and durvalumab (20 mg/kg bodyweight) every 4 weeks for four doses...there was a significant difference in survival between those with a TMB higher than the median of 8·3 mutations per Mb and those with TMB lower than the median in the retreated cohort (41·3 months vs 17·4 months; p=0·02).
DOI:
10.1016/S2213-2600(21)00043-6
