REMORA
Lenvatinib in patients with advanced or metastatic thymic carcinoma (REMORA): a multicentre, phase 2 trial
Phase 2N = 42
- Population
- Adults (20 years or older) with pathologically confirmed unresectable advanced or metastatic thymic carcinoma that progressed after at least one platinum-based chemotherapy, with at least one measurable lesion (RECIST 1.1) and ECOG performance status 0 or 1.
- Design
- Single-arm, multicentre phase 2 trial at eight institutions in Japan (five cancer centres, two medical university hospitals, one public hospital). Lenvatinib 24 mg orally once daily in 4-week cycles until progression or unacceptable adverse events. Enrolment 21 April 2017 to 22 February 2018. Primary endpoint: objective response rate by independent central review in the intention-to-treat population at the data cutoff of 22 February 2019. Registered on JMACCT (JMA-IIA00285) and UMIN-CTR (UMIN000026777); the abstract prints no ClinicalTrials.gov number.
- Primary endpoint
- ORR
- Arms
- Lenvatinib (experimental, n = 42): Lenvatinib 24 mg orally once daily in 4-week cycles
- People
- Sato J
Show the numbers
| Endpoint | Analysis | Lenvatinib | Control | Effect |
|---|---|---|---|---|
| ORR | primarymedian follow-up 15.5 monthsSato 2020 | 38% | — | P<0.0001The abstract prints 38% with a 90% confidence interval of 25.6-52.0 (not a 95% interval). 16 of 42 patients had a partial response and 24 (57%) had stable disease. The PMDA review report prints the same analysis as 38.1% (90% CI 25.6-52.0). Median follow-up 15.5 months (IQR 13.1-17.5). The most frequent grade 3 treatment-related adverse events were hypertension in 27 patients (64%) and palmar-plantar erythrodysaesthesia syndrome in 3 (7%); no patient died from an adverse event. |
| OSAll 42 REMORA patients (analysis population not named in the abstract) | long term-updateNiho 2024 | median 28.3 months (17.1–34.0); 35.7% at 3 y (21.7–49.9%) | — | Updated overall survival from the long-term follow-up report; the report's exploratory analysis by relative dose intensity is not reproduced here. |
| Endpoint | Analysis | Lenvatinib | Control | Effect |
|---|---|---|---|---|
| ORR | primarymedian follow-up 15.5 monthsSato 2020 | 38% | — | P<0.0001The abstract prints 38% with a 90% confidence interval of 25.6-52.0 (not a 95% interval). 16 of 42 patients had a partial response and 24 (57%) had stable disease. The PMDA review report prints the same analysis as 38.1% (90% CI 25.6-52.0). Median follow-up 15.5 months (IQR 13.1-17.5). The most frequent grade 3 treatment-related adverse events were hypertension in 27 patients (64%) and palmar-plantar erythrodysaesthesia syndrome in 3 (7%); no patient died from an adverse event. |
| OSAll 42 REMORA patients (analysis population not named in the abstract) | long term-updateNiho 2024 | median 28.3 months (17.1–34.0); 35.7% at 3 y (21.7–49.9%) | — | Updated overall survival from the long-term follow-up report; the report's exploratory analysis by relative dose intensity is not reproduced here. |
- Lenvatinib (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Lenvatinib |
|---|---|
| 0 | 100.0% |
| 18 | 64.3% |
| 35 | 42.4% |
| 53 | 27.3% |
| 71 | 17.6% |
Appears in
Sources
Sato J, Satouchi M, Itoh S, Okuma Y, Niho S, Mizugaki H, et al. Lenvatinib in patients with advanced or metastatic thymic carcinoma (REMORA): a multicentre, phase 2 trial. Lancet Oncol. 2020;21(6):843-850.
Niho S, Sato J, Satouchi M, Itoh S, Okuma Y, Mizugaki H, et al. Long-term follow-up and exploratory analysis of lenvatinib in patients with metastatic or recurrent thymic carcinoma: Results from the multicenter, phase 2 REMORA trial. Lung Cancer. 2024;191:107557.