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Nintedanib Plus Pemetrexed/Cisplatin vs Placebo Plus Pemetrexed/Cisplatin in First-Line Unresectable Malignant Pleural Mesothelioma
An international, double-blind, randomised, multicentre, placebo-controlled, Phase II/III study of nintedanib* plus pemetrexed/cisplatin vs placebo plus pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma (MPM).
Trial CT.gov-Identifier: NCT019071001
Phase II part (results reported):2
Patients with unresectable MPM (≥18 years old)
Histologically confirmed epithelioid or biphasic MPM
Measurable disease according to modified Response Evaluation Criteria In Solid Tumors
No prior first-line therapies for MPM
Life expectancy ≥3 months
Eastern Cooperative Oncology Group performance status of 0 or 1
N=87
Overall, 87 patients were randomised 1:1 to receive nintedanib plus chemotherapy or placebo plus chemotherapy
Phase III part (ongoing):3
Patients with unresectable MPM (≥18 years old)
Histologically confirmed epithelioid MPM
Measurable disease according to modified Response Evaluation Criteria In Solid Tumours
No prior first-line therapies for MPM
Life expectancy ≥3 months
Eastern Cooperative Oncology Group performance score of 0–1
Planned N=450
Randomisation 1:1 to receive nintedanib plus chemotherapy or placebo plus chemotherapy
Phase II (results reported)2
Primary outcome measure:
Progression-free survival (PFS)
Secondary outcome measure:
Overall survival (OS)
Objective response rate (ORR)
Phase III (ongoing)3
Primary outcome measure:
PFS
Key secondary outcome measure:
OS
Secondary outcome measures:
ORR
Disease control rate
Health-related quality of life
Phase II (completed)2
PFS by investigator assessment according to mRECIST:2
There was an increase in PFS favouring nintedanib vs placebo in the overall patient population at the primary analysis with 69 PFS events (median PFS: 9.4 vs 5.7 months; hazard ratio [HR]=0.56; 95% confidence interval [CI]: 0.34–0.91; p=0.017) and the updated analysis with 72 PFS events (median PFS: 9.4 vs 5.7 months; HR=0.54; 95% CI: 0.33–0.87; p=0.010). This increase in PFS favouring nintedanib was also seen in patients with epithelioid histology at primary analysis with 60 PFS events (median PFS: 9.7 vs 5.7 months; HR=0.51; 95% CI: 0.30–0.86; p=0.10) and in the updated analysis with 63 PFS events (median PFS: 9.7 [n=39] vs 5.7 months [n=38]; HR=0.49; 95% CI: 0.30–0.82; p=0.006).
OS:2
There was an increase in OS favouring nintedanib vs placebo in the overall population (median OS: 18.3 vs 14.2 months; HR=0.77; 95% CI: 0.46–1.29; p=0.319) and in patients with epithelioid histology (median OS: 20.6 months vs 15.2 months; HR=0.70; 95% CI: 0.40–1.21; p=0.197).
Safety:2
The safety profile of nintedanib plus chemotherapy was as expected from previous studies.
Common side effects (group terms; all grades) were:
Grade ≥3 adverse events were reported in 80% of patients in the nintedanib arm and 54% of patients in the placebo arm. There was an increased frequency of Grade ≥3 group-term adverse events of neutropenia in the nintedanib arm (43% vs 12%), although the rate of febrile neutropenia (group term) was low in the nintedanib arm (4.5%; n=2) and no febrile neutropenia was reported in the placebo arm. Serious adverse events occurred in 41% of patients in the nintedanib arm and 42% of patients in the placebo arm. The incidence rates of adverse events commonly associated with anti-angiogenic agents were either balanced between treatment arms or lower in the nintedanib arm. Nintedanib did not compromise delivery of chemotherapy.
The addition of nintedanib to standard chemotherapy demonstrated a clinically meaningful benefit in the first-line treatment of patients with unresectable MPM, and a benefit was observed in patients with epithelioid histology. The global Phase III part of this trial is ongoing to confirm the activity of nintedanib in patients with unresectable epithelioid MPM.
Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT01907100 (Accessed: November 2017).
Grosso F, et al. J Clin Oncol 2017;35: 3591-600.
Scagliotti GV, et al. Clin Lung Cancer 2017;18:589–93.
* Nintedanib is being investigated in malignant pleural mesothelioma (MPM) and is not approved for this use. The efficacy and safety of nintedanib in MPM have not been established.
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Last updated: March 2018