SUMMARY OF KEY EFFICACY DATA
Table 5: Efficacy data from SYLVANT® pivotal trial in iMCD patients; analyses are for the intention-to-treat population, unless specified6,8
| EFFICACY ENDPOINT | SYLVANT® + BSC | PLACEBO + BSC | P-VALUE |
|---|---|---|---|
| PRIMARY ENDPOINT | |||
| Durable tumour and symptomatic response (independent review) | 18/53 (34%) | 0/26 (0%) | 0.0012 |
| Complete response | 1/53 (2%) | 0 (0%) | |
| Partial response | 17/53 (32%) | 0 (0%) | |
| Duration of durable tumour and symptomatic response, median days (max, min) | 383 (232, 676) | NE | |
| TUMOUR RESPONSE | |||
| Best tumour response (independent review) | 20/53 (38%) | 1/26 (4%) | 0.0022 |
| Complete response | 2/53 (4%) | 0/26 (0%) | |
| Partial response | 18/53 (34%) | 1/26 (4%) | |
| Time to tumour response (independent review for responders), median days (min, max) | 155 (44,742) | 65 (65, 65) | |
| Best tumour response (investigator assessment) | 27/53 (51%) | 0/26 (0%) | <0.0001 |
| Complete response | 3/53 (6%) | 0/26 (0%) | |
| Partial response | 24/53 (45%) | 0/26 (0%) | |
| SYMPTOMATIC RESPONSE | |||
| Durable symptomatic response ratea | 30/53 (57%) | 5/26 (19%) | 0.0018 |
| Time to durable symptomatic response, median days (min, max) | 170 (67,274) | NE | |
| Complete symptomatic responseb | 13/53 (25%) | 0/26 (0%) | 0.0037 |
| OTHER ENDPOINTS | |||
| Time to treatment failure, days; median (min, max) | NE | 134 days (85 to NE) | 0.0084 |
| Time to next treatment; median (min, max) | NE | 280 (161 to NE) | 0.0013 |
| Hb increase ≥19 g/L (0.9 mmol/L) at week 13c | 19/31 (61%) | 0/11 (0%) | 0.0002 |
| Patients who discontinued corticosteroids | 4/13 (31%) | 1/9 (11%) | 0.3602 |
BSC, best supportive care; Hb, haemoglobin
N/A not applicable, there were no responders in the placebo arm, therefore duration is not applicable.
NE not evaluable.
a A ≥50% reduction in overall MCD-related Overall Symptom Score sustained for at least 18 weeks prior to treatment failure.
b Complete symptomatic response is defined as 100% reduction in baseline MCD overall symptom score sustained for a least 18 weeks prior to treatment failure.
c Hb response-evaluable population.
d Data from 11 of 13 complete symptomatic responders were censored due to on-going response.
e At the time of primary analysis, data for 19 of 20 tumour and symptomatic responders were censored due to on-going response.
References
- Janssen-Cilag Ltd. SYLVANT® 100 mg powder for concentrate for solution for infusion. Summary of Product Characteristics 2019 [Available from: https://www.medicines.org.uk/emc/product/2132/smpc.
- Janssen Research & Development LLC. A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman’s Disease 2018 [Available from: https://clinicaltrials.gov/ct2/show/NCT01024036?term=siltuximab&recrs=e&phase=1&draw=2&rank=3.
- Van Rhee F, Wong RS, Munshi N, Rossi JF, Ke XY, Fossa A, et al. Siltuximab for multicentric Castleman’s disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014;15(9):966-74.
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Date of prep: November 2021 GL-SIL-2100103
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