dm+d

Unassigned

New Medicines

Non-Hodgkin lymphoma - relapsed or refractory marginal zone lymphoma, mantle cell and follicular lymphoma

Information

New molecular entity
Incyte
Incyte

Development and Regulatory status

Phase II Clinical Trials
Filing withdrawn
Discontinued
Jul 22Incyte withdraw filing for parsaclisib in EU, as it is not able to satisfactorily address concerns raised by CHMP, namely regarding study design and the feasibility of conducting further studies [9].
Jan 22Incyte withdraws parsaclisib for marginal zone lymphoma (MZL), follicular lymphoma (FL) and mantle cell lymphoma in business decision. The withdrawal affects the said three indications in the US and is not associated with any changes in the drug´s safety or efficacy. It also does not have an impact on other ongoing studies on parsaclisib in the US and other locations. [8]
Jan 22Incyte withdraws parsaclisib for marginal zone lymphoma (MZL), follicular lymphoma (FL) and mantle cell lymphoma in business decision. The withdrawal affects the said three indications in the US and is not associated with any changes in the drug´s safety or efficacy. It also does not have an impact on other ongoing studies on parsaclisib in the US and other locations. [8]
Dec 21Filed in EU via centralised procedure [7].
Nov 21US filings based on data from several phase II trials (CITADEL-203, -204 and -205). The Prescription Drug User Fee Act (PDUFA) target action date for MZL and MCL is April 30, 2022. The NDA for parsaclisib treatment in adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies will follow Standard Review and a PDUFA target action date of August 30, 2022 [5].
Nov 21US FDA accept NDA for parsaclisib for relapsed or refractory follicular lymphoma, marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). Priority Review has been granted for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with MCL who have received at least one prior therapy [5].

Category

A phosphatidylinositol 3-kinase-δ inhibitor
There are around 14,100 new non-Hodgkin lymphoma cases in the UK every year [1]. Marginal zone lymphomas (MZLs) account for between 5% and 17% of all NHL. MZLs consist of 3 different subtypes with extranodal being the most commonly reported, representing 50-70% of MZL, followed by splenic (20%) and nodal (10%) [2].
Non-Hodgkin lymphoma - relapsed or refractory marginal zone lymphoma, mantle cell and follicular lymphoma
Oral

Further information

Yes

Trial or other data

Dec 21PII studies, CITADEL-203, 204 and 205, are all active and have finished recruiting. Collection of primary outcome data completed in all three studies in Jan 21. Results released show that in CITADEL-203 trial, treatment with parsaclisib demonstrated overall response rate of 75% in daily dosing group (DG) (n=95), and 73% in overall patients (n=118), with follicular lymphoma. The median duration of response (DOR) was reported to be 14.7 and 15.9 months in the DG and overall group. The median progression free survival (PFS) was reported to be 15.8 months each in both groups. In CITADEL-204 trial, treatment with parsaclisib demonstrated an objective response rate of 54.3% overall and 57.6% in DG, the ORR was 48.3%, 50.0%, and 63.6% for patients with nodal, extranodal, and splenic MZL, respectively. The median time to response was reported to be eight weeks. In CITADEL-205 trial for a cohort of BTK inhibitor-naïve patients (n=104) with R/R MCL, parsaclisib demonstrated an ORR and complete response rate (CRR) of 66.3% and 15.2%, respectively in all evaluable patients, and were 65.6% and 11.5% for the DG. Median time to response for patients with a complete or partial response was 7.9 weeks. The median DOR was 11.0 months for all responders and 9.0 months for DG. Median PFS was 11.1 months overall, and 11.1 months for DG [5,6].
Feb 21PII CITADEL-204 continues [3].
Dec 19Recruitment completes in PII CITADEL-204 study [3].
Dec 17PII CITADEL-204 study to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton´s tyrosine kinase (BTK) inhibitor starts (NCT03144674). 11 adults will be recruited in countries including the UK and US, plus Europe. Primary outcome is objective response rate; collection of these data is due to complete Jan 22 [3].
Nov 17PII CITADEL-205 study to evaluate the safety and efficacy of parsaclisib in participants diagnosed with relapsed or refractory mantle cell lymphoma starts (NCT03235544). Primary outcome is objective response rate; collection of these data is due to complete Mar 21 [4].
Jun 17PII CITADEL-203 study to evaluate the safety and efficacy of parsaclisib with idelalisib in participants diagnosed with relapsed or refractory follicular lymphoma starts (NCT03126019). Primary outcome is objective response rate; collection of these data is due to complete Feb 21 [4].