Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Parsaclisib · 14 trials · 6 indications
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as defined by revised response criteria for lymphoma, as determined by an Independent Review Committee (IRC). CR: target nodes/nodal masses regressed to ≤1.5 centimeters (cm) in the longest transverse diameter (LDi); no nonmeasured lesions; regression to normal for organ enlargement; no new lesions; and normal bone marrow by morphology and negative immunohistochemistry if indeterminate. PR: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites; absent/regressed nonmeasured lesions (but no increase); spleen regressed by \>50% in length beyond normal; and no new lesions.
Number of participants with treatment-related AEs
The SGUS is a combination of the scores of the 4 salivary glands (2 parotid and 2 submandibular) each gland is scored on a 5-point scale (0 to 4; 4 being more severe), with the maximum total score being 16.
A complete response was defined as hemoglobin \>12 grams per deciliter (g/dL) not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion.
A partial response was defined as hemoglobin 10-12 g/dL or at least a 2 g/dL increase from Baseline not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy, or required changes in the study drug. Anemia and transfusions should not have been reported as AEs unless they represented a clinically meaningful decrease from Baseline in hemoglobin. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node\>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by\>50%in length beyond normal.4.No new lesions.
ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign 5mm×5mm as default;if no longer visible,0×0mm.Node \>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by \>50%in length beyond normal.4.No new lesions.
Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.
Maximum Observed Plasma Concentration of parsaclisib
Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
Area Under the concentration- time curve up to the last measurable concentration of parsaclisib
Maximum Observed Plasma Concentration of parsaclisib
Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
Area Under the concentration- time curve up to the last measurable concentration of parsaclisib
Maximum Observed Plasma Concentration of parsaclisib
Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
Area Under the concentration- time curve up to the last measurable concentration of parsaclisib
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
| Arm | Type | Description |
|---|---|---|
| parsaclisib | EXPERIMENTAL | parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits |
| parsaclicib + itacitinib | EXPERIMENTAL | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover. |
| parsaclisib + ruxolitinib | EXPERIMENTAL | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover. |
| parsaclisib + ibrutinib | EXPERIMENTAL | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover. |
| Parsaclisib 1 mg QD | EXPERIMENTAL | Parsaclisib at 1 milligram (mg) once daily (QD) for 12 weeks followed by extension period, with a dose-increase option (to 2.5 mg QD) at Week 6 for participants who fulfill dose increase criteria. |
| Parsaclisib 2.5 mg QD | EXPERIMENTAL | Parsaclisib at 2.5 mg QD for 12 weeks followed by extension period. |
| Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW | EXPERIMENTAL | Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks. |
| Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD | EXPERIMENTAL | Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks. |
| Cohort 1- Closed to Further enrollment | EXPERIMENTAL | Participants who have received prior ibrutinib. |
| Cohort 2 | EXPERIMENTAL | Participants who have not received a prior BTK inhibitor. |
| Cohort 1: Treatment A (Exposed to Ibrutinib) | EXPERIMENTAL | Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. |
| Cohort 1: Treatment B (Exposed to Ibrutinib) | EXPERIMENTAL | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. |
| Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) | EXPERIMENTAL | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who had not received a BTK inhibitor previously were included in this group. |
| Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) | EXPERIMENTAL | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who had not received a BTK inhibitor previously were included in this group. |
| Group A Parsaclisib (no prior BTK inhibitor) | EXPERIMENTAL | Parsaclisib in subjects who were not previously treated with a BTK inhibitor. |
| Group B Parsaclisib (prior BTK inhibitor) | EXPERIMENTAL | Parsaclisib in subjects who were previously treated with a BTK inhibitor. |
| Treat Group 1 : Normal Renal Function | EXPERIMENTAL | eGFR: ≥ 90 mL/min/1.73 m\^2 |
| Treat Group 2 : Mild Renal Impairment | EXPERIMENTAL | eGFR: 60-89 mL/min/1.73 m\^2 |
| Treat Group 3 : Moderate Renal Impairment | EXPERIMENTAL | eGFR: 30-59 mL/min/1.73 m\^2 |
| Treat Group 4 : Severe Renal Impairment | EXPERIMENTAL | eGFR: 15-29 mL/min/1.73 m\^2 and not on Hemo Dialysis |
| Treat Group 5 : Kidney Failure | EXPERIMENTAL | eGFR: \< 15 mL/min/1.73 m\^2 on Hemo Dialysis |
| Treatment Group 1 : Severe hepatic impairment | EXPERIMENTAL | Child Pugh (CP) assessment score of 10-14 points |
| Treatment Group 2 : Moderate hepatic impairment | EXPERIMENTAL | Child Pugh (CP) assessment score of 7-9 points |
| Treatment Group 3 : Mild hepatic impairment | EXPERIMENTAL | Child Pugh (CP) assessment score of 5-6 points |
| Treatment Group 4 : Normal hepatic impairment | EXPERIMENTAL | Normal hepatic function |
| Treatment A | EXPERIMENTAL | Parsaclisib + Rituximab |
| Treatment B | EXPERIMENTAL | Parsaclisib + Bendamustine + Rituximab |
| Treatment C | EXPERIMENTAL | Parsaclisib + Ibrutinib |
| Parsaclisib + Hexal and Gazyvaro | EXPERIMENTAL | - |
| Parsaclisib 5 mg QD | EXPERIMENTAL | Parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles |
| Parsaclisib 10 mg QD | EXPERIMENTAL | Parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles |
| Parsaclisib 15 mg QD | EXPERIMENTAL | Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles |
| Parsaclisib 20 mg QD | EXPERIMENTAL | Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles |
| Parsaclisib 30 mg QD | EXPERIMENTAL | Parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles |
| Parsaclisib 45 mg QD | EXPERIMENTAL | Parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles |
| Parsaclisib 20 mg + itacitinib (INCB039110) 300 mg | EXPERIMENTAL | Parsaclisib 20 mg as oral tablets QD and itacitinib (INCB039110) 300 mg as oral tablets QD in 21-day treatment cycles |
| Parsaclisib 30 mg + itacitinib (INCB039110) 300 mg | EXPERIMENTAL | Parsaclisib 30 mg as oral tablets QD and itacitinib (INCB039110) 300 mg as oral tablets QD in 21-day treatment cycles |
| Parsaclisib 15 mg QD + R-ICE | PLACEBO_COMPARATOR | Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m\^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m\^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m\^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration |
| Parsaclisib 20 mg QD + R-ICE | PLACEBO_COMPARATOR | 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m\^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m\^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m\^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration. |
| Name | Type | Description |
|---|---|---|
| parsaclisib | DRUG | parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits |
| parsaclisib + itacitinib | DRUG | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover. |
| parsaclisib + ruxolitinib | DRUG | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover. |
| parsaclisib + ibrutinib | DRUG | Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover. |
| Rituximab | DRUG | Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group. |
| Bendamustine | DRUG | Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles. |
| Ibrutinib | DRUG | Ibrutinib administered orally once daily. |
| Hexal | DRUG | Bendamustine 90 mg/m\^2 administered intravenously at protocol-defined timepoints. |
| Gazyvaro | DRUG | Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints. |
| Itacitinib | DRUG | - |
| Ifosfamide | DRUG | - |
| Carboplatin | DRUG | - |
| Etoposide | DRUG | - |
Inclusion Criteria: * Male or female Japanese participant who must be ≥ 18 years of age * Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures * Histologically confirmed, relapsed or refractory, FL Grade 1, 2, and 3a * Ineligible for HSCT * Mus...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Ianalumab |
| Zenas BioPharma, Inc. | ZBIO | 1 | PHASE3 | Obexelimab |
| Rigel Pharmaceuticals, Inc. | RIGL | 1 | PHASE3 | Fostamatinib disodium |
| Johnson & Johnson | JNJ | 1 | PHASE2 | M281 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | rilzabrutinib |
| HUTCHMED (China) Limited Sponsored ADR | HCM | 1 | PHASE2 | HMPL-523 |
| Vertex Pharmaceuticals Incorporated | VRTX | 1 | PHASE1 | povetacicept |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX112 |
Parsaclisib is an investigational small molecule being studied for B-cell lymphoma, autoimmune hemolytic anemia, advanced malignancies, lymphoma, B-cell malignancies, and primary Sjögren's syndrome. It is in Phase 2 clinical development and has not been approved by the FDA.
Parsaclisib targets PI3K, a class of enzymes involved in cell growth and survival. It is a small molecule inhibitor of this pathway, which is relevant in hematologic malignancies and autoimmune conditions.
Parsaclisib is being developed by Incyte Corporation, traded on the NASDAQ under the ticker INCY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various indications.
Parsaclisib is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness.
Parsaclisib has been studied in several clinical trials, including NCT03424122 for B-cell lymphoma, NCT03627065 for primary Sjögren's syndrome, and NCT04831944 and NCT04831996 for advanced malignancies with hepatic or renal impairment. These trials are completed.
Yes, Parsaclisib is also known as INCB050465. Clinical trial records often refer to the drug by this alternative name, so both names refer to the same investigational compound.