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Full-human anti-pd-1 monoclonal antibodies

GLS-010

Jun Zhu, MD

Yuqin Song, MD

Patients with refractory cHL. Patients will be treated with GLS-010

Open, uncontrolled, multi-center, phase II study.

Study of GLS-010 Injection in the Treatment of Classical Hodgkin's Lymphoma

A Single Arm，Multicenter， Phase II Clinical Study to Evaluate the Efficacy and Safety of GLS-010 Injection in the Treatment of Recurrent or Refractory Classical Hodgkin's Lymphoma

Based on an independent image assessment board

meaningful benefit in PFS based on Lugano 2014

meaningful benefit in DCR based on Lugano 2014

meaningful benefit in DOR based on Lugano 2014

meaningful benefit in TTR based on Lugano 2014

Guangzhou Gloria Biosciences Co., Ltd.

Antineoplastic Agents

Panobinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).

Novartis Pharmaceuticals

This study evaluated the efficacy of oral panobinostat in participants with refractory/relapsed classical Hodgkins lymphoma (HL) who have received prior treatment with high dose chemotherapy and autologous stem cell transplant. Safety of panobinostat also was assessed. Other markers that may correlate with efficacy or safety were explored.

Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma

A Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkins Lymphoma After High-dose Chemotherapy With Autologous Stem Cell Transplant

ORR was number of participants with best overall disease response of complete response(CR)/partial response(PR).Best overall disease response was best disease response recorded from start of treatment until disease progression/recurrence.CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation.

Best overall radiological response (CT/MRI) was recorded from start of treatment until progression/ recurrence. CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation.

Time to overall disease response (CR or PR) was defined as the time from the date of randomization/start of treatment to the date of first documented disease response (PR or CR). Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study as per Investigator's assessment.

Duration of overall response (CR or PR) was defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to lymphoma. Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study.

Progression-free survival (PFS) was defined as the time from the date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a participant has not had an event, progression-free survival was censored at the date of the last adequate assessment.

OS was the duration from date of randomization to date of death from any cause. If a participant has not had an event, overall survival was censored at the date of the last adequate assessment.

An AE is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) occurring after signing the informed consent even if the event is not considered to be related to the study drug(s). SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.

Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment.

Age, Continuous

Sex: Female, Male

Full analysis set (FAS) included all participants who received at least one dose of study drug.

Study Director

Complete Response

Partial Response

Stable Disease

Progressive Disease

Unknown

Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria

FAS included all participants who received at least one dose of study drug.

Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI)

FAS included all participants who received at least one dose of study drug. Participants who were responders among those who were had relapsed/refractory classical Hodgkin's lymphoma were evaluated for this outcome measure. Time to overall disease response was calculated by Kaplan-Meier estimation.

Time To Overall Disease Response in Responders

Duration of Overall Disease Response

Progression Free Survival (PFS)

The Overall Survival (OS)

SAEs

Deaths

Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat

Pharmacokinetic set (PK) included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile.

Maximum Observed Concentration (Cmax) of Panobinostat

PK population included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile.

The Time to Reach Maximum Plasma Concentration (Tmax) of Panobinostat

Area Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for Panobinostat

PK population included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile. Overall number analyzed is the number of participants with data available for this analyses.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of GLS-010 Injection in the Treatment of Classical Hodgkin's Lymphoma	NCT03655483	Classical Hodgk...	GLS-010	18 Years - 70 Years	Guangzhou Gloria Biosciences Co., Ltd.
Study of GLS-010 Injection in the Treatment of Classical Hodgkin's Lymphoma	NCT03655483	Classical Hodgk...	GLS-010	18 Years - 70 Years	Guangzhou Gloria Biosciences Co., Ltd.
Phase II Study of Oral Panobinostat in Adult Participants With Relapsed/Refractory Classical Hodgkin's Lymphoma	NCT00742027	Classical Hodgk...	Panobinostat	18 Years -	Novartis

Spots Global Cancer Trial Database for classical hodgkin's lymphoma