Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Melanoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Participants with melanoma received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle.

Participants with non-small cell lung cancer (NSCLC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.

Participants with urethelial carcinoma (UC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.

Participants with renal cell carcinoma (RCC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.

Retifanlimab administered intravenously at 500 mg every 4 weeks

Retifanlimab

Mark Cornfeld, MD

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.

A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)

A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by the investigator, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

DOR was defined as the time from initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by the investigator, or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, determined by investigator assessment, or death due to any cause, if occurring sooner than progression.

Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.

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. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. 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 retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.

Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.

tmax was defined as the time to the maximum concentration of retifanlimab.

Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.

AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.

Incyte Corporation

Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab and until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.

Participants with melanoma received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle (Q4W).

Participants with non-small cell lung cancer received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

Non-small Cell Lung Cancer

Participants with urethelial carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

Urothelial Cancer

Participants with renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

Total

Urethelial Carcinoma

Age, Continuous

Sex: Female, Male

White/Caucasian

Asian

Not Reported

Race/Ethnicity, Customized

Hispanic or Latino

Not Hispanic or Latino

Study Director

Full Analysis Set (FAS) Population: all study participants who had received at least 1 dose of study drug. Participants were to be analyzed based on disease-specific diagnosis. Confidence intervals were calculated based on the exact method for binomial distributions.

Overall Response Rate (ORR)

FAS Population. Only those participants with a CR or PR were included in the analysis. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.

Duration of Response (DOR)

FAS Population. Confidence intervals were calculated based on the exact method for binomial distributions.

Disease Control Rate (DCR)

FAS Population. Median PFS was estimated using the Kaplan-Meier method. The confidence interval for median PFS was calculated using the method of Brookmeyer and Crowley.

Progression-free Survival (PFS)

FAS Population. Median survival time in months was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.

Overall Survival

Safety Evaluable Population: all participants who received at least 1 dose of study drug

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Participants with melanoma, non-small cell lung cancer, urethelial carcinoma, and renal cell carcinoma received retifanlimab 500 mg, administered by IV infusion over 30 minutes on Day 1 Q4W.

All Participants

Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and provided a Baseline and at least 1 postdose PK sample

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)	NCT03679767	Metastatic Non-... Locally Advance... Metastatic Urot... Unresectable Me... Metastatic Mela... Locally Advance... Metastatic Clea...	Retifanlimab	18 Years -	Incyte Corporation
A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)	NCT03679767	Metastatic Non-... Locally Advance... Metastatic Urot... Unresectable Me... Metastatic Mela... Locally Advance... Metastatic Clea...	Retifanlimab	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for locally advanced renal cell carcinoma