Zolbetuximab and Other Cancer Treatments in People With Advanced Gastric or GEJ Cancer in Clinical Practice (RADIANCE) (RADIANCE)

Participants with human epidermal growth factor receptor 2-negative (HER2[-]) and claudin-18 isoform 2-positive (CLDN18.2[+]) locally advanced unresectable or metastatic (la/m) gastric or gastroesophageal junction (G/GEJ) adenocarcinoma who received first-line (1L) treatment with zolbetuximab in combination with platinum-fluoropyrimidine doublet chemotherapy.

Real-world exposure to zolbetuximab.

• IMAB362
• ヴィロイ

Real-world exposure to platinum-based chemotherapy.

Real-world exposure to fluoropyrimidine-based chemotherapy.

Participants with HER2(-) and CLDN18.2(+) la/m G/GEJ adenocarcinoma who received 1L treatment which did not contain zolbetuximab.

Real-world exposure to 1L treatment not containing zolbetuximab.

Participants with G/GEJ adenocarcinoma who received off-label treatment with zolbetuximab.

Real-world exposure to zolbetuximab.

• IMAB362
• ヴィロイ

The length of time a participant survives, from the point of initiating 1L treatment, using data retrieved retrospectively. Death due to any case will be considered in the definition of rwOS.

The length of time a participant survives without their cancer progressing, from the point of initiating 1L treatment, using data retrieved retrospectively. Progression will be identified according to clinical notes, radiology reports or pathology reports, and death due to any cause will be considered in the definition of rwPFS.

The length of time until a participant initiates second-line (2L) treatment, from the point of initiating 1L treatment, using data retrieved retrospectively. Death due to any cause will be considered a competing event.

The length of time a participant survives without initiating 2L treatment, from the point of initiating 1L treatment, using data retrieved retrospectively.

The length of time until a participant's cancer progresses, from the point of initiating 1L treatment, using data retrieved retrospectively. Progression will be identified according to clinical notes, radiology reports or pathology reports. Death due to any cause will be considered a competing event.

The length of time a participant responds to 1L treatment without dying or their cancer progressing, from the first record of complete or partial response to 1L treatment, using data retrieved retrospectively. Response will be identified as per clinical assessment, and progression will be identified according to clinical notes, radiology reports or pathology reports. Death due to any cause will be considered in the definition of rwDOR.

The percentage of participants who have responded to 1L treatment within 12 months following initiation of 1L treatment, using data retrieved retrospectively. Complete or partial response will be identified as per clinical assessment.

The percentage of participants who have either responded to 1L treatment or have achieved stable disease within 12 months following initiation of 1L treatment, using data retrieved retrospectively. Complete response, partial response and stable disease will be identified as per clinical assessment.

The percentage change in tumor size over the period of time between the second to last and last tumor size record prior to index date. rwTGR will be assessed prior to initiating 1L treatment based on medical history available, using data retrieved retrospectively. Tumor size will be estimated as the sum of the longest diameters of all recorded measurable lesions (primary or metastatic).

The percentage change in tumor size from prior to initiation of 1L treatment, over a period of time. rwTGR will be assessed during 1L treatment using data retrieved retrospectively. Tumor size will be estimated as the sum of the longest diameters of all recorded measurable lesions (primary or metastatic).

Specified AEs are inclusive of nausea, vomiting, decreased appetite, diarrhea, peripheral sensory neuropathy, anemia, constipation, decreased neutrophil count, fatigue, asthenia, abdominal pain, stomatitis, weight decrease, aspartate aminotransferase increase, platelet count decrease, hypoalbuminemia, white blood cell count decrease and neutropenia.

An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.

The total length of time a participant has a record of experiencing a specified AE occurrence during 1L treatment, using data retrieved retrospectively.

The length of time until a participant experiences each of the specified AEs above during 1L treatment, from the point of initiating 1L treatment, using data retrieved retrospectively.

SAEs are any signs, symptoms, or diseases which lead to inpatient hospitalization, treatment discontinuation and/or cause death and which are experienced during 1L treatment.

Events will be identified from participant records retrieved retrospectively; there is no requirement for the events to be explicitly linked to 1L treatment.

SAEs are any signs, symptoms, or diseases which lead to inpatient hospitalization, treatment discontinuation and/or cause death and which are experienced during 1L treatment.

Events will be identified from participant records retrieved retrospectively.

SAEs are any signs, symptoms, or diseases which lead to inpatient hospitalization, treatment discontinuation and/or cause death and which are experienced during 1L treatment.

Events will be identified from participant records retrieved retrospectively.

SAEs are any signs, symptoms, or diseases which lead to inpatient hospitalization, treatment discontinuation and/or cause death and which are experienced during 1L treatment.

Events will be identified from participant records retrieved retrospectively.

The length of time until a participant experiences a SAE during 1L treatment, from the point of initiating 1L treatment, using data retrieved retrospectively.

Number of inpatient hospitalizations during 1L treatment, as recorded up to end of 1L treatment (inclusive), using data retrieved retrospectively.

Number of inpatients hospitalizations per participant with ICU stay during 1L treatment, as recorded from index date (inclusive) to end of 1L treatment (inclusive), using data retrieved retrospectively.

Number of inpatients hospitalizations per participant with admission via A&E during 1L treatment, as recorded from index date (inclusive) to end of 1L treatment (inclusive), using data retrieved retrospectively.

Average duration (in days) of inpatient hospitalization during 1L treatment, as derived according to the difference between admission and discharge dates for all inpatient hospitalizations from index date (inclusive) to end of 1L treatment (inclusive), using data retrieved retrospectively. One participant may experience more than one hospitalization and may contribute multiple times for this variable.

Primary diagnoses associated with inpatient hospitalizations during 1L treatment, as recorded using diagnosis codes (International Classification of Diseases, 10th revision [ICD-10] codes, or equivalent as available in each data source), using data retrieved retrospectively. A participant can have multiple diagnoses per inpatient hospitalization and multiple inpatient hospitalization.

Number of participants with prescriptions or dispensations of any antiemetic drug from 1 day before index date (inclusive) to the end of 1L treatment (inclusive), using data retrieved retrospectively.

Number of records of prescriptions or dispensations of any antiemetic drug from 1 day before index date (inclusive) to the end of 1L treatment (inclusive), using data retrieved retrospectively.

Time from index date to first prescription or dispensation of antiemetic drugs during 1L treatment, using data retrieved retrospectively.

Type of antiemetic drug prescribed immediately prior to 1L treatment, as recorded 1 day before index date (inclusive) based on medical history available, using data retrieved retrospectively.

Type of antiemetic drug prescribed during 1L treatment, as recorded to the end of 1L treatment (inclusive), using data retrieved retrospectively.

Antiemetic drugs prescribed immediately prior to 1L treatment, as recorded 1 day before index date (inclusive) based on medical history available, using data retrieved retrospectively.

Antiemetic drugs prescribed during 1L treatment, as recorded to the end of 1L treatment (inclusive), using data retrieved retrospectively.

Age as recorded or derived based on participant birth date, date of diagnosis, and 1L treatment initiation, using data retrieved retrospectively.

Sex as recorded at any time in participant records (female, male, or missing/unknown), using data retrieved retrospectively.

Ethnicity or race (Asian, black, mixed, or multiple ethnic groups, white, other ethnic group, or missing/unknown), as recorded at any time in participant records, using data retrieved retrospectively.

Country of treatment site, as derived according to the country in which the data source is located, using data retrieved retrospectively.

Socioeconomic status as derived from available variables recorded any time prior to an including the index date, using data retrieved retrospectively.

Alcohol consumption, as recorded any time between diagnosis of la/m G/GEJ adenocarcinoma (inclusive) and index date (inclusive), using data retrieved retrospectively.

Smoking status, as recorded any time between diagnosis of la/m G/GEJ adenocarcinoma (inclusive) and index date (inclusive), using data retrieved retrospectively.

BMI (in kg/m^2) at index date, as recorded or as derived according to the formula weight/height using the closest measurements of weight (kg) and height (m) which are recorded prior to and including the index date. Weight measurements must be no more than 1 year prior to the index date; height measurements will be considered from the start of participant records (18.5 = underweight, 18.5 to <25.0 = normal weight, 25.0 to <30 = pre-obesity, ≥30 = obesity, or missing/unknown), using data retrieved retrospectively.

Disease stage at initial diagnosis of G/GEJ adenocarcinoma and at la/m diagnosis of G/GEJ adenocarcinoma, as recorded according to 7th or 8th American Joint Committee on Cancer (AJCC) TNM classification (TXNXMX), using data retrieved retrospectively.

Disease stage at initial diagnosis of G/GEJ adenocarcinoma and at la/m diagnosis of G/GEJ adenocarcinoma, as recorded according to the numeric classification (0, I, II, III, IV, or missing/unknown), using data retrieved retrospectively.

Histological grade of primary tumor at initial diagnosis of G/GEJ adenocarcinoma, as recorded (1 = low grade, 2 = moderate grade, 3 = high grade, or missing/unknown), using data retrieved retrospectively.

Histotype of primary tumor at initial diagnosis of G/GEJ adenocarcinoma, as recorded using the Lauren classification (intestinal, diffuse, mixed, other, missing/unknown), using data retrieved retrospectively.

Site of primary tumor at initial diagnosis of G/GEJ adenocarcinoma, as recorded (gastric or gastroesophageal junction), using data retrieved retrospectively.

Size (in mm) of primary tumor at initial diagnosis of G/GEJ adenocarcinoma, as recorded, using data retrieved retrospectively.

ECOG performance status at index date, as recorded from la/m diagnosis (inclusive) to index date (inclusive), using data retrieved retrospectively. Any participant with a score of 5 (i.e., dead) will have their value reported as missing/unknown. Lower scores represent an increased ability to carry out the daily living activities.

CCI score at index date, as derived according to medical diagnoses, including comorbid conditions, recorded using ICD-10 codes or data source equivalent any time prior to and including the index date, using data retrieved retrospectively (0, 1, 2, 3, ≥4, or missing/unknown) where lower scores represent lower comorbidity.

Comorbidities (hypertension, diabetes mellitus, ulcerative digestive tract disease, dyslipidemia, other gastrointestinal disease, cardiovascular disease, and chronic kidney disease) recorded (yes, no) prior to and including index date, defined by 1 or more ICD-10 codes, using data retrieved retrospectively.

Number of metastatic sites at index date, as derived from ICD-10 codes or data source equivalent recorded any time prior to and including the index date (0, 1, 2, 3, …), using data retrieved retrospectively.

Number of metastatic lesions at index date, as derived from participant records any time prior to and including the index date (0, 1, 2, 3, …), using data retrieved retrospectively.

Metastatic sites (liver, lymph node, lung, peritoneum, bone, large intestine or rectum, other specified, or other unspecified site) recorded (yes, no) defined by 1 or more ICD-10 codes or data source equivalent from diagnosis of la/m disease until index date, using data retrieved retrospectively.

SACT received prior to index date, as recorded from initial diagnosis of G/GEJ adenocarcinoma (any stage, inclusive) until index date (exclusive), using data retrieved retrospectively.

Type/intention of SACT (neoadjuvant SACT only, adjuvant SACT only, both neoadjuvant and adjuvant SACT [perioperative], no prior SACT) received prior to index date, as derived according to the dates of SACT and surgery records from initial diagnosis of G/GEJ adenocarcinoma (any stage, inclusive) until index date (exclusive), using data retrieved retrospectively.

Neoadjuvant SACT regimen received prior to index date, as recorded or derived, using data retrieved retrospectively.

Adjuvant SACT regimen received prior to index date, as recorded or derived, using data retrieved retrospectively.

Perioperative SACT regimen received prior to index date, as recorded or derived, using data retrieved retrospectively.

Chemoradiation received prior to index date, as recorded or derived according to records of chemotherapy and radiation therapy which overlap and which are recorded between the date of initial diagnosis of G/GEJ adenocarcinoma (inclusive, any stage) until index date (exclusive), using data retrieved retrospectively.

Chemoradiation therapy regimen received prior to index date, as recorded or derived, using data retrieved retrospectively.

Radiation therapy received prior to index date, as recorded from the date of initial diagnosis of G/GEJ adenocarcinoma (inclusive, any stage) until index date (exclusive), using data retrieved retrospectively.

Type of radiation therapy received prior to index date, as recorded, using data retrieved retrospectively.

Gastrectomy received prior to index date, as recorded from the date of initial diagnosis of G/GEJ adenocarcinoma (inclusive, any stage) until index date (exclusive) (yes or no), using data retrieved retrospectively.

Type of gastrectomy received prior to index date, as recorded (partial, total, other, no gastrectomy), using data retrieved retrospectively.

Among those who have received gastrectomy, time from gastrectomy until index, as derived from the date of gastrectomy and the index date, using data retrieved retrospectively.

HER2 expression level at index date, as recorded (none [IHC 0], low [IHC 1+], indeterminate [IHC 2+], high [IHC 3+], or missing/unknown), using data retrieved retrospectively. Specimens from any primary cancer or metastatic biopsy sites are allowed.

CLDN18.2 status at index date, defined as moderate (IHC 2+) to strong (IHC 3+) membranous staining in ≥75% of tumor cells, as recorded any time prior to and including the index date (negative, positive or not tested), using data retrieved retrospectively.

CLDN18.2 expression level at index date, as recorded (moderate to strong staining in 0% to <25% of cells, moderate to strong staining in ≥25% and <50% of cells, moderate to strong staining in ≥50% and <75% of cells, moderate to strong staining in ≥75% of cells, missing/unknown, or not tested), using data retrieved retrospectively.

PD-L1 tested at index date, as recorded any point prior to and including the index date (yes or no), using data retrieved retrospectively.

CPS at index date, as recorded any point prior to and including the index date (<1, 1 to <5, 5 to <10, ≥10, or not tested), using data retrieved retrospectively.

TAP at index date, as recorded any point prior to and including the index date (<1, 1 to <5, 5 to <10, ≥10, or not tested), using data retrieved retrospectively.

TPS at index date, as recorded any point prior to and including the index date (<1%, 1 to <50%,

≥50%, not tested), using data retrieved retrospectively.

dMMR status at index date, as derived from IHC or MSI testing results any time prior to and including the index date (deficient, proficient or not tested), using data retrieved retrospectively.

EBV status at index date, as recorded any point prior to and including the index date (EBV-positive, EBV-negative or not tested), using data retrieved retrospectively.

FGFR2b expression level at index date, as recorded any point prior to and including the index date (none, <10% of tumor cells with moderate/strong staining [IHC 2+ or 3+], ≥10% of tumor cells with moderate/strong staining [IHC 2+ or 3+], or not tested), using data retrieved retrospectively.

IHC platform used to determine PD-L1 and CLDN18.2 status at index date, as recorded any point prior to and including the index date (Ventana, Dako, Leica, other, missing/unknown, or not tested), using data retrieved retrospectively.

Antibody clone used for IHC testing to determine PD-L1 (22C3, 28-8, SP263, other, missing/unknown, or not tested) and CLDN18.2 (43-14A, 34H14L15, 14F8, 43-14A, LS-B16145, other, missing/unknown, not tested) status at index date, as recorded, using data retrieved retrospectively.

Number of HER2 and CLDN18.2 tests prior to and including index date, as recorded (1, 2, 3, …, or missing/unknown), using data retrieved retrospectively.

Number of positive biopsy samples used for determination of HER2 and CLDN18.2 status at index date, as recorded (1, 2, 3, …, missing/unknown, or not tested), using data retrieved retrospectively.

Time from HER2 test request until CLDN18.2 test request and from PD-L1 test request until CLDN18.2 test request, as derived (CLDN18.2 test request prior to HER2 test request, HER2 test request prior to CLDN18.2 test request, or simultaneous; CLDN18.2 test request prior to PD-L1 test request, PD-L1 test request prior to CLDN18.2 test request, or simultaneous), using data retrieved retrospectively.

Time from most recent biomarker test request and report until zolbetuximab initiation, using data retrieved retrospectively.

1L treatment regimen received, as recorded or as derived according to a line of therapy algorithm, using data retrieved retrospectively.

Duration of 1L treatment, measured from the index date to the earliest of date of 1L discontinuation (i.e., discontinuation of all components of 1L), date of initiation of 2L treatment, date of death due to any case or start of new treatment), date of loss to follow-up or end of study period, plus 1 day, using data retrieved retrospectively.

Time from index date to the date of 1L discontinuation, using data retrieved retrospectively. Participants who did not discontinue 1L will be censored at the earliest of date of death due to any cause, date of loss to follow-up or end of study period, using data retrieved retrospectively.

Reasons for discontinuation of 1L treatment, as recorded (disease progression, death, toxicity, adverse reaction, other, multiple reasons, missing/ unknown, did not discontinue treatment), using data retrieved retrospectively.

Dosing schedule of 1L zolbetuximab treatment, as recorded or derived based on administration dates and recorded 1L treatment doses (every 2 weeks, every 3 weeks, other, or missing/ unknown), using data retrieved retrospectively.

Number of participants with at least one recorded 1L dose modification relative to the initial dose (yes or no), using data retrieved retrospectively.

Reason for the first dose modification during 1L treatment as recorded (AE, SAE, disease progression, participant factors [e.g., weight loss], drug interactions, other, multiple reasons, missing/unknown, no dose modification), using data retrieved retrospectively.

The direction of change (increase, decrease, both increase and decrease [regardless of order], no dose modification) in 1L dose level, as derived per participant, using data retrieved retrospectively.

Total number of dose modifications experienced during 1L treatment per participant, as recorded, using data retrieved retrospectively.

Time from index date to the date of first recorded 1L dose modification. Participants without any recorded dose modification in 1L will be censored at the earliest of end of 1L, date of death due to any cause, date of loss to follow-up or end of study period, using data retrieved retrospectively.

Any record of an interruption in dosage during 1L treatment, as recorded or derived according to observed gaps between treatment cycles (yes or no), using data retrieved retrospectively.

Reason for first dose interruption during 1L treatment, as recorded (AE, disease progression, participant factors [e.g., weight loss], drug interactions, other, multiple reasons, missing/unknown, no dose interruption), using data retrieved retrospectively.

Total number of dose interruptions experienced per participant during 1L treatment, as recorded, using data retrieved retrospectively.

Time from index date to the date of first recorded 1L dose interruption. Participants without any recorded dose interruption in 1L will be censored at the earliest of end of 1L, date of death due to any cause, date of loss to follow-up or end of study period, using data retrieved retrospectively.

Reduction in infusion rate of intravenous (IV) 1L treatment, as recorded, using data retrieved retrospectively.

Reason for first infusion rate reduction during 1L treatment, as recorded, using data retrieved retrospectively.

Time from index date to the date of first administration with infusion rate reduction during 1L. Participants without any recorded infusion rate reduction in 1L will be censored at the earliest of end of 1L, date of death due to any cause, date of loss to follow-up or end of study period, using data retrieved retrospectively.

Any record of interruption in IV 1L treatment (e.g. temporary or permanent halting of an IV infusion), any time from index date (inclusive) to end of 1L treatment (inclusive) (yes, no record), using data retrieved retrospectively.

Reason for first infusion interruption during 1L treatment, as recorded (AE, participant factors, other, multiple reasons, missing/unknown, no infusion interruption), using data retrieved retrospectively.

Time from index date to the date of first administration with infusion interruption during 1L. Participants without any recorded infusion rate reduction in 1L will be censored at the earliest of end of 1L, date of death due to any cause, date of loss to follow-up or end of study period, using data retrieved retrospectively.

Relative dose intensity of zolbetuximab for each 1L treatment cycle, as derived from the actual dosage received divided by the planned dosage, using data retrieved retrospectively.

BMI at each 1L treatment cycle, as recorded or derived from the closest measurements of height and weight (kg/m^2). Weight measurements must be recorded from initiation of the previous treatment cycle (exclusive) to initiation of the current treatment cycle (inclusive); height measurements will be considered from the start of participant records (18.5 = underweight, 18.5 to <25.0 = normal weight, 25.0 to <30 = pre-obesity, ≥30 = obesity, or missing/unknown), using data retrieved retrospectively.

BSA at each 1L treatment cycle, as recorded or derived according to the formula 0.007184*height 0.725* weight 0.425 using the closest measurements of weight (kg) and height (m). Weight measurements must be recorded from initiation of the previous treatment cycle (exclusive) to initiation of the current treatment cycle (inclusive); height measurements will be considered from the start of participant records (1.5 to <1.75, 1.75 to <2.00, 2.00 to <2.25, 2.25 to <2.5, >=2.5, or missing/unknown), using data retrieved retrospectively.

2L treatment regimen received (mono- or combination therapy), as recorded or derived according to a line of therapy algorithm (mono- or combination therapy), using data retrieved retrospectively.