Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients

Age at start of lorlatinib treatment was entered based on the data in medical chart. If there were no details about the applicable age, the age was calculated from the date of birth to the start date of lorlatinib treatment.

Time frame: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Time frame: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The Brinkman index (BI) is a measure of cigarette smoke exposure and is used as a predictor of chronic obstructive pulmonary disease (COPD) in smokers. It is calculated as the number of cigarettes smoked per day multiplied by the number of years of smoking. The scores ranged from 20 to 1050, where higher scores indicated higher cigarette smoke exposure.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Time frame: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Number of participants who developed complications such as high blood pressure, diabetes, hyperlipidemia and other were reported in this outcome measure. One participant may have more than one complication.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Number of participants with previous medical history of high blood pressure, diabetes, hyperlipidemia and other were reported in this outcome measure.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

ECOG PS is used to measure quality of life of participants with grades ranging from 0 to 5; where Grade 0: fully active; Grade 1: restricted in physically strenuous activity but ambulatory; Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities; Grade 3: capable of only limited self-care; Grade 4: completely disabled and Grade 5: dead. Higher scores indicated worsening of quality of life. Number of participants according to ECOG PS were presented. Participants whose ECOG PS was not known were reported under category Unknown.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

ECOG PS is used to measure quality of life of participants with grades ranging from 0 to 5; where Grade 0: fully active; Grade 1: restricted in physically strenuous activity but ambulatory; Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities; Grade 3: capable of only limited self-care; Grade 4: completely disabled and Grade 5: dead. Higher scores indicated worsening of quality of life. Number of participants according to ECOG PS were presented. Participants whose ECOG PS was not known were reported under category Unknown.

Time frame: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Number of participants according to NSCLC histopathological subtype (adenocarcinoma, squamous cell carcinoma and adenosquamous epithelial carcinoma) were reported in this outcome measure.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Complication was defined as a disease or disorder arising as a consequence of another disease. Number of participants according to presence of complications were reported in this outcome measure.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Time frame: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Number of participants with previous medical history related to history of treatment for ALK+ NSCLC were reported in this outcome measure.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Number of participants according to sites of metastasis at start of alectinib treatment were presented in this outcome measure. One participant could have more than one site of metastases.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Number of participants according to sites of metastases at start of lorlatinib treatment were presented in this outcome measure. One participant could have more than one site of metastases.

Time frame: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Number of participants according to treatment administered (Anaplastic Lymphoma Kinase- Tyrosine Kinase Inhibitor \[ALK-TKI\] including brigatinib, ceritinib and crizotinib or Other chemotherapy\]) for NSCLC prior to start of lorlatinib treatment were presented in this outcome measure.

Time frame: Prior to initiation of lorlatinib treatment (up to approximately 23.7 months); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS: participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in first line setting in a medical record. Only participants with any prior therapy for NSCLC other than alectinib as first line were analysed. All participants in Lorlatinib 2L arm were administered first line treatment of alectinib and did not receive any prior therapy for NSCLC other than alectinib.

Number of participants according to the type of ALK testing methods including immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), reverse transcription polymerase chain reaction (RT-PCR) and other methods were presented in this outcome measure. One participant may have more than one type of ALK testing method.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Number of participants for whom dates of performing ALK test was available was presented in this outcome measure.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

ALK test was used to detect specific rearrangements in the ALK gene in cancer cells and tissue. Number of participants with ALK test result were reported in this outcome measure.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Time to treatment failure (TTF) was the time from the first date of lorlatinib treatment to the date of any-cause treatment discontinuation including disease progression, treatment toxicity and death. If participants continued treatment, TTF was censored at the available last date of treatment or the study end period. Disease progression (PD) was defined in a method that complied with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.

Time frame: From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Time frame: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Combined TTF is defined as sum of the time from the first date of alectinib to the date of any-cause alectinib discontinuation, the time from the first date of lorlatinib to the date of lorlatinib discontinuation and the time from the first date of the other subsequent treatment to the date of other subsequent treatment discontinuation. If participants continued treatment, combined TTF was censored at the available last date of treatment or the study end period. Combined TTF was analyzed using Kaplan-Meier method.

Time frame: From date of initiation of alectinib treatment until date of treatment discontinuation or study end, from Sep-2014 until 15-Oct-2021 (up to approximately 85 months); retrospective data was retrieved and analyzed during 4 months of this study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Time frame: From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Objective response rate was defined as the percentage of participants with BOR of either CR or PR according to RECIST version 1.1 from the first date of alectinib until the date of treatment discontinuation. CR = disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, both target and non-target must have short axis measures \<10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement.

Time frame: From the date of initiation of alectinib treatment to the date of any-cause treatment discontinuation (maximum of 61.8 months of alectinib treatment); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Objective response rate was defined as the percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 from first date lorlatinib treatment until date of treatment discontinuation. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures \<10 mm. PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement.

Time frame: From the date of initiation of lorlatinib treatment to the date of treatment discontinuation, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Time to last treatment failure (TLTF) is the time from the first date of lorlatinib to the date of any-cause treatment discontinuation including disease progression, treatment toxicity and death in the last treatment. If participants continued treatment, TLTF was censored at the available last date of treatment or the study end period. PD was defined as \>= 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm and appearance of one or more new lesions. TLTF was analyzed using Kaplan-Meier method.

Time frame: From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Time to treatment failure was the time from the first date of alectinib treatment to the date of any-cause treatment discontinuation including disease progression, treatment toxicity and death. If participants continued treatment, TTF was censored at the available last date of treatment or the study end period. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.

Time frame: From the date of initiation of alectinib treatment to the date of any-cause treatment discontinuation or study end (maximum of 61.8 months of alectinib treatment); retrospective data was retrieved and analyzed during 4 months of this observational study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Time to treatment failure was the time from the first date of the other subsequent treatment to the date of other subsequent treatment discontinuation including disease progression, treatment toxicity and death. If participants continued treatment, TTF was censored at the available last date of treatment or the study end period. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.

Time frame: From the date of initiation of subsequent other treatment to the date of any-cause treatment discontinuation or study end (maximum of 22.9 months of subsequent other treatment); retrospective data was retrieved and analyzed during 4 months of this study

Population: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.