Lorlatinib shows efficacy among patients with ALK mutations…

...PFS`Resistance mechanism of first-line lorlatinib treatment by tumor tissue, and peripheral blood ctDNA (circulating tumor Deoxyribonucleic acid) biomarkers including, but not limited to, ALK gene rearrangement and/or ALK kinase domain mutations as measured by next-generation sequencing (NGS);`Resistance mechanism of lorlatinib...

...Percentage of Participants With Overall and Intracranial Objective Response (Phase 1)`Time to Tumor Response (TTR) and Intracranial TTR (Phase 1)`Duration of Response (DOR) and Intracranial DOR (Phase 1)`Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 Weeks (Phase 1)`Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 1)`Progression-Free Survival (PFS) (Phase 1)`Overall Survival (OS) (Phase 1)`Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Single Oral Doses (Phase 1)`Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Multiple Oral Doses (Phase 1)`Time for Cmax (Tmax) of PF-06463922 Following Single Oral Doses (Phase 1)`Time for Cmax (Tmax) of PF-06463922 Following Multiple Oral Doses (Phase 1)`Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Single Oral Doses (Phase 1)`Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Multiple Oral Doses (Phase 1)`Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06463922 Following Single Oral Doses (Phase 1)`Apparent Oral Clearance (CL/F) of PF-06463922 Following Single Oral Doses (Phase 1)`Apparent Oral Clearance (CL/F) of PF-06463922 Following Multiple Oral Doses (Phase 1)`Apparent Volume of Distribution (Vz/F) of PF-06463922 Following Single Oral Doses (Phase 1)`Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 1)`Terminal Half-Life of PF-06463922 Following Single Oral Doses (Phase 1)`Steady State Accumulation Ratio (Rss) of PF-06463922 Following Multiple Oral Doses (Phase 1)`Renal Clearance (CLr) of PF-06463922 (Phase 1)`Percent of PF-06463922 Recovered Unchanged in Urine up to Dosing Interval (AEtau%) (Phase 1)`Maximum Observed Plasma Concentration (Cmax) of Midazolam (Phase 1)`Time for Cmax (Tmax) of Midazolam (Phase 1)`Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam (Phase 1)`Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Midazolam (Phase 1)`Apparent Oral Clearance (CL/F) of Midazolam (Phase 1)`Apparent Volume of Distribution (Vz/F) of Midazolam (Phase 1)`Terminal Half-Life of Midazolam (Phase 1)`Number of Participants With ALK Mutation Based on Plasma CNA Analysis (Phase 1)`Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (Phase 1)`Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)`Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)`Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)`Time to Tumor Response (TTR) and Intracranial TTR (Phase 2)`Duration of Response (DOR) and Intracranial DOR (Phase 2)`Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 Weeks (Phase 2)`Time to Progression (TTP) on the Last Prior Therapy (Phase 2)`Time to Tumor Progression （TTP) and Intracranial TTP (Phase 2)`Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 2)`Progression-Free Survival (PFS) (Phase 2)`Overall Survival (Phase 2)`Maximum Observed Plasma Concentration (Cmax) of PF-06463922 (Phase 2)`Time for Cmax (Tmax) of PF-06463922 (Phase 2)`Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06463922 (Phase 2)`Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 (Phase 2)`Apparent Oral Clearance (CL/F) of PF-06463922 (Phase 2)`Apparent Volume of Distribution (Vz/F) of PF-06463922 (Phase 2)`Terminal Half-Life of PF-06463922 (Phase 2)`Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 2)`Steady State Accumulation Ratio (Rss) of PF-06463922 Following Multiple Oral Doses (Phase 2)`Number of Participants With ALK Mutation Based on Plasma CNA Analysis (Phase 2)`Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (Phase 2)`Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2)`Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2)`Number of Participants With Treatment-Emergent Adverse Events (Phase 1 and Phase 2)`Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) - Hematology`Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) - Chemistry`Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) - Coagulation, Lipids and Urinalysis`Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1 and Phase 2)`Number of Participants With Maximum Decrease From Baseline Greater Than or Equal to 20 Percent in Left Ventricular Ejection Fraction (LVEF) (Phase 1 and Phase 2)`Number of Participants With Absolute Values and Change From Baseline in QTcF Meeting Pre-defined Criteria (Phase 1 and Phase 2)`Number of Participants With Suicidal Ideation and Suicidal Behavior (Phase 2)`Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)`Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)`Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)`Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)`Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)`Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)...

In patients who have failed 1 or more second-generation ALK TKIs, lorlatinib shows greater efficacy in patients with ALK mutations compared with patients without ALK mutations.