Trial Outcomes & Findings for A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer (NCT NCT02450539)

Last Updated: 2021-08-13

Results Overview

PFS was defined as time from the date of randomization to the date of investigator-determined disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, with reference the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant was not known to have died or have objective progression, PFS time will be censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

159 participants

Primary outcome timeframe

Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)

Results posted on

2021-08-13

Participant Flow

Study completers are participants who died due to any cause, were on follow-up at study completion or completed continued access period.

Participant milestones

Participant milestones
Measure	Abemaciclib 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Study STARTED	106	53
Overall Study Received at Least One Dose of Study Drug	106	52
Overall Study COMPLETED	90	46
Overall Study NOT COMPLETED	16	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Abemaciclib 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Study Withdrawal by Subject	12	6
Overall Study Lost to Follow-up	4	1

Baseline Characteristics

A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abemaciclib n=106 Participants 200 milligram(mg) Abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel n=53 Participants 75 milligram per meter squared (mg/m²) Docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Total n=159 Participants Total of all reporting groups
Age, Continuous	63.1 years STANDARD_DEVIATION 7.8 • n=5 Participants	64.5 years STANDARD_DEVIATION 7.1 • n=7 Participants	63.5 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	90 Participants n=5 Participants	44 Participants n=7 Participants	134 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	84 Participants n=5 Participants	48 Participants n=7 Participants	132 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants	2 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants	50 Participants n=7 Participants	146 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Romania	18 Participants n=5 Participants	4 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment Hungary	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Ukraine	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment Russia	11 Participants n=5 Participants	2 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Spain	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment South Korea	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Taiwan	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Poland	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment Italy	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Australia	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment France	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Germany	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0	22 Participants n=5 Participants	7 Participants n=7 Participants	29 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1	84 Participants n=5 Participants	46 Participants n=7 Participants	130 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)

Population: All participants according to the treatment group to which they were randomized. Participants censored: Abemaciclib=19 and Docetaxel= 15.

Outcome measures

Outcome measures
Measure	Abemaciclib n=106 Participants 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel n=53 Participants 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Progression Free Survival (PFS)	2.53 months Interval 1.68 to 2.89	4.21 months Interval 2.79 to 5.65

SECONDARY outcome

Timeframe: Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose

Population: All participants who received abemaciclib and had evaluable PK data.

Pharmacokinetics (PK): Clearance of Abemaciclib

Outcome measures

Outcome measures
Measure	Abemaciclib n=102 Participants 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Pharmacokinetics (PK): Clearance of Abemaciclib	21.3 Liters/hour (L/h) Geometric Coefficient of Variation 36	—

SECONDARY outcome

Timeframe: Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose

Population: All participants who received Abemaciclib and had evaluable PK data.

PK: Volume of Distribution of Abemaciclib

Outcome measures

Outcome measures
Measure	Abemaciclib n=102 Participants 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
PK: Volume of Distribution of Abemaciclib	769 Liters (L) Geometric Coefficient of Variation 51	—

SECONDARY outcome

Timeframe: Baseline to Date of Death from Any Cause (Up To 28 Months)

Population: All participants according to the treatment group to which they were randomized. Participants censored: Abemaciclib=35 and Docetaxel= 17.

OS was defined as the time from randomization to the date of death due to any cause. For each participant who is not known to have died as the data inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.

Outcome measures

Outcome measures
Measure	Abemaciclib n=106 Participants 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel n=53 Participants 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Overall Survival (OS)	7 Months Interval 5.0 to 8.78	12.39 Months Interval 7.13 to 15.98

SECONDARY outcome

Timeframe: Baseline to Objective Progression (Up To 6 Months)

Population: All randomized participants.

Overall response was defined as the percentage of randomized participants achieving a best overall response (BoR) of complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Participants with unevaluable or unknown response status are considered nonresponders. Complete response (CR) is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.

Outcome measures

Outcome measures
Measure	Abemaciclib n=106 Participants 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel n=53 Participants 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])	2.8 percentage participants	20.8 percentage participants

SECONDARY outcome

Timeframe: Baseline through Measured Progressive Disease or Death Due to Any Cause (Up To 6 Months)

Population: All randomized participants.

DCR is the percentage of randomized participants who achieved a complete response, partial response or stable disease using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Complete response (CR) is defined as the disappearance of all target and non-target lesions, and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions. Stable disease was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.

Outcome measures

Outcome measures
Measure	Abemaciclib n=106 Participants 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel n=53 Participants 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)	50.9 percentage participants	64.2 percentage participants

SECONDARY outcome

Timeframe: Randomization to ECOG PFS of >/=2 (Up To 11.5 Months)

Population: All randomized participants. Participants censored: Abemaciclib =93 and Docetaxel= 43.

Worsening of ECOG performance status is the duration from randomization to ECOG PFS of \>/=2. Participants without an ECOG PFS \>/=2 are censored at last adequate post baseline ECOG Performance Status or randomization date (whichever is last). The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5 - Dead

Outcome measures

Outcome measures
Measure	Abemaciclib n=106 Participants 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel n=53 Participants 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2	NA months Interval 6.58 to Due to insufficient data to support the analysis and the results.	10.52 months Interval 4.64 to Due to insufficient data to support the analysis and the results.

SECONDARY outcome

Timeframe: Baseline through End of Study (Up To 6 Months)

Population: All randomized participants for cycles which at least 25% of participants in each arm have a score.MDASI-LC population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 MDASI-LC assessment after Cycle 1 (for example, a completed MDASI-LC questionnaire at Cycle 2 Day 1 or later)

MDASI-LC included 33 items:6 interference and 27 symptom(3 lung-cancer (LC),8 brain tumor (BT),and 3 study-specific(headache,diarrhea, and rash).Analyzed endpoints were 9 constructs:3 single-items (headache,diarrhea,and rash) and 6 composites(interference+core,LC,core+LC,BT, and core+LC worst 5 baseline).Data for all 9 constructs were collected by an 11-point numeric rating scale anchored at 0(not present or does not interfere) and 10(as bad as you can imagine or interfered completely).The measurement range was 10 (maximum score-minimum score). Between-group difference in regression-predicted change from baseline were estimated for each specified construct. MMRM models included independent variables treatment,visit, treatment\*visit,and baseline score. Group-level negative change from baseline indicated group improvement.

Outcome measures

Outcome measures
Measure	Abemaciclib n=87 Participants 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel n=43 Participants 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores Mean interference	0.50 units on a scale Standard Error 0.20	0.18 units on a scale Standard Error 0.27
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores Mean lung cancer symptom severity	0.20 units on a scale Standard Error 0.12	-0.19 units on a scale Standard Error 0.15
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores Mean core plus lung cancer symptom severity	0.47 units on a scale Standard Error 0.13	-0.04 units on a scale Standard Error 0.17
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores Mean brain tumor symptom severity	0.19 units on a scale Standard Error 0.11	0.13 units on a scale Standard Error 0.15
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores Headache	0.19 units on a scale Standard Error 0.14	0.01 units on a scale Standard Error 0.18
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores Diarrhea	1.01 units on a scale Standard Error 0.18	0.15 units on a scale Standard Error 0.23
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores Mean core symptom severity	0.53 units on a scale Standard Error 0.14	0.00 units on a scale Standard Error 0.18
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores Mean core plus lung worst 5 symptoms severity	-0.25 units on a scale Standard Error 0.17	-0.94 units on a scale Standard Error 0.22
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores Rash	0.28 units on a scale Standard Error 0.14	0.18 units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease (Up To 6 Months)

Population: All randomized participants for cycles which at least 25% of participants in each arm have a score.The EQ-5D-5L population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 EQ-5D-5L assessment after Cycle 1 (for example, a completed EQ-5D-5L questionnaire at Cycle 2 Day 1 or later).

The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Overall self-rated health was measured with a vertical 20 cm visual analog scale (VAS) anchored at 0 (worst health) and ranged through 100 (best health). Between-group differences in regression-predicted change from baseline score were estimated for VAS scores. MMRM models included independent variables treatment, visit, treatment\*visit, and baseline score. Group-level negative change from baseline indicated group improvement.

Outcome measures

Outcome measures
Measure	Abemaciclib n=88 Participants 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel n=42 Participants 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score	-5.49 units on a scale Standard Error 1.28	-2.36 units on a scale Standard Error 1.63

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease (Up To 6 Months)

There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to.The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using UK weights,health dimensions(mobility,self-care,usual activities,pain/discomfort, and anxiety/depression) into a single index value;the dimensions are not separately scored.The index is marked missing when ≥1 dimensions are missing.The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death.The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index .MMRM models included independent variables treatment, visit, treatment\*visit, and baseline score.Group-level negative change from baseline indicated group improvement.

Outcome measures

Outcome measures
Measure	Abemaciclib n=88 Participants 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel n=42 Participants 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value	-0.05 units on a scale Standard Error 0.02	-0.01 units on a scale Standard Error 0.02

Adverse Events

Abemaciclib

Serious events: 29 serious events

Other events: 94 other events

Deaths: 71 deaths

Docetaxel

Serious events: 17 serious events

Other events: 43 other events

Deaths: 35 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Abemaciclib n=106 participants at risk 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel n=52 participants at risk 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Blood and lymphatic system disorders Anaemia	0.94% 1/106 • Number of events 2 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/106 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	5.8% 3/52 • Number of events 3 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/106 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	3.8% 2/52 • Number of events 2 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	7.7% 4/52 • Number of events 4 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Pancytopenia	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Cardiac disorders Cardiovascular insufficiency	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	1.9% 2/106 • Number of events 2 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric haemorrhage	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal fistula	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
General disorders General physical health deterioration	0.00% 0/106 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
General disorders Pyrexia	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Immune system disorders Anaphylactic reaction	0.00% 0/106 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Infections and infestations Bronchitis	0.00% 0/106 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Infections and infestations Lung infection	5.7% 6/106 • Number of events 6 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	7.7% 4/52 • Number of events 4 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Infections and infestations Myelitis	0.00% 0/106 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Infections and infestations Pleural infection	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Infections and infestations Salmonella bacteraemia	0.00% 0/106 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Infections and infestations Wound infection	0.00% 0/106 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Ankle fracture	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wrist fracture	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Investigations Blood creatinine increased	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Investigations International normalised ratio increased	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Nervous system disorders Dizziness	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Nervous system disorders Syncope	0.00% 0/106 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Renal and urinary disorders Renal failure	1.9% 2/106 • Number of events 2 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/106 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/106 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.8% 3/106 • Number of events 3 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Vascular disorders Embolism	2.8% 3/106 • Number of events 3 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.

Measure	Abemaciclib n=106 participants at risk 200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.	Docetaxel n=52 participants at risk 75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Blood and lymphatic system disorders Anaemia	38.7% 41/106 • Number of events 47 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	23.1% 12/52 • Number of events 18 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	9.4% 10/106 • Number of events 10 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	26.9% 14/52 • Number of events 48 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	17.0% 18/106 • Number of events 20 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	50.0% 26/52 • Number of events 76 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	25.5% 27/106 • Number of events 35 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	3.8% 2/52 • Number of events 2 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	7.5% 8/106 • Number of events 10 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	5.8% 3/52 • Number of events 3 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	38.7% 41/106 • Number of events 67 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	9.6% 5/52 • Number of events 5 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	31.1% 33/106 • Number of events 35 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	13.5% 7/52 • Number of events 10 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	8.5% 9/106 • Number of events 11 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	5.8% 3/52 • Number of events 3 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
General disorders Fatigue	28.3% 30/106 • Number of events 34 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	13.5% 7/52 • Number of events 10 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	7.5% 8/106 • Number of events 9 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	3.8% 2/52 • Number of events 2 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
General disorders Pain	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	5.8% 3/52 • Number of events 3 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
General disorders Pyrexia	4.7% 5/106 • Number of events 5 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	7.7% 4/52 • Number of events 4 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Investigations Blood alkaline phosphatase increased	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	5.8% 3/52 • Number of events 3 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Investigations Blood creatinine increased	12.3% 13/106 • Number of events 17 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 6 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Investigations Weight decreased	11.3% 12/106 • Number of events 13 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	11.5% 6/52 • Number of events 6 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	16.0% 17/106 • Number of events 19 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	13.5% 7/52 • Number of events 7 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	7.5% 8/106 • Number of events 10 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 2 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	6.6% 7/106 • Number of events 9 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	1.9% 2/106 • Number of events 2 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	5.8% 3/52 • Number of events 3 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	9.4% 10/106 • Number of events 12 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	13.5% 7/52 • Number of events 8 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Nervous system disorders Dizziness	7.5% 8/106 • Number of events 10 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	5.8% 3/52 • Number of events 3 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Nervous system disorders Headache	6.6% 7/106 • Number of events 7 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	3.8% 2/52 • Number of events 2 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Nervous system disorders Neuropathy	2.8% 3/106 • Number of events 3 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	13.5% 7/52 • Number of events 9 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	10.4% 11/106 • Number of events 11 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	3.8% 2/52 • Number of events 2 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.9% 19/106 • Number of events 20 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	11.5% 6/52 • Number of events 6 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	8.5% 9/106 • Number of events 9 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	1.9% 1/52 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	5.7% 6/106 • Number of events 7 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	3.8% 2/52 • Number of events 2 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.94% 1/106 • Number of events 1 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	13.5% 7/52 • Number of events 8 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.
Vascular disorders Hypotension	7.5% 8/106 • Number of events 8 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.	0.00% 0/52 • Baseline Up To 5 Years All randomized participants who received at least one dose of study drug.