ORR, as determined by central review according to the 2014 Lugano classification, defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).

All-treated population - all participants who received at least 1 dose of treatment.

DOR defined as the time from the first documentation of tumor response to disease progression or death.

Participants in the all-treated population who achieved a complete response (CR) or partial response (PR).

CR rate defined as the percentage of treated participants with a best overall response (BOR) of CR.

All-treated population - all participants who received at least 1 dose of treatment.

RFS was defined as the time from the documentation of CR to disease progression or death.

Participants in the all-treated population who achieved CR.

PFS was defined as the time between start of treatment and the first documentation of recurrence, progression, or death.

All-treated population - all participants who received at least 1 dose of treatment.

OS was defined as the time between the start of treatment and death from any cause.

All-treated population - all participants who received at least 1 dose of treatment.

An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with treatment. A TEAE was an adverse event with an onset that began or worsened on or after the first dose date and until 30 days after the last dose date, or start of a new anticancer therapy/procedure, whichever came earlier. TEAE assessments also included those per the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade ≥3 AEs and serious TEAEs.

AEs were graded using CTCAE version 4 and according to the following: Grade 1 = mild AE, Grade 2 = Moderate AE, Grade 3 = a severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. For events not listed in the CTCAE criteria, the same grading was used.

All-treated population - all participants who received at least 1 dose of treatment.

Clinical laboratory tests included hematology and chemistry. Clinically significant changes were determined by the Investigator.

All-treated population - all participants who received at least 1 dose of treatment.

Vital sign measurements included arterial blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.

All-treated population - all participants who received at least 1 dose of treatment.

ECOG (Eastern Cooperative Oncology Group) Performance Status is scored on a 6-point scale where higher scores indicate a worse outcome. ECOG scores include the following:

• 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, e.g., light house work, office work
• 2 = ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours
• 3 = capable of only limited self-care; confined to bed or chair more than 50% of waking hours
• 4 = completely disabled; cannot carry on any self-care; totally confined to bed or chair
• 5 = dead

All-treated population - all participants who received at least 1 dose of treatment. Results are presented for participants with data available for analysis at end of treatment.

Clinically significant changes from baseline for 12-lead ECGs were measured as abnormal QT interval corrected by Fridericia formula (QTcF) and QT interval corrected by Bazett formula (QTcB) values.

All-treated population - all participants who received at least 1 dose of treatment.

Pharmacokinetic (PK) population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

PK population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

PK population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

PK population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre-Cycle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

Pharmacokinetic (PK) population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre-Cyle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

Pharmacokinetic (PK) population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre-Cyle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

AI is the ratio of AUC0-last for each cycle divided by AUC0-last of the previous cycle.

Pharmacokinetic (PK) population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre- Cyle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

All-treated population - all participants who received at least 1 dose of treatment.

EQ-5D-5L is designed as an international, standardized, instrument for describing and evaluating quality of life (QoL). In the EQ-5D-5L VAS participants are asked to indicate their health state today on a VAS with the endpoints labeled 'the best health you can imagine' (score 100) and 'the worst health you can imagine' (score 0).

A higher score on the VAS indicates better health related QoL. A positive change from baseline indicates an improvement in health related QoL.

Patient reported outcome (PRO) population. Only participants with data available for analysis are included. Overall number of participants analyzed prepresents all participants who contributed data to this assessment, though not all participants contributed data to each time point.

Composed of the Functional Assessment of Cancer Therapy - General (FACT-G) plus the 15-item LymS. The FACT-G questionnaire contains 27 items covering 4 core health related quality of life (QoL) subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The LymS addresses issues including pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. Score range for the LymS was 0 - 60, where a higher score indicates less symptoms. The LymS score is reported. A positive change from baseline indicates an improvement in health related QoL.

PRO population. Only participants with data available for analysis are included. Overall number of participants analyzed represents all participants who contributed data to this assessment, though not all participants contributed data to each time point.