Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

OS was defined as the time from randomization to the date of death due to any cause.

PFS as assessed by blinded IRC per RECIST 1.1 was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.

ORR was defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by IRC per RECIST 1.1.

BOR was defined as the best overall response as determined by the IRC per RECIST 1.1, between the date of randomization and the date of first documented tumor progression or the date of subsequent anti-cancer therapy, whichever occurred earlier.

DoR was defined as the time from date of first documented response of CR or PR to the date of first documented PD (per RECIST 1.1) or death due to any cause, whichever occurred earlier.

The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (physical, role, cognitive, emotional, social), 9 symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Reported here are the EORTC QLQ-C30 GHS/QoL scores only. GHS/QoL is derived from two items: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" Each scored from 1 (very poor) to 7 (excellent). The average of these two items is linearly transformed to a score ranging from 0 to 100; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.

EORTC QLQ-LC13 is a 13-item questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia). Reported here are the EORTC lung cancer coughing scores only. Scores were calculated and transformed to a range from 0 to 100, with a higher score representing a higher level of symptoms/problems and a negative change from baseline value indicating reduction (i.e. improvement) in symptoms.

TEAEs were AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Serious TEAEs were defined as medically significant but not immediately life-threatening AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.

The on-treatment period was defined as the day from the first dose of study drug to the day of the last dose of study drug plus 90 days or 1 day before participants receive their first dose of new anti-cancer systemic therapy, whichever is earlier.

Reported here is the number of participants with at least one laboratory abnormality of any grade in measurements for hematology, electrolytes, liver function, chemistry, and coagulation.

The ADA status of each participant was classified as one of the following:

• Pre-existing - If the baseline sample is positive and all post baseline ADA titers are reported as less than 9-fold the baseline titer value
• Negative - If all samples are found to be negative in the ADA assay
• Treatment-emergent response

The NAb status of each participant was categorized as follows:

• Negative - Samples that tested negative in the ADA assay, or samples positive in the ADA assay but tested negative in the NAb assay
• Positive