A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

DOR was defined for participants who had objective response (OR) as time from first occurrence of a documented OR (CR/PR) to date of PD or death from any cause (whichever occurred first), determined by IRC per RECIST v1.1. CR=Disappearance of all target \& non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to <10 mm. PR=≥30% decrease in SOD of all target lesions, taking as reference baseline SOD, in absence of CR. PD = ≥ 20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Study enrolled participants with measurable disease as per investigator. Participants who had non-measurable disease at baseline according to RECIST v1.1 (IRC assessment or Protocol Deviations) were only considered responders if they achieved CR.

DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD), as determined by the IRC according to RECIST v1.1. CR and PR were defined the same as in the description of primary outcome measure (OM), ORR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD = ≥ 20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Study enrolled participants with measurable disease as per the investigator. Participants who had non-measurable disease at baseline per RECIST v1.1 (IRC assessment or Protocol Deviations) were only considered responders if they achieved CR.

BCR was defined as the percentage of participants with a CR, PR, or SD, as determined by the investigator according to RECIST v1.1. CR=Disappearance of all target \& non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to <10 mm. PR=At least a 30% decrease in SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD=At least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s). Percentages have been rounded off.

Duration of BCR was defined for BCR responders as the time from first occurrence of a documented response (CR, PR, or SD) to date of PD or death from any cause (whichever occurred first), as clinically determined by the investigator according to RECIST v1.1. CR=Disappearance of all target \& non-target lesions or any pathological lymph nodes (whether target/non-target) have reduction in short axis to <10 mm. PR = ≥30% decrease in SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. SD=Neither sufficient shrinkage to qualify for CR/PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments ≥6 weeks apart. PD = ≥20% increase in SOD of target lesions, taking as reference smallest SOD at prior timepoints (including baseline); in addition to relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s).

PFS was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. PD was defined as at least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s).

PFS rate was defined as the percentage of participants who were event-free at 6 months post-randomization, as determined by the IRC according to RECIST v1.1. PFS was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. PD was defined as at least 20% increase in SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline); in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression in non-target lesion(s)..

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

OS rate was defined as the percentage of participants who were still alive at 6 months and 12 months. OS was defined as the time of randomization to death from any cause.

Participants were considered treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 titre units[t.u]) than the titre of the baseline sample (treatment-enhanced ADA response).

Participants were considered treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 t.u) than the titre of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded off.