Table 2 Efficacy results for the time to NLCB (left) and overall survival (right) in the five predefined biomarker signatures or groups

From: Androgen receptor pathway inhibitors and taxanes in metastatic prostate cancer: an outcome-adaptive randomized platform trial

 

NLCB

Overall survival

Biomarker signature or group

Arm (events/N)

Reference (events/N)

PPS

STR (90% CrI)

Arm (events/N)

Reference (events/N)

PPS

STR (90% CrI)

All patients

ARPIs (34/51)

Physician’s choice (69/92)

1.00

1.50 (1.20, 1.86)

ARPIs (8/31)

Physician’s choice (30/64)

1.00

1.77 (1.29, 2.51)

ARPIs (34/51)

Taxanes (61/75)

1.00

1.60 (1.28, 2.01)

ARPIs (8/31)

Taxanes (29/56)

1.00

1.78 (1.28, 2.61)

Taxanes (61/75)

Physician’s choice (69/92)

0.27

0.94 (0.78, 1.12)

Taxanes (29/56)

Physician’s choice (30/64)

0.48

0.99 (0.78, 1.26)

AR (SNV/GSR) negative and TP53 wild-type

ARPIs (11/19)

Physician’s choice (31/42)

1.00

1.76 (1.26, 2.51)

ARPIs (4/15)

Physician’s choice (11/27)

0.90

1.45 (0.90, 2.40)

ARPIs (11/19)

Taxanes (15/22)

0.99

1.74 (1.15, 2.62)

ARPIs (4/15)

Taxanes (4/17)

0.64

1.14 (0.61, 2.11)

Taxanes (15/22)

Physician’s choice (31/42)

0.53

1.01 (0.73, 1.42)

Taxanes (4/17)

Physician’s choice (11/27)

0.79

1.27 (0.78, 2.15)

Homologous recombination deficiency

ARPIs (1/4)

Physician’s choice (13/16)

0.96

1.89 (1.06, 3.53)

ARPIs (0/2)

Physician’s choice (6/10)

0.63

1.15 (0.52, 2.57)

ARPIs (1/4)

Taxanes (9/12)

0.92

1.83 (0.88, 3.89)

ARPIs (0/2)

Taxanes (0/6)

0.39

0.82 (0.27, 2.46)

Taxanes (9/12)

Physician’s choice (13/16)

0.55

1.04 (0.62, 1.72)

Taxanes (0/6)

Physician’s choice (6/10)

0.75

1.42 (0.62, 3.20)

TP53 altered

ARPIs (19/24)

Physician’s choice (30/37)

0.78

1.14 (0.88, 1.48)

ARPIs (4/13)

Physician’s choice (15/27)

0.96

1.60 (1.03, 2.61)

ARPIs (19/24)

Taxanes (31/36)

0.63

1.05 (0.81, 1.38)

ARPIs (4/13)

Taxanes (18/28)

0.98

1.79 (1.13, 3.03)

Taxanes (31/36)

Physician’s choice (30/37)

0.69

1.07 (0.84, 1.37)

Taxanes (18/28)

Physician’s choice (15/27)

0.28

0.89 (0.63, 1.24)

TMPRSS2–ERG fusion positive

ARPIs (9/16)

Physician’s choice (20/24)

0.99

1.80 (1.21, 2.64)

ARPIs (2/10)

Physician’s choice (12/16)

0.99

2.01 (1.26, 3.38)

ARPIs (9/16)

Taxanes (17/22)

0.99

1.99 (1.30, 3.02)

ARPIs (2/10)

Taxanes (12/20)

0.99

2.02 (1.23, 3.55)

Taxanes (17/22)

Physician’s choice (20/24)

0.31

0.90 (0.63, 1.28)

Taxanes (12/20)

Physician’s choice (12/16)

0.49

0.99 (0.68, 1.46)

  1. Efficacy assessed using STR comparing investigational arms (ARPIs and taxanes) to physician’s choice (control group) and AR pathway to taxanes across the five predefined biomarker signatures or groups: (1) any biomarker subgroup combination (that is, biomarker-unselected or ‘all’ patients); (2) no SNV or GSRs in the AR gene and no alterations in the TP53 gene (that is, AR (SNV/GSR) negative and TP53 wild type); (3) homologous recombination deficiency (that is, deactivating somatic or high-impact germline alteration in DNA repair genes); (4) alterations in TP53 (that is, TP53 altered); and (5) presence of the TMPRSS2–ERG fusion (that is, TMPRSS2–ERG fusion positive). Posterior STR distributions summarized with medians and 90% CrI. Forest plot visualizations for the STRs for NLCB and overall survival are available in Supplementary Fig. 3. Posterior probability of superiority (PPS) calculated as STR exceeding one, guiding early termination decisions. Additional information on number of events and total number of randomizations (events/N) provided for each comparison.
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