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TRUQAP CAPItello-291 Clinical Trial

Trial design
Baseline characteristics
PFS data
OS data

CAPItello-291: a global, phase 3, randomized, double-blind, multicentre, placebo-controlled trial (N=708)^1,5†

289 patients (40.8%) in the overall population had tumours with PIK3CA/AKT1/PTEN alterations

* Day 15 is Week 3 Day 1 of Cycle 1.

Stratification factors: Liver metastases, prior CDK4/6i, and region^1,4¶

Dual primary endpoints

Investigator assessed PFS in:
- overall population** and
- subgroup with PIK3CA/AKT1/PTEN-altered tumours

Key secondary endpoints

AI=aromatase inhibitor; BC=breast cancer; ET=endocrine therapy; HbA1c=hemoglobin A1c; IHC=immunohistochemistry; ISH=in situ hybridization; LHRH=luteinizing hormone-releasing hormone; ORR=objective response rate; OS=overall survival; PFS=progression-free survival.
† In CAPItello-291, a total of 708 patients were randomized 1:1 to receive either 400 mg of TRUQAP (n=355) or placebo (n=353) given twice daily for 4 days followed by 3 days off treatment each week of a 28-day treatment cycle. Fulvestrant 500 mg was administered on Cycle 1 Days 1 and 15 and then at Day 1 of a 28-day cycle. In total, 289 patients had tumours with eligible PIK3CA/AKT1/PTEN-alterations.
‡ TRUQAP is not indicated in men.
§ Pre- or peri-menopausal women also received an LHRH agonist for the duration of the study treatment.
¶ Region 1: United States, Canada, Western Europe, Australia, and Israel; Region 2: Latin America, Eastern Europe, and Russia; Region 3: Asia.
** TRUQAP is only indicated for patients with PIK3CA/AKT1/PTEN alterations.

Patients with PIK3CA/AKT1/PTEN-altered tumours (n=289) represented 40.8% of the overall population.^1* Among the altered patients, 76% of patients had a gene alteration in PIK3CA, 13% in AKT1 and 17% in PTEN.¹

Patient demographics and disease characteristics for patients with PIK3CA/AKT1/PTEN-altered tumours

	Capivasertib + fulvestrant (n=155)	Placebo + fulvestrant (n=134)	Total (n=289)
Median age, years (range)	58.0 (36, 84)	60.0 (34, 90)	59.0 (34, 90)

<50 years	27 (17.4)	29 (21.6)	56 (19.4)
≥50 to <65 years	83 (53.5)	60 (44.8)	143 (49.5)
≥65 to <75 years	37 (23.9)	28 (20.9)	65 (22.5)
≥75 years	8 (5.2)	17 (12.7)	25 (8.7)

Male	2 (1.3)	0	2 (0.7)
Female	153 (98.7)	134 (100)	287 (99.3)

Black or African American	2 (1.3)	1 (0.7)	3 (1.0)
American Indian or Alaska Native	1 (0.6)	1 (0.7)	2 (0.7)
Asian	48 (31.0)	35 (26.1)	83 (28.7)
White	75 (48.4)	76 (56.7)	151 (52.2)
Other	29 (18.7)	21 (15.7)	50 (17.3)

(0) Normal activity	93 (60.0)	97 (72.4)	190 (65.7)
(1) Restricted activity	62 (40.0)	36 (26.9)	98 (33.9)
(2) In bed less than or equal to 50% of the time	0	1 (0.7)	1 (0.3)

Pre-/peri-menopausal	23 (14.8)	29 (21.6)	52 (18.0)
Post-menopausal	130 (83.9)	105 (78.4)	235 (81.3)

Aromatase inhibitor	155 (100)	134 (100)	289 (100)
Tamoxifen	69 (44.5)	57 (42.5)	126 (43.6)

Yes	113 (72.9)	93 (69.4)	206 (71.3)
No	42 (27.1)	41 (30.6)	83 (28.7)

(Neo)adjuvant treatment only	62 (40.0)	61 (45.5)	123 (42.6)
Locally advanced (inoperable) / metastatic treatment	30 (19.4)	23 (17.2)	53 (18.3)

0	12 (7.7)	20 (14.9)	32 (11.1)
1	107 (69.0)	79 (59.0)	186 (64.4)
2	31 (20.0)	29 (21.6)	60 (20.8)
3	5 (3.2)	6 (4.5)	11 (3.8)

Adapted from the TRUQAP Product Monograph¹
TRUQAP + fulvestrant: studied in a majority CDK4/6i-exposed population^1,5*
ECOG PS=Eastern Cooperative Oncology Group performance status; WHO=World Health Organization.
* TRUQAP is only indicated for patients with PIK3CA/AKT1/PTEN alterations.

TRUQAP + fulvestrant demonstrated statistically significant improvement in PFS vs. placebo + fulvestrant*

In patients with PIK3CA/AKT1/PTEN-altered tumours (n=289) (40.8% of the overall population)

Adapted from the TRUQAP Product Monograph¹

Demonstrated:
50% reduction in risk of progression or death with TRUQAP + fulvestrant vs. fulvestrant HR=0.50^† (95% CI: 0.38, 0.65; p<0.001^‡)

Number of events (%): TRUQAP + fulvestrant 121 (78.1) vs. fulvestrant 115 (85.8)

CI=confidence interval; HR=hazard ratio; mPFS=median progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumours.
* Analysis was performed by investigator assessment determined by RECIST 1.1.
† Stratified Cox proportional hazards model. A hazard ratio <1 favours capivasertib + fulvestrant.
‡ Stratified log-rank test.

Improvement in PFS observed across pre-specified subgroups

Subgroups included:

presence of visceral metastases,
prior exposure to CDK4/6 inhibitors and
in the non-altered tumour population which comprised patients with a confirmed non-altered tumour and those with no testing result available.¹*

71% of the overall trial patients received prior CDK4/6i¹

* TRUQAP is only indicated for patients with PIK3CA/AKT1/PTEN alterations.

Overall survival analysis in patients with PIK3CA/AKT1/ PTEN-altered tumours (secondary endpoint)

A preliminary assessment of OS (30% maturity) at the time of the primary PFS analysis did not suggest a detrimental effect on survival of treatment with TRUQAP plus fulvestrant compared with placebo plus fulvestrant.¹ The 30% maturity rate was calculated based on the 87 events in the 289 patients from the PIK3CA/AKT1/PTEN-altered population.^7,8

Adapted from Turner, et al.⁵
Tick marks indicate censored data. A 0.01% alpha penalty was assigned to the overall survival analyses of no detriment (i.e., with the HR not favouring the fulvestrant-only group); a sufficient number of deaths for a formal analysis of overall survival had not occurred by the data-cutoff date.

Learn more about biomarker testing

Learn more about the safety profile of TRUQAP

Important safety information for TRUQAP®

TRUQAP CAPItello-291 Clinical Trial

CAPItello-291: a global, phase 3, randomized, double-blind, multicentre, placebo-controlled trial (N=708)1,5†

Patients with PIK3CA/AKT1/PTEN-altered tumours (n=289) represented 40.8% of the overall population.1* Among the altered patients, 76% of patients had a gene alteration in PIK3CA, 13% in AKT1 and 17% in PTEN.1

Patient demographics and disease characteristics for patients with PIK3CA/AKT1/PTEN-altered tumours

Age group, n (%)

Sex, n (%)

Race, n (%)

WHO/ECOG PS, n (%)

Menopausal status (females only), n (%)

Prior hormonal therapy, n (%)

Prior CDK4/6 inhibitors, n (%)

Prior chemotherapy, n (%)

Prior lines of therapy for locally advanced (inoperable) or metastatic disease (includes endocrine or chemotherapy)