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Dosing & Administration

Dosing and administration

TRUQAP’s 4 days on / 3 days off weekly dosing schedule

The recommended dose of TRUQAP is:

  • 400 mg (two 200 mg tablets) taken orally twice daily, approximately 12 hours apart (total daily dose of 800 mg),
  • for 4 days followed by 3 days off treatment.

Treatment with TRUQAP should continue until disease progression or unacceptable toxicity occurs.1

† Day 15 is Week 3 Day 1 of Cycle 1.

Stratification factors: Liver metastases, prior CDK4/6i, and region1,4¶

Dual primary endpoints
  • Investigator assessed PFS in:
    • overall population** and
    • subgroup with PIK3CA/AKT1/PTEN-altered tumours
Key secondary endpoints
  • OS
  • ORR

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)
Age group, n (%)
<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)
Sex, n (%)
Male 2 (1.3) 0 2 (0.7)
Female 153 (98.7) 134 (100) 287 (99.3)
Race, n (%)
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)
WHO/ECOG PS, n (%)
(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)
Menopausal status (females only), n (%)
Pre-/peri-menopausal 23 (14.8) 29 (21.6) 52 (18.0)
Post-menopausal 130 (83.9) 105 (78.4) 235 (81.3)
Prior hormonal therapy, n (%)
Aromatase inhibitor 155 (100) 134 (100) 289 (100)
Tamoxifen 69 (44.5) 57 (42.5) 126 (43.6)
Prior CDK4/6 inhibitors, n (%)
TRUQAP + fulvestrant: studied in a majority CDK4/6i-exposed population1,4*
Yes 113 (72.9) 93 (69.4) 206 (71.3)
No 42 (27.1) 41 (30.6) 83 (28.7)
Prior chemotherapy, n (%)
(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)
Prior lines of therapy for locally advanced (inoperable) or metastatic disease (includes endocrine or chemotherapy)
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
ECOG PS=Eastern Cooperative Oncology Group performance status; WHO=World Health Organization.
* TRUQAP is only indicated for patients with PIK3CA/AKT1/PTEN alterations.

Select patient characteristics

  • Mild persistent asthma
  • ≥12 years of age
  • 3836 patients

Demonstrated reduction in severe exacerbations

  • 64% lower annualized rate of severe exacerbations demonstrated with SYMBICORT 200 TURBUHALER Anti-Inflammatory Reliever therapy vs. terbutaline PRN (2o endpoint, 0.07 vs. 0.20; RR: 0.36; 95% CI: 0.27, 0.49; p<0.001).
  • Comparable reduction in severe exacerbation rate demonstrated with SYMBICORT 200 TURBUHALER Anti-Inflammatory Reliever therapy vs. budesonide maintenance therapy (2o endpoint, 0.07 vs. 0.09, p=0.28).

NNT

NNT = 12
(vs. terbutaline arm)

Select patient characteristics

  • Mild persistent asthma
  • ≥12 years of age
  • 4176 patients

Demonstrated reduction in severe exacerbations

  • Reduction in severe exacerbations was non-inferior with SYMBICORT 200 TURBUHALER Anti-Inflammatory Reliever therapy vs. budesonide maintenance therapy (1o endpoint, 0.11 vs. 0.12, p=NA; RR: 0.97; 95% CI: 0.78, 1.20; upper limit of the 2-sided 95% CI<1.20 for non-inferiority).

NNT

No Data

Select patient characteristics

  • Moderate to severe asthma
  • ≥1 severe asthma exacerbation in the past 12 months
  • Symptomatic on SYMBICORT 200 TURBUHALER one inhalation BID during a 2-week run-in
  • Using ICS ≥3 months
  • 3394 patients

Demonstrated reduction in severe exacerbations

  • 27% reduction in risk of severe exacerbations demonstrated with SYMBICORT 200 TURBUHALER Anti-Inflammatory Reliever plus Maintenance therapy vs. SYMBICORT 200 TURBUHALER + formoterol PRN (2o endpoint, 194 vs. 296, p=0.0038).

NNT

NNT = 12

Select patient characteristics

  • Moderate to severe asthma
  • ≥1 severe asthma exacerbation in the past 12 months
  • Using ICS ≥3 months
  • 3335 patients

Demonstrated reduction in severe exacerbations

  • 39% reduction in severe exacerbations demonstrated with SYMBICORT 200 TURBUHALER Anti-Inflammatory Reliever plus Maintenance therapy vs. fluticasone/salmeterol maintenance + terbutaline PRN (2o endpoint, 125 vs. 208, p<0.001).

NNT

NNT = 14

Select patient characteristics

  • Moderate to severe asthma
  • Symptomatic with ≥1 exacerbation in the past 12 months
  • Treated with 400 to 1000 µg/day of ICS for ≥3 months
  • 1890 patients

Demonstrated reduction in severe exacerbations

  • 39% reduction in severe exacerbations demonstrated with SYMBICORT 200 TURBUHALER Anti-Inflammatory Reliever plus Maintenance therapy vs. budesonide maintenance therapy + terbutaline PRN (2o endpoint, 197 vs. 349, p<0.001).

NNT

NNT = 7

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.6,7

Adapted from Turner, et al.4
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
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