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ERLEADA® + ADT demonstrates a consistent, acceptable safety profile[1]

The median follow-up time in the TITAN final analysis was 44 months.[1] The most common reason for discontinuation was progressive disease.[1]

The safety profile of ERLEADA® + ADT remained consistent with that reported previously, with no new safety signals detected.[1]

Dr helps patient at home
AE, n (%)a
ERLEADA® + ADT (n=524)
Placebo + ADT (n=527)
Crossover (placebo to ERLEADA®) + ADT (n=208)

Patients with ≥1 TEAEb

510 (97.3)

510 (96.8)

174 (83.7)

Patients with ≥1 grade 3/4 TEAE

259 (49.4)

220 (41.7)

57 (27.4)

Any serious TEAEb
153 (29.2)

115 (21.8)

29 (13.9)

Any TEAE leading to treatment discontinuation

62 (11.8)

30 (5.7)

16 (7.7)

TEAE leading to death

20 (3.8)

17 (3.2)

7 (3.4)
Any COVID-19 AE
0
0
3 (1.4)


Adapted from Chi KN, et al. 2021 (supplementary).

AE, n (%)
ERLEADA® + ADT (n=524)
Placebo + ADT (n=527)
Crossover (placebo to ERLEADA®) + ADT (n=208)
Median treatment duration, months (range)c
39.3 (0 to 55.7)
20.2 (0.1 to 37.0)
15.4 (0.6 to 18.2)
Total exposure, PY
1358.9
793.3
243.6
TEAEs by group term, event (event rate/100 PY of exposure)d
All gradese
Grade 3/4e
All grades
Grade 3/4
All grades
Grade 3/4
Any TEAE of interest
543 (40.0)
103 (7.6)

178 (22.4)

21 (2.7)
102 (41.9)
16 (6.5)
Skin rashf

331 (24.4)

40 (2.9)

66 (8.3)

5 (0.6)
44 (18.1)
8 (3.3)
Fractureg

83 (6.1)

21 (1.5)

33 (4.2)

4 (0.5)
5 (2.1)
0
Fall

63 (4.6)

9 (0.7)
54 (6.8)
5 (0.6)
14 (5.7)
0
Ischaemic heart diseaseh

45 (3.3)

21 (1.5)

13 (1.6)

5 (0.7)
1 (0.4)
1 (0.4)
Ischaemic cerebrovascular disordersi

18 (1.3)

11 (0.8)
10 (1.3)
2 (0.3)
7 (2.9)
7 (2.8)
Seizurej
3 (0.2)
1 (0.1)
2 (0.3)
0
0
0

Adapted from Chi KN, et al. 2021.

aShown are AEs of any cause, unless otherwise noted, that occurred from the time of the first dose of the trial intervention through 30 days after the last dose. For each category, patients with multiple events were counted only once. AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3. One patient who was assigned to the ERLEADA® group withdrew consent before treatment.[2]
bExcludes grade 5 events.[2]
cPatients received treatment until disease progression or unacceptable toxicity.[1]
dEvent rate per 100 PY of exposure is calculated as 100 times the number of distinct events with the group term/total PY of exposure (total days of exposure/365.25) for the treatment group. AEs occurred from the time of the first dose of the study intervention through 30 days after the last dose. AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3. One patient who was assigned to the ERLEADA® group withdrew consent before treatment.[1]
eThe worst toxicity grade is included. Patients with missing toxicity grades were counted in the all-grade column.[1]
fSkin rash was a grouped term including rash, maculopapular rash, conjunctivitis, dermatitis, stomatitis, pruritic rash, urticaria, papular rash, skin exfoliation, blister, mouth ulceration, drug eruption, erythema multiforme, exfoliative rash, toxic skin eruption, papule, skin reaction, butterfly rash, generalised exfoliative dermatitis, genital rash, erythematous rash, macular rash, systemic lupus erythematosus rash, oral mucosal blistering, follicular rash, pustular rash and vesicular rash.[1]
gFracture was a grouped term including rib fracture, spinal compression fracture, hand fracture, femoral neck fracture, foot fracture, femur fracture, thoracic vertebral fracture, traumatic fracture, upper limb fracture, wrist fracture, ankle fracture, fracture, hip fracture, spinal fracture, radius fracture, acetabulum fracture, fracture pain, clavicle fracture, comminuted fracture, compression fracture, forearm fracture, humerus fracture, patella fracture, pelvic fracture, sternal fracture, stress fracture, ulna fracture, fibula fracture, lower limb fracture, skull fracture and tibia fracture.[1]
hIschaemic heart disease was a group term including angina pectoris, myocardial infarction, acute myocardial infarction, coronary artery stenosis, coronary artery arteriosclerosis, myocardial ischaemia, coronary artery disease, coronary artery occlusion, acute coronary syndrome, abnormal cardiac stress test, ischaemic cardiomyopathy, unstable angina and increased troponin.[1]
iIschaemic cardiovascular disorder was a group term including cerebrovascular accident, transient ischaemic attack, ischaemic stroke, cerebrovascular disorder, lacunar infarction, cerebral ischaemia, hemiplegia, vascular encephalopathy, carotid artery stenosis and carotid arteriosclerosis.[1]
jSeizure was a group term including seizure and tongue biting.[1]

Cumulative incidences charts

Graphics representing cumulative incidences of selected TEAEs were adapted from Chi KN, et al. 2021.

Treat early and push back on progression with the consistent safety profile demonstrated with ERLEADA® + ADT[1]

Click below to find out more about the clinical benefits with ERLEADA®+ ADT

Increase survival and delay progression

Treat early with ERLEADA® + ADT to delay progression and extend life for your mHSPC patients vs. placebo + ADT[1]

Treat early in a broad range of mHSPC patients

Extend life across a broad range of mHSPC patients with ERLEADA® + ADT[1]

Maintain QoL

Push back on progression and maintain QoL in mHSPC[1]

Abbreviations

ADT, androgen deprivation therapy. AE, adverse event. mHSPC, metastatic hormone-sensitive prostate cancer. PY, patient-years. QoL, quality of life. TEAE, treatment-emergent adverse event


CP-282954 - janeiro 2022