Science - USA (2022-01-14)

Fasslet al.,Science 375 , eabc1495 (2022) 14 January 2022 9 of 19

CDK4/6inhibitor

Trial name

Trial details

Treatment

Patients

Outcome

Ref.

Other outcomes

...............................................................................................................................................................................................................................................................................................................................................................................................................................................Palbociclib

PALLAS

Randomizedphase 3

Palbociclib plusstandard endocrinetherapy versusendocrine therapyalone

Patients with early(stage 2 or 3),HR

+/HER2

• 
  

breast cancer

Preliminary results indicate thatthe trial is unlikely to showa statistically significantimprovement of invasivedisease-free survival

(^138

)

...............................................................................................................................................................................................................................................................................................................................................................................................................................................Palbociclib

PENELOPE-B

Palbociclib inpatients withearly breastcancer at highrisk of recurrence

Ongoing

...............................................................................................................................................................................................................................................................................................................................................................................................................................................Ribociclib

MONALEESA-2 Randomized

phase 3

Ribociclib plusletrozole versusplacebo plusletrozole

First-line treatment forpostmenopausal womenwith HR

+/HER2

• 
  

recurrent

or metastatic breastcancer who had notreceived previoussystemic therapy foradvanced disease

At 18 months, PFSwas 42.2% in theplacebo-letrozolegroup and 63.0%in the ribociclib-letrozole group

(^126

)

...............................................................................................................................................................................................................................................................................................................................................................................................................................................Ribociclib

MONALEESA-3 Phase 3

Ribociclib plusfulvestrant

Patients with advanced(metastatic or recurrent)HR

+/HER2

• 
  

breast cancer

who have either received notreatment for the advanceddisease or previouslyreceived a single line ofendocrine therapy for theadvanced disease

Addition of ribociclib significantlyextended median PFS, from12.8 months (placebo-fulvestrant)to 20.5 months (ribociclib-fulvestrant); overall survival at42 months was also extendedfrom 45.9% (placebo-fulvestrant)to 57.8% (ribociclib-fulvestrant)

(^127

,

133

)

...............................................................................................................................................................................................................................................................................................................................................................................................................................................Ribociclib

MONALEESA-7 Phase 3

randomized,double-blind

Ribociclib versusplacebo togetherwith an anti-estrogen tamoxifenor an aromataseinhibitor (letrozoleor anastrozole)

Premenopausal andperimenopausal womenwith HR

+/HER2

• 
  

advanced

breast cancer who had notreceived previous treatmentwith CDK4/6 inhibitors

Ribociclib significantly increasedmedian PFS from 13.0 months inthe placebo-endocrine therapygroup to 23.8 months in theribociclib-endocrine therapygroup; overall survival was alsostrongly prolonged in the ribociclibgroup (estimated overall survivalat 42 months was 46.0% for theplacebo group and 70.2% in theribociclib group)

(^128

,^132

)

...............................................................................................................................................................................................................................................................................................................................................................................................................................................Ribociclib

EarLEE-1

Phase 3 trial

Ribociclib in thetreatment of early-stage, high-riskHR

+/HER2

• 
  

breast cancers

Ongoing

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