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IBRANCE® (palbociclib) Clinical Studies

14 CLINICAL STUDIES

Study 1: IBRANCE plus Letrozole

Patients with ER-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine based therapy

Study 1 (PALOMA-2) was an international, randomized, double-blind, parallel-group, multicenter study of IBRANCE plus letrozole versus placebo plus letrozole conducted in postmenopausal women with ER-positive, HER2-negative advanced breast cancer who had not received previous systemic treatment for their advanced disease. A total of 666 patients were randomized 2:1 to IBRANCE plus letrozole or placebo plus letrozole. Randomization was stratified by disease site (visceral versus non-visceral), disease-free interval (de novo metastatic versus ≤12 months from the end of adjuvant treatment to disease recurrence versus >12 months from the end of adjuvant treatment to disease recurrence), and nature of prior (neo)adjuvant anticancer therapies (prior hormonal therapies versus no prior hormonal therapy). IBRANCE was given orally at a dose of 125 mg daily for 21 consecutive days followed by 7 days off treatment. Patients received study treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. The major efficacy outcome of the study was investigator-assessed progression-free survival (PFS) evaluated according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST).

Patients enrolled in this study had a median age of 62 years (range 28 to 89). The majority of patients were White (78%), and most patients had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (98%). Forty-eight percent of patients had received chemotherapy and 56% had received antihormonal therapy in the neoadjuvant or adjuvant setting prior to their diagnosis of advanced breast cancer. Thirty-seven percent of patients had no prior systemic therapy in the neoadjuvant or adjuvant setting. The majority of patients (97%) had metastatic disease. Twenty-three percent of patients had bone only disease, and 49% of patients had visceral disease.

Major efficacy results from Study 1 are summarized in Table 8 and Figure 1. Consistent results were observed across patient subgroups of disease-free interval (DFI), disease site, and prior therapy. The treatment effect of the combination on PFS was also supported by an independent review of radiographs. The overall survival (OS) data were not mature at the time of the final PFS analysis (20% of patients had died). Patients will continue to be followed for the final analysis.

Table 8. Efficacy Results – Study 1 (Investigator Assessment, Intent-to-Treat Population)
IBRANCE plus Letrozole Placebo plus Letrozole
CI=confidence interval; ITT=Intent-to-Treat; N=number of patients; NE=not estimable.
*
Response based on confirmed responses.
Progression-free survival for ITT N=444 N=222
  Number of PFS events (%) 194 (43.7) 137 (61.7)
  Median progression-free survival (months, 95% CI) 24.8 (22.1, NE) 14.5 (12.9, 17.1)
  Hazard ratio (95% CI) and p-value 0.576 (0.463, 0.718), p<0.0001
Objective Response for patients with measurable disease N=338 N=171
  Objective response rate* (%, 95% CI) 55.3 (49.9, 60.7) 44.4 (36.9, 52.2)
                                    LET=letrozole; PAL=palbociclib; PCB=placebo.
Figure 1. Kaplan-Meier Plot of Progression-Free Survival – Study 1 (Investigator Assessment, Intent-to-Treat Population)
Figure 1

Study 2: IBRANCE plus Fulvestrant

Patients with HR-positive, HER2-negative advanced or metastatic breast cancer who have had disease progression on or after prior adjuvant or metastatic endocrine therapy

Study 2 (PALOMA-3) was an international, randomized, double-blind, parallel group, multicenter study of IBRANCE plus fulvestrant versus placebo plus fulvestrant conducted in women with HR-positive, HER2-negative advanced breast cancer, regardless of their menopausal status, whose disease progressed on or after prior endocrine therapy. A total of 521 pre/postmenopausal women were randomized 2:1 to IBRANCE plus fulvestrant or placebo plus fulvestrant and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri versus postmenopausal), and presence of visceral metastases. IBRANCE was given orally at a dose of 125 mg daily for 21 consecutive days followed by 7 days off treatment. Pre/perimenopausal women were enrolled in the study and received the LHRH agonist goserelin for at least 4 weeks prior to and for the duration of Study 2. Patients continued to receive assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. The major efficacy outcome of the study was investigator-assessed PFS evaluated according to RECIST 1.1.

Patients enrolled in this study had a median age of 57 years (range 29 to 88). The majority of patients on study were White (74%), all patients had an ECOG PS of 0 or 1, and 80% were postmenopausal. All patients had received prior systemic therapy, and 75% of patients had received a previous chemotherapy regimen. Twenty-five percent of patients had received no prior therapy in the metastatic disease setting, 60% had visceral metastases, and 23% had bone only disease.

The results from the investigator-assessed PFS from Study 2 are summarized in Table 9 and Figure 2. Consistent results were observed across patient subgroups of disease site, sensitivity to prior hormonal therapy, and menopausal status. The OS data were not mature at the time of the final PFS analysis (11% of patients had died). Patients will continue to be followed for the final analysis.

Table 9. Efficacy Results – Study 2 (Investigator Assessment, Intent-to-Treat Population)
IBRANCE plus Fulvestrant Placebo plus Fulvestrant
CI=confidence interval; ITT=Intent-to-Treat; N=number of patients.
*
Response based on confirmed responses.
Progression-free survival for ITT N=347 N=174
  Number of PFS events (%) 145 (41.8%) 114 (65.5%)
  Median progression-free survival (months, 95% CI) 9.5 (9.2, 11.0) 4.6 (3.5, 5.6)
  Hazard ratio (95% CI) and p-value 0.461 (0.360, 0.591), p < 0.0001
Objective Response for patients with measurable disease N=267 N=138
  Objective response rate* (%, 95% CI) 24.6 (19.6, 30.2) 10.9 (6.2, 17.3)
                                    FUL=fulvestrant; PAL=palbociclib; PCB=placebo.
Figure 2. Kaplan-Meier Plot of Progression-Free Survival – Study 2 (Investigator Assessment, Intent-to-Treat Population)
Figure 2

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