pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
---|
advanced breast cancer (metastatic) | abemaciclib | not classified | versus endocrine therapy alone Abemaciclib +nsAI superior to nsAI in terms of progression free survival in MONARCH 3, 2017 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
MONARCH 3, 2017 | Abemaciclib +nsAI vs nsAI | progression free survival 0.54 [0.41; 0.72] median not reached vs. 14.7 mo Demonstrated | | |
Trial | Treatments | Patients | Method |
---|
MONARCH 3, 2017 | Abemaciclib (LY2835219) + nonsteroidal aromatase inhibitors (nSAI) (n=493) vs. Placebo + NSAI (n=0) | Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
| double-blind Parallel groups Sample size: 493/0 Primary endpoint: PFS FU duration: |
|
advanced breast cancer (metastatic) | palbociclib | not classified | versus endocrine therapy alone No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
PALOMA 1/TRIO-18, 2015 | palbociclib + letrozole vs letrozole alone | progression free survival 0.49 [0.32; 0.75] | | |
Trial | Treatments | Patients | Method |
---|
PALOMA 1/TRIO-18, 2015 | continuous oral letrozole 2.5 mg daily plus oral palbociclib 125 mg, given once daily for 3 weeks followed by 1 week off over 28-day cycles (n=84) vs. continuous oral letrozole 2.5 mg daily (n=81) | postmenopausal women with advanced oestrogen receptor-positive and HER2-negative breast cancer who had not received any systemic treatment for their advanced disease | open-label Parallel groups Sample size: 84/81 Primary endpoint: investigator-assessed progression-free survival FU duration: phase 2 |
|
advanced breast cancer (metastatic) | palbociclib | 2nd line | versus endocrine therapy alone palbociclib + fulvestrant superior to fulvestrant alone in terms of progression free survival in PALOMA 3, 2015 (2nd line patients) | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
PALOMA 3, 2015 | palbociclib + fulvestrant vs fulvestrant alone | progression free survival 0.42 [0.32; 0.56] median 9.2 mo vs. 3.8 mo Demonstrated | | |
Trial | Treatments | Patients | Method |
---|
PALOMA 3, 2015 | palbociclib (125 mg per day orally for 3 weeks,
followed by 1 week off) and fulvestrant (500 mg
intramuscularly per standard of care every 14 days
for the first three injections and then every
28 days) (n=347) vs. placebo and fulvestrant (n=174) | women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy | double-blind Parallel groups Sample size: 347/174 Primary endpoint: investigator-assessed PFS FU duration: |
|
advanced breast cancer (metastatic) | palbociclib | first line | versus endocrine therapy alone palbociclib + letrozole superior to letrozole alone in terms of progression free survival in PALOMA-2, 2016 (first line patients) | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
PALOMA-2, 2016 | palbociclib + letrozole vs letrozole alone | progression free survival 0.58 [0.46; 0.73] median 24.8 mo vs. 14.5 mo Demonstrated | | |
Trial | Treatments | Patients | Method |
---|
PALOMA-2, 2016 | PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).) (n=666) vs. Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously (n=0) | postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease | double-blind Parallel groups Sample size: 666/0 Primary endpoint: PFS FU duration: |
|
advanced breast cancer (metastatic) | ribociclib | first line | versus endocrine therapy alone ribociclib (LEE011) + letrozole superior to letrozole alone in terms of progression free survival in MONALEESA-2, 2016 (first line patients) | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
MONALEESA-2, 2016 | ribociclib (LEE011) + letrozole vs letrozole alone | progression free survival 0.56 [0.43; 0.72] median not reached vs. 14.7 mo Demonstrated | | |
Trial | Treatments | Patients | Method |
---|
MONALEESA-2, 2016 | ribociclib
(600 mg per day on a 3-weeks-on, 1-week-off schedule) plus letrozole (2.5 mg per
day) (n=334) vs. placebo + letrozole (n=334) | postmenopausal women with HR-positive, HER2-negative recurrent
or metastatic breast cancer who had not received previous systemic therapy
for advanced disease | double-blind Parallel groups Sample size: 334/334 Primary endpoint: PFS FU duration: 18 months OS data were not mature at the time of the PFS interim analysis.
No treatment
crossover was allowed. |
|
lung cancer (metastatic) | abemaciclib | 2nd line | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
| T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
JUNIPER, 2018 | 200 mg of abemaciclib orally twice daily (n=453) vs. 150 mg of erlotinib (n=0) | patients with stage IV NSCLC with a detectable KRAS mutation who progressed after platinum-based chemotherapy and who may have received 1 additional systemic therapy | open-label Parallel groups Sample size: 453/0 Primary endpoint: OS FU duration: phase 3 |
|