| Abemaciclib | advanced breast cancer (metastatic), in all type of patients | vs nsAI | progression or death (progression free survival PFS) by 46% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.54 [0.41 0.72] | p=0.04 | 0 | 450 | 1 | MONARCH 3, |
| Trial | Studied treatment | Control | Patients |
|---|
| MONARCH 3, 2017 | Abemaciclib (LY2835219) + nonsteroidal aromatase inhibitors (nSAI) | Placebo + NSAI | Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
|
| |
| Abemaciclib | advanced breast cancer (metastatic), in HR+ HER2- | vs nsAI | progression or death (progression free survival PFS) by 46% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.54 [0.41 0.72] | p=0.04 | 0 | 450 | 1 | MONARCH 3, |
| Trial | Studied treatment | Control | Patients |
|---|
| MONARCH 3, 2017 | Abemaciclib (LY2835219) + nonsteroidal aromatase inhibitors (nSAI) | Placebo + NSAI | Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
|
| |
| Abemaciclib | lung cancer (metastatic), in all type of patients | vs erlotinib | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| Trial | Studied treatment | Control | Patients |
|---|
| JUNIPER, 2018 | 200 mg of abemaciclib orally twice daily | 150 mg of erlotinib | 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 |
| |
| Palbociclib | advanced breast cancer (metastatic), in all type of patients | vs fulvestrant alone | progression or death (progression free survival PFS) by 58% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.42 [0.32 0.56] | p=0.04 | 0 | 521 | 1 | PALOMA 3, |
| Trial | Studied treatment | Control | Patients |
|---|
| 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) | placebo and fulvestrant | women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy |
| |
| Palbociclib | | vs letrozole alone | progression or death (progression free survival PFS) by 44% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.56 [0.46 0.68] | p=0.04 | 0 | 815 | 2 | PALOMA-2, PALOMA 1/TRIO-18, |
| Trial | Studied treatment | Control | Patients |
|---|
| 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).) | 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 | postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease | | 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 | continuous oral letrozole 2.5 mg daily | postmenopausal women with advanced oestrogen receptor-positive and HER2-negative breast cancer who had not received any systemic treatment for their advanced disease |
| |
| Palbociclib | advanced breast cancer (metastatic), in HR+ HER2- | vs fulvestrant alone | progression or death (progression free survival PFS) by 58% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.42 [0.32 0.56] | p=0.04 | 0 | 521 | 1 | PALOMA 3, |
| Trial | Studied treatment | Control | Patients |
|---|
| 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) | placebo and fulvestrant | women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy |
| |
| Palbociclib | | vs letrozole alone | progression or death (progression free survival PFS) by 44% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.56 [0.46 0.68] | p=0.04 | 0 | 815 | 2 | PALOMA-2, PALOMA 1/TRIO-18, |
| Trial | Studied treatment | Control | Patients |
|---|
| 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).) | 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 | postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease | | 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 | continuous oral letrozole 2.5 mg daily | postmenopausal women with advanced oestrogen receptor-positive and HER2-negative breast cancer who had not received any systemic treatment for their advanced disease |
| |
| Ribociclib | advanced breast cancer (metastatic), in all type of patients | vs letrozole alone | progression or death (progression free survival PFS) by 44% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.56 [0.43 0.72] | p=0.04 | 0 | 668 | 1 | MONALEESA-2, |
| Trial | Studied treatment | Control | Patients |
|---|
| MONALEESA-2, 2016 | ribociclib
(600 mg per day on a 3-weeks-on, 1-week-off schedule) plus letrozole (2.5 mg per
day) | placebo + letrozole | postmenopausal women with HR-positive, HER2-negative recurrent
or metastatic breast cancer who had not received previous systemic therapy
for advanced disease |
| |
| Ribociclib | advanced breast cancer (metastatic), in HR+ HER2- | vs letrozole alone | progression or death (progression free survival PFS) by 44% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.56 [0.43 0.72] | p=0.04 | 0 | 668 | 1 | MONALEESA-2, |
| Trial | Studied treatment | Control | Patients |
|---|
| MONALEESA-2, 2016 | ribociclib
(600 mg per day on a 3-weeks-on, 1-week-off schedule) plus letrozole (2.5 mg per
day) | placebo + letrozole | postmenopausal women with HR-positive, HER2-negative recurrent
or metastatic breast cancer who had not received previous systemic therapy
for advanced disease |
| |
