Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Abemaciclib
LY3819253 · 2 trials · 1 indication
COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.
SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load \>=5.27 vs otherwise.
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral load and is unitless.
An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.
Mean Concentration of Bamlanivimab in the presence of Etesevimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Mean Concentration of Etesevimab in the presence of Bamlanivimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
AUC0-∞ for Bebtelovimab was reported.
An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| LY3819253 | EXPERIMENTAL | 700 mg, 2800 mg, 7000 mg, LY3819253 administered intravenously (IV) |
| LY3819253 + LY3832479 | EXPERIMENTAL | 350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ) |
| LY3819253 + LY3832479 (Pediatric Addendum, Arm 22) | EXPERIMENTAL | LY3819253 dose based upon weight (weight Group: ≥40 kilogram (kg) = 700 mg dose, \>20 kg to \<40 kg = 350 mg dose, \>12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and LY3832479 dose based upon weight (weight Group: ≥40 kg = 1400 mg dose, \>20 kg to \<40 kg = 700 mg dose, \>12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV. |
| LY3853113 (Pediatric Addendum, Arm 23) | EXPERIMENTAL | LY3853113 dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, \>12 to ≤20 kg = 43.75 mg dose, \>20 to \<40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered IV |
| Name | Type | Description |
|---|---|---|
| LY3819253 | DRUG | Administered IV |
| LY3832479 | DRUG | Administered IV |
| LY3853113 | DRUG | Administered IV |
| Placebo | DRUG | Administered IV |
Inclusion Criteria: * Are currently not hospitalized. (Not applicable to participants in treatment arm 22.) * Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (Not applica...
Abemaciclib is an investigational small molecule being studied for multiple oncology indications, including breast neoplasms, advanced digestive system neuroendocrine neoplasm, triple negative breast neoplasms, non-small cell lung carcinoma, and castration-resistant prostate carcinoma. It is currently in Phase 2 clinical development.
Abemaciclib is a CDK inhibitor, belonging to the -ciclib class of drugs. It targets cyclin-dependent kinases, which are involved in cell cycle regulation. This mechanism is being explored in various cancer types, including breast cancer and non-small cell lung cancer.
Abemaciclib is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The drug is currently in Phase 2 clinical trials for multiple oncology indications.
Abemaciclib is currently in Phase 2 clinical development. While some trials have been completed, it remains an investigational drug and has not been approved by regulatory authorities. It is being studied for various cancers, including breast neoplasms and non-small cell lung carcinoma.
Abemaciclib has been studied in several clinical trials, including NCT01394016, a Phase 1 study in advanced cancer; NCT02107703, a Phase 3 study in hormone receptor positive HER2 negative breast cancer; NCT02919696, a Phase 1 study in Chinese participants with advanced cancers; and NCT04071262, a Phase 1 study in Japanese participants.
Yes, Abemaciclib is also known as LY2835219. Clinical trial records often refer to the drug by this alternative name, such as in the Phase 1 study NCT01394016 titled 'A Phase 1 Study of LY2835219 In Participants With Advanced Cancer'.