Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LCL161 · 4 trials · 4 indications
pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on Bayesian design using a binomial distribution for the data with a beta prior. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). Median values are posterior medians of pCR rate for each group.
To assess the number of patients who experienced a pathological response in breast.
pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on the posterior distribution of the difference in pCR rates between the experimental and control arms of the study, within each gene expression signature group.The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.
Type and frequency of adverse events of oral LCL161 when administered in combination with weekly paclitaxel
| Arm | Type | Description |
|---|---|---|
| Paclitaxel with LCL161 | EXPERIMENTAL | Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm. |
| Paclitaxel without LCL161 | ACTIVE_COMPARATOR | Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm. |
| LCL161 | EXPERIMENTAL | Dose escalation part: Eligible patients will start to receive oral LCL161 once a week and will receive weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour, in combination with LCL161 from cycle 2. Dose expansion part: Eligible patients will receive oral LCL161 at the maximum tolerated dose and/or recommended dose in combination with weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour from cycle 1. |
| LCL161 + Paclitaxel | EXPERIMENTAL | - |
| Weekly dosing of LCL161 | EXPERIMENTAL | by mouth (oral) |
| Comparison of LCL161 | EXPERIMENTAL | tablet versus liquid |
| Twice daily dosing of LCL161 | EXPERIMENTAL | by mouth for 4 days followed by a 3-day rest period every week |
| Name | Type | Description |
|---|---|---|
| LCL161 | DRUG | LCL161 was available as 300 mg, tablets, which was supplied in child-resistant bottles. |
| paclitaxel | DRUG | Commercially available paclitaxel was sourced locally by each study site. Generic paclitaxel could be used for study treatment. iv 80mg/m2 |
Inclusion Criteria: * Histologically confirmed diagnosis of invasive triple negative breast cancer * Known status for the LCL161 predictive gene expression signature as determined during molecular pre-screening * Candidates for mastectomy or breast-conserving surgery * Primary tumor of greater than...
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LCL161 is an investigational small molecule being studied for the treatment of breast cancer, advanced solid tumors, neoplasms, and solid tumors. It has been evaluated in clinical trials for these oncology indications, including a Phase 2 study in patients with triple negative breast cancer.
LCL161 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis has sponsored clinical trials of LCL161 in patients with various solid tumors and breast cancer.
LCL161 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 study was a randomized neoadjuvant trial in patients with triple negative breast cancer. All trials listed for LCL161 are completed, and the drug remains investigational, not approved by regulatory authorities.
LCL161 has been studied in four completed clinical trials. These include NCT01098838, a Phase 1 safety and efficacy study in advanced solid tumors; NCT01240655, a Phase 1 study combining LCL161 with weekly paclitaxel; NCT01617668, a Phase 2 neoadjuvant study in triple negative breast cancer; and NCT01968915, a Phase 1 study in Japanese patients with advanced solid tumors.
LCL161 is not known to have alternative names. It is referred to solely as LCL161 in clinical trial records and by its developer, Novartis AG. No other names for this investigational drug have been reported.