Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BYL719 · 4 trials · 5 indications
Overall response rate is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria (Overall Response (OR) = CR + PR). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
A dose-limiting toxicity (DLT) is an adverse event or abnormal laboratory value assessed as being unrelated to disease, disease progression, inter-current illness, or concomitant medications, and that occurs within the first cycle of treatment with BYL719 plus paclitaxel and meets any of the pre-defined criteria.
type, intensity, severity and seriousness of adverse events according to the NCI CTC AE v4.03. Dose interruptions, reductions and dose intensity.
MTD (or RP2D) of oral BYL719 as single agent and in combination with fulvestrant.
| Arm | Type | Description |
|---|---|---|
| BYL719 350 mg QD | EXPERIMENTAL | Patient's tumor must have molecular alteration of the PIK3CA gene. |
| INC280 400 mg BID tab/600 mg BID cap | EXPERIMENTAL | Patient's tumor must have molecular alteration of the c-MET gene. |
| LDK378 750 mg QD | EXPERIMENTAL | Patient's tumor must have ALK or ROS1 gene rearrangement. |
| MEK162 45 mg BID | EXPERIMENTAL | Patient's tumor must have KRAS, NRAS or BRAF mutation. |
| BYL719 and paclitaxel | EXPERIMENTAL | All patients enrolled in the study will receive BYL719 once daily plus weekly paclitaxel |
| BYL719 | EXPERIMENTAL | - |
| BYL719 + fulvestrant | EXPERIMENTAL | In post-menopausal patients with estrogen receptor positive locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene, and in patients whose tumors are have wild-type PIK3CA gene |
| Name | Type | Description |
|---|---|---|
| BYL719 | DRUG | BYL719 was dosed as 350 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take BYL719 exactly as prescribed. |
| INC280 | DRUG | INC280 was dosed as 600 mg (tablet) or 400mg(Capsule) twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to takeINC280 exactly as prescribed. |
| LDK378 | DRUG | LDK378 was dosed as 750 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take LDK378 exactly as prescribed. |
| MEK162 | DRUG | MEK162 was dosed as 45 mg twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take MEK162 exactly as prescribed. |
| Paclitaxel | DRUG | Paclitaxel will be administered once weekly at a dose of 80 mg/m2 i.v. (days 1, 8, 15 and 22) in a 28 day cycle in both dose escalation and expansion. |
| Fulvestrant | DRUG | In adult patients with advanced solid malignancies whose tumors have an alteration (mutation or amplification) of the PIK3CA gene. Fulvestrant is an estrogen receptor antagonist, administered by monthly intramuscular injection |
Inclusion Criteria: * Advanced (stage IIIB or stage IV) NSCLC * Must have specific molecular alterations Exclusion Criteria: * Symptomatic central nervous system (CNS) metastases which are neurologically unstable or requiring increasing doses of steroids within the 4 weeks prior to study entry to...
BYL-719 is an investigational small molecule being studied for use in oncology, including advanced solid tumors with an alteration of the PIK3CA gene, estrogen receptor positive breast cancer, adenocarcinoma lung cancer, squamous cell lung carcinoma, breast cancer, and head and neck neoplasms. It is being developed by Novartis AG.
BYL-719 targets PIK3CA, a gene that encodes the p110 alpha catalytic subunit of phosphatidylinositol 3-kinase. It is being studied in patients whose tumors have an alteration of the PIK3CA gene, as well as in other advanced solid malignancies.
BYL-719 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is an investigational small molecule in clinical development for oncology indications.
BYL-719 is in clinical development, with trials conducted at Phase 1 and Phase 2 stages. The drug is investigational and has not been approved by regulatory authorities. Clinical trials have been completed across multiple studies, including Phase 1 and Phase 2 trials.
BYL-719 has been studied in several completed clinical trials, including NCT01219699, a Phase 1 study in patients with advanced solid malignancies whose tumors have a PIK3CA gene alteration; NCT01387321, a Phase 1 study in Japanese patients with advanced solid tumors; NCT02051751, a Phase 1 study combining BYL719 with paclitaxel in breast and head-and-neck cancer; and NCT02276027, a Phase 2 study in Chinese patients with non-small cell lung cancer.
Yes, BYL-719 and BYL719 refer to the same investigational drug. Both names are used interchangeably in clinical trial documentation and research literature to describe the small molecule being developed by Novartis AG for oncology indications.