Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Iniparib · 10 trials · 10 indications
Progression free survival was defined as the time interval from the date of randomization to the date of first disease progression (as assessed by Independent Radiologic Review (IRR) based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria), or the date of death due to any cause, whichever occurred first. In the absence disease progression or death, the participant was censored at the date of the last valid tumor assessment performed before the cut-off date.
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, participant was censored at the last date he/she was known to be alive, or at the cut-off date, whichever was earlier.
Proportion of participants with confirmed complete response (CR) or partial response (PR) as confirmed by an Independent Radiology Review Committee (IRRC) based on central review of scans in a blinded manner.
Best overall response was defined as the best evaluation observed through the entire treatment period based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria.
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria.
Clinical benefit rate was defined as the percentage of patients with complete response, partial response or stable disease ≥6 months.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions: * Drug: Iniparib monotherapy * Drug: Iniparib + gemcitabine + carboplatin * Drug: Iniparib + topotecan * Drug: Iniparib + irinotecan * Drug: Iniparib + paclitaxel * Drug: Iniparib + liposomal doxorubicin + carboplatin |
| Arm G/C | ACTIVE_COMPARATOR | gemcitabine/carboplatin on Days 1 and 8 of 21-day cycle(s) |
| Arm G/C/I | EXPERIMENTAL | gemcitabine/carboplatin on Days 1 and 8, plus iniparib on Days 1, 4, 8, and 11 of 21-day cycle(s) |
| SAR240550 twice weekly/ paclitaxel weekly | EXPERIMENTAL | SAR240550 will be administered at the dose of 5.6mg/kg as a 60-min intravenous (IV) infusion. Patients will receive SAR240550 infusions twice weekly (day 1 and day 4; total dose of 11.2mg/kg per week) and paclitaxel weekly as a 60-min IV infusion (day 1; dose of 80mg/m2). |
| SAR240550 weekly/ paclitaxel weekly | EXPERIMENTAL | SAR240550 will be administered at the dose of 11.2 mg/kg as a 60-min intravenous (IV) infusion. Patients will receive SAR240550 infusions once weekly (day 1; total dose of 11.2mg/kg per week) and paclitaxel weekly as a 60-min IV infusion (day 1; dose of 80mg/m2). |
| Paclitaxel alone | ACTIVE_COMPARATOR | Paclitaxel will be administered at the dose of 80mg/m2 as a 60-min IV infusion. Patients will receive weekly (day 1) paclitaxel infusions. |
| Iniparib/ Gemcitabine/ Cisplatin | EXPERIMENTAL | Iniparib, 5.6 mg/kg, 60-min IV infusion twice weekly (days 1, 4, 8, and 11). Infusion starts after completion of GC regimen administration. Gemcitabine, 1250 mg/m2, 30-min IV infusion on day 1 and day 8 and cisplatin 75mg/m², 3- to 4-hour IV infusion on day 1 of each 3-week cycle after the end of gemcitabine infusion. |
| Gemcitabine/ Cisplatin | ACTIVE_COMPARATOR | Gemcitabine, 1250 mg/m2, 30-min IV infusion on day 1 and day 8 and cisplatin 75mg/m², 3- to 4-hour IV infusion on day 1 of each 3-week cycle after the end of gemcitabine infusion. |
| Gencitabine + iniparib twice weekly | EXPERIMENTAL | Gemcitabine, 1000 mg/m² IV over 30 minutes and carboplatin, area under the curve (AUC) = 2, IV over 60 minutes, both on Days 1 and 8 of 3-week cycles. Iniparib, 5.6 mg/kg IV over 60 minutes on Days 1, 4, 8 and 11 of 3-week cycles |
| Gencitabine + iniparib weekly | EXPERIMENTAL | Gemcitabine, 1000 mg/m² IV over 30 minutes and carboplatin, area under the curve (AUC) = 2, IV over 60 minutes, both on Days 1 and 8 of 3-week cycles. Iniparib, 11.2 mg/kg IV over 60 minutes on Days 1 and 8 of 3-week cycles |
| Iniparib | EXPERIMENTAL | Iniparib, twice weekly on Days 1 and 4 of each week during 8-week cycles |
| Iniparib, single agent | EXPERIMENTAL | Iniparib will be initially administered intravenously once weekly (days 1, 8, and 15) for 3 weeks, in a 21-day cycle. Then, iniparib will be administered twice weekly (days 1, 4, 8, 11, 15, and 18) in a 21-day cycle. Cycle1 (day 1 thru day 21) will be defined as the dose limiting toxicities (DLT) observation period. Starting dose is 15 mg/kg once weekly. |
| Iniparib/Gemcitibine/Carboplatin | EXPERIMENTAL | Gemcitabine/carboplatin (GC) : Gemcitabine will be administered at 1,000 mg/m² as a 30min IV infusion and carboplatin area under the curve (AUC) 2 as a 60min IV infusion. Patients will receive gemcitabine/carboplatin infusions once weekly (days 1 and 8). Iniparib will be administered for two weeks, followed by a 1week of rest in a 21-day cycle (weekly schedule: days 1 and 8; twice weekly schedule: days: 1, 4, 8 and 11). |
| Iniparib/Paclitaxel | EXPERIMENTAL | Paclitaxel (P): Paclitaxel will be administered at the dose of 80 mg/m2 as a 60-minute intravenous infusion administered on days 1, 8, and 15 followed by a 1week of rest. Iniparib will be administered for three weeks, followed by 1week of rest in a 28-day cycle (weekly schedule: days 1, 8 and 15; twice weekly schedule: days 1, 4, 8, 11, 15 and 18). |
| Iniparib/Pegylated liposomal doxorubicin/Carboplatin | EXPERIMENTAL | Pegylated liposomal doxorubicin (Doxil)/Carboplatin (PLD) : Doxil will be administered at 30 mg/m² as a 30min IV infusion and carboplatin AUC 4 as a 60min IV infusion on day 1 every four weeks. Iniparib will be administered for two weeks in a 28-day cycle (weekly schedule: days 1, and 8; twice weekly schedule: days 1, 4, 8, and 11). |
| SAR240550 | EXPERIMENTAL | * single cohort: SAR240550 * combination cohort: SAR240550 in combination with Gemcitabine and Carboplatin |
| Name | Type | Description |
|---|---|---|
| Iniparib (SAR240550/BSI-201) | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Carboplatin | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Doxorubicin HCL liposome injection | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Gemcitabine | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Irinotecan | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Paclitaxel | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Topotecan | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| gemcitabine/carboplatin | DRUG | Gemcitabine 1000 mg/m2 intravenous infusion (30 ± 10 minutes) Carboplatin AUC 2 intravenous infusion (30 ± 10 minutes or 60 ± 10 minutes) |
| Iniparib | DRUG | Body weight adjusted dose intravenous infusion (60 ± 10 minutes) |
| Iniparib (SAR2405550 -BSI-201) | DRUG | Pharmaceutical form : solution for infusion Route of administration :Intravenous |
| cisplatin | DRUG | Pharmaceutical form: solution for infusion Route of administration: 1- to 4-hour IV infusion, according to the local standard |
| Iniparib (SAR240550-BSI-201) | DRUG | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
| Placlitaxel | DRUG | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
| Pegylated liposomal doxorubicin | DRUG | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
| Iniparib (SAR240550 - BSI-201) | DRUG | Pharmaceutical form:sterile aqueous solution Route of administration: intravenous |
Inclusion criteria : * Cancer patients greater than 18 years of age who have completed all assessments required to meet the primary objectives of a parental phase 1, 2 or 3 clinical study of iniparib as monotherapy or in a combination regimen. * Previously received and are continuing to derive clin...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
INIPARIB+ irinotecan is an investigational oncology combination being studied for advanced solid tumors, breast cancer in females, malignant neoplasms, and primary peritoneal cancer. It is a small molecule therapeutic developed by Sanofi. The drug is currently in clinical development and has not been approved by regulatory authorities.
INIPARIB is a PARP inhibitor, and when combined with irinotecan, a topoisomerase I inhibitor, the combination targets DNA repair pathways in cancer cells. This mechanism is being evaluated in clinical trials for various solid tumors and breast cancers. The combination is designed to exploit vulnerabilities in tumor cells' DNA damage response.
INIPARIB+ irinotecan is developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this combination therapy in oncology indications.
INIPARIB+ irinotecan is in Phase 2 clinical development. The drug is investigational and has not received FDA approval. Sanofi has completed two trials for this combination, with a total enrollment of 642 patients across studies in advanced solid tumors and breast cancer.
INIPARIB+ irinotecan has been studied in two completed trials: NCT00540358, a Phase 2 study in triple negative metastatic breast cancer, and NCT00938652, a Phase 3 study of gemcitabine/carboplatin with or without BSI-201 in metastatic breast cancer. Both trials enrolled female patients in the United States.
Yes, INIPARIB is also known as BSI-201, as referenced in clinical trial titles. The combination INIPARIB+ irinotecan is being studied in oncology indications. Sanofi has conducted trials using the BSI-201 designation for this PARP inhibitor in breast cancer and advanced solid tumors.