Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NKTR-102 · 6 trials · 8 indications
To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis.
Duration of OS was defined as the time from the date of randomisation to the date of death due to any cause. Subjects were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. OS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. Subjects who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Subjects who did not have any follow-up since the date of randomization were censored at the date of randomization.
PFS was defined as the time from the date of randomisation to the date of disease progression (assessed by central radiological review according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) or death due to any cause, whichever comes first. PFS was determined using the intention-to-treat (ITT) population which included all randomized patients who underwent baseline evaluation, with treatment assigned according to randomized arm. For patients whose disease did not progress or who did not die, the PFS time was censored at the time of the last tumor assessment that demonstrated lack of disease progression. For patients who received new anti-cancer therapy, the PFS time was censored at the time of last tumor assessment prior to the new anti-cancer therapy starts.
Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Number of patients with Dose Limiting Toxicities
10 pre-dose and 18 post-dose ECG measurements to evaluate the effect of NKTR-102
| Arm | Type | Description |
|---|---|---|
| NKTR-102 | EXPERIMENTAL | In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle. |
| Treatment of Physician's Choice (TPC) | ACTIVE_COMPARATOR | In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel. |
| Physician's Treatment of Choice | ACTIVE_COMPARATOR | - |
| irinotecan | ACTIVE_COMPARATOR | irinotecan IV every 3 weeks |
| NKTR-102 q14d | EXPERIMENTAL | NKTR-102 |
| NKTR-102 q21d | EXPERIMENTAL | NKTR-102 |
| NKTR-102 100 mg/m2 + Cetuximab | ACTIVE_COMPARATOR | NKTR-102 100 mg/m2 + Cetuximab Arm All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
| NKTR-102 125 mg/m2 + Cetuximab | ACTIVE_COMPARATOR | NKTR-102 125 mg/m2 + Cetuximab Arm All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
| Name | Type | Description |
|---|---|---|
| NKTR-102 | DRUG | - |
| Eribulin | DRUG | - |
| Ixabepilone | DRUG | - |
| Vinorelbine | DRUG | - |
| Gemcitabine | DRUG | - |
| Paclitaxel | DRUG | - |
| Docetaxel | DRUG | - |
| Nab-paclitaxel | DRUG | - |
| Treatment of Physician's Choice (TPC) | DRUG | One of the following Treatment of Physician Choice will be administered per standard of care: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel |
| irinotecan | DRUG | IV every 3 weeks |
| NKTR-102 100 mg/m2 | DRUG | NKTR-102 100 mg/m2 + Cetuximab Arm: All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
| NKTR-102 125 mg/m2 | DRUG | NKTR-102 125 mg/m2 + Cetuximab Arm: All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
| Cetuximab | DRUG | Cetuximab was administered once weekly via a 2-hour IV infusion at a starting dose of 400 mg/m2 on Day 1 and subsequently administered weekly at 250 mg/m2 via a 1-hour infusion thereafter. |
Inclusion Criteria: * Female or male, age ≥ 18 years. * Histologically-confirmed carcinoma of the breast (either the primary or metastatic lesions) for whom single-agent cytotoxic chemotherapy is indicated. Patients may have either measurable or non-measurable disease according to RECIST version 1....
NKTR-102, also known as etirinotecan pegol, is an investigational small molecule being studied for the treatment of several oncology indications, including colorectal cancer, locally recurrent breast cancer, malignant solid tumors, advanced cancer, and metastasis. It is not yet approved and remains in clinical development.
NKTR-102 is a topoisomerase I inhibitor that works by targeting the enzyme topoisomerase I, which is involved in DNA replication. By inhibiting this enzyme, NKTR-102 is designed to interfere with cancer cell division and promote cell death. Its mechanism is being evaluated in clinical trials for various solid tumors.
NKTR-102 is being developed by Nektar Therapeutics, a biopharmaceutical company listed on the NASDAQ under the ticker symbol NKTR. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with certain types of cancer.
NKTR-102 has completed Phase 2 and Phase 3 clinical trials. It is an investigational drug and is not FDA approved. The completed trials include Phase 2 studies in solid tumors and breast cancer, as well as Phase 3 studies in metastatic breast cancer.
NKTR-102 has been studied in several clinical trials, including NCT00598975, a Phase 2 study in combination with cetuximab for refractory solid tumors and colorectal cancer; NCT00802945, a Phase 2 study in metastatic or locally advanced breast cancer; NCT01492101, the BEACON study in locally recurrent or metastatic breast cancer; and NCT02915744, a Phase 3 study in metastatic breast cancer with stable brain metastases.
Yes, NKTR-102 is also known as etirinotecan pegol. The drug is referred to by both names in clinical research and development. It is an investigational small molecule being developed by Nektar Therapeutics for the treatment of various cancers, including breast cancer and colorectal cancer.