Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Navarixin · 4 trials · 7 indications
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was estimated using an exact method based on the binomial distribution, and the 95% confidence interval was estimated by the method of Clopper-Pearson.
The following toxicities are considered a DLT, assessed as related to study treatment: Grade 4 non-hematologic toxicity, Grade 4 anemia, Grade 3 anemia lasting \>7 days or requiring transfusion, Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia, a) Grade 4 thrombocytopenia of any duration, b) Grade 3 thrombocytopenia associated with bleeding, Grade 3 non-hematologic toxicity lasting \>3 days, any Grade 3 or Grade 4 non-hematologic laboratory value if: medical intervention is required or the abnormality leads to hospitalization or persists for \>72 hours, Liver test abnormalities: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3X Upper Limit of Normal (ULN) with total bilirubin (TBL) \>2X ULN with no elevation in alkaline phosphatase (AP \<2X ULN), Grade 3 or Grade 4 febrile neutropenia, inability to administer ≥75% of the planned navarixin dose due to drug-related tolerability, delay in Cycle 2 start by \>2 weeks due to toxicity
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
This is a measure of the Late Asthmatic Response (LAR) between 3 and 7 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. A percent change \>0 indicates a fall in FEV1 after allergen challenge. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).
Peripheral blood neutrophil counts were performed on Day 2 and Weeks 1, 2, 3, and 4 of the treatment period
PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).
| Arm | Type | Description |
|---|---|---|
| Navarixin 30 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received 30 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years |
| Navarixin 100 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received 100 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years). |
| Navarixin → Placebo | EXPERIMENTAL | Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2 |
| Placebo → Navarixin | EXPERIMENTAL | Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2 |
| Navarixin | EXPERIMENTAL | Navarixin (MK-7123, SCH 527123) 30 mg capsule, to be taken by mouth once daily in the morning for 4 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo capsule to match navarixin, to be taken by mouth once daily in the morning for 4 weeks |
| Name | Type | Description |
|---|---|---|
| Navarixin | DRUG | Oral capsules |
| Pembrolizumab | BIOLOGICAL | Intravenous infusion |
| Placebo | DRUG | Matching capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2 |
| Rescue medication | DRUG | Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms |
| Navarixin 10 mg | DRUG | Navarixin capsules orally, once daily for 28 days. |
Inclusion Criteria: All Participants * Has one of the following histologically- or cytologically-confirmed advanced/metastatic solid tumors: NSCLC, CRPC, or MSS CRC, by pathology report and has received, or been intolerant to, or has been ineligible for all treatment known to confer clinical benef...
Navarixin is an investigational small molecule being studied for use in neutrophilic asthma, asthma, psoriasis, and selected advanced or metastatic solid tumors, including non-small cell lung cancer, castration resistant prostate cancer, and microsatellite stable colorectal cancer. It is in Phase 2 clinical development.
Navarixin is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy across several indications.
Navarixin is in Phase 2 clinical development. It is investigational and has not been approved by regulatory authorities. All completed trials listed are Phase 2 studies, and the drug remains under clinical investigation.
Navarixin has been studied in several completed Phase 2 trials, including NCT00632502 for neutrophilic asthma, NCT00684593 for psoriasis, NCT00688467 for allergen-induced asthma, and NCT03473925 for solid tumors in combination with pembrolizumab.
Yes, Navarixin is also known as MK-7123 and SCH 527123. Clinical trial records reference these alternative names, such as in the study titles for neutrophilic asthma and solid tumors.