Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JDQ443
Opnurasib · 7 trials · 24 indications
PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is based on central assessment and using RECIST 1.1 criteria.
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the Investigator in Cohort A.
The number of participants enrolled and receiving opnurasib as single agent or in combination with other study treatments under the rollover study, will be summarized by treatment arm.
The duration of exposure in months to opnurasib and the combination partner will be summarized by means of descriptive statistics using the SAS.
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value that is not primarily related to disease, disease progression, intercurrent illness/injury, or concomitant medications that occurs within the first 28 days of study treatment and meets a defined criteria.
All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs).
The number of patients with dose adjustments (reductions and interruptions) will be summarized by treatment group.
Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of response.
ORR is the proportion of patients with a best overall response (BOR) of Complete Response (CR) or Partial Response (PR).
Blood samples will be collected for pharmacokinetics characterization. AUClast will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Blood samples will be collected for pharmacokinetics characterization. AUCinf will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Blood samples will be collected for pharmacokinetics characterization. Cmax will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Blood samples will be collected for pharmacokinetics characterization. Tmax will be calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics
Blood samples will be collected for pharmacokinetics characterization. Tlag will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Blood samples will be collected for pharmacokinetics characterization. T1/2 will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Blood samples will be collected for pharmacokinetics characterization. CL/F will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Blood samples will be collected for pharmacokinetics characterization. Vz/F will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Blood samples will be collected for pharmacokinetics characterization. AUC0-t will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Blood samples will be collected for pharmacokinetics characterization. Tlast will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment
All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs).
Overall response rate is defined as the proportion of patients with a BOR of CR or PR according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI). Applies to all groups except the brain metastasis group.
OIRR per mRANO-BM is defined as the proportion of participants with a best overall intracranial response (BOIR) of CR or PR according to mRANO-BM criteria, and will be summarized along with the corresponding 90% and 95% exact CI. Applies to brain metastasis group only.
All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs). Applies to JDQ443 dose randomization group only.
Tolerability of study drug will be assessed by summarizing the number of and reason for dose delays and dose reductions. Applies to JDQ443 dose randomization group only.
Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of treatment. Applies to JDQ443 dose randomization group only
Overall response rate is defined as the proportion of patients with BOR of CR or PR according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI). Applies to JDQ443 dose randomization group only
| Arm | Type | Description |
|---|---|---|
| JDQ443 | EXPERIMENTAL | Participants will be treated with JDQ443 |
| Docetaxel | ACTIVE_COMPARATOR | Participant will be treated with docetaxel following local guidelines as per standard of care and product labels |
| Neoadjuvant therapy (JDQ443) followed by surgery. (ARM CLOSED) | EXPERIMENTAL | If \*MPR/cPR\* - standard of care adjuvant treatment may be followed by experimental adjuvant therapy (JDQ443) \*Major Pathological Response (MPR)/ Complete Pathological Response (cPR) |
| Cohort A- PD-L1<1% | EXPERIMENTAL | Participants whose tumors harbor a KRAS G12C mutation and a PD-L1 expression \< 1%, regardless of STK11 mutation status. |
| Cohort B- PD-L1≥ 1% and STK11 mutation | EXPERIMENTAL | Participants whose tumors harbor a KRAS G12C mutation, a PD-L1 expression ≥ 1% and an STK11 co-mutation. |
| Group 1: opnurasib single agent | EXPERIMENTAL | Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study. |
| Group 2: opnurasib + TNO155 | EXPERIMENTAL | Eligible participants will receive the same starting dose and regimen of opnurasib and any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study. |
| Group 3: opnurasib + trametinib | EXPERIMENTAL | Eligible participants will receive the same starting dose and regimen of opnurasib and any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study. |
| Group 4: opnurasib + cetuximab | EXPERIMENTAL | Eligible participants will receive the same starting dose and regimen of opnurasib and any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study. |
| Group 5: opnurasib + tislelizumab | EXPERIMENTAL | Eligible participants will receive the same starting dose and regimen of opnurasib and any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study. |
| JDQ443+trametinib | EXPERIMENTAL | JDQ443 in combination with trametinib |
| JDQ443+ribociclib | EXPERIMENTAL | JDQ443 in combination with ribociclib |
| JDQ443+cetuximab | EXPERIMENTAL | JDQ443 in combination with cetuximab |
| Normal hepatic function | EXPERIMENTAL | Matched healthy participants with normal hepatic function |
| Mild hepatic impairment | EXPERIMENTAL | Mild hepatic impaired participants with Child-Pugh A (score of 5 to 6) |
| Moderate hepatic impairment | EXPERIMENTAL | Moderate hepatic impairment with Child Pugh B (score from 7 to 9) |
| Severe hepatic impairment | EXPERIMENTAL | Severe hepatic impairment with Child Pugh C (score from 10 to 15) |
| Arm A | EXPERIMENTAL | JDQ443 |
| Arm B | EXPERIMENTAL | JDQ443 in combination with TNO155 |
| Arm C | EXPERIMENTAL | JDQ443 in combination with tislelizumab |
| Arm D | EXPERIMENTAL | JDQ443 in combination with TNO155 and tislelizumab |
| Name | Type | Description |
|---|---|---|
| JDQ443 | DRUG | JDQ443 tablets, orally administered |
| docetaxel | DRUG | docetaxel concentrated solution for infusion, intravenously administered |
| Opnurasib | DRUG | Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study. |
| TNO155 | DRUG | Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study. |
| trametinib | DRUG | Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study. |
| cetuximab | BIOLOGICAL | Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study. |
| tislelizumab | BIOLOGICAL | Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study. |
| Ribociclib | DRUG | CDK4/6 inhibitor, oral |
Inclusion Criteria: * Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV) * Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novartis designated central laboratory or by accepted local tests. * Pa...
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Opnurasib is an investigational small molecule oncology drug being developed by Novartis AG for KRAS G12C mutant solid tumors. It is being studied in KRAS G12C-mutated non-small cell lung cancer and other advanced solid tumors harboring the KRAS G12C mutation. It is not yet approved and remains in clinical development.
Opnurasib targets KRAS G12C, a mutant form of the KRAS protein. By binding this specific mutant target, the drug is designed to act on tumors that carry the KRAS G12C mutation. Its clinical program selects patients based on this biomarker, including KRAS G12C-mutated non-small cell lung cancer and other advanced solid tumors.
Opnurasib is developed by Novartis AG, which trades under the ticker NVS. Novartis is running the clinical program for the drug, including studies in KRAS G12C-mutated non-small cell lung cancer and other advanced solid tumors harboring the KRAS G12C mutation.
Opnurasib is in Phase 1 and Phase 2 clinical development. It is investigational and has not been approved by the FDA. The program includes a Phase 2 first-line study in KRAS G12C-mutated non-small cell lung cancer and Phase 1 combination and rollover studies.
Opnurasib is being studied in several trials, including NCT05445843, a Phase 2 first-line study in KRAS G12C-mutated non-small cell lung cancer; NCT05358249, a Phase 1 platform study of combinations in advanced solid tumors with the KRAS G12C mutation; NCT07468071, a Phase 1 rollover study; and NCT05714891, a Phase 2 neoadjuvant platform trial in non-small cell lung cancer.
Yes, Opnurasib is also known as JDQ443. Both names refer to the same investigational KRAS G12C-targeted small molecule developed by Novartis AG. The clinical trials for this drug are listed under both names, including the Phase 2 study NCT05445843, which uses the JDQ443 designation.