Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tomivosertib · 1 trial · 1 indication
Defined as the time from randomization to the first occurrence of disease progression as assessed by the Investigator using RECIST 1.1 or death from any cause, whichever occurs earlier.
Defined as the time from randomization to the first occurrence of disease progression as assessed by the Investigator using RECIST 1.1 or death from any cause, whichever occurs earlier.
Defined as the time from randomization to the first occurrence of disease progression as assessed by the Investigator using RECIST 1.1 or death from any cause, whichever occurs earlier.
| Arm | Type | Description |
|---|---|---|
| A1 Tomi + Current Pembro | EXPERIMENTAL | Subjects who have initiated pembrolizumab as a single agent and in accordance with the package insert will receive tomivosertib in addition to pembrolizumab. |
| Pbo + Current Pembro | PLACEBO_COMPARATOR | Subjects who have initiated pembrolizumab as a single agent and in accordance with the package insert, will receive matching placebo in addition to pembrolizumab. |
| B1 Tomi + Pembro | EXPERIMENTAL | Subjects will initiate pembrolizumab as first-line therapy and receive tomivosertib. |
| Pbo + Pembro | PLACEBO_COMPARATOR | Subjects will initiate pembrolizumab as first-line therapy and receive matching placebo. |
| C1 Tomi + Pembro + Pemetrexed (Non-sqamous) or Tomi + Pembro (Squamous) | EXPERIMENTAL | Subjects who have completed 4 to 6 cycles of platinum-based chemotherapy doublet will receive tomi plus pembrolizumab and pemetrexed (non-squamous NSCLC) or tomi plus pembro as a single agent (squamous) in accordance with the package insert. |
| Pbo + Pembro + Pemetrexed (Non-sqamous) or Pbo + Pembro (Squamous) | PLACEBO_COMPARATOR | Subjects who have completed 4 to 6 cycles of platinum-based chemotherapy doublet will receive placebo plus pembrolizumab and pemetrexed (non-squamous NSCLC) or placebo plus pembro as a single agent (squamous) in accordance with the package insert. |
| Name | Type | Description |
|---|---|---|
| Tomivosertib | DRUG | Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals |
| Pembrolizumab | BIOLOGICAL | Subjects will initiate or continue to receive pembrolizumab at either 200 mg intravenously (IV) at a frequency of every 3 weeks or 400 mg IV at a frequency of every 6 weeks. |
| Pemetrexed | DRUG | Subjects will initiate pemetrexed at 500 mg/m2 intravenously (IV) at a frequency of every 3 weeks. |
Inclusion Criteria: Inclusion Criteria for Cohort A: Subjects who meet all of the following criteria will be eligible to participate in Cohort A of the study: 1\. Have initiated first-line therapy for NSCLC with pembrolizumab and satisfy the following: * Have tumor PD-L1 ≥1% by 22C3 IHC; * Are ju...
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Tomivosertib is an investigational small molecule being studied for the treatment of non-small cell lung cancer (NSCLC). It is currently in Phase 2 clinical development, specifically in combination with pembrolizumab for patients with PD-L1 positive NSCLC.
Tomivosertib is being developed by Icon Plc, a company listed on the stock exchange under the ticker ICLR. The drug is currently in Phase 2 clinical trials for non-small cell lung cancer.
Tomivosertib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants.
Tomivosertib is being evaluated in a Phase 2 clinical trial with the identifier NCT04622007, titled 'Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART)'. The trial is a randomized, double-blind, placebo-controlled study with an enrollment of 68 participants.
Tomivosertib is also known by its investigational name and is being studied under the trial name KICKSTART. No other alternative names have been reported for this drug.