On June 9, 2021 eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulation inhibitors (STRIs) for the treatment of cancer, reported that the first patient with non-small cell lung cancer (NSCLC) has been dosed in a Phase 2b trial of tomivosertib in combination with KEYTRUDA (pembrolizumab) (Press release, eFFECTOR Therapeutics, JUN 9, 2021, View Source [SID1234583750]). KICKSTART is a randomized, double-blind, placebo-controlled clinical trial assessing the efficacy and safety of tomivosertib in combination with pembrolizumab, a U.S. Food and Drug Administration (FDA)-approved PD-1 inhibitor, as frontline combination therapy or as an extension of frontline therapy at the first radiographic progression of disease on pembrolizumab therapy alone. Patients enrolled in this trial will have demonstrated biomarker expression of PD-L1 >50% assessed by an FDA-approved diagnostic test. These NSCLC patients are generally the most responsive patient population to immunotherapy and for whom treatment with checkpoint inhibitors as a monotherapy is the standard of care.

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"We observed in our Phase 2a trial of tomivosertib in combination with checkpoint inhibitors that following disease progression, the addition of tomivosertib was correlated with a noted change in tumor trajectory, as well as durable treatment benefit, demonstrating our product candidate’s potential to reverse resistance to checkpoint inhibitors. Furthermore, a retrospective analysis of the Phase 2a data showed that PD-L1 positivity correlated with duration of benefit, supporting use of PD-L1 >50% as a biomarker for patient selection in KICKSTART," said Steve Worland, Ph.D., president and CEO of eFFECTOR. "Based on those encouraging results that substantially extended patient benefit from immunotherapy, we are launching KICKSTART to be focused in both the frontline and frontline-extension settings in combination with pembrolizumab. We designed tomivosertib to down-regulate multiple factors that suppress an immune response and to reprogram T cells to enhance immune response and fight tumors, and ultimately hope to bring a novel and improved treatment option for patients with cancer."

The KICKSTART trial is designed to enroll approximately 120 participants in two cohorts. Cohort one is a frontline-extension cohort that will assess the efficacy and safety of adding tomivosertib to the treatment regimen in combination with pembrolizumab for patients who initially benefited from therapy and then developed radiographic progression on treatment with pembrolizumab alone. Cohort two will assess the safety and efficacy of tomivosertib in combination with pembrolizumab at treatment initiation in the frontline setting. Both cohorts in the trial will have a control arm with placebo in combination with pembrolizumab. The primary endpoint of the trial is progression free survival (PFS) in each the frontline-extension and frontline settings. In addition, PFS in the combined population from both cohorts, overall survival (OS) and overall response rate (ORR) will be assessed as secondary endpoints. Additional information about the trial can be found at www.clinicaltrials.gov under the identifier NCT04622007.

About Tomivosertib (eFT508)
Tomivosertib is eFFECTOR’s wholly-owned, highly selective translation regulation inhibitor that targets MNK1 and MNK2 (MNK1/2). The oral, small molecule drug candidate has been shown to enhance killing of tumor cells by T cells, delay T-cell exhaustion/dysfunction and enhance the T-cell central memory pool, in part by down-regulating multiple checkpoint proteins including PD-1, PD-L1, TIM-3 and LAG-3. Tomivosertib is being evaluated in KICKSTART, eFFECTOR’s randomized, double-blind, placebo-controlled Phase 2b study in NSCLC in combination with pembrolizumab. The KICKSTART trial builds on results obtained in an earlier study of tomivosertib as an extension of checkpoint inhibitor treatment in patients experiencing insufficient response to an FDA-approved checkpoint inhibitor alone.

Please visit www.clinicaltrials.gov for further information on ongoing clinical trials of tomivosertib.