The first patient was treated in the phase 2b KICKSTART trial testing the safety and efficacy of tomivosertib in combination with Keytruda.
The first patient was dosed in the phase 2b KICKSTART clinical trial from eFFECTOR Therapeutics, Inc. in early June. The randomized trial will treat patients who have non-small cell lung cancer (NSCLC) with a combination of tomivosertib and Keytruda (pembrolizumab).
“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,” said Steve Worland, president and CEO of eFFECTOR Therapeutics, Inc., in a release.
Further analysis of the phase 2a data revealed that PD-L1 positivity correlated with duration of benefit, Worland added. The data therefore supports the use of PD-L1 as a biomarker in KICKSTART.
The phase 2a results encouraged eFFECTOR to launch the trial in the frontline and frontline-extension settings for patients, to be treated with tomivosertib in combination with Keytruda.
“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,” Worland added.
Approximately 120 patients will be enrolled into two groups within the trial. The first group will be intended to assess the safety and efficacy of the treatment combination in the frontline-extension setting for patients who first benefited from therapy and developed radiographic progression when treated with Keytruda alone. The second group is intended to assess the safety and efficacy of the treatment combination in the frontline setting.
Tomivosertib is a highly selective translation regulation inhibitor that targets MNK1 and MNK2, according to the release.
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