Over the past several years, a class of drugs called checkpoint inhibitors (primarily anti-PD-(L)1 therapies), have emerged as an important new therapeutic area modality for the treatment of cancer. While checkpoint inhibitor treatment is very effective for some patients for a variety of cancers, these agents are generally not curative – including for people with non-small cell lung cancer (NSCLC). The majority of patients ultimately progress on their checkpoint inhibitor therapy.
There are approximately 70,000 U.S. patients with metastatic NSCLC who have some degree of PD-L1 expression. Patients with high PD-L1 expression (≥ 50%), who have historically responded the best to pembrolizumab and other checkpoint inhibitors, are eligible to enroll in KICKSTART, a double-blind, randomized, placebo-controlled Phase 2b trial of tomivosertib combined with pembrolizumab in patients with metastatic NSCLC. Patients enrolled in KICKSTART will receive tomivosertib or placebo plus pembrolizumab as their frontline treatment.
We are also investigating our second product candidate, zotatifin, in KRAS-mutant NSCLC as a single agent in non-G12C patients and in combination with a G12C KRAS inhibitor for patients who are G12C-positive. Activating KRAS mutations occur in approximately 25% of patients with NSCLC, an area in which there is a significant need to improve treatment outcome.