GSK has announced that its anti-TIM-3 antibody cobolimab did not meet the primary endpoint in a phase 3 clinical trial for non-small cell lung cancer (NSCLC). The company shared the trial results in its second-quarter earnings report, which also outlined additional program discontinuations and a significant impairment charge related to another oncology asset.
Cobolimab, acquired through GSK’s $5.1 billion purchase of Tesaro in 2018, was being evaluated in combination with Jemperli and the chemotherapy agent docetaxel. The phase 3 study involved 750 patients with advanced NSCLC who had previously received immuno-oncology therapies. According to the company, the trial did not achieve its goal of improving overall survival.
“All regimens were well-tolerated and toxicities were consistent with known safety profiles of docetaxel and immune checkpoint inhibitors,” GSK stated in its July 30 earnings release. The company also noted that the treatment setting remains a difficult area where new combinations have yet to demonstrate improved patient outcomes.
Despite the outcome of the phase 3 trial, cobolimab is still under evaluation in other studies. GSK is continuing to assess the antibody in a phase 1/2 trial across various pediatric cancer indications, as well as in a mid-stage study for advanced liver cancer.
TIM-3 is present on immune effector cells and leukemic stem cells, functioning as an immune checkpoint. This has led multiple pharmaceutical companies to target it in attempts to simultaneously activate the immune system and control cancer cell proliferation.
Cobolimab had been the most advanced anti-TIM-3 antibody still in development after the failure of Novartis’ candidate in a late-stage study for myelodysplastic syndrome or leukemia earlier this year. While Novartis concentrated on blood cancers, GSK and other companies investigated TIM-3’s potential in solid tumors.
Several other companies have previously discontinued their TIM-3 programs. Roche removed a PD-1xTIM-3 bispecific antibody from its pipeline in 2022. Bristol Myers Squibb also ended a phase 1 trial of its TIM-3 candidate, BMS-986299, in the same year, citing a shift in business objectives. Eli Lilly and Incyte have similarly halted development of their TIM-3-related drugs. AstraZeneca continues work on a PD-1xTIM-3 bispecific, with a phase 1/2 study expected to complete this year.
In the same earnings release, GSK reported a £471 million ($629 million) impairment charge associated with the discontinuation of belrestotug, its anti-TIGIT antibody. GSK had initially paid iTeos $625 million upfront for rights to belrestotug four years ago. Following the drug’s failure in a phase 2 trial, iTeos began the process of winding down its operations before accepting a takeover offer from Concentra Biosciences earlier this month.
GSK also announced the discontinuation of two additional pipeline assets. The company has stopped development of a phase 2-stage adjuvanted recombinant protein malaria vaccine, GSK3437949. A company spokesperson linked this decision to GSK’s ongoing shift toward second-generation, multistage malaria vaccines.
In addition, the oral prodrug sanfetrinem cilexetil has been removed from the phase 2 pipeline. A spokesperson stated that the drug “has not compared favourably in early studies to existing treatments and other tuberculosis-specific assets also in development at GSK.”
