Roche, one of the world’s largest biotech companies, announced Wednesday that it had inadvertently disclosed information regarding research into a lung cancer therapy.
“The interim results for the primary endpoint of overall survival were not mature at the time of the second interim analysis,” said the 125-year-old Switzerland-based company in its announcement. Results of this interim analysis of the Phase III SKYSCRAPER-01 study were what was released, Roche explained.
Phase III SKYSCRAPER-01 is an ongoing study regarding an investigational T cell immunoglobulin and ITIM domain (TIGIT) immunotherapy treatment for people with programmed death-ligand 1 (PD-L1)-high locally advanced or metastatic non-small cell lung cancer. Therapies included in the study include tiragolumab and atezolizumab, the latter branded as Tecentriq.
PD-L1 is a regulatory molecule expressed in T cells that can dampen immune response “when bound to one of its complementary ligands,” per 2018 research.
According to the U.S. Food and Drug Administration, atezolizumab was approved “for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy,” in 2016. It is described as PD-L1 blocking antibody.
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Tiragolumab is “a novel immune checkpoint inhibitor with an intact Fc region,” per Roche. It works by binding to TIGIT receptors that inhibit the body’s immune response to certain cancers. Research indicates that this treatment is an immune amplifier when paired with other treatments such as Tecentriq.
“Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit or unacceptable toxicity,” said Roche of the Phase III SKYSCRAPER-01.
The second interim analysis for the study took place in February. It revealed tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified. Since the study is ongoing, Roche said it remains blinded to both the 534 patient participants and the investigators.
“We are continuing the study until the final analysis for overall survival,” said the company. “All other studies in the tiragolumab programme will continue as planned.”
According to a Reuters report, a Roche spokesperson said more solid survival results are due to be published in the first quarter of next year.
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