Roche’s struggles with finding a foothold for its immune checkpoint inhibitor tiragolumab the cancer treatment space have been reinforced with the latest failure of the Phase III SKYSCRAPER-01 trial in lung cancer patients.
The Swiss company was evaluating tiragolumab with its blockbuster PD-L1 inhibitor Tecentriq (atezolizumab) in patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). Roche said the study “did not reach the primary endpoint of overall survival at the final analysis”, in a 26 November press release.
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Shares in Roche opened 0.55% lower at market open compared to a pre-announcement market close. The Swiss company has a market cap of $201.9bn.
SKYSCRAPER-01 (NCT04294810) is a randomised, double-blind study, which enrolled 534 patients. Roche compared tiragolumab in combination with Tecentriq to placebo plus Tecentriq. Patients were administered the drugs every three weeks until disease progression, loss of clinical benefit or unacceptable toxicity, as per the ClinicalTrials.gov entry.
Roche did not announce further details about the overall survival, though the company reported that the “overall safety profile observed remained consistent with longer follow-up”, adding that no new safety signals were identified.
Tiragolumab is an inhibitor of T cell immunoreceptor with immunoglobulin and ITIM domain (TIGIT), which is upregulated by immune cells, including activated T cells, natural killer cells, and regulatory T cells. Normally, TIGIT suppresses the immune response to cancer and is considered an immune checkpoint.
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By GlobalDataGSK and iTeos scored a win in this space in September, revealing positive Phase II data for its PD-1 inhibitor Jemperli (dostarlimab) and the investigational anti-TIGIT therapy belrestotug in NSCLC. The two companies began enrolment in a Phase III trial for the regimen in June.
Tiragolumab already came up short in terms of proving a statistically significant progression-free survival (PFS) benefit in SKYSCRAPER-01, as per data reported in 2022. The arm with patients who received the drug with Tecentriq reported a median PFS of 5.4 months compared to 4.8 months with Tecentriq alone.
This is not the first setback for Roche’s anti-TIGIT candidate. The drug also fell short on both PFS and OS endpoints in the SKYSCRAPER-02 (NCT04256421) trial in patients with extensive-stage small-cell lung cancer in 2022.
In July 2024, the Phase II/III SKYSCRAPER-06 (NCT04619797) failed to meet its primary endpoints. Roche was pitting the tiragolumab/Tecentriq combination against MSD’s Keytruda (pembrolizumab) plus chemotherapy in non-squamous NSCLC.
“Roche continuously reviews its study programmes to determine if any adjustments are necessary for the purposes of ongoing research. Roche will apply the same principles to this programme, with additional data from phase III studies across different settings or tumour types anticipated next year,” Roche said in a statement.
