The primary endpoint of overall survival was not met in the phase 3 SKYSCRAPER-01 study comparing tiragolumab plus Tecentriq (atezolizumab) with Tecentriq alone to treat PD-L1-high, locally advanced or metastatic non-small cell lung cancer.
The announcement was made in a press release from Genentech, the manufacturer of tiragolumab. Tiragolumab, according to the release, is an immune checkpoint inhibitor that selectively binds to TIGIT, a novel inhibitory immune checkpoint that may suppress the immune response to cancer.
Of note, when a primary endpoint is not met in a clinical trial, it means that the treatment that was tested did not meet the specific goal set by researchers for that trial.
“Genentech continuously reviews its study programs to determine if any adjustments are necessary for the purposes of ongoing research,” as noted in the release. “Genentech will apply the same principles to this program, with additional data from phase 3 studies across different settings or tumor types anticipated next year.”
Glossary:
PD-L1: a protein that serves as a brake to keep the body’s immune responses under control. There may be higher counts of this protein on some types of cancer cells.
Overall survival: the time when a patient with cancer is still alive.
Immune checkpoint inhibitor: a drug that blocks checkpoints, a type of protein created by immune system cells like T cells and some cancer cells. Blocking these checkpoints can help T cells improve their ability to kill cancer cells.
Progression-free survival: the time from treatment assignment to the first occurrence of disease progression or all-cause death.
Objective response rate: the percentage of patients who had a complete or partial response to treatment.
Duration of response: how long a patient’s disease responds to treatment, or the time period between when the cancer starts to shrink or disappear and when it starts to grow again.
In addition to the study not meeting its primary endpoint of overall survival, the overall safety profile of the treatment was consistent with that observed in longer follow-up with no new safety signals, as noted in the release.
Findings from this study will be presented at an oncology conference in 2025, Genentech mentioned.
SKYSCRAPER-01 Study
The SKYSCRAPER-01 included 534 patients with PD-L1-high, previously untreated, locally advanced unrespectable or metastatic non-small cell lung cancer, according to the release. The ClinicalTrials.gov listing for the study noted that the exact patient population included those with non-small cell lung cancer previously treated with two or more cycles of concurrent platinum-based chemoradiotherapy and did not experience radiographic disease progression.
Patients were randomly assigned to receive either tiragolumab plus Tecentriq or Tecentriq alone. According to the ClinicalTrials.gov listing, Tecentriq was given intravenously every four weeks, whereas tiragolumab was given intravenously on day 1 of each 28-day cycle. Treatment was administered until loss of clinical benefit, disease progression or unacceptable toxicity.
Roche, who partners with Genentech, shared preliminary findings from the SKYSCRAPER-01 study in August 2023. In particular, the overall survival estimates were 22.9 months for patients assigned tiragolumab plus Tecentriq compared with 16.7 months in those assigned Tecentriq monotherapy, which was not statistically significant.
According to the study’s ClinicalTrials.gov listing, researchers were focusing on other areas of interest including progression-free survival, objective response rate, duration of response and several quality-of-life measures.
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