SKYSCRAPER-02: Additional Tiragolumab Does Not Help Patients With Untreated SCLC


Tiragolumab, added to atezolizumab, carboplatin, and etoposide, did not improve the progression-free survival (PFS) or overall survival (OS) of patients with untreated extensive-stage small-cell lung cancer (SCLC), as was shown by the primary results of the phase 3 SKYSCRAPER-02 trial.

Tiragolumab is a human anti-TIGIT monoclonal antibody under investigation in several cancer settings, such as non-SCLC and oesophageal cancer. Dr. Charles Rudin (Memorial Sloan Kettering Cancer Center, NY, USA) aimed to assess the efficacy of tiragolumab in addition to the standard-of-care (atezolizumab plus carboplatin and etoposide) for patients with extensive-stage SCLC in the SKYSCRAPER-02 trial (NCT04256421) [1,2]. Patients were randomised 1:1 to additional tiragolumab (n=243) or placebo (n=247). PFS was the primary endpoint of the study.

The primary endpoint was not met in the primary analysis set, excluding patients with brain metastases at baseline (± 19%); the median PFS was comparable for patients who received tiragolumab or placebo (5.4 months vs 5.6 months; HR 1.11; P=0.35). Similarly, there was no difference in median OS between the 2 treatment groups (13.6 months vs 13.6 months; HR 1.04; P=0.80). The results did not change when patients with brain metastases were added to the analysis.

The addition of tiragolumab did not substantially change the safety profile of the treatment regimen. “This is important, since tiragolumab is being tested in several other settings as well,” explained Dr. Rudin. Pruritus was slightly elevated in the tiragolumab arm, a known side effect of this agent, according to Dr. Rudin.

“Based on the data of the SKYSCRAPER-02 trial, tiragolumab, or other TIGIT-targeting agents, do not appear to be relevant in patients with extensive-stage SCLC,” concluded Dr Rudin.

  1. Rudin CM, et al. SKYSCRAPER-02: Primary results of a phase III, randomized, double-blind, placebo-controlled study of atezolizumab (atezo) + carboplatin + etoposide (CE) with or without tiragolumab (tira) in patients (pts) with untreated extensive-stage small cell lung cancer (ES-SCLC). LBA8507, ASCO 2022 Annual Meeting, 3–7 June, Chicago, IL, USA.
  2. Horn L, et al. NEJM. 2018;379:2220‒2229.

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