Roche initiates a new Phase 3 clinical trial with tiragolumab (anti-TIGIT) in the resectable lung cancer (NSCLC) setting

On February 20th, 2024, Roche initiated Phase 3 SKYSCRAPER-15 trial (NCT06267001); tiragolumab (TIGIT) + atezolizumab (PD-L1) vs atezolizumab + placebo in patients with completely resected SIIB, IIIA, or select SIIIB, PD-L1+ NSCLC who have received adjuvant platinum-based chemo.

• New P3 SKYSCRAPER-15 (NCT06267001):
  • Target population: sq & nsq Stage IIB/IIIA, and select IIIB NSCLC with PD-L1 TPS≥1%
  • 1EP: DFS
  • 2EP: AEs, OS
  • Estimated enrolment: 1150
  • Study design:
    • Experimental Arm: atezolizumab + tiragolumab co-infused IV
    • Placebo Comparator: atezolizumab + placebo co-infused IV
  • Study start date: March 31, 2024
  • PCD: March 31, 2034

Implications:

• SKY-15 trial presents a moderate threat to STAR-131 trial investigating domvanalimab + zimberelimab + chemo vs. pembrolizumab + chemo in perioperative NSCLC patients
  • Although both trials are in the resectable setting, SKY-15 and STAR-131 address patient populations on different treatment algorithms (adjuvant vs. perioperative) and different PD-L1 expression levels (PD-L1+ vs. all comers)  
• The initiation of SKYSCRAPER-15 marks Roche’s expansion of the tiragolumab program into the resectable setting, highlighting continued confidence in the asset across NSCLC treatment settings and indicating that they believe that the adjuvant only setting is a meaningful patient population
  • This trial builds on Roche’s current presence in the resectable NSCLC setting, where atezo was the first approved adj. IO therapy (October 2021; based on P3 IMpower010).
  • SKY-15 will further demonstrate the rationale of adding TIGIT to IO regimens in NSCLC
• Data from the ongoing P2 SKYSCRAPER-05 trial (neoadj. and adj. tira + atezo ± chemo in unresectable SII, IIIA, or select SIIIB NSCLC) likely supports the initiation of this trial, although no data has been publicly presented.